PRP injections don’t top placebo for ankle osteoarthritis

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Tue, 10/26/2021 - 15:05

Platelet-rich plasma (PRP) injections did not significantly improve pain or function when compared with placebo injections in patients with ankle osteoarthritis (OA), a new study has found.

“Previous evidence for PRP injections in ankle osteoarthritis was limited to 4 small case series with methodological flaws,” wrote Liam D. A. Paget, MD, of the University of Amsterdam, and coauthors. The study was published online Oct. 26 in JAMA.

To assess the value of PRP injections as a treatment for ankle OA, the researchers launched a double-blind, randomized clinical trial of Dutch patients with notable ankle pain and tibiotalar joint space narrowing. From six sites in the Netherlands, 100 patients (45% women, mean age 56 years) were split into two groups: one that received two intra-articular injections of PRP 6 weeks apart (n = 48) and one that received two injections of saline placebo (n = 52).

At baseline, mean American Orthopaedic Foot and Ankle Society (AOFAS) scores were 63 in the PRP group and 64 in the placebo group (range 0-100, with higher scores indicating less pain and more function). At 26-week follow-up, the mean AOFAS score improved by 10 points in the PRP group (95% confidence interval, 6-14; P < .001) and by 11 points in the placebo group (95% CI, 7-15; P < .001). The adjusted between-group difference for AOFAS improvement over 26 weeks was –1 point (95% CI, –6 to 3; P = .56).

There was one serious adverse event in the placebo group – a transient ischemic attack 3 weeks after the first injection – but it was deemed unrelated.
 

Searching for answers regarding PRP and osteoarthritis

“From my standpoint, this study is a great step forward to where the field needs to be, which is honing in on longer-term studies that are standardizing PRP and teasing out its effects,” Prathap Jayaram, MD, director of regenerative sports medicine at the Baylor College of Medicine in Houston, said in an interview.

Dr. Prathap Jayaram

He highlighted the authors’ acknowledgment of previous studies in which PRP injections appeared effective in treating knee OA, including their statement that the “results reported here for ankle osteoarthritis were not consistent with these potentially beneficial effects in knee osteoarthritis.”

“They’re acknowledging that this does have some benefit in knees,” he said. “Could that translate toward the ankle?”

“PRP did lead to an improvement,” he added. “There just wasn’t a big enough difference to say one was superior to the other.”

Citing his team’s recent preclinical study that was published in Osteoarthritis and Cartilage, Dr. Jayaram emphasized the possibility that PRP could have much-needed disease-modifying effects in osteoarthritis. More work is needed to pin down the details.

“We need more mechanistic studies to be done so we can actually identify the therapeutic properties in PRP and leverage them to track reproducible outcomes,” he said, adding that “simply put, your blood and my blood might be different. There is going to be heterogeneity there. The analogy I give my patients is, when they take an antibiotic, we have a specific dose, a specific drug, and a specific duration. It’s very standardized. We’re just not there yet with PRP.”

The authors acknowledged their study’s limitations, including a likely inability to generalize their results to other platelet-rich blood products as well as a lack of composition analysis of the PRP they used. That said, they added that this particular PRP has been “analyzed previously” for another trial and noted that such analysis is not typically performed in a clinical setting.

The study was supported by a grant from the Dutch Arthritis Society. Its authors reported several potential conflicts of interest, including receiving their own grants from the Dutch Arthritis Society and other organizations, as well as accepting loaned Hettich centrifuges from a medical device company for the study.

A version of this article first appeared on Medscape.com.

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Platelet-rich plasma (PRP) injections did not significantly improve pain or function when compared with placebo injections in patients with ankle osteoarthritis (OA), a new study has found.

“Previous evidence for PRP injections in ankle osteoarthritis was limited to 4 small case series with methodological flaws,” wrote Liam D. A. Paget, MD, of the University of Amsterdam, and coauthors. The study was published online Oct. 26 in JAMA.

To assess the value of PRP injections as a treatment for ankle OA, the researchers launched a double-blind, randomized clinical trial of Dutch patients with notable ankle pain and tibiotalar joint space narrowing. From six sites in the Netherlands, 100 patients (45% women, mean age 56 years) were split into two groups: one that received two intra-articular injections of PRP 6 weeks apart (n = 48) and one that received two injections of saline placebo (n = 52).

At baseline, mean American Orthopaedic Foot and Ankle Society (AOFAS) scores were 63 in the PRP group and 64 in the placebo group (range 0-100, with higher scores indicating less pain and more function). At 26-week follow-up, the mean AOFAS score improved by 10 points in the PRP group (95% confidence interval, 6-14; P < .001) and by 11 points in the placebo group (95% CI, 7-15; P < .001). The adjusted between-group difference for AOFAS improvement over 26 weeks was –1 point (95% CI, –6 to 3; P = .56).

There was one serious adverse event in the placebo group – a transient ischemic attack 3 weeks after the first injection – but it was deemed unrelated.
 

Searching for answers regarding PRP and osteoarthritis

“From my standpoint, this study is a great step forward to where the field needs to be, which is honing in on longer-term studies that are standardizing PRP and teasing out its effects,” Prathap Jayaram, MD, director of regenerative sports medicine at the Baylor College of Medicine in Houston, said in an interview.

Dr. Prathap Jayaram

He highlighted the authors’ acknowledgment of previous studies in which PRP injections appeared effective in treating knee OA, including their statement that the “results reported here for ankle osteoarthritis were not consistent with these potentially beneficial effects in knee osteoarthritis.”

“They’re acknowledging that this does have some benefit in knees,” he said. “Could that translate toward the ankle?”

“PRP did lead to an improvement,” he added. “There just wasn’t a big enough difference to say one was superior to the other.”

Citing his team’s recent preclinical study that was published in Osteoarthritis and Cartilage, Dr. Jayaram emphasized the possibility that PRP could have much-needed disease-modifying effects in osteoarthritis. More work is needed to pin down the details.

“We need more mechanistic studies to be done so we can actually identify the therapeutic properties in PRP and leverage them to track reproducible outcomes,” he said, adding that “simply put, your blood and my blood might be different. There is going to be heterogeneity there. The analogy I give my patients is, when they take an antibiotic, we have a specific dose, a specific drug, and a specific duration. It’s very standardized. We’re just not there yet with PRP.”

The authors acknowledged their study’s limitations, including a likely inability to generalize their results to other platelet-rich blood products as well as a lack of composition analysis of the PRP they used. That said, they added that this particular PRP has been “analyzed previously” for another trial and noted that such analysis is not typically performed in a clinical setting.

The study was supported by a grant from the Dutch Arthritis Society. Its authors reported several potential conflicts of interest, including receiving their own grants from the Dutch Arthritis Society and other organizations, as well as accepting loaned Hettich centrifuges from a medical device company for the study.

A version of this article first appeared on Medscape.com.

Platelet-rich plasma (PRP) injections did not significantly improve pain or function when compared with placebo injections in patients with ankle osteoarthritis (OA), a new study has found.

“Previous evidence for PRP injections in ankle osteoarthritis was limited to 4 small case series with methodological flaws,” wrote Liam D. A. Paget, MD, of the University of Amsterdam, and coauthors. The study was published online Oct. 26 in JAMA.

To assess the value of PRP injections as a treatment for ankle OA, the researchers launched a double-blind, randomized clinical trial of Dutch patients with notable ankle pain and tibiotalar joint space narrowing. From six sites in the Netherlands, 100 patients (45% women, mean age 56 years) were split into two groups: one that received two intra-articular injections of PRP 6 weeks apart (n = 48) and one that received two injections of saline placebo (n = 52).

At baseline, mean American Orthopaedic Foot and Ankle Society (AOFAS) scores were 63 in the PRP group and 64 in the placebo group (range 0-100, with higher scores indicating less pain and more function). At 26-week follow-up, the mean AOFAS score improved by 10 points in the PRP group (95% confidence interval, 6-14; P < .001) and by 11 points in the placebo group (95% CI, 7-15; P < .001). The adjusted between-group difference for AOFAS improvement over 26 weeks was –1 point (95% CI, –6 to 3; P = .56).

There was one serious adverse event in the placebo group – a transient ischemic attack 3 weeks after the first injection – but it was deemed unrelated.
 

Searching for answers regarding PRP and osteoarthritis

“From my standpoint, this study is a great step forward to where the field needs to be, which is honing in on longer-term studies that are standardizing PRP and teasing out its effects,” Prathap Jayaram, MD, director of regenerative sports medicine at the Baylor College of Medicine in Houston, said in an interview.

Dr. Prathap Jayaram

He highlighted the authors’ acknowledgment of previous studies in which PRP injections appeared effective in treating knee OA, including their statement that the “results reported here for ankle osteoarthritis were not consistent with these potentially beneficial effects in knee osteoarthritis.”

“They’re acknowledging that this does have some benefit in knees,” he said. “Could that translate toward the ankle?”

“PRP did lead to an improvement,” he added. “There just wasn’t a big enough difference to say one was superior to the other.”

Citing his team’s recent preclinical study that was published in Osteoarthritis and Cartilage, Dr. Jayaram emphasized the possibility that PRP could have much-needed disease-modifying effects in osteoarthritis. More work is needed to pin down the details.

“We need more mechanistic studies to be done so we can actually identify the therapeutic properties in PRP and leverage them to track reproducible outcomes,” he said, adding that “simply put, your blood and my blood might be different. There is going to be heterogeneity there. The analogy I give my patients is, when they take an antibiotic, we have a specific dose, a specific drug, and a specific duration. It’s very standardized. We’re just not there yet with PRP.”

The authors acknowledged their study’s limitations, including a likely inability to generalize their results to other platelet-rich blood products as well as a lack of composition analysis of the PRP they used. That said, they added that this particular PRP has been “analyzed previously” for another trial and noted that such analysis is not typically performed in a clinical setting.

The study was supported by a grant from the Dutch Arthritis Society. Its authors reported several potential conflicts of interest, including receiving their own grants from the Dutch Arthritis Society and other organizations, as well as accepting loaned Hettich centrifuges from a medical device company for the study.

A version of this article first appeared on Medscape.com.

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Few JAK inhibitor users have diminished immune response to COVID-19 vaccines

Article Type
Changed
Tue, 02/07/2023 - 16:44

Patients who are being treated with Janus kinase (JAK) inhibitors overall show a high immune response rate to COVID-19 vaccination, one that matches the rates seen in patients on other immunosuppressants, a new study has found.

The patients taking a JAK inhibitor who are most at risk of a diminished response may be those on upadacitinib (Rinvoq) and anyone 65 years or older, wrote Raphaèle Seror, MD, PhD, of Paris-Saclay (France) University and coauthors. The study was published in The Lancet Rheumatology.

Dr. Alfred Kim

To gauge the effectiveness of COVID-19 vaccines in this subset of immunosuppressed patients, the researchers analyzed 113 participants in the MAJIK-SFR Registry, a multicenter study of French patients with rheumatoid or psoriatic arthritis. The participants were treated at 13 centers throughout France; their mean age was 61.8 years (standard deviation, 12.5), and 72% were female. A total of 56 were taking baricitinib (Olumiant), 30 were taking tofacitinib (Xeljanz), and 27 were taking upadacitinib.

Serologic assessment was performed an average of 8.7 weeks (SD, 5.2) after the last dose of vaccine. The overall response rate – defined as the proportion of patients with detectable anti-spike antibodies per manufacturer’s cutoff values – was 88% (100 of 113). The nonresponse rate was higher with upadacitinib (7 of 27 patients, 26%) than with baricitinib (5 of 56, 9%) or tofacitinib (1 of 30, 3%). The only nonresponders who were not age 65 or older were four of the seven who received upadacitinib. The interval between the last vaccine dose and serologic assessment was somewhat longer in nonresponders (11.3 weeks) than in responders (8.3 weeks).



Earlier this year, the American College of Rheumatology recommended withholding JAK inhibitors for 1 week after each vaccine dose because of “concern related to the effects of this medication class on interferon signaling that may result in a diminished vaccine response Only two patients in the study had treatment with JAK inhibitors stopped before or after vaccination.

Questions about antibody levels remain difficult to answer

“This study does further confirm a big point,” said Alfred Kim, MD, PhD, of Washington University, St. Louis, in an interview. “Most people on any sort of immunosuppression, with rare exceptions, can mount responses to COVID-19 vaccination.”

“What level of response is going to be sufficient, of course, is not clear,” he added. “Even though most people generate responses, at the population level those responses seem lower than those in nonimmunosuppressed people. Particularly for those on upadacitinib, which is lower than patients on the other JAK inhibitors. Is that problematic? We don’t know yet.”

Dr. Kim, who was part of a separate, earlier study that assessed vaccine response in patients with chronic inflammatory disease who were being treated with immunosuppressive medications, noted that many of the questions patients are asking about their antibody levels cannot yet be answered.

“It’s kind of the Wild West of serologic testing out there right now,” he said. “Even though we’re recommending that people still don’t check their antibody levels because their results are largely inactionable, everyone is still getting them anyway. But each of these tests are slightly different, and the results and the interpretation are further clouded because of those slight performance differences between each platform.”



Dr. Kim highlighted the number of different tests as one of this study’s notable limitations: 11 different assays were used to determine patients’ immune responses. “The authors made the argument that these tests are FDA approved, and that’s true, but that doesn’t necessarily mean much. Approval does translate to technical reliability but not to comparisons between the tests.”

As for next steps, both the authors and Dr. Kim recognized the need for a prospective trial. “To do a vaccine effectiveness–type study and show clinical protection against either infection or hospitalization – those are going to take a while, simply because of the nature of how many people you need for each of these studies,” he said. “Time will tell whether or not the data that are being presented here will translate literally into protective outcomes downstream.”

The MAJIK Registry is supported by the French Rheumatology Society. The authors acknowledged numerous potential conflicts of interest, including receiving consulting fees, research support, and honoraria from various pharmaceutical companies.

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Patients who are being treated with Janus kinase (JAK) inhibitors overall show a high immune response rate to COVID-19 vaccination, one that matches the rates seen in patients on other immunosuppressants, a new study has found.

The patients taking a JAK inhibitor who are most at risk of a diminished response may be those on upadacitinib (Rinvoq) and anyone 65 years or older, wrote Raphaèle Seror, MD, PhD, of Paris-Saclay (France) University and coauthors. The study was published in The Lancet Rheumatology.

Dr. Alfred Kim

To gauge the effectiveness of COVID-19 vaccines in this subset of immunosuppressed patients, the researchers analyzed 113 participants in the MAJIK-SFR Registry, a multicenter study of French patients with rheumatoid or psoriatic arthritis. The participants were treated at 13 centers throughout France; their mean age was 61.8 years (standard deviation, 12.5), and 72% were female. A total of 56 were taking baricitinib (Olumiant), 30 were taking tofacitinib (Xeljanz), and 27 were taking upadacitinib.

Serologic assessment was performed an average of 8.7 weeks (SD, 5.2) after the last dose of vaccine. The overall response rate – defined as the proportion of patients with detectable anti-spike antibodies per manufacturer’s cutoff values – was 88% (100 of 113). The nonresponse rate was higher with upadacitinib (7 of 27 patients, 26%) than with baricitinib (5 of 56, 9%) or tofacitinib (1 of 30, 3%). The only nonresponders who were not age 65 or older were four of the seven who received upadacitinib. The interval between the last vaccine dose and serologic assessment was somewhat longer in nonresponders (11.3 weeks) than in responders (8.3 weeks).



Earlier this year, the American College of Rheumatology recommended withholding JAK inhibitors for 1 week after each vaccine dose because of “concern related to the effects of this medication class on interferon signaling that may result in a diminished vaccine response Only two patients in the study had treatment with JAK inhibitors stopped before or after vaccination.

Questions about antibody levels remain difficult to answer

“This study does further confirm a big point,” said Alfred Kim, MD, PhD, of Washington University, St. Louis, in an interview. “Most people on any sort of immunosuppression, with rare exceptions, can mount responses to COVID-19 vaccination.”

“What level of response is going to be sufficient, of course, is not clear,” he added. “Even though most people generate responses, at the population level those responses seem lower than those in nonimmunosuppressed people. Particularly for those on upadacitinib, which is lower than patients on the other JAK inhibitors. Is that problematic? We don’t know yet.”

Dr. Kim, who was part of a separate, earlier study that assessed vaccine response in patients with chronic inflammatory disease who were being treated with immunosuppressive medications, noted that many of the questions patients are asking about their antibody levels cannot yet be answered.

“It’s kind of the Wild West of serologic testing out there right now,” he said. “Even though we’re recommending that people still don’t check their antibody levels because their results are largely inactionable, everyone is still getting them anyway. But each of these tests are slightly different, and the results and the interpretation are further clouded because of those slight performance differences between each platform.”



Dr. Kim highlighted the number of different tests as one of this study’s notable limitations: 11 different assays were used to determine patients’ immune responses. “The authors made the argument that these tests are FDA approved, and that’s true, but that doesn’t necessarily mean much. Approval does translate to technical reliability but not to comparisons between the tests.”

As for next steps, both the authors and Dr. Kim recognized the need for a prospective trial. “To do a vaccine effectiveness–type study and show clinical protection against either infection or hospitalization – those are going to take a while, simply because of the nature of how many people you need for each of these studies,” he said. “Time will tell whether or not the data that are being presented here will translate literally into protective outcomes downstream.”

The MAJIK Registry is supported by the French Rheumatology Society. The authors acknowledged numerous potential conflicts of interest, including receiving consulting fees, research support, and honoraria from various pharmaceutical companies.

Patients who are being treated with Janus kinase (JAK) inhibitors overall show a high immune response rate to COVID-19 vaccination, one that matches the rates seen in patients on other immunosuppressants, a new study has found.

The patients taking a JAK inhibitor who are most at risk of a diminished response may be those on upadacitinib (Rinvoq) and anyone 65 years or older, wrote Raphaèle Seror, MD, PhD, of Paris-Saclay (France) University and coauthors. The study was published in The Lancet Rheumatology.

Dr. Alfred Kim

To gauge the effectiveness of COVID-19 vaccines in this subset of immunosuppressed patients, the researchers analyzed 113 participants in the MAJIK-SFR Registry, a multicenter study of French patients with rheumatoid or psoriatic arthritis. The participants were treated at 13 centers throughout France; their mean age was 61.8 years (standard deviation, 12.5), and 72% were female. A total of 56 were taking baricitinib (Olumiant), 30 were taking tofacitinib (Xeljanz), and 27 were taking upadacitinib.

Serologic assessment was performed an average of 8.7 weeks (SD, 5.2) after the last dose of vaccine. The overall response rate – defined as the proportion of patients with detectable anti-spike antibodies per manufacturer’s cutoff values – was 88% (100 of 113). The nonresponse rate was higher with upadacitinib (7 of 27 patients, 26%) than with baricitinib (5 of 56, 9%) or tofacitinib (1 of 30, 3%). The only nonresponders who were not age 65 or older were four of the seven who received upadacitinib. The interval between the last vaccine dose and serologic assessment was somewhat longer in nonresponders (11.3 weeks) than in responders (8.3 weeks).



Earlier this year, the American College of Rheumatology recommended withholding JAK inhibitors for 1 week after each vaccine dose because of “concern related to the effects of this medication class on interferon signaling that may result in a diminished vaccine response Only two patients in the study had treatment with JAK inhibitors stopped before or after vaccination.

Questions about antibody levels remain difficult to answer

“This study does further confirm a big point,” said Alfred Kim, MD, PhD, of Washington University, St. Louis, in an interview. “Most people on any sort of immunosuppression, with rare exceptions, can mount responses to COVID-19 vaccination.”

“What level of response is going to be sufficient, of course, is not clear,” he added. “Even though most people generate responses, at the population level those responses seem lower than those in nonimmunosuppressed people. Particularly for those on upadacitinib, which is lower than patients on the other JAK inhibitors. Is that problematic? We don’t know yet.”

Dr. Kim, who was part of a separate, earlier study that assessed vaccine response in patients with chronic inflammatory disease who were being treated with immunosuppressive medications, noted that many of the questions patients are asking about their antibody levels cannot yet be answered.

“It’s kind of the Wild West of serologic testing out there right now,” he said. “Even though we’re recommending that people still don’t check their antibody levels because their results are largely inactionable, everyone is still getting them anyway. But each of these tests are slightly different, and the results and the interpretation are further clouded because of those slight performance differences between each platform.”



Dr. Kim highlighted the number of different tests as one of this study’s notable limitations: 11 different assays were used to determine patients’ immune responses. “The authors made the argument that these tests are FDA approved, and that’s true, but that doesn’t necessarily mean much. Approval does translate to technical reliability but not to comparisons between the tests.”

As for next steps, both the authors and Dr. Kim recognized the need for a prospective trial. “To do a vaccine effectiveness–type study and show clinical protection against either infection or hospitalization – those are going to take a while, simply because of the nature of how many people you need for each of these studies,” he said. “Time will tell whether or not the data that are being presented here will translate literally into protective outcomes downstream.”

The MAJIK Registry is supported by the French Rheumatology Society. The authors acknowledged numerous potential conflicts of interest, including receiving consulting fees, research support, and honoraria from various pharmaceutical companies.

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Study of biologics’ impact on psoriasis-to-PsA transition contradicts previous findings

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Tue, 02/07/2023 - 16:44

Data source likely contributes biases

A new study has found that patients with psoriasis who were treated with biologics were more likely to develop psoriatic arthritis (PsA) than those treated with phototherapy, oral therapy, or no therapy at all, although the authors cautioned readers to consider potential biases when reviewing their findings.

“We do not suggest that these results should be interpreted causally; in other words, biologics likely do not cause PsA,” Elana Meer of the University of Pennsylvania, Philadelphia, and coauthors wrote. The study was published in Annals of the Rheumatic Diseases.

Three studies in dermatology clinic-based populations published this past summer – one from Italy, one from Argentina, and one from Israel – suggested that biologics can decrease a psoriasis patient’s risk of developing PsA. To further assess the impact of treatment with biologics, Ms. Meer and associates retrospectively examined the health records of thousands of patients with psoriasis between the ages of 16 and 90 who were initiating therapy. All told, data from 193,709 patients with psoriasis and without PsA who were treated between 2006 and 2017 were gathered from the OptumInsights Electronic Health Record Database.



A total of 14,569 patients from that cohort initiated biologic therapy while 20,321 patients initiated either oral therapy or phototherapy. The mean age in the biologics group was 45.9 years, compared with 49.8 years in the oral and phototherapy group.

The incidence of PsA across all patients was 9.75 cases per 1,000 person-years, compared with 77.26 among the biologic group, 61.99 among the oral therapy group, 26.11 among the phototherapy group, and 5.85 among those who did not receive therapy. After a multivariable adjustment in which biologics were a time-varying exposure, receiving biologics was associated with a higher incidence of PsA (hazard ratio, 4.48; 95% confidence interval, 4.23-4.75). In a model where time starts at the first use of biologics, the incidence was lower – but still notable – after multivariable adjustment (HR, 2.14; 95% CI, 2.00-2.28) and propensity score matching (HR, 2.17; 95% CI, 2.03-2.33).

Bias likely plays a large role in retrospective PsA study

“We’ve been struggling for the last several years to find a database that allows us to really address this question retrospectively,” study coauthor Christopher T. Ritchlin, MD, of the University of Rochester (N.Y.), said in an interview. “It looks like the model you use for a retrospective analysis heavily influences what you come out with.”

Dr. Christopher T. Ritchlin

He described the potential biases they identified, including the possibility of protopathic bias indicating that patients being treated with biologics who then report joint pain have developed PsA – and are coded accordingly after visiting a rheumatologist.

“This has convinced us that you have to do a prospective study,” he said. “We’ve known that there were flaws with previous studies in this area. We tried to overcome them with our methodology, but there’s no way you can overcome a coding issue when you’re looking at such a large database.”

He noted another likely bias: The patients who are more likely to develop PsA are the ones with severe psoriasis, and they are also the patients most likely to be prescribed biologics.

Courtesy Dr. Joel M. Gelfand
Dr. Joel M. Gelfand

“In my clinical experience, I have seen many patients develop psoriatic arthritis while on biologics for their psoriasis,” coauthor Joel M. Gelfand, MD, of the University of Pennsylvania, added in an interview. “Currently, we do not have adequate data to recommend treating psoriasis with a particular modality in order to prevent psoriatic arthritis. This question, however, is very important to patients and clinicians and ultimately is best answered with a large-scale pragmatic trial.”

Dr. Ritchlin reported that a prospective study in which “patients with psoriasis who do not have arthritis but do have certain risk factors and abnormal findings on musculoskeletal ultrasounds” will be treated with either biologic agents or placebo is about to begin, with a goal of “either attenuating or preventing the onset of PsA.”



The authors recognized their study’s additional limitations, including electronic health records being used as the primary data source and the possibility that medications were prescribed but never filled. That said, they did attempt to address the latter by using two prescriptions for a given therapy as the primary analysis, “suggesting a refill was initiated.”

The authors said that no commercial entities provided support for the study. Two of the authors acknowledged receiving funding from the National Psoriasis Foundation, and several authors declared potential conflicts of interests that included consulting and receiving honoraria from various pharmaceutical companies.

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Data source likely contributes biases

Data source likely contributes biases

A new study has found that patients with psoriasis who were treated with biologics were more likely to develop psoriatic arthritis (PsA) than those treated with phototherapy, oral therapy, or no therapy at all, although the authors cautioned readers to consider potential biases when reviewing their findings.

“We do not suggest that these results should be interpreted causally; in other words, biologics likely do not cause PsA,” Elana Meer of the University of Pennsylvania, Philadelphia, and coauthors wrote. The study was published in Annals of the Rheumatic Diseases.

Three studies in dermatology clinic-based populations published this past summer – one from Italy, one from Argentina, and one from Israel – suggested that biologics can decrease a psoriasis patient’s risk of developing PsA. To further assess the impact of treatment with biologics, Ms. Meer and associates retrospectively examined the health records of thousands of patients with psoriasis between the ages of 16 and 90 who were initiating therapy. All told, data from 193,709 patients with psoriasis and without PsA who were treated between 2006 and 2017 were gathered from the OptumInsights Electronic Health Record Database.



A total of 14,569 patients from that cohort initiated biologic therapy while 20,321 patients initiated either oral therapy or phototherapy. The mean age in the biologics group was 45.9 years, compared with 49.8 years in the oral and phototherapy group.

The incidence of PsA across all patients was 9.75 cases per 1,000 person-years, compared with 77.26 among the biologic group, 61.99 among the oral therapy group, 26.11 among the phototherapy group, and 5.85 among those who did not receive therapy. After a multivariable adjustment in which biologics were a time-varying exposure, receiving biologics was associated with a higher incidence of PsA (hazard ratio, 4.48; 95% confidence interval, 4.23-4.75). In a model where time starts at the first use of biologics, the incidence was lower – but still notable – after multivariable adjustment (HR, 2.14; 95% CI, 2.00-2.28) and propensity score matching (HR, 2.17; 95% CI, 2.03-2.33).

Bias likely plays a large role in retrospective PsA study

“We’ve been struggling for the last several years to find a database that allows us to really address this question retrospectively,” study coauthor Christopher T. Ritchlin, MD, of the University of Rochester (N.Y.), said in an interview. “It looks like the model you use for a retrospective analysis heavily influences what you come out with.”

Dr. Christopher T. Ritchlin

He described the potential biases they identified, including the possibility of protopathic bias indicating that patients being treated with biologics who then report joint pain have developed PsA – and are coded accordingly after visiting a rheumatologist.

“This has convinced us that you have to do a prospective study,” he said. “We’ve known that there were flaws with previous studies in this area. We tried to overcome them with our methodology, but there’s no way you can overcome a coding issue when you’re looking at such a large database.”

He noted another likely bias: The patients who are more likely to develop PsA are the ones with severe psoriasis, and they are also the patients most likely to be prescribed biologics.

Courtesy Dr. Joel M. Gelfand
Dr. Joel M. Gelfand

“In my clinical experience, I have seen many patients develop psoriatic arthritis while on biologics for their psoriasis,” coauthor Joel M. Gelfand, MD, of the University of Pennsylvania, added in an interview. “Currently, we do not have adequate data to recommend treating psoriasis with a particular modality in order to prevent psoriatic arthritis. This question, however, is very important to patients and clinicians and ultimately is best answered with a large-scale pragmatic trial.”

Dr. Ritchlin reported that a prospective study in which “patients with psoriasis who do not have arthritis but do have certain risk factors and abnormal findings on musculoskeletal ultrasounds” will be treated with either biologic agents or placebo is about to begin, with a goal of “either attenuating or preventing the onset of PsA.”



The authors recognized their study’s additional limitations, including electronic health records being used as the primary data source and the possibility that medications were prescribed but never filled. That said, they did attempt to address the latter by using two prescriptions for a given therapy as the primary analysis, “suggesting a refill was initiated.”

The authors said that no commercial entities provided support for the study. Two of the authors acknowledged receiving funding from the National Psoriasis Foundation, and several authors declared potential conflicts of interests that included consulting and receiving honoraria from various pharmaceutical companies.

A new study has found that patients with psoriasis who were treated with biologics were more likely to develop psoriatic arthritis (PsA) than those treated with phototherapy, oral therapy, or no therapy at all, although the authors cautioned readers to consider potential biases when reviewing their findings.

“We do not suggest that these results should be interpreted causally; in other words, biologics likely do not cause PsA,” Elana Meer of the University of Pennsylvania, Philadelphia, and coauthors wrote. The study was published in Annals of the Rheumatic Diseases.

Three studies in dermatology clinic-based populations published this past summer – one from Italy, one from Argentina, and one from Israel – suggested that biologics can decrease a psoriasis patient’s risk of developing PsA. To further assess the impact of treatment with biologics, Ms. Meer and associates retrospectively examined the health records of thousands of patients with psoriasis between the ages of 16 and 90 who were initiating therapy. All told, data from 193,709 patients with psoriasis and without PsA who were treated between 2006 and 2017 were gathered from the OptumInsights Electronic Health Record Database.



A total of 14,569 patients from that cohort initiated biologic therapy while 20,321 patients initiated either oral therapy or phototherapy. The mean age in the biologics group was 45.9 years, compared with 49.8 years in the oral and phototherapy group.

The incidence of PsA across all patients was 9.75 cases per 1,000 person-years, compared with 77.26 among the biologic group, 61.99 among the oral therapy group, 26.11 among the phototherapy group, and 5.85 among those who did not receive therapy. After a multivariable adjustment in which biologics were a time-varying exposure, receiving biologics was associated with a higher incidence of PsA (hazard ratio, 4.48; 95% confidence interval, 4.23-4.75). In a model where time starts at the first use of biologics, the incidence was lower – but still notable – after multivariable adjustment (HR, 2.14; 95% CI, 2.00-2.28) and propensity score matching (HR, 2.17; 95% CI, 2.03-2.33).

Bias likely plays a large role in retrospective PsA study

“We’ve been struggling for the last several years to find a database that allows us to really address this question retrospectively,” study coauthor Christopher T. Ritchlin, MD, of the University of Rochester (N.Y.), said in an interview. “It looks like the model you use for a retrospective analysis heavily influences what you come out with.”

Dr. Christopher T. Ritchlin

He described the potential biases they identified, including the possibility of protopathic bias indicating that patients being treated with biologics who then report joint pain have developed PsA – and are coded accordingly after visiting a rheumatologist.

“This has convinced us that you have to do a prospective study,” he said. “We’ve known that there were flaws with previous studies in this area. We tried to overcome them with our methodology, but there’s no way you can overcome a coding issue when you’re looking at such a large database.”

He noted another likely bias: The patients who are more likely to develop PsA are the ones with severe psoriasis, and they are also the patients most likely to be prescribed biologics.

Courtesy Dr. Joel M. Gelfand
Dr. Joel M. Gelfand

“In my clinical experience, I have seen many patients develop psoriatic arthritis while on biologics for their psoriasis,” coauthor Joel M. Gelfand, MD, of the University of Pennsylvania, added in an interview. “Currently, we do not have adequate data to recommend treating psoriasis with a particular modality in order to prevent psoriatic arthritis. This question, however, is very important to patients and clinicians and ultimately is best answered with a large-scale pragmatic trial.”

Dr. Ritchlin reported that a prospective study in which “patients with psoriasis who do not have arthritis but do have certain risk factors and abnormal findings on musculoskeletal ultrasounds” will be treated with either biologic agents or placebo is about to begin, with a goal of “either attenuating or preventing the onset of PsA.”



The authors recognized their study’s additional limitations, including electronic health records being used as the primary data source and the possibility that medications were prescribed but never filled. That said, they did attempt to address the latter by using two prescriptions for a given therapy as the primary analysis, “suggesting a refill was initiated.”

The authors said that no commercial entities provided support for the study. Two of the authors acknowledged receiving funding from the National Psoriasis Foundation, and several authors declared potential conflicts of interests that included consulting and receiving honoraria from various pharmaceutical companies.

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Assessing headache severity via migraine symptoms can help predict outcomes

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Thu, 12/15/2022 - 15:40

A headache severity score compiled by assessing various migraine symptoms can help predict the likelihood of doctor visits and missed work or school, according to an analysis of data from thousands of headache sufferers who recorded variables like pain and duration in a daily digital diary.

“Our hope is that this work serves as foundational basis for better understanding the complexity of headache as a symptom-based condition,” James S. McGinley, PhD, of Vector Psychometric Group in Chapel Hill, N.C., and coauthors wrote. The study was published in Cephalalgia.

To evaluate whether keeping track of daily headache features can produce a useful, predictive score, the researchers reviewed data from migraine patients that were collected via N1‑Headache, a commercial digital health platform. Ultimately, information from 4,380 adults with a self-reported migraine diagnosis was analyzed; the sample was 90% female and their mean age was 37 years. Study participants reported an average of 33 headaches per month over the last 3 months. Nine patient-reported variables were initially considered in calculating the Headache Day Severity (HDS) score: pain intensity, headache duration, aura, pulsating/throbbing pain, unilateral pain, pain aggravation by activity, nausea/vomiting, photophobia, and phonophobia.

After determining that unilateral pain was not a meaningful variable, the researchers’ model found that, for every 1 standard deviation increase in HDS, the patient’s odds of physician visit increased by 71% (odds ratio, 1.71; 95% confidence interval, 1.32-2.21) and the odds of an ED visit increased by 342% (OR, 4.42; 95% CI, 2.23-7.60). They also found that the likelihood of missed work or school increased by 190% (OR, 2.90; 95% CI, 2.56-3.29), the chances of missing household work increased by 237% (OR, 3.37; 95% CI, 3.06-3.72) and the odds of missing other leisure or social activity increased by 228% (OR, 3.28; 95% CI, 2.97-3.64).
 

Tracking multiple variables

“We encourage all of our patients to monitor their headaches; there are just too many variables to try to keep it in your head,” Robert Cowan, MD, professor of neurology and chief of the division of headache medicine at Stanford (Calif.) University, said in an interview. He referenced a previous study from the University of Washington where patients were asked to track their headaches; that data was then compared against their self-reported headaches at a quarterly physician visit.

Dr. Robert Cowan

“What they found was there was absolutely no correlation with reported frequency of headache at the visit and what was seen in the tracker,” he said. “If patients had a headache in the previous 3 days before their visit, they felt that their headaches were poorly controlled. If they hadn’t, they thought their headaches were under good control. So the value of tracking is pretty clear.”

He added that, while not every headache sufferer needs to track their daily routines and symptoms, once those symptoms interfere with your life on a day-to-day basis, it’s probably time to consider keeping tabs on yourself with a tool of some sort. And while this study’s calculated HDS score supports the idea of migraine’s complexity, it also leaves unanswered the question of how to treat patients with severe symptoms.

“Frequently,” he said, “we’ll see patients who say: ‘I can deal with the pain, but the nausea makes it impossible to work, or the light sensitivity makes it impossible to go outside.’ The big question within the headache community is, can you treat migraine and have it address the whole spectrum, from dizziness to light sensitivity to sound sensitivity to vertigo, or should you be going after individual symptoms? That’s a controversy that rages on; I think most of us go for a combination. We’re in a polypharmacy phase: ‘If nausea is a big problem, take this, but we also try to prevent the whole migraine complex, so take this as well.’ ”

The authors acknowledged their study’s limitations, including the inability to determine how many participants’ migraines were formally diagnosed by a trained medical professional and the lack of generalizability of data from a convenience sample, though they added that patients who independently track their own headaches “may be representative of those who would participate in a clinical trial.” In addition, as seven of the nine features were collected in N1‑Headache on a yes/no scale, they recognized that “increasing the number of response options for each item may improve our ability to measure HDS.”

The study was funded by Amgen through the Competitive Grant Program in Migraine Research. The authors declared several potential conflicts of interest, including receiving funding, research support, salary, and honoraria from various pharmaceutical companies.

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A headache severity score compiled by assessing various migraine symptoms can help predict the likelihood of doctor visits and missed work or school, according to an analysis of data from thousands of headache sufferers who recorded variables like pain and duration in a daily digital diary.

“Our hope is that this work serves as foundational basis for better understanding the complexity of headache as a symptom-based condition,” James S. McGinley, PhD, of Vector Psychometric Group in Chapel Hill, N.C., and coauthors wrote. The study was published in Cephalalgia.

To evaluate whether keeping track of daily headache features can produce a useful, predictive score, the researchers reviewed data from migraine patients that were collected via N1‑Headache, a commercial digital health platform. Ultimately, information from 4,380 adults with a self-reported migraine diagnosis was analyzed; the sample was 90% female and their mean age was 37 years. Study participants reported an average of 33 headaches per month over the last 3 months. Nine patient-reported variables were initially considered in calculating the Headache Day Severity (HDS) score: pain intensity, headache duration, aura, pulsating/throbbing pain, unilateral pain, pain aggravation by activity, nausea/vomiting, photophobia, and phonophobia.

After determining that unilateral pain was not a meaningful variable, the researchers’ model found that, for every 1 standard deviation increase in HDS, the patient’s odds of physician visit increased by 71% (odds ratio, 1.71; 95% confidence interval, 1.32-2.21) and the odds of an ED visit increased by 342% (OR, 4.42; 95% CI, 2.23-7.60). They also found that the likelihood of missed work or school increased by 190% (OR, 2.90; 95% CI, 2.56-3.29), the chances of missing household work increased by 237% (OR, 3.37; 95% CI, 3.06-3.72) and the odds of missing other leisure or social activity increased by 228% (OR, 3.28; 95% CI, 2.97-3.64).
 

Tracking multiple variables

“We encourage all of our patients to monitor their headaches; there are just too many variables to try to keep it in your head,” Robert Cowan, MD, professor of neurology and chief of the division of headache medicine at Stanford (Calif.) University, said in an interview. He referenced a previous study from the University of Washington where patients were asked to track their headaches; that data was then compared against their self-reported headaches at a quarterly physician visit.

Dr. Robert Cowan

“What they found was there was absolutely no correlation with reported frequency of headache at the visit and what was seen in the tracker,” he said. “If patients had a headache in the previous 3 days before their visit, they felt that their headaches were poorly controlled. If they hadn’t, they thought their headaches were under good control. So the value of tracking is pretty clear.”

He added that, while not every headache sufferer needs to track their daily routines and symptoms, once those symptoms interfere with your life on a day-to-day basis, it’s probably time to consider keeping tabs on yourself with a tool of some sort. And while this study’s calculated HDS score supports the idea of migraine’s complexity, it also leaves unanswered the question of how to treat patients with severe symptoms.

“Frequently,” he said, “we’ll see patients who say: ‘I can deal with the pain, but the nausea makes it impossible to work, or the light sensitivity makes it impossible to go outside.’ The big question within the headache community is, can you treat migraine and have it address the whole spectrum, from dizziness to light sensitivity to sound sensitivity to vertigo, or should you be going after individual symptoms? That’s a controversy that rages on; I think most of us go for a combination. We’re in a polypharmacy phase: ‘If nausea is a big problem, take this, but we also try to prevent the whole migraine complex, so take this as well.’ ”

The authors acknowledged their study’s limitations, including the inability to determine how many participants’ migraines were formally diagnosed by a trained medical professional and the lack of generalizability of data from a convenience sample, though they added that patients who independently track their own headaches “may be representative of those who would participate in a clinical trial.” In addition, as seven of the nine features were collected in N1‑Headache on a yes/no scale, they recognized that “increasing the number of response options for each item may improve our ability to measure HDS.”

The study was funded by Amgen through the Competitive Grant Program in Migraine Research. The authors declared several potential conflicts of interest, including receiving funding, research support, salary, and honoraria from various pharmaceutical companies.

A headache severity score compiled by assessing various migraine symptoms can help predict the likelihood of doctor visits and missed work or school, according to an analysis of data from thousands of headache sufferers who recorded variables like pain and duration in a daily digital diary.

“Our hope is that this work serves as foundational basis for better understanding the complexity of headache as a symptom-based condition,” James S. McGinley, PhD, of Vector Psychometric Group in Chapel Hill, N.C., and coauthors wrote. The study was published in Cephalalgia.

To evaluate whether keeping track of daily headache features can produce a useful, predictive score, the researchers reviewed data from migraine patients that were collected via N1‑Headache, a commercial digital health platform. Ultimately, information from 4,380 adults with a self-reported migraine diagnosis was analyzed; the sample was 90% female and their mean age was 37 years. Study participants reported an average of 33 headaches per month over the last 3 months. Nine patient-reported variables were initially considered in calculating the Headache Day Severity (HDS) score: pain intensity, headache duration, aura, pulsating/throbbing pain, unilateral pain, pain aggravation by activity, nausea/vomiting, photophobia, and phonophobia.

After determining that unilateral pain was not a meaningful variable, the researchers’ model found that, for every 1 standard deviation increase in HDS, the patient’s odds of physician visit increased by 71% (odds ratio, 1.71; 95% confidence interval, 1.32-2.21) and the odds of an ED visit increased by 342% (OR, 4.42; 95% CI, 2.23-7.60). They also found that the likelihood of missed work or school increased by 190% (OR, 2.90; 95% CI, 2.56-3.29), the chances of missing household work increased by 237% (OR, 3.37; 95% CI, 3.06-3.72) and the odds of missing other leisure or social activity increased by 228% (OR, 3.28; 95% CI, 2.97-3.64).
 

Tracking multiple variables

“We encourage all of our patients to monitor their headaches; there are just too many variables to try to keep it in your head,” Robert Cowan, MD, professor of neurology and chief of the division of headache medicine at Stanford (Calif.) University, said in an interview. He referenced a previous study from the University of Washington where patients were asked to track their headaches; that data was then compared against their self-reported headaches at a quarterly physician visit.

Dr. Robert Cowan

“What they found was there was absolutely no correlation with reported frequency of headache at the visit and what was seen in the tracker,” he said. “If patients had a headache in the previous 3 days before their visit, they felt that their headaches were poorly controlled. If they hadn’t, they thought their headaches were under good control. So the value of tracking is pretty clear.”

He added that, while not every headache sufferer needs to track their daily routines and symptoms, once those symptoms interfere with your life on a day-to-day basis, it’s probably time to consider keeping tabs on yourself with a tool of some sort. And while this study’s calculated HDS score supports the idea of migraine’s complexity, it also leaves unanswered the question of how to treat patients with severe symptoms.

“Frequently,” he said, “we’ll see patients who say: ‘I can deal with the pain, but the nausea makes it impossible to work, or the light sensitivity makes it impossible to go outside.’ The big question within the headache community is, can you treat migraine and have it address the whole spectrum, from dizziness to light sensitivity to sound sensitivity to vertigo, or should you be going after individual symptoms? That’s a controversy that rages on; I think most of us go for a combination. We’re in a polypharmacy phase: ‘If nausea is a big problem, take this, but we also try to prevent the whole migraine complex, so take this as well.’ ”

The authors acknowledged their study’s limitations, including the inability to determine how many participants’ migraines were formally diagnosed by a trained medical professional and the lack of generalizability of data from a convenience sample, though they added that patients who independently track their own headaches “may be representative of those who would participate in a clinical trial.” In addition, as seven of the nine features were collected in N1‑Headache on a yes/no scale, they recognized that “increasing the number of response options for each item may improve our ability to measure HDS.”

The study was funded by Amgen through the Competitive Grant Program in Migraine Research. The authors declared several potential conflicts of interest, including receiving funding, research support, salary, and honoraria from various pharmaceutical companies.

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Researchers describe first reports of breakthrough COVID infections, booster shots in rheumatology patients

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Tue, 09/14/2021 - 09:26

Although breakthrough COVID-19 infections appear to be infrequent in people with inflammatory rheumatic and musculoskeletal diseases (iRMDs), these patients’ comparatively low antibodies after their initial vaccine series validate the recommendation that booster doses could reinforce their immune responses. These findings were highlighted in three letters recently published in Annals of the Rheumatic Diseases.

In the first letter, the researchers assessed breakthrough COVID-19 infections among vaccinated patients with iRMDs who were treated within the Mass General Brigham health care system in the Boston area. Of the 340 COVID-19 infections in patients with iRMDs after vaccinations were approved by the Food and Drug Administration for emergency use, 16 (4.7%) were breakthrough infections. All but one of the breakthrough infections were symptomatic, and six of the patients were hospitalized.

Patients who had breakthrough infections took disease-modifying antirheumatic drugs (DMARDs) that included rituximab and glucocorticoids (five patients each), mycophenolate mofetil or mycophenolic acid (four patients), and methotrexate (three patients). Two of the patients died, both of whom were on rituximab and had interstitial lung disease.

“Some DMARD users may require alternative risk-mitigation strategies, including passive immunity or booster vaccines, and may need to continue shielding practices,” the authors wrote.

Dr. Camille Kotton

“Honestly, it’s hard to know what to make of that rate of breakthrough infections,” Camille Kotton, MD, clinical director of transplant and immunocompromised host infectious diseases in the infectious diseases division at Massachusetts General Hospital in Boston, said in an interview. “People who are immunocompromised were strongly advised to change behavior so as to avoid infection, which probably greatly alters their risk of breakthrough infection. It’s thus hard to evaluate vaccine efficacy.

“Also, 93% were symptomatic, which is fairly high,” she added. “I’m not sure if these patients were more likely to be symptomatic or if there was some bias in testing based on symptoms.”

In the second letter, the researchers assessed postvaccination COVID-19 infections in European patients with iRMDs. Two COVID-19 registries with thousands of patients were reviewed, with less than 1% of patients in each deemed eligible for this study. Of the 34 patients who were ultimately analyzed with available COVID-19 outcomes – 10 were fully vaccinated and 24 were partially vaccinated – 28 fully recovered, 3 recovered with ongoing sequelae, and 3 patients died. The three patients who died were all over 70 years old and had been treated with glucocorticoids and mycophenolate mofetil, glucocorticoids, and rituximab, respectively.

The medications most frequently used by the iRMDs patients with breakthrough cases included glucocorticoids (32%), methotrexate (26%), and tumor necrosis factor inhibitors (26%).

“Overall, the low numbers of SARS-CoV-2 infection post vaccination in both registries are encouraging,” the authors wrote, adding that “all three deceased patients were treated with medications that are potential negative influences on postvaccination SARS-CoV-2 immunogenicity in the RMD population.”
 

Patients with RMDs: Consider COVID-19 booster shots

In the third letter, the researchers investigated booster doses of COVID-19 vaccine in patients with autoimmune diseases. Of the 18 participants who received a booster dose, 14 were on antimetabolite therapy and 8 of those were on mycophenolate. At a median of 29 days after completion of their initial vaccine series, antispike antibodies were negative in 10 of the participants and low positive in 6 others, with a median antispike antibody level of less than 0.4 U/mL (interquartile range, <0.4-222 U/mL).

Booster doses were administered at a median of 77 days after completion of the initial series. At a median of 30 days after booster dose, 89% of the participants had an augmented humoral response, with a median antispike antibody level of 2,500 (IQR, 885-2,500 U/mL). Of the 10 participants who had negative anti-spike antibodies after the initial series, 80% were positive after the booster.

Dr. Julie J. Paik

“I think this study supports the wealth of evidence that contributed to the [Centers for Disease Control and Prevention]’s and the FDA’s recommendation to get the third dose of the COVID vaccination,” coauthor Julie J. Paik, MD, of Johns Hopkins University, Baltimore, said in an interview. “Our patients are a very vulnerable group, including lupus patients or myositis patients, both of whom can get severe COVID if they were to contract it. They think they’re protected after a two-dose series, but in reality they’re not.

“We were just happy that they had a response,” she added. “Most of them had absolutely no response whatsoever after the first series.”

One other recently published case report in Arthritis & Rheumatology describes booster vaccination with the viral vector Johnson & Johnson vaccine in a man with seropositive RA who had previously received both doses of the Moderna mRNA-1273 vaccine. The 74-year-old man, who had low disease activity over the past 5 years on hydroxychloroquine, etanercept, and leflunomide, received the booster dose of his own accord after undergoing testing that showed a semiquantitative spike protein receptor binding domain (RBD) antibody level of 53.9 U/mL (reference range, 0-2,500 U/mL) and a negative SARS-CoV-2 antispike (S1/RBD) IgG test, as well as less than 10% blocking activity on an assay designed to detect blocking of the interaction between the SARS-CoV-2 spike protein RBD and the human ACE2 receptor and a negative interferon-gamma release assay detecting SARS-CoV-2–specific T cells. Several weeks after the booster dose, a repeat semiquantitative spike protein RBD antibody level was 2,455.0 U/mL and the S1/RBD IgG level was positive. An ACE2 blocking assay demonstrated 90%-100% blocking activity, but the interferon-gamma release assay remained negative.



“I would recommend abiding by the CDC guidelines regarding boosters for immunocompromised patients,” Dr. Kotton stated. “Patients with rheumatologic disease generally fit into the last category on that list. We don’t have an antibody titer that ensures protection, and as per CDC guidance, we don’t recommend checking antibody titers. Furthermore, boosters were given for this study before the CDC recommendation came out.”

Dr. Paik and coauthors acknowledged their study’s limitations, including a small, inhomogeneous sample and a lack of data on memory B-cell and T-cell response. They also echoed Dr. Kotton’s thoughts by noting that, although this subset of patients had notably limited antibody responses, “no antibody titer has been defined to correlate with protection.”

“Of course, the humoral response isn’t the whole story,” Dr. Paik said. “Some studies are showing that some vaccine recipients may not have the antibodies but their T-cell response may still be intact; it just takes time, and we’re not picking it up. Even if the antibody test is coming up negative, there may be some immunogenicity to the vaccine that we’re not detecting.

“Hopefully at some point, we’ll have more T-cell immunophenotyping to provide better insight into the full vaccine response.”

The Boston-area breakthrough study and the booster shot study were both funded primarily by grants from various institutes within the National Institutes of Health. The European study was financially supported by the European Alliance of Associations for Rheumatology.

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Although breakthrough COVID-19 infections appear to be infrequent in people with inflammatory rheumatic and musculoskeletal diseases (iRMDs), these patients’ comparatively low antibodies after their initial vaccine series validate the recommendation that booster doses could reinforce their immune responses. These findings were highlighted in three letters recently published in Annals of the Rheumatic Diseases.

In the first letter, the researchers assessed breakthrough COVID-19 infections among vaccinated patients with iRMDs who were treated within the Mass General Brigham health care system in the Boston area. Of the 340 COVID-19 infections in patients with iRMDs after vaccinations were approved by the Food and Drug Administration for emergency use, 16 (4.7%) were breakthrough infections. All but one of the breakthrough infections were symptomatic, and six of the patients were hospitalized.

Patients who had breakthrough infections took disease-modifying antirheumatic drugs (DMARDs) that included rituximab and glucocorticoids (five patients each), mycophenolate mofetil or mycophenolic acid (four patients), and methotrexate (three patients). Two of the patients died, both of whom were on rituximab and had interstitial lung disease.

“Some DMARD users may require alternative risk-mitigation strategies, including passive immunity or booster vaccines, and may need to continue shielding practices,” the authors wrote.

Dr. Camille Kotton

“Honestly, it’s hard to know what to make of that rate of breakthrough infections,” Camille Kotton, MD, clinical director of transplant and immunocompromised host infectious diseases in the infectious diseases division at Massachusetts General Hospital in Boston, said in an interview. “People who are immunocompromised were strongly advised to change behavior so as to avoid infection, which probably greatly alters their risk of breakthrough infection. It’s thus hard to evaluate vaccine efficacy.

“Also, 93% were symptomatic, which is fairly high,” she added. “I’m not sure if these patients were more likely to be symptomatic or if there was some bias in testing based on symptoms.”

In the second letter, the researchers assessed postvaccination COVID-19 infections in European patients with iRMDs. Two COVID-19 registries with thousands of patients were reviewed, with less than 1% of patients in each deemed eligible for this study. Of the 34 patients who were ultimately analyzed with available COVID-19 outcomes – 10 were fully vaccinated and 24 were partially vaccinated – 28 fully recovered, 3 recovered with ongoing sequelae, and 3 patients died. The three patients who died were all over 70 years old and had been treated with glucocorticoids and mycophenolate mofetil, glucocorticoids, and rituximab, respectively.

The medications most frequently used by the iRMDs patients with breakthrough cases included glucocorticoids (32%), methotrexate (26%), and tumor necrosis factor inhibitors (26%).

“Overall, the low numbers of SARS-CoV-2 infection post vaccination in both registries are encouraging,” the authors wrote, adding that “all three deceased patients were treated with medications that are potential negative influences on postvaccination SARS-CoV-2 immunogenicity in the RMD population.”
 

Patients with RMDs: Consider COVID-19 booster shots

In the third letter, the researchers investigated booster doses of COVID-19 vaccine in patients with autoimmune diseases. Of the 18 participants who received a booster dose, 14 were on antimetabolite therapy and 8 of those were on mycophenolate. At a median of 29 days after completion of their initial vaccine series, antispike antibodies were negative in 10 of the participants and low positive in 6 others, with a median antispike antibody level of less than 0.4 U/mL (interquartile range, <0.4-222 U/mL).

Booster doses were administered at a median of 77 days after completion of the initial series. At a median of 30 days after booster dose, 89% of the participants had an augmented humoral response, with a median antispike antibody level of 2,500 (IQR, 885-2,500 U/mL). Of the 10 participants who had negative anti-spike antibodies after the initial series, 80% were positive after the booster.

Dr. Julie J. Paik

“I think this study supports the wealth of evidence that contributed to the [Centers for Disease Control and Prevention]’s and the FDA’s recommendation to get the third dose of the COVID vaccination,” coauthor Julie J. Paik, MD, of Johns Hopkins University, Baltimore, said in an interview. “Our patients are a very vulnerable group, including lupus patients or myositis patients, both of whom can get severe COVID if they were to contract it. They think they’re protected after a two-dose series, but in reality they’re not.

“We were just happy that they had a response,” she added. “Most of them had absolutely no response whatsoever after the first series.”

One other recently published case report in Arthritis & Rheumatology describes booster vaccination with the viral vector Johnson & Johnson vaccine in a man with seropositive RA who had previously received both doses of the Moderna mRNA-1273 vaccine. The 74-year-old man, who had low disease activity over the past 5 years on hydroxychloroquine, etanercept, and leflunomide, received the booster dose of his own accord after undergoing testing that showed a semiquantitative spike protein receptor binding domain (RBD) antibody level of 53.9 U/mL (reference range, 0-2,500 U/mL) and a negative SARS-CoV-2 antispike (S1/RBD) IgG test, as well as less than 10% blocking activity on an assay designed to detect blocking of the interaction between the SARS-CoV-2 spike protein RBD and the human ACE2 receptor and a negative interferon-gamma release assay detecting SARS-CoV-2–specific T cells. Several weeks after the booster dose, a repeat semiquantitative spike protein RBD antibody level was 2,455.0 U/mL and the S1/RBD IgG level was positive. An ACE2 blocking assay demonstrated 90%-100% blocking activity, but the interferon-gamma release assay remained negative.



“I would recommend abiding by the CDC guidelines regarding boosters for immunocompromised patients,” Dr. Kotton stated. “Patients with rheumatologic disease generally fit into the last category on that list. We don’t have an antibody titer that ensures protection, and as per CDC guidance, we don’t recommend checking antibody titers. Furthermore, boosters were given for this study before the CDC recommendation came out.”

Dr. Paik and coauthors acknowledged their study’s limitations, including a small, inhomogeneous sample and a lack of data on memory B-cell and T-cell response. They also echoed Dr. Kotton’s thoughts by noting that, although this subset of patients had notably limited antibody responses, “no antibody titer has been defined to correlate with protection.”

“Of course, the humoral response isn’t the whole story,” Dr. Paik said. “Some studies are showing that some vaccine recipients may not have the antibodies but their T-cell response may still be intact; it just takes time, and we’re not picking it up. Even if the antibody test is coming up negative, there may be some immunogenicity to the vaccine that we’re not detecting.

“Hopefully at some point, we’ll have more T-cell immunophenotyping to provide better insight into the full vaccine response.”

The Boston-area breakthrough study and the booster shot study were both funded primarily by grants from various institutes within the National Institutes of Health. The European study was financially supported by the European Alliance of Associations for Rheumatology.

Although breakthrough COVID-19 infections appear to be infrequent in people with inflammatory rheumatic and musculoskeletal diseases (iRMDs), these patients’ comparatively low antibodies after their initial vaccine series validate the recommendation that booster doses could reinforce their immune responses. These findings were highlighted in three letters recently published in Annals of the Rheumatic Diseases.

In the first letter, the researchers assessed breakthrough COVID-19 infections among vaccinated patients with iRMDs who were treated within the Mass General Brigham health care system in the Boston area. Of the 340 COVID-19 infections in patients with iRMDs after vaccinations were approved by the Food and Drug Administration for emergency use, 16 (4.7%) were breakthrough infections. All but one of the breakthrough infections were symptomatic, and six of the patients were hospitalized.

Patients who had breakthrough infections took disease-modifying antirheumatic drugs (DMARDs) that included rituximab and glucocorticoids (five patients each), mycophenolate mofetil or mycophenolic acid (four patients), and methotrexate (three patients). Two of the patients died, both of whom were on rituximab and had interstitial lung disease.

“Some DMARD users may require alternative risk-mitigation strategies, including passive immunity or booster vaccines, and may need to continue shielding practices,” the authors wrote.

Dr. Camille Kotton

“Honestly, it’s hard to know what to make of that rate of breakthrough infections,” Camille Kotton, MD, clinical director of transplant and immunocompromised host infectious diseases in the infectious diseases division at Massachusetts General Hospital in Boston, said in an interview. “People who are immunocompromised were strongly advised to change behavior so as to avoid infection, which probably greatly alters their risk of breakthrough infection. It’s thus hard to evaluate vaccine efficacy.

“Also, 93% were symptomatic, which is fairly high,” she added. “I’m not sure if these patients were more likely to be symptomatic or if there was some bias in testing based on symptoms.”

In the second letter, the researchers assessed postvaccination COVID-19 infections in European patients with iRMDs. Two COVID-19 registries with thousands of patients were reviewed, with less than 1% of patients in each deemed eligible for this study. Of the 34 patients who were ultimately analyzed with available COVID-19 outcomes – 10 were fully vaccinated and 24 were partially vaccinated – 28 fully recovered, 3 recovered with ongoing sequelae, and 3 patients died. The three patients who died were all over 70 years old and had been treated with glucocorticoids and mycophenolate mofetil, glucocorticoids, and rituximab, respectively.

The medications most frequently used by the iRMDs patients with breakthrough cases included glucocorticoids (32%), methotrexate (26%), and tumor necrosis factor inhibitors (26%).

“Overall, the low numbers of SARS-CoV-2 infection post vaccination in both registries are encouraging,” the authors wrote, adding that “all three deceased patients were treated with medications that are potential negative influences on postvaccination SARS-CoV-2 immunogenicity in the RMD population.”
 

Patients with RMDs: Consider COVID-19 booster shots

In the third letter, the researchers investigated booster doses of COVID-19 vaccine in patients with autoimmune diseases. Of the 18 participants who received a booster dose, 14 were on antimetabolite therapy and 8 of those were on mycophenolate. At a median of 29 days after completion of their initial vaccine series, antispike antibodies were negative in 10 of the participants and low positive in 6 others, with a median antispike antibody level of less than 0.4 U/mL (interquartile range, <0.4-222 U/mL).

Booster doses were administered at a median of 77 days after completion of the initial series. At a median of 30 days after booster dose, 89% of the participants had an augmented humoral response, with a median antispike antibody level of 2,500 (IQR, 885-2,500 U/mL). Of the 10 participants who had negative anti-spike antibodies after the initial series, 80% were positive after the booster.

Dr. Julie J. Paik

“I think this study supports the wealth of evidence that contributed to the [Centers for Disease Control and Prevention]’s and the FDA’s recommendation to get the third dose of the COVID vaccination,” coauthor Julie J. Paik, MD, of Johns Hopkins University, Baltimore, said in an interview. “Our patients are a very vulnerable group, including lupus patients or myositis patients, both of whom can get severe COVID if they were to contract it. They think they’re protected after a two-dose series, but in reality they’re not.

“We were just happy that they had a response,” she added. “Most of them had absolutely no response whatsoever after the first series.”

One other recently published case report in Arthritis & Rheumatology describes booster vaccination with the viral vector Johnson & Johnson vaccine in a man with seropositive RA who had previously received both doses of the Moderna mRNA-1273 vaccine. The 74-year-old man, who had low disease activity over the past 5 years on hydroxychloroquine, etanercept, and leflunomide, received the booster dose of his own accord after undergoing testing that showed a semiquantitative spike protein receptor binding domain (RBD) antibody level of 53.9 U/mL (reference range, 0-2,500 U/mL) and a negative SARS-CoV-2 antispike (S1/RBD) IgG test, as well as less than 10% blocking activity on an assay designed to detect blocking of the interaction between the SARS-CoV-2 spike protein RBD and the human ACE2 receptor and a negative interferon-gamma release assay detecting SARS-CoV-2–specific T cells. Several weeks after the booster dose, a repeat semiquantitative spike protein RBD antibody level was 2,455.0 U/mL and the S1/RBD IgG level was positive. An ACE2 blocking assay demonstrated 90%-100% blocking activity, but the interferon-gamma release assay remained negative.



“I would recommend abiding by the CDC guidelines regarding boosters for immunocompromised patients,” Dr. Kotton stated. “Patients with rheumatologic disease generally fit into the last category on that list. We don’t have an antibody titer that ensures protection, and as per CDC guidance, we don’t recommend checking antibody titers. Furthermore, boosters were given for this study before the CDC recommendation came out.”

Dr. Paik and coauthors acknowledged their study’s limitations, including a small, inhomogeneous sample and a lack of data on memory B-cell and T-cell response. They also echoed Dr. Kotton’s thoughts by noting that, although this subset of patients had notably limited antibody responses, “no antibody titer has been defined to correlate with protection.”

“Of course, the humoral response isn’t the whole story,” Dr. Paik said. “Some studies are showing that some vaccine recipients may not have the antibodies but their T-cell response may still be intact; it just takes time, and we’re not picking it up. Even if the antibody test is coming up negative, there may be some immunogenicity to the vaccine that we’re not detecting.

“Hopefully at some point, we’ll have more T-cell immunophenotyping to provide better insight into the full vaccine response.”

The Boston-area breakthrough study and the booster shot study were both funded primarily by grants from various institutes within the National Institutes of Health. The European study was financially supported by the European Alliance of Associations for Rheumatology.

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MS plus depression can increase risk of death, vascular disease

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People with multiple sclerosis (MS) and depression have an increased risk of death, compared with those with one or neither condition, as well as an increased risk of vascular disease, a new study has found. “The effects of depression and MS on all-cause mortality are synergistic,” wrote lead author Raffaele Palladino, MD, PhD, research associate, faculty of medicine, Imperial College London.

Dr. Raffaele Palladino

The study was published in Neurology.

To assess the association between depression, vascular disease, and death in patients with MS, the researchers launched a population-based retrospective cohort study that reviewed English medical records from January 1987 to December 2018 and matched people with and without MS. Ultimately, 12,251 people with MS were matched with 72,572 controls. At baseline, 21% of the MS group (n = 2,535) and 9% of the controls (n = 6,278) had depression. Women were the majority in both cohorts and were more likely than men to be depressed.

People with both MS and depression had an all-cause mortality rate of 10.3 cases per 100,000 person-years (95% confidence interval, 9.17-11.57), compared with 10.6 for people with MS without depression (95% CI, 9.99-11.21), 3.6 for people with depression but not MS (95% CI, 3.18-4.05), and 2.5 for people with neither condition (95% CI, 2.42-2.64). Compared with controls without depression, the 10-year hazard of all-cause mortality was increasingly greater in controls with depression (hazard ratio, 1.75; 95% CI, 1.59-1.91), people with MS but not depression (HR, 3.88; 95% CI, 3.66-4.10), and people with MS and depression (HR, 5.43; 95% CI, 4.88-5.96). Overall, 14% of the observed effect on mortality was attributable to the interaction between MS status and depression.

As for vascular diseases, people with MS had an increased risk regardless of their depression status. That said, people with MS and depression (HR, 3.30; 95% CI, 2.37-4.23) had a notably higher risk than people with MS and no depression (HR, 1.48; 95% CI, 1.23-1.74). Women with MS and depression also had a greater risk of vascular disease than women with MS and no depression, while men with MS did not have significantly different risks of acute coronary syndrome or composite macrovascular disease than those in the control group who did not suffer from depression.
 

Does treating depression decrease the likelihood of vascular disease?

“The take-home message for me is the importance of treating depression in this population, in which we see it with great regularity,” Joseph Berger, MD, professor of neurology and associate chief of the multiple sclerosis division at the University of Pennsylvania, Philadelphia, said in an interview. “The question that I have is: If you treat depression in an individual with MS or an individual who is simply depressed and thus at risk for the subsequent development of vascular disease, does it decrease the likelihood of their subsequent development of vascular disease in comparison to had you not?

“I presume it does,” he added, noting that “the theories underlying why depression would increase one’s risk of subsequent vascular disease are enumerated by the authors, including such things as increased inflammation. Now, the inflammation may be contributing to the depression, or the depression may be contributing to the inflammation; it may be one of those chicken-and-egg scenarios. But if you decrease the depression, do you thereby decrease the inflammation, which has a pernicious effect on endothelial cells and increases one’s vascular risk?

“Alternatively, lifestyle in depressed patients is also altered,” he said. “They’re far less likely to engage in exercise, healthy habits, and healthy diets, and more likely perhaps to smoke. These all need to be addressed, but this study certainly gives you a greater impetus as a MS neurologist to address the issue of depression, realizing that there is also this comorbidity of vascular disease.”
 

 

 

Evaluating the biological interaction between MS and depression

Based on this and other studies, the joint effect of MS and depression on all-cause mortality may qualify as a biological interaction, Amber Salter, PhD, of the University of Texas Southwestern Medical Center, Dallas, wrote in an accompanying editorial.

“Biological interactions consider whether the joint effect of two factors follow an additive pattern, or the joint effect of two factors is greater than the sum of the individual effects for each factor alone,” she wrote. And though the interaction was not found to be present for vascular disease and cardiovascular mortality, it was for all-cause mortality.

“When warranted, the evaluation of biological interactions in future studies should be considered to provide insight on target subpopulations for interventions or test for potential mechanistic forms of interaction,” she added.

Dr. Salter highlighted the study’s strengths, including a large sample size and six controls matched to each MS patient. She also stated that the researchers’ inability to control for risk factors like body mass index and physical activity means the 14% increase in mortality “may not be a large absolute increase in mortality when other covariates cannot be considered.” In addition, their lack of data on suicide – and its association with depression – offers up the possibility that increases in mortality could be tied to a “potentially modifiable risk” as opposed to a biologically increased one.

In acknowledging their study’s limitations, the authors stated that body mass index, though an important vascular risk factor, has a “modest” association with mortality, and that the average annual suicide rate in the MS population – though higher than in the non-MS population – is still “relatively low.”

Two of the authors disclosed receiving support, including grants and research funding, from various institutions and organizations in the United Kingdom, the United States, and Canada, as well as several pharmaceutical companies. Dr. Salter reported no relevant disclosures.

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People with multiple sclerosis (MS) and depression have an increased risk of death, compared with those with one or neither condition, as well as an increased risk of vascular disease, a new study has found. “The effects of depression and MS on all-cause mortality are synergistic,” wrote lead author Raffaele Palladino, MD, PhD, research associate, faculty of medicine, Imperial College London.

Dr. Raffaele Palladino

The study was published in Neurology.

To assess the association between depression, vascular disease, and death in patients with MS, the researchers launched a population-based retrospective cohort study that reviewed English medical records from January 1987 to December 2018 and matched people with and without MS. Ultimately, 12,251 people with MS were matched with 72,572 controls. At baseline, 21% of the MS group (n = 2,535) and 9% of the controls (n = 6,278) had depression. Women were the majority in both cohorts and were more likely than men to be depressed.

People with both MS and depression had an all-cause mortality rate of 10.3 cases per 100,000 person-years (95% confidence interval, 9.17-11.57), compared with 10.6 for people with MS without depression (95% CI, 9.99-11.21), 3.6 for people with depression but not MS (95% CI, 3.18-4.05), and 2.5 for people with neither condition (95% CI, 2.42-2.64). Compared with controls without depression, the 10-year hazard of all-cause mortality was increasingly greater in controls with depression (hazard ratio, 1.75; 95% CI, 1.59-1.91), people with MS but not depression (HR, 3.88; 95% CI, 3.66-4.10), and people with MS and depression (HR, 5.43; 95% CI, 4.88-5.96). Overall, 14% of the observed effect on mortality was attributable to the interaction between MS status and depression.

As for vascular diseases, people with MS had an increased risk regardless of their depression status. That said, people with MS and depression (HR, 3.30; 95% CI, 2.37-4.23) had a notably higher risk than people with MS and no depression (HR, 1.48; 95% CI, 1.23-1.74). Women with MS and depression also had a greater risk of vascular disease than women with MS and no depression, while men with MS did not have significantly different risks of acute coronary syndrome or composite macrovascular disease than those in the control group who did not suffer from depression.
 

Does treating depression decrease the likelihood of vascular disease?

“The take-home message for me is the importance of treating depression in this population, in which we see it with great regularity,” Joseph Berger, MD, professor of neurology and associate chief of the multiple sclerosis division at the University of Pennsylvania, Philadelphia, said in an interview. “The question that I have is: If you treat depression in an individual with MS or an individual who is simply depressed and thus at risk for the subsequent development of vascular disease, does it decrease the likelihood of their subsequent development of vascular disease in comparison to had you not?

“I presume it does,” he added, noting that “the theories underlying why depression would increase one’s risk of subsequent vascular disease are enumerated by the authors, including such things as increased inflammation. Now, the inflammation may be contributing to the depression, or the depression may be contributing to the inflammation; it may be one of those chicken-and-egg scenarios. But if you decrease the depression, do you thereby decrease the inflammation, which has a pernicious effect on endothelial cells and increases one’s vascular risk?

“Alternatively, lifestyle in depressed patients is also altered,” he said. “They’re far less likely to engage in exercise, healthy habits, and healthy diets, and more likely perhaps to smoke. These all need to be addressed, but this study certainly gives you a greater impetus as a MS neurologist to address the issue of depression, realizing that there is also this comorbidity of vascular disease.”
 

 

 

Evaluating the biological interaction between MS and depression

Based on this and other studies, the joint effect of MS and depression on all-cause mortality may qualify as a biological interaction, Amber Salter, PhD, of the University of Texas Southwestern Medical Center, Dallas, wrote in an accompanying editorial.

“Biological interactions consider whether the joint effect of two factors follow an additive pattern, or the joint effect of two factors is greater than the sum of the individual effects for each factor alone,” she wrote. And though the interaction was not found to be present for vascular disease and cardiovascular mortality, it was for all-cause mortality.

“When warranted, the evaluation of biological interactions in future studies should be considered to provide insight on target subpopulations for interventions or test for potential mechanistic forms of interaction,” she added.

Dr. Salter highlighted the study’s strengths, including a large sample size and six controls matched to each MS patient. She also stated that the researchers’ inability to control for risk factors like body mass index and physical activity means the 14% increase in mortality “may not be a large absolute increase in mortality when other covariates cannot be considered.” In addition, their lack of data on suicide – and its association with depression – offers up the possibility that increases in mortality could be tied to a “potentially modifiable risk” as opposed to a biologically increased one.

In acknowledging their study’s limitations, the authors stated that body mass index, though an important vascular risk factor, has a “modest” association with mortality, and that the average annual suicide rate in the MS population – though higher than in the non-MS population – is still “relatively low.”

Two of the authors disclosed receiving support, including grants and research funding, from various institutions and organizations in the United Kingdom, the United States, and Canada, as well as several pharmaceutical companies. Dr. Salter reported no relevant disclosures.

People with multiple sclerosis (MS) and depression have an increased risk of death, compared with those with one or neither condition, as well as an increased risk of vascular disease, a new study has found. “The effects of depression and MS on all-cause mortality are synergistic,” wrote lead author Raffaele Palladino, MD, PhD, research associate, faculty of medicine, Imperial College London.

Dr. Raffaele Palladino

The study was published in Neurology.

To assess the association between depression, vascular disease, and death in patients with MS, the researchers launched a population-based retrospective cohort study that reviewed English medical records from January 1987 to December 2018 and matched people with and without MS. Ultimately, 12,251 people with MS were matched with 72,572 controls. At baseline, 21% of the MS group (n = 2,535) and 9% of the controls (n = 6,278) had depression. Women were the majority in both cohorts and were more likely than men to be depressed.

People with both MS and depression had an all-cause mortality rate of 10.3 cases per 100,000 person-years (95% confidence interval, 9.17-11.57), compared with 10.6 for people with MS without depression (95% CI, 9.99-11.21), 3.6 for people with depression but not MS (95% CI, 3.18-4.05), and 2.5 for people with neither condition (95% CI, 2.42-2.64). Compared with controls without depression, the 10-year hazard of all-cause mortality was increasingly greater in controls with depression (hazard ratio, 1.75; 95% CI, 1.59-1.91), people with MS but not depression (HR, 3.88; 95% CI, 3.66-4.10), and people with MS and depression (HR, 5.43; 95% CI, 4.88-5.96). Overall, 14% of the observed effect on mortality was attributable to the interaction between MS status and depression.

As for vascular diseases, people with MS had an increased risk regardless of their depression status. That said, people with MS and depression (HR, 3.30; 95% CI, 2.37-4.23) had a notably higher risk than people with MS and no depression (HR, 1.48; 95% CI, 1.23-1.74). Women with MS and depression also had a greater risk of vascular disease than women with MS and no depression, while men with MS did not have significantly different risks of acute coronary syndrome or composite macrovascular disease than those in the control group who did not suffer from depression.
 

Does treating depression decrease the likelihood of vascular disease?

“The take-home message for me is the importance of treating depression in this population, in which we see it with great regularity,” Joseph Berger, MD, professor of neurology and associate chief of the multiple sclerosis division at the University of Pennsylvania, Philadelphia, said in an interview. “The question that I have is: If you treat depression in an individual with MS or an individual who is simply depressed and thus at risk for the subsequent development of vascular disease, does it decrease the likelihood of their subsequent development of vascular disease in comparison to had you not?

“I presume it does,” he added, noting that “the theories underlying why depression would increase one’s risk of subsequent vascular disease are enumerated by the authors, including such things as increased inflammation. Now, the inflammation may be contributing to the depression, or the depression may be contributing to the inflammation; it may be one of those chicken-and-egg scenarios. But if you decrease the depression, do you thereby decrease the inflammation, which has a pernicious effect on endothelial cells and increases one’s vascular risk?

“Alternatively, lifestyle in depressed patients is also altered,” he said. “They’re far less likely to engage in exercise, healthy habits, and healthy diets, and more likely perhaps to smoke. These all need to be addressed, but this study certainly gives you a greater impetus as a MS neurologist to address the issue of depression, realizing that there is also this comorbidity of vascular disease.”
 

 

 

Evaluating the biological interaction between MS and depression

Based on this and other studies, the joint effect of MS and depression on all-cause mortality may qualify as a biological interaction, Amber Salter, PhD, of the University of Texas Southwestern Medical Center, Dallas, wrote in an accompanying editorial.

“Biological interactions consider whether the joint effect of two factors follow an additive pattern, or the joint effect of two factors is greater than the sum of the individual effects for each factor alone,” she wrote. And though the interaction was not found to be present for vascular disease and cardiovascular mortality, it was for all-cause mortality.

“When warranted, the evaluation of biological interactions in future studies should be considered to provide insight on target subpopulations for interventions or test for potential mechanistic forms of interaction,” she added.

Dr. Salter highlighted the study’s strengths, including a large sample size and six controls matched to each MS patient. She also stated that the researchers’ inability to control for risk factors like body mass index and physical activity means the 14% increase in mortality “may not be a large absolute increase in mortality when other covariates cannot be considered.” In addition, their lack of data on suicide – and its association with depression – offers up the possibility that increases in mortality could be tied to a “potentially modifiable risk” as opposed to a biologically increased one.

In acknowledging their study’s limitations, the authors stated that body mass index, though an important vascular risk factor, has a “modest” association with mortality, and that the average annual suicide rate in the MS population – though higher than in the non-MS population – is still “relatively low.”

Two of the authors disclosed receiving support, including grants and research funding, from various institutions and organizations in the United Kingdom, the United States, and Canada, as well as several pharmaceutical companies. Dr. Salter reported no relevant disclosures.

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Young Black and White athletes differ in how they recover from concussions

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Young Black athletes who suffered concussions while playing sports were quicker to return to school and less likely to adjust their daily routines than young White athletes, according to a new study on racial differences in concussion recovery.

“The findings from this study provide novel evidence that the recovery experience following sport-related concussion likely differs between Black and White athletes, and understanding these differences may serve to provide better and more personalized intervention and management strategies,” wrote lead author Aaron M. Yengo-Kahn, MD, of Vanderbilt University Medical Center in Nashville, Tenn. The study was published in the Journal of Neurosurgery: Pediatrics.

To assess how postconcussion experiences and recovery time differ among young White and Black athletes, the researchers launched a retrospective cohort study of youths between the ages of 12 and 23 from the middle Tennessee, northern Alabama, and southern Kentucky regions who had been treated for sport-related concussion. Using data from the Vanderbilt Sports Concussion Center’s outcome registry, they examined the records of 247 student-athletes, 211 of whom were White and 36 of whom were Black.

The majority of the athletes were male – 58% of the White group and 78% of the Black group – and their average age across groups was roughly 16 years. Thirty-three percent of the Black athletes were on public insurance, compared with just 6% of the White athletes, and 41% of the Black athletes lived in low–median income areas while 55% of the White athletes lived in areas with a high median income. Approximately 90% of each group played contact sports.

The median time to symptom resolution was 21 days (interquartile range, 10.5-61.0) for White athletes but just 12.3 days (IQR, 6.8-28.0) for Black athletes. Multivariable regression confirmed that Black athletes reached asymptomatic status sooner than White athletes (hazard ratio, 1.497; 95% confidence interval, 1.014-2.209; P = .042). “The observed shorter symptom resolution among the Black athletes may be explained by a complex interplay among race, concussion knowledge, attitudes toward sport-related concussion, reporting behavior, and sociodemographic disparities,” the authors noted.

The median time until returning to school post injury was 2 school days (IQR, 0-5) for White athletes and 0 school days (IQR, 0-2) for Black athletes. After multivariable analysis, being Black was indeed associated with returning to school sooner, compared with being White (HR, 1.522; 95% CI, 1.02-2,27; P = .040). Being Black was also associated with being less likely to a report a change in daily activity post concussion (odds ratio, 0.368; 95% CI, 0.136-0.996; P = .049).
 

Adding race to research

To make headway toward understanding race’s impact on concussion research, the authors proposed three immediate steps: Work directly with schools instead of clinics or emergency departments, match the diversity of study cohorts with the racial makeup of the surrounding community, and consider race as a covariate during study design.

“In our work with concussions, there is very little reported on race or racism or how racism affects how patients are navigating these spaces,” said coauthor Jessica Wallace, PhD, of the department of health science at the University of Alabama in Tuscaloosa, Ala., in an interview. “But we have so many athletes at the youth level, adolescent level, even the collegiate level; it’s such a diverse array of patients. We need to have data representative of all of our groups so that we know where we need to be intentional about reducing disparities and closing gaps.”

Dr. Wallace, who recently authored a study on the underreporting of concussions among Black and White high school athletes, emphasized the need for concussion research to be a true collaboration across disciplines.

“I approach this work from this public health and athletic training lens, whereas a lot of my collaborators are in neurosurgery and neurology,” she said. “Moving forward, we as a scientific clinical community have to do interdisciplinary work and be very intentional about how we go about closing these gaps. We have to recognize that there are differences in knowledge and in care, and they’re unacceptable, and we have to work collaboratively in providing resources to communities equitably to decrease them.”

The authors acknowledged their study’s limitations, including the retrospective nature of the study, using zip codes to determine median household income, and an unbalanced number of White and Black athletes. They did add, however, that the ratio of participants “generally aligns with census data in the surrounding metropolitan and county areas.” That said, they also surmised that the scarcity of Black athletes could indicate a deeper disparity in health care system usage and asked future researchers to “consider enrolling athletes directly from schools rather than from within the concussion clinic only.”

Dr. Yengo-Kahn disclosed holding a compensated position on the scientific advisory board of BlinkTBI, but the authors noted that the company had no role in the study and its products were not used. No other conflicts of interest were reported.

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Young Black athletes who suffered concussions while playing sports were quicker to return to school and less likely to adjust their daily routines than young White athletes, according to a new study on racial differences in concussion recovery.

“The findings from this study provide novel evidence that the recovery experience following sport-related concussion likely differs between Black and White athletes, and understanding these differences may serve to provide better and more personalized intervention and management strategies,” wrote lead author Aaron M. Yengo-Kahn, MD, of Vanderbilt University Medical Center in Nashville, Tenn. The study was published in the Journal of Neurosurgery: Pediatrics.

To assess how postconcussion experiences and recovery time differ among young White and Black athletes, the researchers launched a retrospective cohort study of youths between the ages of 12 and 23 from the middle Tennessee, northern Alabama, and southern Kentucky regions who had been treated for sport-related concussion. Using data from the Vanderbilt Sports Concussion Center’s outcome registry, they examined the records of 247 student-athletes, 211 of whom were White and 36 of whom were Black.

The majority of the athletes were male – 58% of the White group and 78% of the Black group – and their average age across groups was roughly 16 years. Thirty-three percent of the Black athletes were on public insurance, compared with just 6% of the White athletes, and 41% of the Black athletes lived in low–median income areas while 55% of the White athletes lived in areas with a high median income. Approximately 90% of each group played contact sports.

The median time to symptom resolution was 21 days (interquartile range, 10.5-61.0) for White athletes but just 12.3 days (IQR, 6.8-28.0) for Black athletes. Multivariable regression confirmed that Black athletes reached asymptomatic status sooner than White athletes (hazard ratio, 1.497; 95% confidence interval, 1.014-2.209; P = .042). “The observed shorter symptom resolution among the Black athletes may be explained by a complex interplay among race, concussion knowledge, attitudes toward sport-related concussion, reporting behavior, and sociodemographic disparities,” the authors noted.

The median time until returning to school post injury was 2 school days (IQR, 0-5) for White athletes and 0 school days (IQR, 0-2) for Black athletes. After multivariable analysis, being Black was indeed associated with returning to school sooner, compared with being White (HR, 1.522; 95% CI, 1.02-2,27; P = .040). Being Black was also associated with being less likely to a report a change in daily activity post concussion (odds ratio, 0.368; 95% CI, 0.136-0.996; P = .049).
 

Adding race to research

To make headway toward understanding race’s impact on concussion research, the authors proposed three immediate steps: Work directly with schools instead of clinics or emergency departments, match the diversity of study cohorts with the racial makeup of the surrounding community, and consider race as a covariate during study design.

“In our work with concussions, there is very little reported on race or racism or how racism affects how patients are navigating these spaces,” said coauthor Jessica Wallace, PhD, of the department of health science at the University of Alabama in Tuscaloosa, Ala., in an interview. “But we have so many athletes at the youth level, adolescent level, even the collegiate level; it’s such a diverse array of patients. We need to have data representative of all of our groups so that we know where we need to be intentional about reducing disparities and closing gaps.”

Dr. Wallace, who recently authored a study on the underreporting of concussions among Black and White high school athletes, emphasized the need for concussion research to be a true collaboration across disciplines.

“I approach this work from this public health and athletic training lens, whereas a lot of my collaborators are in neurosurgery and neurology,” she said. “Moving forward, we as a scientific clinical community have to do interdisciplinary work and be very intentional about how we go about closing these gaps. We have to recognize that there are differences in knowledge and in care, and they’re unacceptable, and we have to work collaboratively in providing resources to communities equitably to decrease them.”

The authors acknowledged their study’s limitations, including the retrospective nature of the study, using zip codes to determine median household income, and an unbalanced number of White and Black athletes. They did add, however, that the ratio of participants “generally aligns with census data in the surrounding metropolitan and county areas.” That said, they also surmised that the scarcity of Black athletes could indicate a deeper disparity in health care system usage and asked future researchers to “consider enrolling athletes directly from schools rather than from within the concussion clinic only.”

Dr. Yengo-Kahn disclosed holding a compensated position on the scientific advisory board of BlinkTBI, but the authors noted that the company had no role in the study and its products were not used. No other conflicts of interest were reported.

Young Black athletes who suffered concussions while playing sports were quicker to return to school and less likely to adjust their daily routines than young White athletes, according to a new study on racial differences in concussion recovery.

“The findings from this study provide novel evidence that the recovery experience following sport-related concussion likely differs between Black and White athletes, and understanding these differences may serve to provide better and more personalized intervention and management strategies,” wrote lead author Aaron M. Yengo-Kahn, MD, of Vanderbilt University Medical Center in Nashville, Tenn. The study was published in the Journal of Neurosurgery: Pediatrics.

To assess how postconcussion experiences and recovery time differ among young White and Black athletes, the researchers launched a retrospective cohort study of youths between the ages of 12 and 23 from the middle Tennessee, northern Alabama, and southern Kentucky regions who had been treated for sport-related concussion. Using data from the Vanderbilt Sports Concussion Center’s outcome registry, they examined the records of 247 student-athletes, 211 of whom were White and 36 of whom were Black.

The majority of the athletes were male – 58% of the White group and 78% of the Black group – and their average age across groups was roughly 16 years. Thirty-three percent of the Black athletes were on public insurance, compared with just 6% of the White athletes, and 41% of the Black athletes lived in low–median income areas while 55% of the White athletes lived in areas with a high median income. Approximately 90% of each group played contact sports.

The median time to symptom resolution was 21 days (interquartile range, 10.5-61.0) for White athletes but just 12.3 days (IQR, 6.8-28.0) for Black athletes. Multivariable regression confirmed that Black athletes reached asymptomatic status sooner than White athletes (hazard ratio, 1.497; 95% confidence interval, 1.014-2.209; P = .042). “The observed shorter symptom resolution among the Black athletes may be explained by a complex interplay among race, concussion knowledge, attitudes toward sport-related concussion, reporting behavior, and sociodemographic disparities,” the authors noted.

The median time until returning to school post injury was 2 school days (IQR, 0-5) for White athletes and 0 school days (IQR, 0-2) for Black athletes. After multivariable analysis, being Black was indeed associated with returning to school sooner, compared with being White (HR, 1.522; 95% CI, 1.02-2,27; P = .040). Being Black was also associated with being less likely to a report a change in daily activity post concussion (odds ratio, 0.368; 95% CI, 0.136-0.996; P = .049).
 

Adding race to research

To make headway toward understanding race’s impact on concussion research, the authors proposed three immediate steps: Work directly with schools instead of clinics or emergency departments, match the diversity of study cohorts with the racial makeup of the surrounding community, and consider race as a covariate during study design.

“In our work with concussions, there is very little reported on race or racism or how racism affects how patients are navigating these spaces,” said coauthor Jessica Wallace, PhD, of the department of health science at the University of Alabama in Tuscaloosa, Ala., in an interview. “But we have so many athletes at the youth level, adolescent level, even the collegiate level; it’s such a diverse array of patients. We need to have data representative of all of our groups so that we know where we need to be intentional about reducing disparities and closing gaps.”

Dr. Wallace, who recently authored a study on the underreporting of concussions among Black and White high school athletes, emphasized the need for concussion research to be a true collaboration across disciplines.

“I approach this work from this public health and athletic training lens, whereas a lot of my collaborators are in neurosurgery and neurology,” she said. “Moving forward, we as a scientific clinical community have to do interdisciplinary work and be very intentional about how we go about closing these gaps. We have to recognize that there are differences in knowledge and in care, and they’re unacceptable, and we have to work collaboratively in providing resources to communities equitably to decrease them.”

The authors acknowledged their study’s limitations, including the retrospective nature of the study, using zip codes to determine median household income, and an unbalanced number of White and Black athletes. They did add, however, that the ratio of participants “generally aligns with census data in the surrounding metropolitan and county areas.” That said, they also surmised that the scarcity of Black athletes could indicate a deeper disparity in health care system usage and asked future researchers to “consider enrolling athletes directly from schools rather than from within the concussion clinic only.”

Dr. Yengo-Kahn disclosed holding a compensated position on the scientific advisory board of BlinkTBI, but the authors noted that the company had no role in the study and its products were not used. No other conflicts of interest were reported.

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FROM THE JOURNAL OF NEUROSURGERY: PEDIATRICS

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Diet, exercise in older adults with knee OA have long-term payoff

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Thu, 08/19/2021 - 14:24

Older patients with knee osteoarthritis (OA) who underwent lengthy diet and exercise interventions reported less pain and maintained some weight loss years after the program ended, according to a new study published in Arthritis Care & Research.

AlexRaths/Getty Images

“These data imply that clinicians who treat people with knee osteoarthritis have a variety of nonpharmacologic options that preserve clinically important effects 3.5 years after the treatments end,” wrote lead author Stephen P. Messier, PhD, professor and director of the J.B. Snow Biomechanics Laboratory at Wake Forest University, Winston-Salem, N.C.

The study involved patients with overweight or obesity aged 55 years or older who were previously enrolled in the 1.5-year Intensive Diet and Exercise for Arthritis (IDEA) trial.

“You have to remember, this is 3.5 years after the IDEA trial ended,” Dr. Messier said in an interview. “There was no contact with them for that entire time; you’d expect, based on the literature, that they’d revert back to where they were before they entered the trial. And certainly, there was some regression, there was some weight regain, but the important part of the study is that, even after 3.5 years, and even with some weight regain, there were some clinically important effects that lasted.”

Dr. Stephen P. Messier

“What we feel now is that if we can somehow prepare people better for that time after they finish a weight loss intervention, from a psychological standpoint, it will make a real difference,” he added. “We are very good at helping people have the confidence to lose weight. But having the confidence to lose weight is totally different than having confidence to maintain weight loss. If we can give folks an intervention that has a psychological component, hopefully we can increase their confidence to maintain the weight loss that they attained.”
 

Study details

Of the 184 participants who were contacted for a follow-up visit, 94 consented to participate, 67% of whom were females and 88% of whom were White. A total of 27 participants had completed the diet and exercise intervention, and another 35 completed the diet-only and 32 exercise-only interventions.

In the 3.5-year period between the IDEA trial’s end and follow-up, body weight increased by 5.9 kg in the diet and exercise group (P < .0001) and by 3.1 kg in the diet-only group (P = .0006) but decreased in the exercise-only group by 1.0 kg (P = .25). However, from baseline to 5-year follow-up, all groups saw a reduction in body weight. Mean weight loss was –3.7 kg for the diet and exercise group (P = .0007), –5.8 kg for the diet group (P < .0001), and –2.9 kg for the exercise group (P = .003). Body mass index also decreased in all groups: by –1.2 kg/m2 in the diet and exercise group (P = .001), by –2.0 kg/m2 in the diet group (P < .0001), and by –1.0 kg/m2 in the exercise group (P = .004).

Pain – as measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score – was reduced in all groups across 5-year follow-up: –1.2 (P = .03) for the diet and exercise group, –1.5 (P = .001) for the diet-only group, and –1.6 (P = .0008) for the exercise-only group. WOMAC function also significantly improved relative to baseline by 6.2 (P = .0001) in the diet and exercise group, by 6.1 (P < .0001) in the diet group, and by 3.7 (P = .01) in the exercise-only group.
 

 

 

Finding time to advise on weight loss, exercise

“If exercise and weight loss were easy, this country wouldn’t be in the state we’re in,” Tuhina Neogi, MD, PhD, of Boston University said in an interview. “Shared decision-making and personalized medicine are important; unfortunately, for the majority of physicians – particularly primary care physicians, where a good deal of OA management is undertaken – they don’t have a lot of time in their 20 minutes with a patient who has OA to counsel individuals toward a healthy weight and physical activity program when they’re also addressing common comorbidities seen in OA such as diabetes and heart disease.

Dr. Tuhina Neogi

“But as we know,” she added, “when you do address weight loss and physical activity, it has wide-ranging health benefits. This study provides support for utilizing formal diet and exercise programs to achieve important and durable benefits for people with OA.”

Dr. Neogi did note one of the study’s acknowledged limitations: Only slightly more than half of the contacted participants returned for follow-up. Though the authors stated that the individuals who returned were representative of both the pool of potential participants and the IDEA cohort as a whole, “we don’t want to make too many inferences when you don’t have the whole study population available,” she said. “The people who have agreed to come back 3.5 years later for follow-up testing, maybe they are a little more health conscious, more resilient. Those people might be systematically different than the people who [did not return], even though most of the factors were not statistically different between the groups.

“Whatever positive attributes they may have, though, we need to understand more about them,” she added. “We need to know how they maintained the benefits they had 3.5 years prior. That kind of understanding is important to inform long-term strategies in OA management.”



Dr. Messier highlighted a related, ongoing study he’s leading in which more than 800 overweight patients in North Carolina who suffer from knee pain are being led through diet and exercise interventions in a community setting. The goal is to replicate the IDEA results outside of a clinical trial setting and show skeptical physicians that diet and exercise can be enacted and maintained in this subset of patients.

“I think we know how effective weight loss is, especially when combined with exercise, in reducing pain, improving function, improving quality of life in these patients,” he said. “The next step is to allow them to maintain those benefits for a long period of time after the intervention ends.”

The study was supported by grants from the National Institutes of Health and by General Nutrition Centers. Its authors reported no potential conflicts of interest.

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Older patients with knee osteoarthritis (OA) who underwent lengthy diet and exercise interventions reported less pain and maintained some weight loss years after the program ended, according to a new study published in Arthritis Care & Research.

AlexRaths/Getty Images

“These data imply that clinicians who treat people with knee osteoarthritis have a variety of nonpharmacologic options that preserve clinically important effects 3.5 years after the treatments end,” wrote lead author Stephen P. Messier, PhD, professor and director of the J.B. Snow Biomechanics Laboratory at Wake Forest University, Winston-Salem, N.C.

The study involved patients with overweight or obesity aged 55 years or older who were previously enrolled in the 1.5-year Intensive Diet and Exercise for Arthritis (IDEA) trial.

“You have to remember, this is 3.5 years after the IDEA trial ended,” Dr. Messier said in an interview. “There was no contact with them for that entire time; you’d expect, based on the literature, that they’d revert back to where they were before they entered the trial. And certainly, there was some regression, there was some weight regain, but the important part of the study is that, even after 3.5 years, and even with some weight regain, there were some clinically important effects that lasted.”

Dr. Stephen P. Messier

“What we feel now is that if we can somehow prepare people better for that time after they finish a weight loss intervention, from a psychological standpoint, it will make a real difference,” he added. “We are very good at helping people have the confidence to lose weight. But having the confidence to lose weight is totally different than having confidence to maintain weight loss. If we can give folks an intervention that has a psychological component, hopefully we can increase their confidence to maintain the weight loss that they attained.”
 

Study details

Of the 184 participants who were contacted for a follow-up visit, 94 consented to participate, 67% of whom were females and 88% of whom were White. A total of 27 participants had completed the diet and exercise intervention, and another 35 completed the diet-only and 32 exercise-only interventions.

In the 3.5-year period between the IDEA trial’s end and follow-up, body weight increased by 5.9 kg in the diet and exercise group (P < .0001) and by 3.1 kg in the diet-only group (P = .0006) but decreased in the exercise-only group by 1.0 kg (P = .25). However, from baseline to 5-year follow-up, all groups saw a reduction in body weight. Mean weight loss was –3.7 kg for the diet and exercise group (P = .0007), –5.8 kg for the diet group (P < .0001), and –2.9 kg for the exercise group (P = .003). Body mass index also decreased in all groups: by –1.2 kg/m2 in the diet and exercise group (P = .001), by –2.0 kg/m2 in the diet group (P < .0001), and by –1.0 kg/m2 in the exercise group (P = .004).

Pain – as measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score – was reduced in all groups across 5-year follow-up: –1.2 (P = .03) for the diet and exercise group, –1.5 (P = .001) for the diet-only group, and –1.6 (P = .0008) for the exercise-only group. WOMAC function also significantly improved relative to baseline by 6.2 (P = .0001) in the diet and exercise group, by 6.1 (P < .0001) in the diet group, and by 3.7 (P = .01) in the exercise-only group.
 

 

 

Finding time to advise on weight loss, exercise

“If exercise and weight loss were easy, this country wouldn’t be in the state we’re in,” Tuhina Neogi, MD, PhD, of Boston University said in an interview. “Shared decision-making and personalized medicine are important; unfortunately, for the majority of physicians – particularly primary care physicians, where a good deal of OA management is undertaken – they don’t have a lot of time in their 20 minutes with a patient who has OA to counsel individuals toward a healthy weight and physical activity program when they’re also addressing common comorbidities seen in OA such as diabetes and heart disease.

Dr. Tuhina Neogi

“But as we know,” she added, “when you do address weight loss and physical activity, it has wide-ranging health benefits. This study provides support for utilizing formal diet and exercise programs to achieve important and durable benefits for people with OA.”

Dr. Neogi did note one of the study’s acknowledged limitations: Only slightly more than half of the contacted participants returned for follow-up. Though the authors stated that the individuals who returned were representative of both the pool of potential participants and the IDEA cohort as a whole, “we don’t want to make too many inferences when you don’t have the whole study population available,” she said. “The people who have agreed to come back 3.5 years later for follow-up testing, maybe they are a little more health conscious, more resilient. Those people might be systematically different than the people who [did not return], even though most of the factors were not statistically different between the groups.

“Whatever positive attributes they may have, though, we need to understand more about them,” she added. “We need to know how they maintained the benefits they had 3.5 years prior. That kind of understanding is important to inform long-term strategies in OA management.”



Dr. Messier highlighted a related, ongoing study he’s leading in which more than 800 overweight patients in North Carolina who suffer from knee pain are being led through diet and exercise interventions in a community setting. The goal is to replicate the IDEA results outside of a clinical trial setting and show skeptical physicians that diet and exercise can be enacted and maintained in this subset of patients.

“I think we know how effective weight loss is, especially when combined with exercise, in reducing pain, improving function, improving quality of life in these patients,” he said. “The next step is to allow them to maintain those benefits for a long period of time after the intervention ends.”

The study was supported by grants from the National Institutes of Health and by General Nutrition Centers. Its authors reported no potential conflicts of interest.

Older patients with knee osteoarthritis (OA) who underwent lengthy diet and exercise interventions reported less pain and maintained some weight loss years after the program ended, according to a new study published in Arthritis Care & Research.

AlexRaths/Getty Images

“These data imply that clinicians who treat people with knee osteoarthritis have a variety of nonpharmacologic options that preserve clinically important effects 3.5 years after the treatments end,” wrote lead author Stephen P. Messier, PhD, professor and director of the J.B. Snow Biomechanics Laboratory at Wake Forest University, Winston-Salem, N.C.

The study involved patients with overweight or obesity aged 55 years or older who were previously enrolled in the 1.5-year Intensive Diet and Exercise for Arthritis (IDEA) trial.

“You have to remember, this is 3.5 years after the IDEA trial ended,” Dr. Messier said in an interview. “There was no contact with them for that entire time; you’d expect, based on the literature, that they’d revert back to where they were before they entered the trial. And certainly, there was some regression, there was some weight regain, but the important part of the study is that, even after 3.5 years, and even with some weight regain, there were some clinically important effects that lasted.”

Dr. Stephen P. Messier

“What we feel now is that if we can somehow prepare people better for that time after they finish a weight loss intervention, from a psychological standpoint, it will make a real difference,” he added. “We are very good at helping people have the confidence to lose weight. But having the confidence to lose weight is totally different than having confidence to maintain weight loss. If we can give folks an intervention that has a psychological component, hopefully we can increase their confidence to maintain the weight loss that they attained.”
 

Study details

Of the 184 participants who were contacted for a follow-up visit, 94 consented to participate, 67% of whom were females and 88% of whom were White. A total of 27 participants had completed the diet and exercise intervention, and another 35 completed the diet-only and 32 exercise-only interventions.

In the 3.5-year period between the IDEA trial’s end and follow-up, body weight increased by 5.9 kg in the diet and exercise group (P < .0001) and by 3.1 kg in the diet-only group (P = .0006) but decreased in the exercise-only group by 1.0 kg (P = .25). However, from baseline to 5-year follow-up, all groups saw a reduction in body weight. Mean weight loss was –3.7 kg for the diet and exercise group (P = .0007), –5.8 kg for the diet group (P < .0001), and –2.9 kg for the exercise group (P = .003). Body mass index also decreased in all groups: by –1.2 kg/m2 in the diet and exercise group (P = .001), by –2.0 kg/m2 in the diet group (P < .0001), and by –1.0 kg/m2 in the exercise group (P = .004).

Pain – as measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score – was reduced in all groups across 5-year follow-up: –1.2 (P = .03) for the diet and exercise group, –1.5 (P = .001) for the diet-only group, and –1.6 (P = .0008) for the exercise-only group. WOMAC function also significantly improved relative to baseline by 6.2 (P = .0001) in the diet and exercise group, by 6.1 (P < .0001) in the diet group, and by 3.7 (P = .01) in the exercise-only group.
 

 

 

Finding time to advise on weight loss, exercise

“If exercise and weight loss were easy, this country wouldn’t be in the state we’re in,” Tuhina Neogi, MD, PhD, of Boston University said in an interview. “Shared decision-making and personalized medicine are important; unfortunately, for the majority of physicians – particularly primary care physicians, where a good deal of OA management is undertaken – they don’t have a lot of time in their 20 minutes with a patient who has OA to counsel individuals toward a healthy weight and physical activity program when they’re also addressing common comorbidities seen in OA such as diabetes and heart disease.

Dr. Tuhina Neogi

“But as we know,” she added, “when you do address weight loss and physical activity, it has wide-ranging health benefits. This study provides support for utilizing formal diet and exercise programs to achieve important and durable benefits for people with OA.”

Dr. Neogi did note one of the study’s acknowledged limitations: Only slightly more than half of the contacted participants returned for follow-up. Though the authors stated that the individuals who returned were representative of both the pool of potential participants and the IDEA cohort as a whole, “we don’t want to make too many inferences when you don’t have the whole study population available,” she said. “The people who have agreed to come back 3.5 years later for follow-up testing, maybe they are a little more health conscious, more resilient. Those people might be systematically different than the people who [did not return], even though most of the factors were not statistically different between the groups.

“Whatever positive attributes they may have, though, we need to understand more about them,” she added. “We need to know how they maintained the benefits they had 3.5 years prior. That kind of understanding is important to inform long-term strategies in OA management.”



Dr. Messier highlighted a related, ongoing study he’s leading in which more than 800 overweight patients in North Carolina who suffer from knee pain are being led through diet and exercise interventions in a community setting. The goal is to replicate the IDEA results outside of a clinical trial setting and show skeptical physicians that diet and exercise can be enacted and maintained in this subset of patients.

“I think we know how effective weight loss is, especially when combined with exercise, in reducing pain, improving function, improving quality of life in these patients,” he said. “The next step is to allow them to maintain those benefits for a long period of time after the intervention ends.”

The study was supported by grants from the National Institutes of Health and by General Nutrition Centers. Its authors reported no potential conflicts of interest.

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FROM ARTHRITIS CARE & RESEARCH

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HBV screening often incomplete or forgone when starting tocilizumab, tofacitinib

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Tue, 02/07/2023 - 16:44

People beginning treatment with the immunosuppressive drugs tocilizumab (Actemra) or tofacitinib (Xeljanz) are infrequently screened for hepatitis B virus (HBV) infection, according to a new study of patients with rheumatic diseases who are starting one of the two treatments.

“Perhaps not unexpectedly, these screening patterns conform more with recommendations from the American College of Rheumatology, which do not explicitly stipulate universal HBV screening,” wrote lead author Amir M. Mohareb, MD, of Massachusetts General Hospital in Boston. The study was published in The Journal of Rheumatology.

To determine the frequency of HBV screening among this specific population, the researchers conducted a retrospective, cross-sectional study of patients 18 years or older within the Mass General Brigham health system in the Boston area who initiated either of the two drugs before Dec. 31, 2018. Tocilizumab was approved by the Food and Drug Administration on Jan. 11, 2010, and tofacitinib was approved on Nov. 6, 2012.



The final study population included 678 patients on tocilizumab and 391 patients on tofacitinib. The mean age of the patients in each group was 61 years for tocilizumab and 60 years for tofacitinib. A large majority were female (78% of the tocilizumab group, 88% of the tofacitinib group) and 84% of patients in both groups were white. Their primary diagnosis was rheumatoid arthritis (53% of the tocilizumab group, 77% of the tofacitinib group), and most of them – 57% of patients on tocilizumab and 72% of patients on tofacitinib – had a history of being on both conventional synthetic and biologic disease-modifying antirheumatic drugs (DMARDs).

HBV screening patterns were classified into three categories: complete (all three of the HBV surface antigen [HBsAg], total core antibody [anti-HBcAb], and surface antibody [HBsAb] tests); partial (any one to two tests); and none. Of the 678 patients on tocilizumab, 194 (29%) underwent complete screening, 307 (45%) underwent partial screening, and 177 (26%) had no screening. Of the 391 patients on tofacitinib, 94 (24%) underwent complete screening, 195 (50%) underwent partial screening, and 102 (26%) had none.

Inappropriate testing – defined as either HBV e-antigen (HBeAg), anti-HBcAb IgM, or HBV DNA without a positive HBsAg or total anti-HBcAb – occurred in 22% of patients on tocilizumab and 23% of patients on tofacitinib. After multivariable analysis, the authors found that Whites were less likely to undergo complete screening (odds ratio, 0.74; 95% confidence interval, 0.57-0.95) compared to non-Whites. Previous use of immunosuppressive agents such as conventional synthetic DMARDs (OR, 1.05; 95% CI, 0.72-1.55) and biologic DMARDs with or without prior csDMARDs (OR, 0.73; 95% CI, 0.48-1.12) was not associated with a likelihood of complete appropriate screening.

Dr. Gabriela Schmajuk

“These data add to the evidence indicating that clinicians are not completing pretreatment screening for latent infections prior to patients starting high-risk immunosuppressant drugs,” Gabriela Schmajuk, MD, of the University of California, San Francisco, said in an interview. “It can be dangerous, since a fraction of these patients may reactivate latent infections with HBV that can result in liver failure or death.

“On the bright side,” she added, “we have antivirals that can be given as prophylaxis against reactivation of latent HBV if patients do test positive.”

Dr. Schmajuk was previously the senior author of a similar study from the 2019 American College of Rheumatology annual meeting that found only a small percentage of patients who were new users of biologics or new synthetic DMARDs were screened for HBV or hepatitis C virus.

When asked if anything in the study stood out, she acknowledged being “somewhat surprised that patients with prior immunosuppression did not have higher rates of screening. One might expect that since those patients had more opportunities for screening – since they started new medications more times – they would have higher rates, but this did not appear to be the case.”

As a message to rheumatologists who may be starting their patients on any biologic or new synthetic DMARD, she reinforced that “we need universal HBV screening for patients starting these medications. Many clinicians are used to ordering a hepatitis B surface antigen test, but one key message is that we also need to be ordering hepatitis B core antibody tests. Patients with a positive core antibody are still at risk for reactivation.”

The authors noted their study’s limitations, including the data being retrospectively collected and some of the subjects potentially being screened in laboratories outside of the Mass General Brigham health system. In addition, they stated that their findings “may not be generalizable to nonrheumatologic settings or other immunomodulators,” although they added that studies of other patient populations have also uncovered “similarly low HBV screening frequencies.”

Several of the authors reported being supported by institutes within the National Institutes of Health. Beyond that, they declared no potential conflicts of interest.

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People beginning treatment with the immunosuppressive drugs tocilizumab (Actemra) or tofacitinib (Xeljanz) are infrequently screened for hepatitis B virus (HBV) infection, according to a new study of patients with rheumatic diseases who are starting one of the two treatments.

“Perhaps not unexpectedly, these screening patterns conform more with recommendations from the American College of Rheumatology, which do not explicitly stipulate universal HBV screening,” wrote lead author Amir M. Mohareb, MD, of Massachusetts General Hospital in Boston. The study was published in The Journal of Rheumatology.

To determine the frequency of HBV screening among this specific population, the researchers conducted a retrospective, cross-sectional study of patients 18 years or older within the Mass General Brigham health system in the Boston area who initiated either of the two drugs before Dec. 31, 2018. Tocilizumab was approved by the Food and Drug Administration on Jan. 11, 2010, and tofacitinib was approved on Nov. 6, 2012.



The final study population included 678 patients on tocilizumab and 391 patients on tofacitinib. The mean age of the patients in each group was 61 years for tocilizumab and 60 years for tofacitinib. A large majority were female (78% of the tocilizumab group, 88% of the tofacitinib group) and 84% of patients in both groups were white. Their primary diagnosis was rheumatoid arthritis (53% of the tocilizumab group, 77% of the tofacitinib group), and most of them – 57% of patients on tocilizumab and 72% of patients on tofacitinib – had a history of being on both conventional synthetic and biologic disease-modifying antirheumatic drugs (DMARDs).

HBV screening patterns were classified into three categories: complete (all three of the HBV surface antigen [HBsAg], total core antibody [anti-HBcAb], and surface antibody [HBsAb] tests); partial (any one to two tests); and none. Of the 678 patients on tocilizumab, 194 (29%) underwent complete screening, 307 (45%) underwent partial screening, and 177 (26%) had no screening. Of the 391 patients on tofacitinib, 94 (24%) underwent complete screening, 195 (50%) underwent partial screening, and 102 (26%) had none.

Inappropriate testing – defined as either HBV e-antigen (HBeAg), anti-HBcAb IgM, or HBV DNA without a positive HBsAg or total anti-HBcAb – occurred in 22% of patients on tocilizumab and 23% of patients on tofacitinib. After multivariable analysis, the authors found that Whites were less likely to undergo complete screening (odds ratio, 0.74; 95% confidence interval, 0.57-0.95) compared to non-Whites. Previous use of immunosuppressive agents such as conventional synthetic DMARDs (OR, 1.05; 95% CI, 0.72-1.55) and biologic DMARDs with or without prior csDMARDs (OR, 0.73; 95% CI, 0.48-1.12) was not associated with a likelihood of complete appropriate screening.

Dr. Gabriela Schmajuk

“These data add to the evidence indicating that clinicians are not completing pretreatment screening for latent infections prior to patients starting high-risk immunosuppressant drugs,” Gabriela Schmajuk, MD, of the University of California, San Francisco, said in an interview. “It can be dangerous, since a fraction of these patients may reactivate latent infections with HBV that can result in liver failure or death.

“On the bright side,” she added, “we have antivirals that can be given as prophylaxis against reactivation of latent HBV if patients do test positive.”

Dr. Schmajuk was previously the senior author of a similar study from the 2019 American College of Rheumatology annual meeting that found only a small percentage of patients who were new users of biologics or new synthetic DMARDs were screened for HBV or hepatitis C virus.

When asked if anything in the study stood out, she acknowledged being “somewhat surprised that patients with prior immunosuppression did not have higher rates of screening. One might expect that since those patients had more opportunities for screening – since they started new medications more times – they would have higher rates, but this did not appear to be the case.”

As a message to rheumatologists who may be starting their patients on any biologic or new synthetic DMARD, she reinforced that “we need universal HBV screening for patients starting these medications. Many clinicians are used to ordering a hepatitis B surface antigen test, but one key message is that we also need to be ordering hepatitis B core antibody tests. Patients with a positive core antibody are still at risk for reactivation.”

The authors noted their study’s limitations, including the data being retrospectively collected and some of the subjects potentially being screened in laboratories outside of the Mass General Brigham health system. In addition, they stated that their findings “may not be generalizable to nonrheumatologic settings or other immunomodulators,” although they added that studies of other patient populations have also uncovered “similarly low HBV screening frequencies.”

Several of the authors reported being supported by institutes within the National Institutes of Health. Beyond that, they declared no potential conflicts of interest.

People beginning treatment with the immunosuppressive drugs tocilizumab (Actemra) or tofacitinib (Xeljanz) are infrequently screened for hepatitis B virus (HBV) infection, according to a new study of patients with rheumatic diseases who are starting one of the two treatments.

“Perhaps not unexpectedly, these screening patterns conform more with recommendations from the American College of Rheumatology, which do not explicitly stipulate universal HBV screening,” wrote lead author Amir M. Mohareb, MD, of Massachusetts General Hospital in Boston. The study was published in The Journal of Rheumatology.

To determine the frequency of HBV screening among this specific population, the researchers conducted a retrospective, cross-sectional study of patients 18 years or older within the Mass General Brigham health system in the Boston area who initiated either of the two drugs before Dec. 31, 2018. Tocilizumab was approved by the Food and Drug Administration on Jan. 11, 2010, and tofacitinib was approved on Nov. 6, 2012.



The final study population included 678 patients on tocilizumab and 391 patients on tofacitinib. The mean age of the patients in each group was 61 years for tocilizumab and 60 years for tofacitinib. A large majority were female (78% of the tocilizumab group, 88% of the tofacitinib group) and 84% of patients in both groups were white. Their primary diagnosis was rheumatoid arthritis (53% of the tocilizumab group, 77% of the tofacitinib group), and most of them – 57% of patients on tocilizumab and 72% of patients on tofacitinib – had a history of being on both conventional synthetic and biologic disease-modifying antirheumatic drugs (DMARDs).

HBV screening patterns were classified into three categories: complete (all three of the HBV surface antigen [HBsAg], total core antibody [anti-HBcAb], and surface antibody [HBsAb] tests); partial (any one to two tests); and none. Of the 678 patients on tocilizumab, 194 (29%) underwent complete screening, 307 (45%) underwent partial screening, and 177 (26%) had no screening. Of the 391 patients on tofacitinib, 94 (24%) underwent complete screening, 195 (50%) underwent partial screening, and 102 (26%) had none.

Inappropriate testing – defined as either HBV e-antigen (HBeAg), anti-HBcAb IgM, or HBV DNA without a positive HBsAg or total anti-HBcAb – occurred in 22% of patients on tocilizumab and 23% of patients on tofacitinib. After multivariable analysis, the authors found that Whites were less likely to undergo complete screening (odds ratio, 0.74; 95% confidence interval, 0.57-0.95) compared to non-Whites. Previous use of immunosuppressive agents such as conventional synthetic DMARDs (OR, 1.05; 95% CI, 0.72-1.55) and biologic DMARDs with or without prior csDMARDs (OR, 0.73; 95% CI, 0.48-1.12) was not associated with a likelihood of complete appropriate screening.

Dr. Gabriela Schmajuk

“These data add to the evidence indicating that clinicians are not completing pretreatment screening for latent infections prior to patients starting high-risk immunosuppressant drugs,” Gabriela Schmajuk, MD, of the University of California, San Francisco, said in an interview. “It can be dangerous, since a fraction of these patients may reactivate latent infections with HBV that can result in liver failure or death.

“On the bright side,” she added, “we have antivirals that can be given as prophylaxis against reactivation of latent HBV if patients do test positive.”

Dr. Schmajuk was previously the senior author of a similar study from the 2019 American College of Rheumatology annual meeting that found only a small percentage of patients who were new users of biologics or new synthetic DMARDs were screened for HBV or hepatitis C virus.

When asked if anything in the study stood out, she acknowledged being “somewhat surprised that patients with prior immunosuppression did not have higher rates of screening. One might expect that since those patients had more opportunities for screening – since they started new medications more times – they would have higher rates, but this did not appear to be the case.”

As a message to rheumatologists who may be starting their patients on any biologic or new synthetic DMARD, she reinforced that “we need universal HBV screening for patients starting these medications. Many clinicians are used to ordering a hepatitis B surface antigen test, but one key message is that we also need to be ordering hepatitis B core antibody tests. Patients with a positive core antibody are still at risk for reactivation.”

The authors noted their study’s limitations, including the data being retrospectively collected and some of the subjects potentially being screened in laboratories outside of the Mass General Brigham health system. In addition, they stated that their findings “may not be generalizable to nonrheumatologic settings or other immunomodulators,” although they added that studies of other patient populations have also uncovered “similarly low HBV screening frequencies.”

Several of the authors reported being supported by institutes within the National Institutes of Health. Beyond that, they declared no potential conflicts of interest.

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COVID-19 vaccination does not increase risk of flare in patients with lupus

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Thu, 08/26/2021 - 15:44

 

COVID-19 vaccinations appear to be well tolerated in patients with systemic lupus erythematosus (SLE) and come with a low risk of flare, according to the results of a global, web-based survey.

Steve Mann/Thinkstock

“Disseminating these reassuring data might prove crucial to increasing vaccine coverage in patients with SLE,” wrote lead author Renaud Felten, MD, of Strasbourg (France) University Hospital. Their results were published as a comment in Lancet Rheumatology.

To assess vaccine tolerability among lupus patients, the cross-sectional Tolerance and Consequences of Vaccination Against COVID-19 in Lupus Patients (VACOLUP) study analyzed a 43-question survey of 696 participants with a self-reported, medically confirmed diagnosis of SLE from 30 countries between March 22, 2021, and May 17, 2021. The cohort was 96% women, and their median age was 42 (interquartile range, 34-51). Nearly 36% of respondents were from Italy, 27% were from Chile, 13% were from France, and just under 9% were Americans. All participants received at least one dose of COVID-19 vaccine, and 49% received a second dose. The most common vaccines were Pfizer-BioNTech (57%), Sinovac (22%), AstraZeneca (10%), and Moderna (8%).



Only 21 participants (3%) reported a medically confirmed SLE flare after a median of 3 days (IQR, 0-29) post COVID vaccination, with most experiencing musculoskeletal symptoms (90%) and fatigue (86%). Of the 21 cases, 15 reported a subsequent change in SLE treatment and 4 were admitted to the hospital. A previous flare that occurred within a year before vaccination was associated with an increased risk of flare post vaccination (relative risk, 5.52; 95% confidence interval, 2.17-14.03; P < .0001).

Side effects – including swelling, soreness, fever, chills, fatigue, joint and muscle pain, nausea, and headache – were reported in 45% of participants (n = 316) after their first dose and in 53% of the 343 participants who received a second dose. There was no notable difference in the likelihood of side effects across gender and age or in patients who received mRNA vaccines, compared with vaccines with other modes of action. Patients who reported side effects after the first dose were more likely to also report them after the second, compared with those who reported none (109 [81%] of 135 vs. 72 [35%] of 205; RR, 2.30; 95% CI, 1.88-2.82; P < .0001).

In the majority of cases (2,232 of 2,683), the side effects were of minor or moderate intensity and did not affect the participants’ ability to perform daily tasks. The study found no significant association between side effects and a SLE flare and SLE medications or previous SLE disease manifestations.

Dr. Amit Saxena

When asked to comment on the study, Amit Saxena, MD, of the Lupus Center at New York University Langone Health, said: “What we are seeing is pretty mild to moderate in terms of follow-up side effects or lupus-related activity. Several studies have shown this amongst our autoimmune rheumatology cohort, as well as what I’ve seen clinically in my own patients. More than anything else, numbers are the most important, and this is a large study.”

He acknowledged the benefits of going directly to patients to gauge their responses and reactions, giving them the opportunity to share concerns that physicians may not think about.

“As rheumatologists, we tend to focus on certain things that might not necessarily be what the patients themselves focus on,” he said. “I think the fact that this questionnaire dealt with a lot of what people complain about – fatigue, sore arm, things that we know are part of getting the vaccine – they aren’t necessarily things we capture with tools that screen for lupus flares, for example.”



More than anything, Dr. Saxena commended the study’s timeliness. “Patients are constantly asking us about the vaccine, and there’s so much misinformation,” he said. “People say, ‘Because I have lupus, I was told not to get vaccinated.’ I don’t know where they get that information from; we are telling everyone to get it, especially our lupus patients.”

The authors recognized their study’s main limitation as the self-reported and subjective nature of the survey, which they attempted to mitigate by asking for medically confirmed flares only. They noted, however, that the short median time between vaccination and flare onset could be caused by patients confusing expected side effects for something more serious, meaning the 3% figure “could be an overestimation of the actual flare rate.”

“Vaccination is recommended for patients with rheumatic and musculoskeletal diseases according to the American College of Rheumatology,” they added, “irrespective of disease activity and severity.”

Several authors reported potential conflicts of interest, including receiving consultancy fees and grants from Pfizer, GlaxoSmithKline, AbbVie, and Janssen, all unrelated to the study.

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COVID-19 vaccinations appear to be well tolerated in patients with systemic lupus erythematosus (SLE) and come with a low risk of flare, according to the results of a global, web-based survey.

Steve Mann/Thinkstock

“Disseminating these reassuring data might prove crucial to increasing vaccine coverage in patients with SLE,” wrote lead author Renaud Felten, MD, of Strasbourg (France) University Hospital. Their results were published as a comment in Lancet Rheumatology.

To assess vaccine tolerability among lupus patients, the cross-sectional Tolerance and Consequences of Vaccination Against COVID-19 in Lupus Patients (VACOLUP) study analyzed a 43-question survey of 696 participants with a self-reported, medically confirmed diagnosis of SLE from 30 countries between March 22, 2021, and May 17, 2021. The cohort was 96% women, and their median age was 42 (interquartile range, 34-51). Nearly 36% of respondents were from Italy, 27% were from Chile, 13% were from France, and just under 9% were Americans. All participants received at least one dose of COVID-19 vaccine, and 49% received a second dose. The most common vaccines were Pfizer-BioNTech (57%), Sinovac (22%), AstraZeneca (10%), and Moderna (8%).



Only 21 participants (3%) reported a medically confirmed SLE flare after a median of 3 days (IQR, 0-29) post COVID vaccination, with most experiencing musculoskeletal symptoms (90%) and fatigue (86%). Of the 21 cases, 15 reported a subsequent change in SLE treatment and 4 were admitted to the hospital. A previous flare that occurred within a year before vaccination was associated with an increased risk of flare post vaccination (relative risk, 5.52; 95% confidence interval, 2.17-14.03; P < .0001).

Side effects – including swelling, soreness, fever, chills, fatigue, joint and muscle pain, nausea, and headache – were reported in 45% of participants (n = 316) after their first dose and in 53% of the 343 participants who received a second dose. There was no notable difference in the likelihood of side effects across gender and age or in patients who received mRNA vaccines, compared with vaccines with other modes of action. Patients who reported side effects after the first dose were more likely to also report them after the second, compared with those who reported none (109 [81%] of 135 vs. 72 [35%] of 205; RR, 2.30; 95% CI, 1.88-2.82; P < .0001).

In the majority of cases (2,232 of 2,683), the side effects were of minor or moderate intensity and did not affect the participants’ ability to perform daily tasks. The study found no significant association between side effects and a SLE flare and SLE medications or previous SLE disease manifestations.

Dr. Amit Saxena

When asked to comment on the study, Amit Saxena, MD, of the Lupus Center at New York University Langone Health, said: “What we are seeing is pretty mild to moderate in terms of follow-up side effects or lupus-related activity. Several studies have shown this amongst our autoimmune rheumatology cohort, as well as what I’ve seen clinically in my own patients. More than anything else, numbers are the most important, and this is a large study.”

He acknowledged the benefits of going directly to patients to gauge their responses and reactions, giving them the opportunity to share concerns that physicians may not think about.

“As rheumatologists, we tend to focus on certain things that might not necessarily be what the patients themselves focus on,” he said. “I think the fact that this questionnaire dealt with a lot of what people complain about – fatigue, sore arm, things that we know are part of getting the vaccine – they aren’t necessarily things we capture with tools that screen for lupus flares, for example.”



More than anything, Dr. Saxena commended the study’s timeliness. “Patients are constantly asking us about the vaccine, and there’s so much misinformation,” he said. “People say, ‘Because I have lupus, I was told not to get vaccinated.’ I don’t know where they get that information from; we are telling everyone to get it, especially our lupus patients.”

The authors recognized their study’s main limitation as the self-reported and subjective nature of the survey, which they attempted to mitigate by asking for medically confirmed flares only. They noted, however, that the short median time between vaccination and flare onset could be caused by patients confusing expected side effects for something more serious, meaning the 3% figure “could be an overestimation of the actual flare rate.”

“Vaccination is recommended for patients with rheumatic and musculoskeletal diseases according to the American College of Rheumatology,” they added, “irrespective of disease activity and severity.”

Several authors reported potential conflicts of interest, including receiving consultancy fees and grants from Pfizer, GlaxoSmithKline, AbbVie, and Janssen, all unrelated to the study.

 

COVID-19 vaccinations appear to be well tolerated in patients with systemic lupus erythematosus (SLE) and come with a low risk of flare, according to the results of a global, web-based survey.

Steve Mann/Thinkstock

“Disseminating these reassuring data might prove crucial to increasing vaccine coverage in patients with SLE,” wrote lead author Renaud Felten, MD, of Strasbourg (France) University Hospital. Their results were published as a comment in Lancet Rheumatology.

To assess vaccine tolerability among lupus patients, the cross-sectional Tolerance and Consequences of Vaccination Against COVID-19 in Lupus Patients (VACOLUP) study analyzed a 43-question survey of 696 participants with a self-reported, medically confirmed diagnosis of SLE from 30 countries between March 22, 2021, and May 17, 2021. The cohort was 96% women, and their median age was 42 (interquartile range, 34-51). Nearly 36% of respondents were from Italy, 27% were from Chile, 13% were from France, and just under 9% were Americans. All participants received at least one dose of COVID-19 vaccine, and 49% received a second dose. The most common vaccines were Pfizer-BioNTech (57%), Sinovac (22%), AstraZeneca (10%), and Moderna (8%).



Only 21 participants (3%) reported a medically confirmed SLE flare after a median of 3 days (IQR, 0-29) post COVID vaccination, with most experiencing musculoskeletal symptoms (90%) and fatigue (86%). Of the 21 cases, 15 reported a subsequent change in SLE treatment and 4 were admitted to the hospital. A previous flare that occurred within a year before vaccination was associated with an increased risk of flare post vaccination (relative risk, 5.52; 95% confidence interval, 2.17-14.03; P < .0001).

Side effects – including swelling, soreness, fever, chills, fatigue, joint and muscle pain, nausea, and headache – were reported in 45% of participants (n = 316) after their first dose and in 53% of the 343 participants who received a second dose. There was no notable difference in the likelihood of side effects across gender and age or in patients who received mRNA vaccines, compared with vaccines with other modes of action. Patients who reported side effects after the first dose were more likely to also report them after the second, compared with those who reported none (109 [81%] of 135 vs. 72 [35%] of 205; RR, 2.30; 95% CI, 1.88-2.82; P < .0001).

In the majority of cases (2,232 of 2,683), the side effects were of minor or moderate intensity and did not affect the participants’ ability to perform daily tasks. The study found no significant association between side effects and a SLE flare and SLE medications or previous SLE disease manifestations.

Dr. Amit Saxena

When asked to comment on the study, Amit Saxena, MD, of the Lupus Center at New York University Langone Health, said: “What we are seeing is pretty mild to moderate in terms of follow-up side effects or lupus-related activity. Several studies have shown this amongst our autoimmune rheumatology cohort, as well as what I’ve seen clinically in my own patients. More than anything else, numbers are the most important, and this is a large study.”

He acknowledged the benefits of going directly to patients to gauge their responses and reactions, giving them the opportunity to share concerns that physicians may not think about.

“As rheumatologists, we tend to focus on certain things that might not necessarily be what the patients themselves focus on,” he said. “I think the fact that this questionnaire dealt with a lot of what people complain about – fatigue, sore arm, things that we know are part of getting the vaccine – they aren’t necessarily things we capture with tools that screen for lupus flares, for example.”



More than anything, Dr. Saxena commended the study’s timeliness. “Patients are constantly asking us about the vaccine, and there’s so much misinformation,” he said. “People say, ‘Because I have lupus, I was told not to get vaccinated.’ I don’t know where they get that information from; we are telling everyone to get it, especially our lupus patients.”

The authors recognized their study’s main limitation as the self-reported and subjective nature of the survey, which they attempted to mitigate by asking for medically confirmed flares only. They noted, however, that the short median time between vaccination and flare onset could be caused by patients confusing expected side effects for something more serious, meaning the 3% figure “could be an overestimation of the actual flare rate.”

“Vaccination is recommended for patients with rheumatic and musculoskeletal diseases according to the American College of Rheumatology,” they added, “irrespective of disease activity and severity.”

Several authors reported potential conflicts of interest, including receiving consultancy fees and grants from Pfizer, GlaxoSmithKline, AbbVie, and Janssen, all unrelated to the study.

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