Conference Coverage

A gene expression signature may help physicians diagnose endometriosis by analyzing samples from endometrial biopsies instead of relying on more invasive methods, research suggests.

Yana B. Aznaurova, MD, and colleagues identified and validated a genetic biomarker based on differences in the endometrium of women with and without endometriosis. The biomarker is based on five genes that were down-regulated in patients with the disease.

Endometriosis is an enigmatic gynecologic disease that is associated with chronic pelvic pain, dyspareunia, and dysmenorrhea, said Dr. Aznaurova, of the department of reproductive medicine and surgery at A.I. Evdokimov Moscow State Medical and Dental University. Laparoscopy with histological confirmation is the standard method of diagnosis.

“Development of minimally invasive or even noninvasive diagnostic tests is a research priority in endometriosis,” she said at the meeting sponsored by the American Association of Gynecologic Laparoscopists, held virtually this year.

Attempts to identify biomarkers have tended to focus on single genes or proteins, but “endometriosis is a ... multifactorial disease,” said Dr. Aznaurova. Researchers have found that signaling pathway activation profiles are a more stable and reliable marker of some diseases.

To validate a complex gene expression biomarker for the diagnosis of endometriosis, the researchers conducted an observational cohort study that included 50 women with endometriosis and 35 controls. The patients with endometriosis were 18-49 years old, had not received hormone therapy in the past year, and did not have other gynecologic diseases. Patients in the control group had uterine scar incompetence after cesarean section, but did not have endometriosis or other gynecologic disease.

Investigators performed RNA sequencing of endometrial samples, including 50 eutopic and 50 ectopic samples from patients with endometriosis, and 35 samples from patients in the control group.

They analyzed gene expression and intracellular pathway activation profiles to identify an endometrial gene expression signature that differentiated samples from patients with and without the disease, with an area under the receiver operating characteristic curve of approximately 0.99.

The researchers further studied the biomarker using preexisting datasets with 120 other tissue samples, including from the cervix, ovarian surface epithelium, stomach, and lung. The biomarker had a sensitivity of 94% and specificity of 97% for endometriosis in these analyses.

The results suggest that the genetic biomarker “could be potentially used as a basis for early diagnosis of endometriosis via utilization of endometrial biopsy only,” Dr. Aznaurova said.

Further studies are needed to validate these findings, she noted.

“If we had a noninvasive way to look for endometriosis, this would be very powerful – very important as potentially a diagnostic test, or a triage test, or a monitoring test of treatment,” Patrick P. Yeung Jr., MD, said in a discussion following Dr. Aznaurova’s presentation.

The test might even suggest a target for treatment, said Dr. Yeung, professor of obstetrics, gynecology, and women’s health at Saint Louis University.

Dr. Aznaurova and Dr. Yeung had no relevant financial disclosures.
 

jremaly@mdedge.com

SOURCE: Aznaurova YB et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.040.

A gene expression signature may help physicians diagnose endometriosis by analyzing samples from endometrial biopsies instead of relying on more invasive methods, research suggests.

Yana B. Aznaurova, MD, and colleagues identified and validated a genetic biomarker based on differences in the endometrium of women with and without endometriosis. The biomarker is based on five genes that were down-regulated in patients with the disease.

Endometriosis is an enigmatic gynecologic disease that is associated with chronic pelvic pain, dyspareunia, and dysmenorrhea, said Dr. Aznaurova, of the department of reproductive medicine and surgery at A.I. Evdokimov Moscow State Medical and Dental University. Laparoscopy with histological confirmation is the standard method of diagnosis.

“Development of minimally invasive or even noninvasive diagnostic tests is a research priority in endometriosis,” she said at the meeting sponsored by the American Association of Gynecologic Laparoscopists, held virtually this year.

Attempts to identify biomarkers have tended to focus on single genes or proteins, but “endometriosis is a ... multifactorial disease,” said Dr. Aznaurova. Researchers have found that signaling pathway activation profiles are a more stable and reliable marker of some diseases.

To validate a complex gene expression biomarker for the diagnosis of endometriosis, the researchers conducted an observational cohort study that included 50 women with endometriosis and 35 controls. The patients with endometriosis were 18-49 years old, had not received hormone therapy in the past year, and did not have other gynecologic diseases. Patients in the control group had uterine scar incompetence after cesarean section, but did not have endometriosis or other gynecologic disease.

Investigators performed RNA sequencing of endometrial samples, including 50 eutopic and 50 ectopic samples from patients with endometriosis, and 35 samples from patients in the control group.

They analyzed gene expression and intracellular pathway activation profiles to identify an endometrial gene expression signature that differentiated samples from patients with and without the disease, with an area under the receiver operating characteristic curve of approximately 0.99.

The researchers further studied the biomarker using preexisting datasets with 120 other tissue samples, including from the cervix, ovarian surface epithelium, stomach, and lung. The biomarker had a sensitivity of 94% and specificity of 97% for endometriosis in these analyses.

The results suggest that the genetic biomarker “could be potentially used as a basis for early diagnosis of endometriosis via utilization of endometrial biopsy only,” Dr. Aznaurova said.

Further studies are needed to validate these findings, she noted.

“If we had a noninvasive way to look for endometriosis, this would be very powerful – very important as potentially a diagnostic test, or a triage test, or a monitoring test of treatment,” Patrick P. Yeung Jr., MD, said in a discussion following Dr. Aznaurova’s presentation.

The test might even suggest a target for treatment, said Dr. Yeung, professor of obstetrics, gynecology, and women’s health at Saint Louis University.

Dr. Aznaurova and Dr. Yeung had no relevant financial disclosures.
 

jremaly@mdedge.com

SOURCE: Aznaurova YB et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.040.

A gene expression signature may help physicians diagnose endometriosis by analyzing samples from endometrial biopsies instead of relying on more invasive methods, research suggests.

Yana B. Aznaurova, MD, and colleagues identified and validated a genetic biomarker based on differences in the endometrium of women with and without endometriosis. The biomarker is based on five genes that were down-regulated in patients with the disease.

Endometriosis is an enigmatic gynecologic disease that is associated with chronic pelvic pain, dyspareunia, and dysmenorrhea, said Dr. Aznaurova, of the department of reproductive medicine and surgery at A.I. Evdokimov Moscow State Medical and Dental University. Laparoscopy with histological confirmation is the standard method of diagnosis.

“Development of minimally invasive or even noninvasive diagnostic tests is a research priority in endometriosis,” she said at the meeting sponsored by the American Association of Gynecologic Laparoscopists, held virtually this year.

Attempts to identify biomarkers have tended to focus on single genes or proteins, but “endometriosis is a ... multifactorial disease,” said Dr. Aznaurova. Researchers have found that signaling pathway activation profiles are a more stable and reliable marker of some diseases.

To validate a complex gene expression biomarker for the diagnosis of endometriosis, the researchers conducted an observational cohort study that included 50 women with endometriosis and 35 controls. The patients with endometriosis were 18-49 years old, had not received hormone therapy in the past year, and did not have other gynecologic diseases. Patients in the control group had uterine scar incompetence after cesarean section, but did not have endometriosis or other gynecologic disease.

Investigators performed RNA sequencing of endometrial samples, including 50 eutopic and 50 ectopic samples from patients with endometriosis, and 35 samples from patients in the control group.

They analyzed gene expression and intracellular pathway activation profiles to identify an endometrial gene expression signature that differentiated samples from patients with and without the disease, with an area under the receiver operating characteristic curve of approximately 0.99.

The researchers further studied the biomarker using preexisting datasets with 120 other tissue samples, including from the cervix, ovarian surface epithelium, stomach, and lung. The biomarker had a sensitivity of 94% and specificity of 97% for endometriosis in these analyses.

The results suggest that the genetic biomarker “could be potentially used as a basis for early diagnosis of endometriosis via utilization of endometrial biopsy only,” Dr. Aznaurova said.

Further studies are needed to validate these findings, she noted.

“If we had a noninvasive way to look for endometriosis, this would be very powerful – very important as potentially a diagnostic test, or a triage test, or a monitoring test of treatment,” Patrick P. Yeung Jr., MD, said in a discussion following Dr. Aznaurova’s presentation.

The test might even suggest a target for treatment, said Dr. Yeung, professor of obstetrics, gynecology, and women’s health at Saint Louis University.

Dr. Aznaurova and Dr. Yeung had no relevant financial disclosures.
 

jremaly@mdedge.com

SOURCE: Aznaurova YB et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.040.

In patients with RA whose disease is well controlled by methotrexate combined with etanercept, withdrawal of methotrexate led to long-term outcomes that were nearly as good as continuation of combination therapy. The finding comes from the randomized, controlled SEAM-RA trial that sought to address weaknesses of previous studies. It included a long lead-in time with stringent criteria to ensure that participants had very good disease control.

Courtesy University of Alabama at Birmingham

Both the American College of Rheumatology and the European League Against Rheumatism recommend tapering medication in RA patients who are in long-term remission, but there is no established optimal strategy.

“There have been some prior RA trials that have looked at therapy reduction or withdrawal, but most did not use a very stringent definition of how well people were when they began. Were they in remission, or only in low disease activity?” said Jeffrey R. Curtis, MD, during a presentation of the results at the virtual annual meeting of the ACR. The study was also published online Nov. 18 in Arthritis & Rheumatology.
 

Stringent remission criteria

The key feature of the trial was the 6-month run-in period, when subjects were taking 50 mg etanercept once per week and 10-25 mg of oral methotrexate once per week, and had to complete at least three visits. They were excluded from the ensuing randomization if they had a Simplified Disease Activity Index (SDAI) score >3.3 and ≤11 at two or more visits, had an SDAI >11 at any time during the run-in period, or had an SDAI >3.3 at the third run-in visit.

“We [wanted them] to be doing quite well for a long period of time. That was empirically confirmed under observation as part of the lead-in period, and even before that, the clinical investigator had to affirm that they believed the patient was doing well for 6 or more months even before they were screened to enter the trial,” said Dr. Curtis, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham.

Once enrolled in the trial, patients were randomized 2:2:1 to continuing etanercept only (n = 101), continuing methotrexate only (n = 101), or continuing both medications (n = 51). Patients were eligible for rescue after randomization if they had an SDAI score >11 at any time, SDAI between 3.3 and 11 on three separate visits, or between 3.3 and 11 at two consecutive visits at least 2 weeks apart. About three-quarters of patients in each treatment arm were female, with a mean age of about 55 years, and 82%-91% were White.

Good remission recovery with rescue therapy

At week 48, 28.7% of the methotrexate-only group were in remission (SDAI ≤3.3), compared with 49.5% of the etanercept-only group (P = .004) and 52.9% of the combination group (P = .006). Time to disease worsening was shorter in the methotrexate-only group (median, 198 days) than in the etanercept-only group (median, not estimable; P < .001) and the combined therapy group (median, not estimable; P < .001).

The researchers also found that most patients who underwent rescue therapy once again achieved remission, including 71% of the methotrexate-only group, 75% of the etanercept-only group, and 80% of the combination therapy group. There was no between-group differences in the time required to reattain remission.

The high rate of remission recovery was a good sign, Dr. Curtis said. “To me as a clinician, the risk to try [withdrawing a medication] is quite low because the likelihood you can regain where you were before is quite good. It’s obviously more successful if you stop methotrexate and continue etanercept than if you do the reverse, but to me, this is quite a practical trial, and in fact the rigor of the inclusion criteria are much more like the patients I’m talking to about stopping therapy than some of the past studies in this regard. I think it’s quite useful in terms of generalizability. We want people that are doing this well or close to it before we take away medication.”
 

Positive reactions from rheumatologists

The reaction from the viewing audience was also positive. “I think this study fills a big data gap for what we do in clinical practice,” wrote Janet Pope, MD, in comments during the session.

Dr. Pope, who is a professor of medicine at the University of Western Ontario and head of rheumatology at St. Joseph’s Health Centre, both in London, said that the results build on previous work, including the CAMEO study, which showed that discontinuation of methotrexate in patients taking methotrexate and etanercept failed to achieve noninferiority to continuation of both medications, and the PRIZE study, which showed that continuing combination therapy at a reduced dose led to better outcomes than did switching to methotrexate alone or placebo. “This may be for some patients what they prefer if they don’t tolerate methotrexate,” she added.

“It’s wonderful to have these data to counsel patients. This is something we face every day,” wrote Elizabeth Wahl, MD, who is an acting assistant professor at the University of Washington, Seattle, and acting chief of rheumatology at the VA Puget Sound Healthcare System.

The study was funded by Amgen. Dr. Curtis has received grants or research support from AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, and UCB. Dr. Pope consults for a variety of pharmaceutical companies. Dr. Wahl has no relevant financial disclosures.

SOURCE: Curtis JR et al. Arthritis Rheumatol. 2020;72(suppl 10), Abstract 0939.

In patients with RA whose disease is well controlled by methotrexate combined with etanercept, withdrawal of methotrexate led to long-term outcomes that were nearly as good as continuation of combination therapy. The finding comes from the randomized, controlled SEAM-RA trial that sought to address weaknesses of previous studies. It included a long lead-in time with stringent criteria to ensure that participants had very good disease control.

Courtesy University of Alabama at Birmingham

Both the American College of Rheumatology and the European League Against Rheumatism recommend tapering medication in RA patients who are in long-term remission, but there is no established optimal strategy.

“There have been some prior RA trials that have looked at therapy reduction or withdrawal, but most did not use a very stringent definition of how well people were when they began. Were they in remission, or only in low disease activity?” said Jeffrey R. Curtis, MD, during a presentation of the results at the virtual annual meeting of the ACR. The study was also published online Nov. 18 in Arthritis & Rheumatology.
 

Stringent remission criteria

The key feature of the trial was the 6-month run-in period, when subjects were taking 50 mg etanercept once per week and 10-25 mg of oral methotrexate once per week, and had to complete at least three visits. They were excluded from the ensuing randomization if they had a Simplified Disease Activity Index (SDAI) score >3.3 and ≤11 at two or more visits, had an SDAI >11 at any time during the run-in period, or had an SDAI >3.3 at the third run-in visit.

“We [wanted them] to be doing quite well for a long period of time. That was empirically confirmed under observation as part of the lead-in period, and even before that, the clinical investigator had to affirm that they believed the patient was doing well for 6 or more months even before they were screened to enter the trial,” said Dr. Curtis, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham.

Once enrolled in the trial, patients were randomized 2:2:1 to continuing etanercept only (n = 101), continuing methotrexate only (n = 101), or continuing both medications (n = 51). Patients were eligible for rescue after randomization if they had an SDAI score >11 at any time, SDAI between 3.3 and 11 on three separate visits, or between 3.3 and 11 at two consecutive visits at least 2 weeks apart. About three-quarters of patients in each treatment arm were female, with a mean age of about 55 years, and 82%-91% were White.

Good remission recovery with rescue therapy

At week 48, 28.7% of the methotrexate-only group were in remission (SDAI ≤3.3), compared with 49.5% of the etanercept-only group (P = .004) and 52.9% of the combination group (P = .006). Time to disease worsening was shorter in the methotrexate-only group (median, 198 days) than in the etanercept-only group (median, not estimable; P < .001) and the combined therapy group (median, not estimable; P < .001).

The researchers also found that most patients who underwent rescue therapy once again achieved remission, including 71% of the methotrexate-only group, 75% of the etanercept-only group, and 80% of the combination therapy group. There was no between-group differences in the time required to reattain remission.

The high rate of remission recovery was a good sign, Dr. Curtis said. “To me as a clinician, the risk to try [withdrawing a medication] is quite low because the likelihood you can regain where you were before is quite good. It’s obviously more successful if you stop methotrexate and continue etanercept than if you do the reverse, but to me, this is quite a practical trial, and in fact the rigor of the inclusion criteria are much more like the patients I’m talking to about stopping therapy than some of the past studies in this regard. I think it’s quite useful in terms of generalizability. We want people that are doing this well or close to it before we take away medication.”
 

Positive reactions from rheumatologists

The reaction from the viewing audience was also positive. “I think this study fills a big data gap for what we do in clinical practice,” wrote Janet Pope, MD, in comments during the session.

Dr. Pope, who is a professor of medicine at the University of Western Ontario and head of rheumatology at St. Joseph’s Health Centre, both in London, said that the results build on previous work, including the CAMEO study, which showed that discontinuation of methotrexate in patients taking methotrexate and etanercept failed to achieve noninferiority to continuation of both medications, and the PRIZE study, which showed that continuing combination therapy at a reduced dose led to better outcomes than did switching to methotrexate alone or placebo. “This may be for some patients what they prefer if they don’t tolerate methotrexate,” she added.

“It’s wonderful to have these data to counsel patients. This is something we face every day,” wrote Elizabeth Wahl, MD, who is an acting assistant professor at the University of Washington, Seattle, and acting chief of rheumatology at the VA Puget Sound Healthcare System.

The study was funded by Amgen. Dr. Curtis has received grants or research support from AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, and UCB. Dr. Pope consults for a variety of pharmaceutical companies. Dr. Wahl has no relevant financial disclosures.

SOURCE: Curtis JR et al. Arthritis Rheumatol. 2020;72(suppl 10), Abstract 0939.

In patients with RA whose disease is well controlled by methotrexate combined with etanercept, withdrawal of methotrexate led to long-term outcomes that were nearly as good as continuation of combination therapy. The finding comes from the randomized, controlled SEAM-RA trial that sought to address weaknesses of previous studies. It included a long lead-in time with stringent criteria to ensure that participants had very good disease control.

Courtesy University of Alabama at Birmingham

Both the American College of Rheumatology and the European League Against Rheumatism recommend tapering medication in RA patients who are in long-term remission, but there is no established optimal strategy.

“There have been some prior RA trials that have looked at therapy reduction or withdrawal, but most did not use a very stringent definition of how well people were when they began. Were they in remission, or only in low disease activity?” said Jeffrey R. Curtis, MD, during a presentation of the results at the virtual annual meeting of the ACR. The study was also published online Nov. 18 in Arthritis & Rheumatology.
 

Stringent remission criteria

The key feature of the trial was the 6-month run-in period, when subjects were taking 50 mg etanercept once per week and 10-25 mg of oral methotrexate once per week, and had to complete at least three visits. They were excluded from the ensuing randomization if they had a Simplified Disease Activity Index (SDAI) score >3.3 and ≤11 at two or more visits, had an SDAI >11 at any time during the run-in period, or had an SDAI >3.3 at the third run-in visit.

“We [wanted them] to be doing quite well for a long period of time. That was empirically confirmed under observation as part of the lead-in period, and even before that, the clinical investigator had to affirm that they believed the patient was doing well for 6 or more months even before they were screened to enter the trial,” said Dr. Curtis, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham.

Once enrolled in the trial, patients were randomized 2:2:1 to continuing etanercept only (n = 101), continuing methotrexate only (n = 101), or continuing both medications (n = 51). Patients were eligible for rescue after randomization if they had an SDAI score >11 at any time, SDAI between 3.3 and 11 on three separate visits, or between 3.3 and 11 at two consecutive visits at least 2 weeks apart. About three-quarters of patients in each treatment arm were female, with a mean age of about 55 years, and 82%-91% were White.

Good remission recovery with rescue therapy

At week 48, 28.7% of the methotrexate-only group were in remission (SDAI ≤3.3), compared with 49.5% of the etanercept-only group (P = .004) and 52.9% of the combination group (P = .006). Time to disease worsening was shorter in the methotrexate-only group (median, 198 days) than in the etanercept-only group (median, not estimable; P < .001) and the combined therapy group (median, not estimable; P < .001).

The researchers also found that most patients who underwent rescue therapy once again achieved remission, including 71% of the methotrexate-only group, 75% of the etanercept-only group, and 80% of the combination therapy group. There was no between-group differences in the time required to reattain remission.

The high rate of remission recovery was a good sign, Dr. Curtis said. “To me as a clinician, the risk to try [withdrawing a medication] is quite low because the likelihood you can regain where you were before is quite good. It’s obviously more successful if you stop methotrexate and continue etanercept than if you do the reverse, but to me, this is quite a practical trial, and in fact the rigor of the inclusion criteria are much more like the patients I’m talking to about stopping therapy than some of the past studies in this regard. I think it’s quite useful in terms of generalizability. We want people that are doing this well or close to it before we take away medication.”
 

Positive reactions from rheumatologists

The reaction from the viewing audience was also positive. “I think this study fills a big data gap for what we do in clinical practice,” wrote Janet Pope, MD, in comments during the session.

Dr. Pope, who is a professor of medicine at the University of Western Ontario and head of rheumatology at St. Joseph’s Health Centre, both in London, said that the results build on previous work, including the CAMEO study, which showed that discontinuation of methotrexate in patients taking methotrexate and etanercept failed to achieve noninferiority to continuation of both medications, and the PRIZE study, which showed that continuing combination therapy at a reduced dose led to better outcomes than did switching to methotrexate alone or placebo. “This may be for some patients what they prefer if they don’t tolerate methotrexate,” she added.

“It’s wonderful to have these data to counsel patients. This is something we face every day,” wrote Elizabeth Wahl, MD, who is an acting assistant professor at the University of Washington, Seattle, and acting chief of rheumatology at the VA Puget Sound Healthcare System.

The study was funded by Amgen. Dr. Curtis has received grants or research support from AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, and UCB. Dr. Pope consults for a variety of pharmaceutical companies. Dr. Wahl has no relevant financial disclosures.

SOURCE: Curtis JR et al. Arthritis Rheumatol. 2020;72(suppl 10), Abstract 0939.

Finerenone, the first nonsteroidal mineralocorticoid receptor antagonist to complete a phase 3 trial, showed cardiovascular benefits in patients with type 2 diabetes and chronic kidney disease, regardless of whether they entered the study with a history of cardiovascular disease, in follow-up analyses of the FIDELIO-DKD trial, which included 5,674 patients.

“Finerenone demonstrated benefits for primary and secondary cardiovascular disease protection,” said Gerasimos Filippatos, MD, at the American Heart Association scientific sessions. Finerenone treatment cut the rate of cardiovascular death, nonfatal MI or stroke, or heart failure hospitalization, when compared with placebo, by a relative 15% among patients with a history of cardiovascular disease (CVD), and by a relative 14% in patients without this history, differences that met a statistical test for consistency. But the absolute, drug-associated increments in benefit over placebo differed between the two CVD subgroups because of a sharp underlying difference in event rates.

In contrast, the analyses reported by Dr. Filippatos and associates from the FIDELIO-DKD study showed significant heterogeneity based on the presence or absence of CVD for the study’s primary endpoint, a composite renal metric that tallied the combined rate of death from renal causes, renal failure, or a sustained drop in estimated glomerular filtration rate of at least 40%. Researchers enrolled patients into FIDELIO-DKD based on having type 2 diabetes (T2D) and chronic kidney disease (CKD). The prevalence of a history of CVD was 46%.

Among patients with a history of CVD, the composite adverse CVD outcome occurred at a rate of 8.5/100 patient-years in patients on placebo and in 7.18/100 patients years among those on finerenone during a median of 2.6 years of follow-up, a 1.32/100–patient-year absolute between-group difference. Among patients in a primary prevention setting, incident CVD event rates during follow-up were roughly half that in the secondary prevention patients. The upshot was that, in the placebo group, the rate was 3.92/100 patient- years, and in those on finerenone was 3.43/100 patient-years, a 0.49/100–patient-year absolute difference.
 

CVD history produced heterogeneity for the primary endpoint

In the analysis that focused on the study’s primary, renal endpoint, among patients identified as having CVD at study entry, the outcome occurred at a rate of 9.06/100 patient-years in the placebo subgroup and at a rate of 6.6/100 patient years in those who received finerenone, a significant 30% relative risk reduction and an absolute between-group difference of 2.46/100 patient-years.

In contrast, among patients without a CVD history, the composite renal endpoint occurred at a rate of 9.1/100 patient-years in the placebo patients and 8.42/100 patient-years in those on finerenone, a 6% relative risk reduction that was not significant, and a 0.68/100–patient-year absolute difference. This disparity in the primary event rate between the two treatment arms reached statistical significance (P = .016), the investigators reported in the published version of the report in Circulation that simultaneously appeared online.

“The totality of evidence suggests that finerenone could be used in patients with T2D with or without a history of CVD,” explained Dr. Filippatos in an interview. “The P-interaction for the composite kidney outcome is significant, but it is not corrected for multiple testing; therefore, it might be a false-chance finding and must be interpreted cautiously.

Furthermore, in another prespecified kidney composite outcome the results were consistent in patients with and without a history of CVD. In sum, all the FIDELIO-DKD analyses so far are “suggestive of a beneficial effect in patients without a history of CVD.”

Despite these patients receiving guideline directed therapies, “there remains a high unmet medical need in patients with T2D and CKD,” added Dr. Filippatos, professor of cardiology at the University of Athens. “We use multiple treatments for patients with heart failure, and we should use the same mindset for treating patients with T2D and CKD. The costs of dialysis and kidney transplant are very high, so it is important to consider options that slow progression of CKD in these patients.”

In FIDELIO-DKD, virtually all patients were on background therapy with a renin-angiotensin-system (RAS) inhibitor, so the trial’s results suggest that treatment should at least involve dual therapy with finerenone and a RAS inhibitor. Fewer than 5% were on background therapy with a sodium-glucose cotransporter 2 (SGLT2) inhibitor, a drug class recently established as another key agent for treating CKD in patients with T2D, setting up the prospect for triple therapy, although this approach has not yet undergone prospective testing.

Combining RAS inhibition, finerenone, and an SGLT2 inhibitor is “potentially a marriage made in diabetes heaven,” commented Deepak L. Bhatt, MD, a professor of medicine at Harvard Medical School, Boston, who has not participated in finerenone studies.

Finerenone looks better for safety

Regardless of subgroup analyses based on history of CVD, the findings from all patients enrolled in FIDELIO-DKD were positive for the both the primary renal outcome and key secondary outcome of composite CVD events. In the total randomized cohort, treatment with finerenone on top of optimized treatment with an ACE inhibitor or angiotensin receptor blocker (RAS inhibition) led to a significant 18% relative risk reduction, compared with placebo, for the primary renal endpoint, and a significant 14% relative drop in the key secondary CVD outcome. Those results were published in October in the New England Journal of Medicine.

mzoler@mdedge.com

Finerenone, the first nonsteroidal mineralocorticoid receptor antagonist to complete a phase 3 trial, showed cardiovascular benefits in patients with type 2 diabetes and chronic kidney disease, regardless of whether they entered the study with a history of cardiovascular disease, in follow-up analyses of the FIDELIO-DKD trial, which included 5,674 patients.

“Finerenone demonstrated benefits for primary and secondary cardiovascular disease protection,” said Gerasimos Filippatos, MD, at the American Heart Association scientific sessions. Finerenone treatment cut the rate of cardiovascular death, nonfatal MI or stroke, or heart failure hospitalization, when compared with placebo, by a relative 15% among patients with a history of cardiovascular disease (CVD), and by a relative 14% in patients without this history, differences that met a statistical test for consistency. But the absolute, drug-associated increments in benefit over placebo differed between the two CVD subgroups because of a sharp underlying difference in event rates.

In contrast, the analyses reported by Dr. Filippatos and associates from the FIDELIO-DKD study showed significant heterogeneity based on the presence or absence of CVD for the study’s primary endpoint, a composite renal metric that tallied the combined rate of death from renal causes, renal failure, or a sustained drop in estimated glomerular filtration rate of at least 40%. Researchers enrolled patients into FIDELIO-DKD based on having type 2 diabetes (T2D) and chronic kidney disease (CKD). The prevalence of a history of CVD was 46%.

Among patients with a history of CVD, the composite adverse CVD outcome occurred at a rate of 8.5/100 patient-years in patients on placebo and in 7.18/100 patients years among those on finerenone during a median of 2.6 years of follow-up, a 1.32/100–patient-year absolute between-group difference. Among patients in a primary prevention setting, incident CVD event rates during follow-up were roughly half that in the secondary prevention patients. The upshot was that, in the placebo group, the rate was 3.92/100 patient- years, and in those on finerenone was 3.43/100 patient-years, a 0.49/100–patient-year absolute difference.
 

CVD history produced heterogeneity for the primary endpoint

In the analysis that focused on the study’s primary, renal endpoint, among patients identified as having CVD at study entry, the outcome occurred at a rate of 9.06/100 patient-years in the placebo subgroup and at a rate of 6.6/100 patient years in those who received finerenone, a significant 30% relative risk reduction and an absolute between-group difference of 2.46/100 patient-years.

In contrast, among patients without a CVD history, the composite renal endpoint occurred at a rate of 9.1/100 patient-years in the placebo patients and 8.42/100 patient-years in those on finerenone, a 6% relative risk reduction that was not significant, and a 0.68/100–patient-year absolute difference. This disparity in the primary event rate between the two treatment arms reached statistical significance (P = .016), the investigators reported in the published version of the report in Circulation that simultaneously appeared online.

“The totality of evidence suggests that finerenone could be used in patients with T2D with or without a history of CVD,” explained Dr. Filippatos in an interview. “The P-interaction for the composite kidney outcome is significant, but it is not corrected for multiple testing; therefore, it might be a false-chance finding and must be interpreted cautiously.

Furthermore, in another prespecified kidney composite outcome the results were consistent in patients with and without a history of CVD. In sum, all the FIDELIO-DKD analyses so far are “suggestive of a beneficial effect in patients without a history of CVD.”

Despite these patients receiving guideline directed therapies, “there remains a high unmet medical need in patients with T2D and CKD,” added Dr. Filippatos, professor of cardiology at the University of Athens. “We use multiple treatments for patients with heart failure, and we should use the same mindset for treating patients with T2D and CKD. The costs of dialysis and kidney transplant are very high, so it is important to consider options that slow progression of CKD in these patients.”

In FIDELIO-DKD, virtually all patients were on background therapy with a renin-angiotensin-system (RAS) inhibitor, so the trial’s results suggest that treatment should at least involve dual therapy with finerenone and a RAS inhibitor. Fewer than 5% were on background therapy with a sodium-glucose cotransporter 2 (SGLT2) inhibitor, a drug class recently established as another key agent for treating CKD in patients with T2D, setting up the prospect for triple therapy, although this approach has not yet undergone prospective testing.

Combining RAS inhibition, finerenone, and an SGLT2 inhibitor is “potentially a marriage made in diabetes heaven,” commented Deepak L. Bhatt, MD, a professor of medicine at Harvard Medical School, Boston, who has not participated in finerenone studies.

Finerenone looks better for safety

Regardless of subgroup analyses based on history of CVD, the findings from all patients enrolled in FIDELIO-DKD were positive for the both the primary renal outcome and key secondary outcome of composite CVD events. In the total randomized cohort, treatment with finerenone on top of optimized treatment with an ACE inhibitor or angiotensin receptor blocker (RAS inhibition) led to a significant 18% relative risk reduction, compared with placebo, for the primary renal endpoint, and a significant 14% relative drop in the key secondary CVD outcome. Those results were published in October in the New England Journal of Medicine.

mzoler@mdedge.com

Finerenone, the first nonsteroidal mineralocorticoid receptor antagonist to complete a phase 3 trial, showed cardiovascular benefits in patients with type 2 diabetes and chronic kidney disease, regardless of whether they entered the study with a history of cardiovascular disease, in follow-up analyses of the FIDELIO-DKD trial, which included 5,674 patients.

“Finerenone demonstrated benefits for primary and secondary cardiovascular disease protection,” said Gerasimos Filippatos, MD, at the American Heart Association scientific sessions. Finerenone treatment cut the rate of cardiovascular death, nonfatal MI or stroke, or heart failure hospitalization, when compared with placebo, by a relative 15% among patients with a history of cardiovascular disease (CVD), and by a relative 14% in patients without this history, differences that met a statistical test for consistency. But the absolute, drug-associated increments in benefit over placebo differed between the two CVD subgroups because of a sharp underlying difference in event rates.

In contrast, the analyses reported by Dr. Filippatos and associates from the FIDELIO-DKD study showed significant heterogeneity based on the presence or absence of CVD for the study’s primary endpoint, a composite renal metric that tallied the combined rate of death from renal causes, renal failure, or a sustained drop in estimated glomerular filtration rate of at least 40%. Researchers enrolled patients into FIDELIO-DKD based on having type 2 diabetes (T2D) and chronic kidney disease (CKD). The prevalence of a history of CVD was 46%.

Among patients with a history of CVD, the composite adverse CVD outcome occurred at a rate of 8.5/100 patient-years in patients on placebo and in 7.18/100 patients years among those on finerenone during a median of 2.6 years of follow-up, a 1.32/100–patient-year absolute between-group difference. Among patients in a primary prevention setting, incident CVD event rates during follow-up were roughly half that in the secondary prevention patients. The upshot was that, in the placebo group, the rate was 3.92/100 patient- years, and in those on finerenone was 3.43/100 patient-years, a 0.49/100–patient-year absolute difference.
 

CVD history produced heterogeneity for the primary endpoint

In the analysis that focused on the study’s primary, renal endpoint, among patients identified as having CVD at study entry, the outcome occurred at a rate of 9.06/100 patient-years in the placebo subgroup and at a rate of 6.6/100 patient years in those who received finerenone, a significant 30% relative risk reduction and an absolute between-group difference of 2.46/100 patient-years.

In contrast, among patients without a CVD history, the composite renal endpoint occurred at a rate of 9.1/100 patient-years in the placebo patients and 8.42/100 patient-years in those on finerenone, a 6% relative risk reduction that was not significant, and a 0.68/100–patient-year absolute difference. This disparity in the primary event rate between the two treatment arms reached statistical significance (P = .016), the investigators reported in the published version of the report in Circulation that simultaneously appeared online.

“The totality of evidence suggests that finerenone could be used in patients with T2D with or without a history of CVD,” explained Dr. Filippatos in an interview. “The P-interaction for the composite kidney outcome is significant, but it is not corrected for multiple testing; therefore, it might be a false-chance finding and must be interpreted cautiously.

Furthermore, in another prespecified kidney composite outcome the results were consistent in patients with and without a history of CVD. In sum, all the FIDELIO-DKD analyses so far are “suggestive of a beneficial effect in patients without a history of CVD.”

Despite these patients receiving guideline directed therapies, “there remains a high unmet medical need in patients with T2D and CKD,” added Dr. Filippatos, professor of cardiology at the University of Athens. “We use multiple treatments for patients with heart failure, and we should use the same mindset for treating patients with T2D and CKD. The costs of dialysis and kidney transplant are very high, so it is important to consider options that slow progression of CKD in these patients.”

In FIDELIO-DKD, virtually all patients were on background therapy with a renin-angiotensin-system (RAS) inhibitor, so the trial’s results suggest that treatment should at least involve dual therapy with finerenone and a RAS inhibitor. Fewer than 5% were on background therapy with a sodium-glucose cotransporter 2 (SGLT2) inhibitor, a drug class recently established as another key agent for treating CKD in patients with T2D, setting up the prospect for triple therapy, although this approach has not yet undergone prospective testing.

Combining RAS inhibition, finerenone, and an SGLT2 inhibitor is “potentially a marriage made in diabetes heaven,” commented Deepak L. Bhatt, MD, a professor of medicine at Harvard Medical School, Boston, who has not participated in finerenone studies.

Finerenone looks better for safety

Regardless of subgroup analyses based on history of CVD, the findings from all patients enrolled in FIDELIO-DKD were positive for the both the primary renal outcome and key secondary outcome of composite CVD events. In the total randomized cohort, treatment with finerenone on top of optimized treatment with an ACE inhibitor or angiotensin receptor blocker (RAS inhibition) led to a significant 18% relative risk reduction, compared with placebo, for the primary renal endpoint, and a significant 14% relative drop in the key secondary CVD outcome. Those results were published in October in the New England Journal of Medicine.

mzoler@mdedge.com

Slowly tapering off – or remaining on – antimalarial medications can help prevent disease flare in patients with systemic lupus erythematosus (SLE) who’ve achieved clinical remission for at least a year, according to a new study that was presented at the virtual annual meeting of the American College of Rheumatology.

“Except in the setting of toxicity, cessation of antimalarial medication in patients with disease quiescence is feasible using a slow taper,” lead author Danaë Papachristos, MBBS, said during an oral abstract presentation at the online meeting. Dr. Papachristos conducted the research while a clinical and research fellow at the University of Toronto’s lupus clinic, but is now a consultant rheumatologist at the Wesley Hospital in Brisbane, Queensland, Australia.

To investigate flare in patients with SLE who were on or recently off antimalarial medications (AMs), the researchers identified 1,573 potential participants from a long-term observational cohort study at the university’s lupus clinic. From that larger group, 88 cases – patients who achieved clinical remission for at least a year and stopped taking AMs – were matched to at least one control – patients who also achieved remission and continued on medication. Most cases were also matched to a second control, bringing the total number to 173. All patients had at least 2 years of follow-up.

Flare was defined as any increase in the SLEDAI-2K score, with major flare defined as an increase of 4 or more. Patients in the case group were roughly 44 years old, compared with an average age of 46 in the control group. Both groups were almost entirely female and largely white. Reasons for withdrawal in the case group included self-cessation, disease quiescence, and retinal, mucocutaneous, or cardiac toxicities. Twenty participants in the case group reported AM toxicity, compared with four controls.

Dr. Papachristos noted in her presentation that the toxicity disparity was expected, “because controls are those who continue their medication, and most patients who have toxicity will stop their medication.”

Disease flare occurred in 61.4% of cases, compared with 45.1% of controls (P = .002), with the most common types being cutaneous and musculoskeletal flares. After multivariate analysis, the risk of flare more than doubled for those who ceased AMs (odds ratio, 2.26; 95% confidence interval, 1.24-4.11; P = .008). More than half of the cases (n = 46) restarted AMs after withdrawal, which was largely due to disease flare. Of the patients who restarted due to flare, 88% either recaptured control or improved, and the remaining 12% had further flares.

Of the 88 patients in the case group, 51 abruptly withdrew AMs while 37 tapered off. Patients who tapered had fewer flares (45.9%), compared with patients who withdrew abruptly (72.6%). After multivariate analysis, the risk of flare more than tripled for the abrupt withdrawal group (OR, 3.42; 95% CI, 1.26-9.26; P = .016). Fewer patients who tapered later restarted AMs, compared with the abrupt withdrawal group (37.8% vs. 62.7%; P = .02).

When asked about other differences in medications between the two groups, Dr. Papachristos answered: “We didn’t look into that specifically. We did look at those patients who were on prednisone and on any immunosuppression, although we didn’t look at specific therapies. Those variables were adjusted for in the analysis, and it didn’t make any difference if patients were on immunosuppression or prednisone at the point of index date.

“But we would like to look into the different forms of immunosuppression,” she added, “just to see if that made any difference.”

Withdrawing hydroxychloroquine in older patients

Older patients with SLE who discontinue their use of hydroxychloroquine (HCQ) are also not at increased risk of disease flare, according to a retrospective chart review from rheumatologists Ruth Fernandez-Ruiz, MD, and Peter M. Izmirly, MD, of New York University (Arthritis Res Ther. 2020;22:191. doi: 10.1186/s13075-020-02282-0).

“We wanted to focus on older patients who may have a lower risk of flaring and a higher risk of side effects from the drug,” Dr. Fernandez-Ruiz said in an interview.

The doctors embarked on the study after noticing eye and heart toxicities in certain older patients. They matched 26 lupus patients who had been on HCQ for at least 5 years before discontinuing the drug with 32 control patients who remained on HCQ, ultimately finding that withdrawal had no effect on their risk of lupus flares within a year.

“After starting a drug, the second question most people ask, after ‘What are the side effects?’ is ‘How long do I have to be on this?’ ” Dr. Izmirly said in an interview. “These patients are having side effects associated with long-term HCQ use. And we were noticing that, after you stop the drug, despite what you’re taught, they weren’t flaring.”

Only five patients from each group – 19.2% of the withdrawal group and 15.6% of the continuation group – experienced a flare (OR, 1.28; 95% CI, 0.31-5.30; P = .73). Most of the flares were cutaneous and musculoskeletal in nature, and no severe flares occurred in either group.

“On each side, the overall flare rate was not that high, and they were all relatively mild,” Dr. Izmirly said.

The two doctors acknowledged their study’s smaller sample size, compared with the study by Papachristos and colleagues, along with the advanced age of their patient population, which limits the generalizability of their findings. “We selected patients who had a very low disease activity to begin with, and who were older,” Dr. Fernandez-Ruiz noted.

That said, they reinforced the scarcity of existing research on this subset of lupus patients, one that will only continue to grow.

“Older [patients with] lupus,” Dr. Izmirly said, are “an understudied demographic.”

One of the authors of the study presented at ACR 2020 acknowledged receiving research support and consulting fees from various pharmaceutical companies. The HCQ study was supported by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases; its authors declared no conflicts of interest.

SOURCE: Papachristos D et al. Arthritis Rheumatol. 2020;72(suppl 10). Abstract 0983.

Slowly tapering off – or remaining on – antimalarial medications can help prevent disease flare in patients with systemic lupus erythematosus (SLE) who’ve achieved clinical remission for at least a year, according to a new study that was presented at the virtual annual meeting of the American College of Rheumatology.

“Except in the setting of toxicity, cessation of antimalarial medication in patients with disease quiescence is feasible using a slow taper,” lead author Danaë Papachristos, MBBS, said during an oral abstract presentation at the online meeting. Dr. Papachristos conducted the research while a clinical and research fellow at the University of Toronto’s lupus clinic, but is now a consultant rheumatologist at the Wesley Hospital in Brisbane, Queensland, Australia.

To investigate flare in patients with SLE who were on or recently off antimalarial medications (AMs), the researchers identified 1,573 potential participants from a long-term observational cohort study at the university’s lupus clinic. From that larger group, 88 cases – patients who achieved clinical remission for at least a year and stopped taking AMs – were matched to at least one control – patients who also achieved remission and continued on medication. Most cases were also matched to a second control, bringing the total number to 173. All patients had at least 2 years of follow-up.

Flare was defined as any increase in the SLEDAI-2K score, with major flare defined as an increase of 4 or more. Patients in the case group were roughly 44 years old, compared with an average age of 46 in the control group. Both groups were almost entirely female and largely white. Reasons for withdrawal in the case group included self-cessation, disease quiescence, and retinal, mucocutaneous, or cardiac toxicities. Twenty participants in the case group reported AM toxicity, compared with four controls.

Dr. Papachristos noted in her presentation that the toxicity disparity was expected, “because controls are those who continue their medication, and most patients who have toxicity will stop their medication.”

Disease flare occurred in 61.4% of cases, compared with 45.1% of controls (P = .002), with the most common types being cutaneous and musculoskeletal flares. After multivariate analysis, the risk of flare more than doubled for those who ceased AMs (odds ratio, 2.26; 95% confidence interval, 1.24-4.11; P = .008). More than half of the cases (n = 46) restarted AMs after withdrawal, which was largely due to disease flare. Of the patients who restarted due to flare, 88% either recaptured control or improved, and the remaining 12% had further flares.

Of the 88 patients in the case group, 51 abruptly withdrew AMs while 37 tapered off. Patients who tapered had fewer flares (45.9%), compared with patients who withdrew abruptly (72.6%). After multivariate analysis, the risk of flare more than tripled for the abrupt withdrawal group (OR, 3.42; 95% CI, 1.26-9.26; P = .016). Fewer patients who tapered later restarted AMs, compared with the abrupt withdrawal group (37.8% vs. 62.7%; P = .02).

When asked about other differences in medications between the two groups, Dr. Papachristos answered: “We didn’t look into that specifically. We did look at those patients who were on prednisone and on any immunosuppression, although we didn’t look at specific therapies. Those variables were adjusted for in the analysis, and it didn’t make any difference if patients were on immunosuppression or prednisone at the point of index date.

“But we would like to look into the different forms of immunosuppression,” she added, “just to see if that made any difference.”

Withdrawing hydroxychloroquine in older patients

Older patients with SLE who discontinue their use of hydroxychloroquine (HCQ) are also not at increased risk of disease flare, according to a retrospective chart review from rheumatologists Ruth Fernandez-Ruiz, MD, and Peter M. Izmirly, MD, of New York University (Arthritis Res Ther. 2020;22:191. doi: 10.1186/s13075-020-02282-0).

“We wanted to focus on older patients who may have a lower risk of flaring and a higher risk of side effects from the drug,” Dr. Fernandez-Ruiz said in an interview.

The doctors embarked on the study after noticing eye and heart toxicities in certain older patients. They matched 26 lupus patients who had been on HCQ for at least 5 years before discontinuing the drug with 32 control patients who remained on HCQ, ultimately finding that withdrawal had no effect on their risk of lupus flares within a year.

“After starting a drug, the second question most people ask, after ‘What are the side effects?’ is ‘How long do I have to be on this?’ ” Dr. Izmirly said in an interview. “These patients are having side effects associated with long-term HCQ use. And we were noticing that, after you stop the drug, despite what you’re taught, they weren’t flaring.”

Only five patients from each group – 19.2% of the withdrawal group and 15.6% of the continuation group – experienced a flare (OR, 1.28; 95% CI, 0.31-5.30; P = .73). Most of the flares were cutaneous and musculoskeletal in nature, and no severe flares occurred in either group.

“On each side, the overall flare rate was not that high, and they were all relatively mild,” Dr. Izmirly said.

The two doctors acknowledged their study’s smaller sample size, compared with the study by Papachristos and colleagues, along with the advanced age of their patient population, which limits the generalizability of their findings. “We selected patients who had a very low disease activity to begin with, and who were older,” Dr. Fernandez-Ruiz noted.

That said, they reinforced the scarcity of existing research on this subset of lupus patients, one that will only continue to grow.

“Older [patients with] lupus,” Dr. Izmirly said, are “an understudied demographic.”

One of the authors of the study presented at ACR 2020 acknowledged receiving research support and consulting fees from various pharmaceutical companies. The HCQ study was supported by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases; its authors declared no conflicts of interest.

SOURCE: Papachristos D et al. Arthritis Rheumatol. 2020;72(suppl 10). Abstract 0983.

Slowly tapering off – or remaining on – antimalarial medications can help prevent disease flare in patients with systemic lupus erythematosus (SLE) who’ve achieved clinical remission for at least a year, according to a new study that was presented at the virtual annual meeting of the American College of Rheumatology.

“Except in the setting of toxicity, cessation of antimalarial medication in patients with disease quiescence is feasible using a slow taper,” lead author Danaë Papachristos, MBBS, said during an oral abstract presentation at the online meeting. Dr. Papachristos conducted the research while a clinical and research fellow at the University of Toronto’s lupus clinic, but is now a consultant rheumatologist at the Wesley Hospital in Brisbane, Queensland, Australia.

To investigate flare in patients with SLE who were on or recently off antimalarial medications (AMs), the researchers identified 1,573 potential participants from a long-term observational cohort study at the university’s lupus clinic. From that larger group, 88 cases – patients who achieved clinical remission for at least a year and stopped taking AMs – were matched to at least one control – patients who also achieved remission and continued on medication. Most cases were also matched to a second control, bringing the total number to 173. All patients had at least 2 years of follow-up.

Flare was defined as any increase in the SLEDAI-2K score, with major flare defined as an increase of 4 or more. Patients in the case group were roughly 44 years old, compared with an average age of 46 in the control group. Both groups were almost entirely female and largely white. Reasons for withdrawal in the case group included self-cessation, disease quiescence, and retinal, mucocutaneous, or cardiac toxicities. Twenty participants in the case group reported AM toxicity, compared with four controls.

Dr. Papachristos noted in her presentation that the toxicity disparity was expected, “because controls are those who continue their medication, and most patients who have toxicity will stop their medication.”

Disease flare occurred in 61.4% of cases, compared with 45.1% of controls (P = .002), with the most common types being cutaneous and musculoskeletal flares. After multivariate analysis, the risk of flare more than doubled for those who ceased AMs (odds ratio, 2.26; 95% confidence interval, 1.24-4.11; P = .008). More than half of the cases (n = 46) restarted AMs after withdrawal, which was largely due to disease flare. Of the patients who restarted due to flare, 88% either recaptured control or improved, and the remaining 12% had further flares.

Of the 88 patients in the case group, 51 abruptly withdrew AMs while 37 tapered off. Patients who tapered had fewer flares (45.9%), compared with patients who withdrew abruptly (72.6%). After multivariate analysis, the risk of flare more than tripled for the abrupt withdrawal group (OR, 3.42; 95% CI, 1.26-9.26; P = .016). Fewer patients who tapered later restarted AMs, compared with the abrupt withdrawal group (37.8% vs. 62.7%; P = .02).

When asked about other differences in medications between the two groups, Dr. Papachristos answered: “We didn’t look into that specifically. We did look at those patients who were on prednisone and on any immunosuppression, although we didn’t look at specific therapies. Those variables were adjusted for in the analysis, and it didn’t make any difference if patients were on immunosuppression or prednisone at the point of index date.

“But we would like to look into the different forms of immunosuppression,” she added, “just to see if that made any difference.”

Withdrawing hydroxychloroquine in older patients

Older patients with SLE who discontinue their use of hydroxychloroquine (HCQ) are also not at increased risk of disease flare, according to a retrospective chart review from rheumatologists Ruth Fernandez-Ruiz, MD, and Peter M. Izmirly, MD, of New York University (Arthritis Res Ther. 2020;22:191. doi: 10.1186/s13075-020-02282-0).

“We wanted to focus on older patients who may have a lower risk of flaring and a higher risk of side effects from the drug,” Dr. Fernandez-Ruiz said in an interview.

The doctors embarked on the study after noticing eye and heart toxicities in certain older patients. They matched 26 lupus patients who had been on HCQ for at least 5 years before discontinuing the drug with 32 control patients who remained on HCQ, ultimately finding that withdrawal had no effect on their risk of lupus flares within a year.

“After starting a drug, the second question most people ask, after ‘What are the side effects?’ is ‘How long do I have to be on this?’ ” Dr. Izmirly said in an interview. “These patients are having side effects associated with long-term HCQ use. And we were noticing that, after you stop the drug, despite what you’re taught, they weren’t flaring.”

Only five patients from each group – 19.2% of the withdrawal group and 15.6% of the continuation group – experienced a flare (OR, 1.28; 95% CI, 0.31-5.30; P = .73). Most of the flares were cutaneous and musculoskeletal in nature, and no severe flares occurred in either group.

“On each side, the overall flare rate was not that high, and they were all relatively mild,” Dr. Izmirly said.

The two doctors acknowledged their study’s smaller sample size, compared with the study by Papachristos and colleagues, along with the advanced age of their patient population, which limits the generalizability of their findings. “We selected patients who had a very low disease activity to begin with, and who were older,” Dr. Fernandez-Ruiz noted.

That said, they reinforced the scarcity of existing research on this subset of lupus patients, one that will only continue to grow.

“Older [patients with] lupus,” Dr. Izmirly said, are “an understudied demographic.”

One of the authors of the study presented at ACR 2020 acknowledged receiving research support and consulting fees from various pharmaceutical companies. The HCQ study was supported by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases; its authors declared no conflicts of interest.

SOURCE: Papachristos D et al. Arthritis Rheumatol. 2020;72(suppl 10). Abstract 0983.

Recognizing the ongoing value of benzoyl peroxide, educating patients about the role of antibiotics, and embracing spironolactone are among the acne treatment pearls provided by Hilary Baldwin, MD, during a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

Courtesy Wikimedia Commons/Kinan Ayu/Creative Commons license

Benzoyl peroxide celebrates its 60th birthday and is still going strong as an acne treatment, said Dr. Baldwin, of the department of dermatology, Rutgers Robert Wood Johnston Medical Center, New Brunswick, N.J. Benzoyl peroxide can be used as a stand-alone and has the added benefit of not being associated with antimicrobial resistance. In addition, “benzoyl peroxide is the heavy lifter in combinations,” she said. In fact, benzoyl peroxide can prevent the development of resistance to topical and oral antibiotics such as clindamycin, and can reverse resistance that has occurred, she noted.

However, patient compliance can be an issue. Benzoyl peroxide often is underused because of its tendency to bleach fabric, noted Dr. Baldwin, who is also medical director of The Acne Treatment and Research Center in New York. To help combat this problem and improve compliance, she advises patients to establish a dosing schedule for benzoyl peroxide, such as using it first thing in the morning, or applying in the afternoon and using a paper towel first, or a white towel, to wash their faces at bedtime, she said. When dealing with teenagers, “it sounds like a lot of work, but it makes the mothers much happier not to have their towels bleached.”

Although clinicians want to reduce unnecessary antibiotic use in acne, there is a place for antibiotics, but not as monotherapy, Dr. Baldwin said. Instead, initiate topical therapy, such as a retinoid or benzoyl peroxide, simultaneously with antibiotics and evaluate the response in 6-8 weeks, she advised. At that point, the antibiotics can be stopped, even if 100% clearing has not been achieved, and “the topicals can carry you on for months and months,” she noted.

Also, in female patients, consider oral contraceptive pills or spironolactone at the same time as oral antibiotics, then discontinue the antibiotics and continue with the hormonal therapy, she added. “Plan your exit strategy early,” she said. Explain to patients that you will stop the oral antibiotics after 2 months, so they must continue with the topicals.

“Embrace spironolactone if you haven’t already,” said Dr. Baldwin, who noted that spironolactone has been underused in recent years. Spironolactone use for acne has not been well studied, “but consensus groups and expert opinions certainly favor its use,” she added.

Recognizing the ongoing value of benzoyl peroxide, educating patients about the role of antibiotics, and embracing spironolactone are among the acne treatment pearls provided by Hilary Baldwin, MD, during a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

Courtesy Wikimedia Commons/Kinan Ayu/Creative Commons license

Benzoyl peroxide celebrates its 60th birthday and is still going strong as an acne treatment, said Dr. Baldwin, of the department of dermatology, Rutgers Robert Wood Johnston Medical Center, New Brunswick, N.J. Benzoyl peroxide can be used as a stand-alone and has the added benefit of not being associated with antimicrobial resistance. In addition, “benzoyl peroxide is the heavy lifter in combinations,” she said. In fact, benzoyl peroxide can prevent the development of resistance to topical and oral antibiotics such as clindamycin, and can reverse resistance that has occurred, she noted.

However, patient compliance can be an issue. Benzoyl peroxide often is underused because of its tendency to bleach fabric, noted Dr. Baldwin, who is also medical director of The Acne Treatment and Research Center in New York. To help combat this problem and improve compliance, she advises patients to establish a dosing schedule for benzoyl peroxide, such as using it first thing in the morning, or applying in the afternoon and using a paper towel first, or a white towel, to wash their faces at bedtime, she said. When dealing with teenagers, “it sounds like a lot of work, but it makes the mothers much happier not to have their towels bleached.”

Although clinicians want to reduce unnecessary antibiotic use in acne, there is a place for antibiotics, but not as monotherapy, Dr. Baldwin said. Instead, initiate topical therapy, such as a retinoid or benzoyl peroxide, simultaneously with antibiotics and evaluate the response in 6-8 weeks, she advised. At that point, the antibiotics can be stopped, even if 100% clearing has not been achieved, and “the topicals can carry you on for months and months,” she noted.

Also, in female patients, consider oral contraceptive pills or spironolactone at the same time as oral antibiotics, then discontinue the antibiotics and continue with the hormonal therapy, she added. “Plan your exit strategy early,” she said. Explain to patients that you will stop the oral antibiotics after 2 months, so they must continue with the topicals.

“Embrace spironolactone if you haven’t already,” said Dr. Baldwin, who noted that spironolactone has been underused in recent years. Spironolactone use for acne has not been well studied, “but consensus groups and expert opinions certainly favor its use,” she added.

Recognizing the ongoing value of benzoyl peroxide, educating patients about the role of antibiotics, and embracing spironolactone are among the acne treatment pearls provided by Hilary Baldwin, MD, during a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

Courtesy Wikimedia Commons/Kinan Ayu/Creative Commons license

Benzoyl peroxide celebrates its 60th birthday and is still going strong as an acne treatment, said Dr. Baldwin, of the department of dermatology, Rutgers Robert Wood Johnston Medical Center, New Brunswick, N.J. Benzoyl peroxide can be used as a stand-alone and has the added benefit of not being associated with antimicrobial resistance. In addition, “benzoyl peroxide is the heavy lifter in combinations,” she said. In fact, benzoyl peroxide can prevent the development of resistance to topical and oral antibiotics such as clindamycin, and can reverse resistance that has occurred, she noted.

However, patient compliance can be an issue. Benzoyl peroxide often is underused because of its tendency to bleach fabric, noted Dr. Baldwin, who is also medical director of The Acne Treatment and Research Center in New York. To help combat this problem and improve compliance, she advises patients to establish a dosing schedule for benzoyl peroxide, such as using it first thing in the morning, or applying in the afternoon and using a paper towel first, or a white towel, to wash their faces at bedtime, she said. When dealing with teenagers, “it sounds like a lot of work, but it makes the mothers much happier not to have their towels bleached.”

Although clinicians want to reduce unnecessary antibiotic use in acne, there is a place for antibiotics, but not as monotherapy, Dr. Baldwin said. Instead, initiate topical therapy, such as a retinoid or benzoyl peroxide, simultaneously with antibiotics and evaluate the response in 6-8 weeks, she advised. At that point, the antibiotics can be stopped, even if 100% clearing has not been achieved, and “the topicals can carry you on for months and months,” she noted.

Also, in female patients, consider oral contraceptive pills or spironolactone at the same time as oral antibiotics, then discontinue the antibiotics and continue with the hormonal therapy, she added. “Plan your exit strategy early,” she said. Explain to patients that you will stop the oral antibiotics after 2 months, so they must continue with the topicals.

“Embrace spironolactone if you haven’t already,” said Dr. Baldwin, who noted that spironolactone has been underused in recent years. Spironolactone use for acne has not been well studied, “but consensus groups and expert opinions certainly favor its use,” she added.

Treatments in the pipeline may offer more options for rosacea sufferers, according to Linda Stein Gold, MD, director of clinical research, in the department of dermatology, Henry Ford Hospital in Detroit.

sruilk/shutterstock

In addition, topical minocycline has recently been approved by the Food and Drug Administration for the treatment of rosacea in a 1.5% foam formulation. “The reason it has taken so long to have a minocycline product is that it is challenging to deliver it topically,” she said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually. Studies of higher concentrations were not significantly better for rosacea, so development of the 1.5% foam was pursued, although a 4% foam is approved for the treatment of acne.

Dr. Stein Gold shared results from a pair of 12-week randomized trials in which significantly more patients treated with topical minocycline foam showed treatment success, compared with those on vehicle, based on Investigator’s Global Assessment (IGA) scores of clear or almost clear and a decrease of at least two grades from baseline: 52.1% versus 43.0% in one study and 49.1% versus 39.0% in the second, statistically significant differences. The product also was well tolerated, with most patients reporting no side effects or mild side effects.

Research on how to maximize effectiveness of available treatments such as ivermectin is ongoing, but several new treatments in the pipeline continue to show promising results, she noted.

An up-and-coming rosacea treatment is an old product used in a new way: Benzoyl peroxide in a microencapsulated form. “Benzoyl peroxide is encased in silica molecules that allow very slow release of the benzoyl peroxide into the skin and that leads to decreased irritation,” Dr. Stein Gold explained. The deposit of active ingredient on the skin appears to stay below the level of irritation.

Dr. Stein Gold and colleagues conducted two randomized, vehicle-controlled trials in which 733 adults with moderate to severe rosacea were treated with either the encapsulated benzoyl peroxide cream formulation or a vehicle applied once daily for 12 weeks.

At 12 weeks, IGA success increased over the course of the studies, and reached 43.5% in one and 50.1% in the other, compared with 16.1% and 25.9%, respectively, for the vehicle groups in those studies (P < .001 for both). Overall, she described this as “a nice improvement for a drug that we had not considered to be part of our treatment armamentarium for our rosacea patients.”

Dr. Stein Gold also shared data from a phase 2 study of low-dose oral minocycline in adults with papulopustular rosacea. A group of 200 patients used the drug or a placebo once daily for 16 weeks. The study examined 20-mg and 40-mg extended-release formulations, and found a significant improvement with the 40-mg dose over the 20-mg dose and over placebo, in terms of those who reached an IGA of 0 or 1, with a 2 grade improvement. While this is a phase 2 study, it may lead to oral minocycline as another treatment option, she said.

“It is an exciting time for the treatment of rosacea, with a variety of options and an active pipeline, so we can aim for clear skin for our patients,” she commented.

Dr. Stein Gold disclosed serving as an investigator and consultant for Galderma, Vyne, Sun, Sol Gel, and Almirall; she is a consultant and speaker for Ortho.

MedscapeLive and this news organization are owned by the same parent company.
 

Treatments in the pipeline may offer more options for rosacea sufferers, according to Linda Stein Gold, MD, director of clinical research, in the department of dermatology, Henry Ford Hospital in Detroit.

sruilk/shutterstock

In addition, topical minocycline has recently been approved by the Food and Drug Administration for the treatment of rosacea in a 1.5% foam formulation. “The reason it has taken so long to have a minocycline product is that it is challenging to deliver it topically,” she said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually. Studies of higher concentrations were not significantly better for rosacea, so development of the 1.5% foam was pursued, although a 4% foam is approved for the treatment of acne.

Dr. Stein Gold shared results from a pair of 12-week randomized trials in which significantly more patients treated with topical minocycline foam showed treatment success, compared with those on vehicle, based on Investigator’s Global Assessment (IGA) scores of clear or almost clear and a decrease of at least two grades from baseline: 52.1% versus 43.0% in one study and 49.1% versus 39.0% in the second, statistically significant differences. The product also was well tolerated, with most patients reporting no side effects or mild side effects.

Research on how to maximize effectiveness of available treatments such as ivermectin is ongoing, but several new treatments in the pipeline continue to show promising results, she noted.

An up-and-coming rosacea treatment is an old product used in a new way: Benzoyl peroxide in a microencapsulated form. “Benzoyl peroxide is encased in silica molecules that allow very slow release of the benzoyl peroxide into the skin and that leads to decreased irritation,” Dr. Stein Gold explained. The deposit of active ingredient on the skin appears to stay below the level of irritation.

Dr. Stein Gold and colleagues conducted two randomized, vehicle-controlled trials in which 733 adults with moderate to severe rosacea were treated with either the encapsulated benzoyl peroxide cream formulation or a vehicle applied once daily for 12 weeks.

At 12 weeks, IGA success increased over the course of the studies, and reached 43.5% in one and 50.1% in the other, compared with 16.1% and 25.9%, respectively, for the vehicle groups in those studies (P < .001 for both). Overall, she described this as “a nice improvement for a drug that we had not considered to be part of our treatment armamentarium for our rosacea patients.”

Dr. Stein Gold also shared data from a phase 2 study of low-dose oral minocycline in adults with papulopustular rosacea. A group of 200 patients used the drug or a placebo once daily for 16 weeks. The study examined 20-mg and 40-mg extended-release formulations, and found a significant improvement with the 40-mg dose over the 20-mg dose and over placebo, in terms of those who reached an IGA of 0 or 1, with a 2 grade improvement. While this is a phase 2 study, it may lead to oral minocycline as another treatment option, she said.

“It is an exciting time for the treatment of rosacea, with a variety of options and an active pipeline, so we can aim for clear skin for our patients,” she commented.

Dr. Stein Gold disclosed serving as an investigator and consultant for Galderma, Vyne, Sun, Sol Gel, and Almirall; she is a consultant and speaker for Ortho.

MedscapeLive and this news organization are owned by the same parent company.
 

Treatments in the pipeline may offer more options for rosacea sufferers, according to Linda Stein Gold, MD, director of clinical research, in the department of dermatology, Henry Ford Hospital in Detroit.

sruilk/shutterstock

In addition, topical minocycline has recently been approved by the Food and Drug Administration for the treatment of rosacea in a 1.5% foam formulation. “The reason it has taken so long to have a minocycline product is that it is challenging to deliver it topically,” she said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually. Studies of higher concentrations were not significantly better for rosacea, so development of the 1.5% foam was pursued, although a 4% foam is approved for the treatment of acne.

Dr. Stein Gold shared results from a pair of 12-week randomized trials in which significantly more patients treated with topical minocycline foam showed treatment success, compared with those on vehicle, based on Investigator’s Global Assessment (IGA) scores of clear or almost clear and a decrease of at least two grades from baseline: 52.1% versus 43.0% in one study and 49.1% versus 39.0% in the second, statistically significant differences. The product also was well tolerated, with most patients reporting no side effects or mild side effects.

Research on how to maximize effectiveness of available treatments such as ivermectin is ongoing, but several new treatments in the pipeline continue to show promising results, she noted.

An up-and-coming rosacea treatment is an old product used in a new way: Benzoyl peroxide in a microencapsulated form. “Benzoyl peroxide is encased in silica molecules that allow very slow release of the benzoyl peroxide into the skin and that leads to decreased irritation,” Dr. Stein Gold explained. The deposit of active ingredient on the skin appears to stay below the level of irritation.

Dr. Stein Gold and colleagues conducted two randomized, vehicle-controlled trials in which 733 adults with moderate to severe rosacea were treated with either the encapsulated benzoyl peroxide cream formulation or a vehicle applied once daily for 12 weeks.

At 12 weeks, IGA success increased over the course of the studies, and reached 43.5% in one and 50.1% in the other, compared with 16.1% and 25.9%, respectively, for the vehicle groups in those studies (P < .001 for both). Overall, she described this as “a nice improvement for a drug that we had not considered to be part of our treatment armamentarium for our rosacea patients.”

Dr. Stein Gold also shared data from a phase 2 study of low-dose oral minocycline in adults with papulopustular rosacea. A group of 200 patients used the drug or a placebo once daily for 16 weeks. The study examined 20-mg and 40-mg extended-release formulations, and found a significant improvement with the 40-mg dose over the 20-mg dose and over placebo, in terms of those who reached an IGA of 0 or 1, with a 2 grade improvement. While this is a phase 2 study, it may lead to oral minocycline as another treatment option, she said.

“It is an exciting time for the treatment of rosacea, with a variety of options and an active pipeline, so we can aim for clear skin for our patients,” she commented.

Dr. Stein Gold disclosed serving as an investigator and consultant for Galderma, Vyne, Sun, Sol Gel, and Almirall; she is a consultant and speaker for Ortho.

MedscapeLive and this news organization are owned by the same parent company.
 

Conventional wisdom holds that patients with atopic dermatitis (AD) should shun wool clothing in favor of cotton or silk, because wool is said to be irritating and promote itching. But not so when the garments are made of fine-diameter fibers of merino wool, Joseph F. Fowler, Jr., MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually.

“We’ve always though that wool is bad in atopics, right? Indeed, rough wool might be. But fine wool garments can actually improve atopic dermatitis, probably because wool is the most breathable fabric and has the best temperature regulation qualities of any fabric we can wear,” said Dr. Fowler, a dermatologist at the University of Louisville (Ky).

He was first author of a randomized, 12-week, crossover, assessor-blinded clinical trial which showed precisely that. And a second, similarly designed study, this one conducted in Australia, also concluded that fine merino wool assists in the management of AD.

The study by Dr. Fowler and coinvestigators included 50 children and adults with mild or moderate AD who either wore top-and-bottom base layer merino wool ensembles for 6 weeks and then switched to their regular nonwoolen clothing, or vice versa. The mean Eczema Area and Severity Index (EASI) score in those initially randomized to merino wool improved from a mean baseline of 4.5 to 1.7 at week 6, a significantly greater improvement than in the group wearing their regular clothing. Similarly, those who switched to merino wool after 6 weeks experienced a significant decrease in EASI scores from that point on to week 12, while those who switched from merino wool to their regular clothing did not.

Mean Dermatology Life Quality Index (DLQI) scores in patients who wore merino wool first improved from 6.9 at baseline to 3.4 at week 6. Those who wore their regular clothing first went from a mean baseline DLQI of 6.7 to 6.2 at week 6 – a nonsignificant change – but then improved to a week 12 mean DLQI of 3.7 while wearing wool. There was no improvement in DLQI scores while participants were wearing their regular clothing.

Static Investigator’s Global Assessment scores showed significantly greater improvement while patients wore merino wool garments than their regular clothing.

The Australian study included 39 patients with mild to moderate AD aged between 4 weeks and 3 years. This, too, was a 12-week, randomized, crossover, assessor-blinded clinical trial. Participating children wore merino wool for 6 weeks and cotton ensembles chosen by their parents for an equal time. The primary endpoint was change in the SCORing Atopic Dermatitis (SCORAD) index after each 6-week period. The mean 7.6-point greater SCORAD reduction at 6 weeks while wearing merino wool, compared with cotton, was “a pretty impressive reduction,” Dr. Fowler observed.

Reductions in the secondary endpoints of Atopic Dermatitis Severity Index and Infants’ Dermatitis Quality of Life Index while wearing merino wool followed suit. In contrast, switching from wool to cotton resulted in an increase in both scores. Also, use of topical corticosteroids was significantly reduced while patients wore merino wool.

Wool harvested from merino sheep is characterized by fine-diameter fibers. In Dr. Fowler’s study the mean fiber diameter was 17.5 mcm. This makes for a soft fabric with outstanding moisture absorbance capacity, a quality that’s beneficial in patients with AD, since their lesional skin loses the ability to regulate moisture, the dermatologist explained.

Both randomized trials were funded by Australian Wool Innovation and the Australian government.

MedscapeLive and this news organization are owned by the same parent company.
 

bjancin@mdedge.com

Conventional wisdom holds that patients with atopic dermatitis (AD) should shun wool clothing in favor of cotton or silk, because wool is said to be irritating and promote itching. But not so when the garments are made of fine-diameter fibers of merino wool, Joseph F. Fowler, Jr., MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually.

“We’ve always though that wool is bad in atopics, right? Indeed, rough wool might be. But fine wool garments can actually improve atopic dermatitis, probably because wool is the most breathable fabric and has the best temperature regulation qualities of any fabric we can wear,” said Dr. Fowler, a dermatologist at the University of Louisville (Ky).

He was first author of a randomized, 12-week, crossover, assessor-blinded clinical trial which showed precisely that. And a second, similarly designed study, this one conducted in Australia, also concluded that fine merino wool assists in the management of AD.

The study by Dr. Fowler and coinvestigators included 50 children and adults with mild or moderate AD who either wore top-and-bottom base layer merino wool ensembles for 6 weeks and then switched to their regular nonwoolen clothing, or vice versa. The mean Eczema Area and Severity Index (EASI) score in those initially randomized to merino wool improved from a mean baseline of 4.5 to 1.7 at week 6, a significantly greater improvement than in the group wearing their regular clothing. Similarly, those who switched to merino wool after 6 weeks experienced a significant decrease in EASI scores from that point on to week 12, while those who switched from merino wool to their regular clothing did not.

Mean Dermatology Life Quality Index (DLQI) scores in patients who wore merino wool first improved from 6.9 at baseline to 3.4 at week 6. Those who wore their regular clothing first went from a mean baseline DLQI of 6.7 to 6.2 at week 6 – a nonsignificant change – but then improved to a week 12 mean DLQI of 3.7 while wearing wool. There was no improvement in DLQI scores while participants were wearing their regular clothing.

Static Investigator’s Global Assessment scores showed significantly greater improvement while patients wore merino wool garments than their regular clothing.

The Australian study included 39 patients with mild to moderate AD aged between 4 weeks and 3 years. This, too, was a 12-week, randomized, crossover, assessor-blinded clinical trial. Participating children wore merino wool for 6 weeks and cotton ensembles chosen by their parents for an equal time. The primary endpoint was change in the SCORing Atopic Dermatitis (SCORAD) index after each 6-week period. The mean 7.6-point greater SCORAD reduction at 6 weeks while wearing merino wool, compared with cotton, was “a pretty impressive reduction,” Dr. Fowler observed.

Reductions in the secondary endpoints of Atopic Dermatitis Severity Index and Infants’ Dermatitis Quality of Life Index while wearing merino wool followed suit. In contrast, switching from wool to cotton resulted in an increase in both scores. Also, use of topical corticosteroids was significantly reduced while patients wore merino wool.

Wool harvested from merino sheep is characterized by fine-diameter fibers. In Dr. Fowler’s study the mean fiber diameter was 17.5 mcm. This makes for a soft fabric with outstanding moisture absorbance capacity, a quality that’s beneficial in patients with AD, since their lesional skin loses the ability to regulate moisture, the dermatologist explained.

Both randomized trials were funded by Australian Wool Innovation and the Australian government.

MedscapeLive and this news organization are owned by the same parent company.
 

bjancin@mdedge.com

Conventional wisdom holds that patients with atopic dermatitis (AD) should shun wool clothing in favor of cotton or silk, because wool is said to be irritating and promote itching. But not so when the garments are made of fine-diameter fibers of merino wool, Joseph F. Fowler, Jr., MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually.

“We’ve always though that wool is bad in atopics, right? Indeed, rough wool might be. But fine wool garments can actually improve atopic dermatitis, probably because wool is the most breathable fabric and has the best temperature regulation qualities of any fabric we can wear,” said Dr. Fowler, a dermatologist at the University of Louisville (Ky).

He was first author of a randomized, 12-week, crossover, assessor-blinded clinical trial which showed precisely that. And a second, similarly designed study, this one conducted in Australia, also concluded that fine merino wool assists in the management of AD.

The study by Dr. Fowler and coinvestigators included 50 children and adults with mild or moderate AD who either wore top-and-bottom base layer merino wool ensembles for 6 weeks and then switched to their regular nonwoolen clothing, or vice versa. The mean Eczema Area and Severity Index (EASI) score in those initially randomized to merino wool improved from a mean baseline of 4.5 to 1.7 at week 6, a significantly greater improvement than in the group wearing their regular clothing. Similarly, those who switched to merino wool after 6 weeks experienced a significant decrease in EASI scores from that point on to week 12, while those who switched from merino wool to their regular clothing did not.

Mean Dermatology Life Quality Index (DLQI) scores in patients who wore merino wool first improved from 6.9 at baseline to 3.4 at week 6. Those who wore their regular clothing first went from a mean baseline DLQI of 6.7 to 6.2 at week 6 – a nonsignificant change – but then improved to a week 12 mean DLQI of 3.7 while wearing wool. There was no improvement in DLQI scores while participants were wearing their regular clothing.

Static Investigator’s Global Assessment scores showed significantly greater improvement while patients wore merino wool garments than their regular clothing.

The Australian study included 39 patients with mild to moderate AD aged between 4 weeks and 3 years. This, too, was a 12-week, randomized, crossover, assessor-blinded clinical trial. Participating children wore merino wool for 6 weeks and cotton ensembles chosen by their parents for an equal time. The primary endpoint was change in the SCORing Atopic Dermatitis (SCORAD) index after each 6-week period. The mean 7.6-point greater SCORAD reduction at 6 weeks while wearing merino wool, compared with cotton, was “a pretty impressive reduction,” Dr. Fowler observed.

Reductions in the secondary endpoints of Atopic Dermatitis Severity Index and Infants’ Dermatitis Quality of Life Index while wearing merino wool followed suit. In contrast, switching from wool to cotton resulted in an increase in both scores. Also, use of topical corticosteroids was significantly reduced while patients wore merino wool.

Wool harvested from merino sheep is characterized by fine-diameter fibers. In Dr. Fowler’s study the mean fiber diameter was 17.5 mcm. This makes for a soft fabric with outstanding moisture absorbance capacity, a quality that’s beneficial in patients with AD, since their lesional skin loses the ability to regulate moisture, the dermatologist explained.

Both randomized trials were funded by Australian Wool Innovation and the Australian government.

MedscapeLive and this news organization are owned by the same parent company.
 

bjancin@mdedge.com

One month of dual-antiplatelet therapy followed by aspirin monotherapy in patients who’ve received a drug-eluting stent proved noninferior to 6-12 months of DAPT for a composite 1-year endpoint of cardiovascular events or major bleeding in the large, randomized One-Month DAPT trial.

Svisio/Thinkstock

This is the first test of such a strategy. Other trials of short-course DAPT, such as the successful TWILIGHT trial, have dropped the aspirin and continued the P2Y12 inhibitor. But aspirin monotherapy after a single month of DAPT is an attractive alternative in patients undergoing PCI for noncomplex lesions, Myeong-Ki Hong, MD, PhD, said in presenting his results at the American Heart Association scientific sessions.

“In everyday clinical practice, people receiving P2Y12 receptor blockers usually complain of several episodes of minor bleeding. And the cost. Those are strong factors in patient noncompliance,” he said, adding, “I think aspirin monotherapy is more comfortable for the physician and the patient.”

The One-Month DAPT trial included 3,020 patients who underwent percutaneous coronary intervention with drug-eluting stents (DES) at 23 Korean centers. They were split roughly 60/40 between patients with stable angina and those with acute coronary syndrome involving unstable angina. Patients with complex coronary lesions or acute MI were not eligible for enrollment. Participants were randomized to receive either the polymer-free drug-coated BioFreedom stent, in which case they got 1 month of DAPT followed by 11 months of aspirin antiplatelet monotherapy, or they received 6 or 12 months of DAPT in conjunction with a thick-strut BioMatrix or an Ultimaster polymer-based DES. The reason for using different stents in the two study arms is that only the polymer-free stent completes drug release within 1 month; other contemporary DESs release their drug for 3-4 months, and it’s risky to discontinue one of the antiplatelet agents during drug elution, said Dr. Hong, professor of cardiology at Yonsei University in Seoul, South Korea.
 

Patients with stable angina fared best

The primary endpoint in this noninferiority trial was the 1-year composite of cardiac death, MI, target vessel revascularization, stroke, or major bleeding. The incidence was 5.9% in the 1-month DAPT group, statistically noninferior to the 6.5% figure in the 6- or 12-month DAPT group. The major bleeding rate at 1 year was 1.7% with 1 month of DAPT and 2.5% with 6-12 months of DAPT, a nonsignificant difference. Of note, the primary composite endpoint occurred in 5.1% of patients with stable angina who were randomized to 1 month of DAPT, compared with 7.6% with 6 or 12 months of DAPT, a statistically significant difference that translated into a 33% relative risk reduction. In contrast, in patients with unstable angina the primary endpoint occurred in 7.2% of those on 1 month of DAPT and 5.1% with 6 or 12 months of DAPT, a trend that didn’t reach significance.

Roughly 75% of patients in the long-DAPT arm were assigned to 12 months of DAPT. That’s because the trial began in 2015, before clinical practice guidelines declared 6 months of DAPT to be the recommendation in patients with stable coronary artery disease. The choice of 6 versus 12 months of DAPT in the trial was left up to the patient’s physician.

Discussant Roisin Colleran, MBBCh, said the study addresses “an unmet clinical need” for improved antiplatelet regimens following PCI with DES.
 

Trial’s shortcomings temper reaction

“After a period of short DAPT, aspirin monotherapy may be preferable to P2Y12 monotherapy because it’s cheaper, with fewer off-target side effects, less variation in treatment response, and fewer contraindications,” said Dr. Colleran, a cardiologist at Mater Private Hospital, Dublin.

That being said, she shared several reservations about the study. For one, none of the three stents used in the trial is approved by the Food and Drug Administration. The results may not be generalizable to non–East Asian populations. The use of 12 months of DAPT in stable angina patients is out of step with current U.S. and European practice guidelines, which recommend 6 months. And 17% of patients in the 1-month DAPT group were noncompliant with that strategy, meaning they continued on DAPT; had that reverse noncompliance rate been lower, the between-group difference in the primary endpoint might have become statistically significant.

Dr. Hong said he thinks the study findings are applicable elsewhere in the world. The 1-month DAPT followed by aspirin monotherapy strategy is attractive in elderly patients, those on oral anticoagulation for atrial fibrillation, individuals who need to undergo noncardiac surgery, and in the large group of stable patients with noncomplex coronary lesions.

“Let’s provide these patients with some options,” the cardiologist urged.

He is particularly keen on the combination of a polymer-free stent with a drug-elution period of less than 1 month.

“Is polymer perfect? I don’t think so. The polymer is a foreign body. It’s fantastic, but in 5 or 10 years the polymer may cause irritation and chronic inflammation and a new lesion,” Dr. Hong said.

Session moderator Wayne B. Batchelor, MD, commented on the battle for stent market share: “It almost appears that we’re getting to a ceiling point with coronary interventions whereby at a year we’re getting such low ischemic event rates – they’re often in the 5%-7% range – that all of these [head-to-head] studies are noninferiority studies, because it’s just the only way to do these comparisons nowadays. We can’t do 10-, 15-, or 20,000-patient trials. But these noninferiority margins are quite broad.”

“Are we stuck just saying: ‘All stents are equal,’ or are we going to be able to get to the point that we can show that a healing stent is superior?” asked Dr. Batchelor, director of interventional cardiology and interventional cardiology research at the Inova Medical Group in Falls Church, Va.

“I think it’s going to be very hard to beat the current technology,” observed panelist Alexandre Abizaid, MD, PhD, of the Dante Pazzanese Institute of Cardiology in São Paulo. “Even though the polymers are durable, they’re biocompatible, and they’re hard to beat. It’s not going to be easy to show superiority. Maybe in patient subsets.”

Dr. Hong reported having no financial conflicts of interest regarding the One-Month DAPT trial, funded by DIO, Cardinal Health Korea, and Terumo.

bjancin@mdedge.com

One month of dual-antiplatelet therapy followed by aspirin monotherapy in patients who’ve received a drug-eluting stent proved noninferior to 6-12 months of DAPT for a composite 1-year endpoint of cardiovascular events or major bleeding in the large, randomized One-Month DAPT trial.

Svisio/Thinkstock

This is the first test of such a strategy. Other trials of short-course DAPT, such as the successful TWILIGHT trial, have dropped the aspirin and continued the P2Y12 inhibitor. But aspirin monotherapy after a single month of DAPT is an attractive alternative in patients undergoing PCI for noncomplex lesions, Myeong-Ki Hong, MD, PhD, said in presenting his results at the American Heart Association scientific sessions.

“In everyday clinical practice, people receiving P2Y12 receptor blockers usually complain of several episodes of minor bleeding. And the cost. Those are strong factors in patient noncompliance,” he said, adding, “I think aspirin monotherapy is more comfortable for the physician and the patient.”

The One-Month DAPT trial included 3,020 patients who underwent percutaneous coronary intervention with drug-eluting stents (DES) at 23 Korean centers. They were split roughly 60/40 between patients with stable angina and those with acute coronary syndrome involving unstable angina. Patients with complex coronary lesions or acute MI were not eligible for enrollment. Participants were randomized to receive either the polymer-free drug-coated BioFreedom stent, in which case they got 1 month of DAPT followed by 11 months of aspirin antiplatelet monotherapy, or they received 6 or 12 months of DAPT in conjunction with a thick-strut BioMatrix or an Ultimaster polymer-based DES. The reason for using different stents in the two study arms is that only the polymer-free stent completes drug release within 1 month; other contemporary DESs release their drug for 3-4 months, and it’s risky to discontinue one of the antiplatelet agents during drug elution, said Dr. Hong, professor of cardiology at Yonsei University in Seoul, South Korea.
 

Patients with stable angina fared best

The primary endpoint in this noninferiority trial was the 1-year composite of cardiac death, MI, target vessel revascularization, stroke, or major bleeding. The incidence was 5.9% in the 1-month DAPT group, statistically noninferior to the 6.5% figure in the 6- or 12-month DAPT group. The major bleeding rate at 1 year was 1.7% with 1 month of DAPT and 2.5% with 6-12 months of DAPT, a nonsignificant difference. Of note, the primary composite endpoint occurred in 5.1% of patients with stable angina who were randomized to 1 month of DAPT, compared with 7.6% with 6 or 12 months of DAPT, a statistically significant difference that translated into a 33% relative risk reduction. In contrast, in patients with unstable angina the primary endpoint occurred in 7.2% of those on 1 month of DAPT and 5.1% with 6 or 12 months of DAPT, a trend that didn’t reach significance.

Roughly 75% of patients in the long-DAPT arm were assigned to 12 months of DAPT. That’s because the trial began in 2015, before clinical practice guidelines declared 6 months of DAPT to be the recommendation in patients with stable coronary artery disease. The choice of 6 versus 12 months of DAPT in the trial was left up to the patient’s physician.

Discussant Roisin Colleran, MBBCh, said the study addresses “an unmet clinical need” for improved antiplatelet regimens following PCI with DES.
 

Trial’s shortcomings temper reaction

“After a period of short DAPT, aspirin monotherapy may be preferable to P2Y12 monotherapy because it’s cheaper, with fewer off-target side effects, less variation in treatment response, and fewer contraindications,” said Dr. Colleran, a cardiologist at Mater Private Hospital, Dublin.

That being said, she shared several reservations about the study. For one, none of the three stents used in the trial is approved by the Food and Drug Administration. The results may not be generalizable to non–East Asian populations. The use of 12 months of DAPT in stable angina patients is out of step with current U.S. and European practice guidelines, which recommend 6 months. And 17% of patients in the 1-month DAPT group were noncompliant with that strategy, meaning they continued on DAPT; had that reverse noncompliance rate been lower, the between-group difference in the primary endpoint might have become statistically significant.

Dr. Hong said he thinks the study findings are applicable elsewhere in the world. The 1-month DAPT followed by aspirin monotherapy strategy is attractive in elderly patients, those on oral anticoagulation for atrial fibrillation, individuals who need to undergo noncardiac surgery, and in the large group of stable patients with noncomplex coronary lesions.

“Let’s provide these patients with some options,” the cardiologist urged.

He is particularly keen on the combination of a polymer-free stent with a drug-elution period of less than 1 month.

“Is polymer perfect? I don’t think so. The polymer is a foreign body. It’s fantastic, but in 5 or 10 years the polymer may cause irritation and chronic inflammation and a new lesion,” Dr. Hong said.

Session moderator Wayne B. Batchelor, MD, commented on the battle for stent market share: “It almost appears that we’re getting to a ceiling point with coronary interventions whereby at a year we’re getting such low ischemic event rates – they’re often in the 5%-7% range – that all of these [head-to-head] studies are noninferiority studies, because it’s just the only way to do these comparisons nowadays. We can’t do 10-, 15-, or 20,000-patient trials. But these noninferiority margins are quite broad.”

“Are we stuck just saying: ‘All stents are equal,’ or are we going to be able to get to the point that we can show that a healing stent is superior?” asked Dr. Batchelor, director of interventional cardiology and interventional cardiology research at the Inova Medical Group in Falls Church, Va.

“I think it’s going to be very hard to beat the current technology,” observed panelist Alexandre Abizaid, MD, PhD, of the Dante Pazzanese Institute of Cardiology in São Paulo. “Even though the polymers are durable, they’re biocompatible, and they’re hard to beat. It’s not going to be easy to show superiority. Maybe in patient subsets.”

Dr. Hong reported having no financial conflicts of interest regarding the One-Month DAPT trial, funded by DIO, Cardinal Health Korea, and Terumo.

bjancin@mdedge.com

One month of dual-antiplatelet therapy followed by aspirin monotherapy in patients who’ve received a drug-eluting stent proved noninferior to 6-12 months of DAPT for a composite 1-year endpoint of cardiovascular events or major bleeding in the large, randomized One-Month DAPT trial.

Svisio/Thinkstock

This is the first test of such a strategy. Other trials of short-course DAPT, such as the successful TWILIGHT trial, have dropped the aspirin and continued the P2Y12 inhibitor. But aspirin monotherapy after a single month of DAPT is an attractive alternative in patients undergoing PCI for noncomplex lesions, Myeong-Ki Hong, MD, PhD, said in presenting his results at the American Heart Association scientific sessions.

“In everyday clinical practice, people receiving P2Y12 receptor blockers usually complain of several episodes of minor bleeding. And the cost. Those are strong factors in patient noncompliance,” he said, adding, “I think aspirin monotherapy is more comfortable for the physician and the patient.”

The One-Month DAPT trial included 3,020 patients who underwent percutaneous coronary intervention with drug-eluting stents (DES) at 23 Korean centers. They were split roughly 60/40 between patients with stable angina and those with acute coronary syndrome involving unstable angina. Patients with complex coronary lesions or acute MI were not eligible for enrollment. Participants were randomized to receive either the polymer-free drug-coated BioFreedom stent, in which case they got 1 month of DAPT followed by 11 months of aspirin antiplatelet monotherapy, or they received 6 or 12 months of DAPT in conjunction with a thick-strut BioMatrix or an Ultimaster polymer-based DES. The reason for using different stents in the two study arms is that only the polymer-free stent completes drug release within 1 month; other contemporary DESs release their drug for 3-4 months, and it’s risky to discontinue one of the antiplatelet agents during drug elution, said Dr. Hong, professor of cardiology at Yonsei University in Seoul, South Korea.
 

Patients with stable angina fared best

The primary endpoint in this noninferiority trial was the 1-year composite of cardiac death, MI, target vessel revascularization, stroke, or major bleeding. The incidence was 5.9% in the 1-month DAPT group, statistically noninferior to the 6.5% figure in the 6- or 12-month DAPT group. The major bleeding rate at 1 year was 1.7% with 1 month of DAPT and 2.5% with 6-12 months of DAPT, a nonsignificant difference. Of note, the primary composite endpoint occurred in 5.1% of patients with stable angina who were randomized to 1 month of DAPT, compared with 7.6% with 6 or 12 months of DAPT, a statistically significant difference that translated into a 33% relative risk reduction. In contrast, in patients with unstable angina the primary endpoint occurred in 7.2% of those on 1 month of DAPT and 5.1% with 6 or 12 months of DAPT, a trend that didn’t reach significance.

Roughly 75% of patients in the long-DAPT arm were assigned to 12 months of DAPT. That’s because the trial began in 2015, before clinical practice guidelines declared 6 months of DAPT to be the recommendation in patients with stable coronary artery disease. The choice of 6 versus 12 months of DAPT in the trial was left up to the patient’s physician.

Discussant Roisin Colleran, MBBCh, said the study addresses “an unmet clinical need” for improved antiplatelet regimens following PCI with DES.
 

Trial’s shortcomings temper reaction

“After a period of short DAPT, aspirin monotherapy may be preferable to P2Y12 monotherapy because it’s cheaper, with fewer off-target side effects, less variation in treatment response, and fewer contraindications,” said Dr. Colleran, a cardiologist at Mater Private Hospital, Dublin.

That being said, she shared several reservations about the study. For one, none of the three stents used in the trial is approved by the Food and Drug Administration. The results may not be generalizable to non–East Asian populations. The use of 12 months of DAPT in stable angina patients is out of step with current U.S. and European practice guidelines, which recommend 6 months. And 17% of patients in the 1-month DAPT group were noncompliant with that strategy, meaning they continued on DAPT; had that reverse noncompliance rate been lower, the between-group difference in the primary endpoint might have become statistically significant.

Dr. Hong said he thinks the study findings are applicable elsewhere in the world. The 1-month DAPT followed by aspirin monotherapy strategy is attractive in elderly patients, those on oral anticoagulation for atrial fibrillation, individuals who need to undergo noncardiac surgery, and in the large group of stable patients with noncomplex coronary lesions.

“Let’s provide these patients with some options,” the cardiologist urged.

He is particularly keen on the combination of a polymer-free stent with a drug-elution period of less than 1 month.

“Is polymer perfect? I don’t think so. The polymer is a foreign body. It’s fantastic, but in 5 or 10 years the polymer may cause irritation and chronic inflammation and a new lesion,” Dr. Hong said.

Session moderator Wayne B. Batchelor, MD, commented on the battle for stent market share: “It almost appears that we’re getting to a ceiling point with coronary interventions whereby at a year we’re getting such low ischemic event rates – they’re often in the 5%-7% range – that all of these [head-to-head] studies are noninferiority studies, because it’s just the only way to do these comparisons nowadays. We can’t do 10-, 15-, or 20,000-patient trials. But these noninferiority margins are quite broad.”

“Are we stuck just saying: ‘All stents are equal,’ or are we going to be able to get to the point that we can show that a healing stent is superior?” asked Dr. Batchelor, director of interventional cardiology and interventional cardiology research at the Inova Medical Group in Falls Church, Va.

“I think it’s going to be very hard to beat the current technology,” observed panelist Alexandre Abizaid, MD, PhD, of the Dante Pazzanese Institute of Cardiology in São Paulo. “Even though the polymers are durable, they’re biocompatible, and they’re hard to beat. It’s not going to be easy to show superiority. Maybe in patient subsets.”

Dr. Hong reported having no financial conflicts of interest regarding the One-Month DAPT trial, funded by DIO, Cardinal Health Korea, and Terumo.

bjancin@mdedge.com

Marijuana use was associated with a higher prevalence of recurrent MI and a greater risk of bleeding or stroke after percutaneous coronary intervention (PCI) in separate studies.

Rhushik Bhuva, MD, presented the recurrent-MI results from a national U.S. study, and Sang Gune K. Yoo, MD, presented the PCI study, which used data from a Michigan cohort. The studies were presented at the American Heart Association scientific sessions.

Both studies “add to our accumulating knowledge of the cardiovascular risks of marijuana,” Ersilia M. DeFilippis, MD, a cardiology fellow at Columbia University Irvine Medical Center, New York, who was not involved with this research, said in an interview.

Dr. DeFilippis and the two study authors say clinicians and patients need to be more aware of cardiovascular risks from smoking marijuana, and they call for more patient screening, counseling, and research.
 

Need for screening and counseling

Marijuana is a Schedule 1 controlled substance in the United States, which makes it illegal to conduct rigorous controlled trials of marijuana products. Existing knowledge is therefore based on observational studies, Dr. DeFilippis noted.

She was lead author of a review of marijuana use by patients with cardiovascular disease. The review was published in the Journal of the American College of Cardiology. An AHA scientific statement about marijuana and cardiovascular health was published in Circulation.

Both documents drew attention to risks from marijuana use in patients with cardiovascular disease.

Until more data are available, “I think it is absolutely critical” that cardiologists and general providers screen patients for marijuana use, “either at the time of their MI or ideally prior to that, when they are making a cardiovascular risk assessment,” said Dr. DeFilippis.

That is also the time to “counsel patients, especially those who have had an MI, about risks associated with continuing to use marijuana.”

Importantly, providers and patients need to be aware that “cannabinoids, through the cytochrome P450 system, can interact with well-known cardiovascular medications, which we know provide benefit in the post-MI period,” she added. “For example, marijuana can interfere with beta-blockers, statins, antiarrhythmics, and certain anticoagulants.”

Dr. Bhuva, a cardiology fellow with the Wright Center for Community Health, Scranton, Pa., said that it is “concerning” that “recurrent heart attacks and cardiac interventions [were] higher among cannabis users, even though they were younger and had fewer risk factors for heart disease.

“Spreading awareness regarding the potential risk of recurrent heart attacks in middle-aged, African American, and male cannabis users and screening them at an earlier age for potential risk factors of future heart attacks should be encouraged among clinicians,” he urged in a statement from the AHA.

Dr. Yoo, an internal medicine resident at the University of Michigan, Ann Arbor, pointed out that, in their study of patients who underwent PCI after MI or because they had coronary artery disease, those who smoked or vaped marijuana were younger and were more likely to be male. They were less likely to have traditional cardiovascular risk factors except for smoking tobacco, which was highly prevalent.

After propensity matching, patients who used marijuana had a 1.5-fold increased risk of in-hospital bleeding and an 11-fold higher risk for in-hospital stroke following PCI.

However, the absolute number of strokes in PCI was small, and the confidence interval was wide (indicating a large uncertainty), Dr. Yoo said in an interview.

These risks “should not deter patients from undergoing these [lifesaving] procedures,” he said; however, clinicians should be aware of these risks with marijuana use and should screen and counsel patients about this.
 

Hospitalized patients with prior MI

Dr. Bhuva and colleagues identified patients from the National Inpatient Sample who were hospitalized in the United States from 2007 to 2014 and who had experienced a prior MI and had undergone revascularization with PCI or coronary artery bypass grafting (CABG).

There were about 8 million hospital stays per year. The database did not specify the type of marijuana that patients used.

During the 8-year study period, many states legalized or decriminalized medical and/or recreational marijuana, and marijuana use increased steadily, from 0.2% to 0.7%.

Compared with nonusers, those who used marijuana were younger (median age, 53 vs. 72 years), and there were more men (77% vs. 62%) or Black persons (34% vs. 10%) (all P < .001). Fewer marijuana users had hypertension (72% vs. 75%), diabetes (24% vs. 33%), or dyslipidemia (51% vs. 58%) (all P < .001). More marijuana users underwent a repeat MI (67% vs. 41%).

On the other hand, marijuana users, who were younger and healthier than the other patients, were less likely to die during hospitalization for a recurrent MI (0.8% vs. 2.5%), and their hospital costs were lower.

The researchers acknowledged that study limitations include lack of information about marijuana type (smoked, edible, medicinal, or recreational) or dose, as well as the time from marijuana use to cardiac event.
 

In-Hospital outcomes after PCI

Dr. Yoo and colleagues analyzed data from patients who underwent PCI from Jan. 1, 2013, to Oct. 1, 2016, at Michigan’s 48 nonfederal hospitals, which are part of the Blue Cross Blue Shield Michigan Cardiovascular Consortium PCI registry.

In this cohort, 3,970 patients (3.5%) had smoked or vaped marijuana in the month prior to PCI, and 109,507 patients had not done so. The marijuana users were younger (mean age, 54 vs. 66 years) and were more likely to be male (79% vs. 67%) and to smoke cigarettes (73% vs. 27%).

They were less likely to have hypertension, type 2 diabetes, dyslipidemia, cerebrovascular disease, or prior CABG and were equally likely to have had a prior MI (36%).

Compared with nonusers, marijuana users were more likely to present with non–ST-elevation MI (30% vs. 23%) or ST-elevation MI (27% vs. 16%) and were less likely to present with angina.

Using propensity score matching, the researchers matched 3,803 marijuana users with the same number of nonusers.

In the matched cohort, patients who used marijuana had a greater risk of in-hospital bleeding (adjusted odds ratio, 1.54; 95% confidence interval, 1.20-1.97; P < .001) or stroke (aOR, 11.01; 95% CI, 1.32-91.67; P = .026) following PCI.

Marijuana users had a lower risk for acute kidney injury (2.2% vs. 2.9%; P = .007). Transfusion and mortality rates were similar in both groups.

The researchers acknowledged study limitations, including the fact that it did not include marijuana edibles, that the results may not be generalizable, and that marijuana use is now likely more common in Michigan following legalization of recreational marijuana in 2018.

Dr. Bhuva, Dr. Yoo, and Dr. DeFilippis have disclosed no relevant financial relationships.

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

Marijuana use was associated with a higher prevalence of recurrent MI and a greater risk of bleeding or stroke after percutaneous coronary intervention (PCI) in separate studies.

Rhushik Bhuva, MD, presented the recurrent-MI results from a national U.S. study, and Sang Gune K. Yoo, MD, presented the PCI study, which used data from a Michigan cohort. The studies were presented at the American Heart Association scientific sessions.

Both studies “add to our accumulating knowledge of the cardiovascular risks of marijuana,” Ersilia M. DeFilippis, MD, a cardiology fellow at Columbia University Irvine Medical Center, New York, who was not involved with this research, said in an interview.

Dr. DeFilippis and the two study authors say clinicians and patients need to be more aware of cardiovascular risks from smoking marijuana, and they call for more patient screening, counseling, and research.
 

Need for screening and counseling

Marijuana is a Schedule 1 controlled substance in the United States, which makes it illegal to conduct rigorous controlled trials of marijuana products. Existing knowledge is therefore based on observational studies, Dr. DeFilippis noted.

She was lead author of a review of marijuana use by patients with cardiovascular disease. The review was published in the Journal of the American College of Cardiology. An AHA scientific statement about marijuana and cardiovascular health was published in Circulation.

Both documents drew attention to risks from marijuana use in patients with cardiovascular disease.

Until more data are available, “I think it is absolutely critical” that cardiologists and general providers screen patients for marijuana use, “either at the time of their MI or ideally prior to that, when they are making a cardiovascular risk assessment,” said Dr. DeFilippis.

That is also the time to “counsel patients, especially those who have had an MI, about risks associated with continuing to use marijuana.”

Importantly, providers and patients need to be aware that “cannabinoids, through the cytochrome P450 system, can interact with well-known cardiovascular medications, which we know provide benefit in the post-MI period,” she added. “For example, marijuana can interfere with beta-blockers, statins, antiarrhythmics, and certain anticoagulants.”

Dr. Bhuva, a cardiology fellow with the Wright Center for Community Health, Scranton, Pa., said that it is “concerning” that “recurrent heart attacks and cardiac interventions [were] higher among cannabis users, even though they were younger and had fewer risk factors for heart disease.

“Spreading awareness regarding the potential risk of recurrent heart attacks in middle-aged, African American, and male cannabis users and screening them at an earlier age for potential risk factors of future heart attacks should be encouraged among clinicians,” he urged in a statement from the AHA.

Dr. Yoo, an internal medicine resident at the University of Michigan, Ann Arbor, pointed out that, in their study of patients who underwent PCI after MI or because they had coronary artery disease, those who smoked or vaped marijuana were younger and were more likely to be male. They were less likely to have traditional cardiovascular risk factors except for smoking tobacco, which was highly prevalent.

After propensity matching, patients who used marijuana had a 1.5-fold increased risk of in-hospital bleeding and an 11-fold higher risk for in-hospital stroke following PCI.

However, the absolute number of strokes in PCI was small, and the confidence interval was wide (indicating a large uncertainty), Dr. Yoo said in an interview.

These risks “should not deter patients from undergoing these [lifesaving] procedures,” he said; however, clinicians should be aware of these risks with marijuana use and should screen and counsel patients about this.
 

Hospitalized patients with prior MI

Dr. Bhuva and colleagues identified patients from the National Inpatient Sample who were hospitalized in the United States from 2007 to 2014 and who had experienced a prior MI and had undergone revascularization with PCI or coronary artery bypass grafting (CABG).

There were about 8 million hospital stays per year. The database did not specify the type of marijuana that patients used.

During the 8-year study period, many states legalized or decriminalized medical and/or recreational marijuana, and marijuana use increased steadily, from 0.2% to 0.7%.

Compared with nonusers, those who used marijuana were younger (median age, 53 vs. 72 years), and there were more men (77% vs. 62%) or Black persons (34% vs. 10%) (all P < .001). Fewer marijuana users had hypertension (72% vs. 75%), diabetes (24% vs. 33%), or dyslipidemia (51% vs. 58%) (all P < .001). More marijuana users underwent a repeat MI (67% vs. 41%).

On the other hand, marijuana users, who were younger and healthier than the other patients, were less likely to die during hospitalization for a recurrent MI (0.8% vs. 2.5%), and their hospital costs were lower.

The researchers acknowledged that study limitations include lack of information about marijuana type (smoked, edible, medicinal, or recreational) or dose, as well as the time from marijuana use to cardiac event.
 

In-Hospital outcomes after PCI

Dr. Yoo and colleagues analyzed data from patients who underwent PCI from Jan. 1, 2013, to Oct. 1, 2016, at Michigan’s 48 nonfederal hospitals, which are part of the Blue Cross Blue Shield Michigan Cardiovascular Consortium PCI registry.

In this cohort, 3,970 patients (3.5%) had smoked or vaped marijuana in the month prior to PCI, and 109,507 patients had not done so. The marijuana users were younger (mean age, 54 vs. 66 years) and were more likely to be male (79% vs. 67%) and to smoke cigarettes (73% vs. 27%).

They were less likely to have hypertension, type 2 diabetes, dyslipidemia, cerebrovascular disease, or prior CABG and were equally likely to have had a prior MI (36%).

Compared with nonusers, marijuana users were more likely to present with non–ST-elevation MI (30% vs. 23%) or ST-elevation MI (27% vs. 16%) and were less likely to present with angina.

Using propensity score matching, the researchers matched 3,803 marijuana users with the same number of nonusers.

In the matched cohort, patients who used marijuana had a greater risk of in-hospital bleeding (adjusted odds ratio, 1.54; 95% confidence interval, 1.20-1.97; P < .001) or stroke (aOR, 11.01; 95% CI, 1.32-91.67; P = .026) following PCI.

Marijuana users had a lower risk for acute kidney injury (2.2% vs. 2.9%; P = .007). Transfusion and mortality rates were similar in both groups.

The researchers acknowledged study limitations, including the fact that it did not include marijuana edibles, that the results may not be generalizable, and that marijuana use is now likely more common in Michigan following legalization of recreational marijuana in 2018.

Dr. Bhuva, Dr. Yoo, and Dr. DeFilippis have disclosed no relevant financial relationships.

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

Marijuana use was associated with a higher prevalence of recurrent MI and a greater risk of bleeding or stroke after percutaneous coronary intervention (PCI) in separate studies.

Rhushik Bhuva, MD, presented the recurrent-MI results from a national U.S. study, and Sang Gune K. Yoo, MD, presented the PCI study, which used data from a Michigan cohort. The studies were presented at the American Heart Association scientific sessions.

Both studies “add to our accumulating knowledge of the cardiovascular risks of marijuana,” Ersilia M. DeFilippis, MD, a cardiology fellow at Columbia University Irvine Medical Center, New York, who was not involved with this research, said in an interview.

Dr. DeFilippis and the two study authors say clinicians and patients need to be more aware of cardiovascular risks from smoking marijuana, and they call for more patient screening, counseling, and research.
 

Need for screening and counseling

Marijuana is a Schedule 1 controlled substance in the United States, which makes it illegal to conduct rigorous controlled trials of marijuana products. Existing knowledge is therefore based on observational studies, Dr. DeFilippis noted.

She was lead author of a review of marijuana use by patients with cardiovascular disease. The review was published in the Journal of the American College of Cardiology. An AHA scientific statement about marijuana and cardiovascular health was published in Circulation.

Both documents drew attention to risks from marijuana use in patients with cardiovascular disease.

Until more data are available, “I think it is absolutely critical” that cardiologists and general providers screen patients for marijuana use, “either at the time of their MI or ideally prior to that, when they are making a cardiovascular risk assessment,” said Dr. DeFilippis.

That is also the time to “counsel patients, especially those who have had an MI, about risks associated with continuing to use marijuana.”

Importantly, providers and patients need to be aware that “cannabinoids, through the cytochrome P450 system, can interact with well-known cardiovascular medications, which we know provide benefit in the post-MI period,” she added. “For example, marijuana can interfere with beta-blockers, statins, antiarrhythmics, and certain anticoagulants.”

Dr. Bhuva, a cardiology fellow with the Wright Center for Community Health, Scranton, Pa., said that it is “concerning” that “recurrent heart attacks and cardiac interventions [were] higher among cannabis users, even though they were younger and had fewer risk factors for heart disease.

“Spreading awareness regarding the potential risk of recurrent heart attacks in middle-aged, African American, and male cannabis users and screening them at an earlier age for potential risk factors of future heart attacks should be encouraged among clinicians,” he urged in a statement from the AHA.

Dr. Yoo, an internal medicine resident at the University of Michigan, Ann Arbor, pointed out that, in their study of patients who underwent PCI after MI or because they had coronary artery disease, those who smoked or vaped marijuana were younger and were more likely to be male. They were less likely to have traditional cardiovascular risk factors except for smoking tobacco, which was highly prevalent.

After propensity matching, patients who used marijuana had a 1.5-fold increased risk of in-hospital bleeding and an 11-fold higher risk for in-hospital stroke following PCI.

However, the absolute number of strokes in PCI was small, and the confidence interval was wide (indicating a large uncertainty), Dr. Yoo said in an interview.

These risks “should not deter patients from undergoing these [lifesaving] procedures,” he said; however, clinicians should be aware of these risks with marijuana use and should screen and counsel patients about this.
 

Hospitalized patients with prior MI

Dr. Bhuva and colleagues identified patients from the National Inpatient Sample who were hospitalized in the United States from 2007 to 2014 and who had experienced a prior MI and had undergone revascularization with PCI or coronary artery bypass grafting (CABG).

There were about 8 million hospital stays per year. The database did not specify the type of marijuana that patients used.

During the 8-year study period, many states legalized or decriminalized medical and/or recreational marijuana, and marijuana use increased steadily, from 0.2% to 0.7%.

Compared with nonusers, those who used marijuana were younger (median age, 53 vs. 72 years), and there were more men (77% vs. 62%) or Black persons (34% vs. 10%) (all P < .001). Fewer marijuana users had hypertension (72% vs. 75%), diabetes (24% vs. 33%), or dyslipidemia (51% vs. 58%) (all P < .001). More marijuana users underwent a repeat MI (67% vs. 41%).

On the other hand, marijuana users, who were younger and healthier than the other patients, were less likely to die during hospitalization for a recurrent MI (0.8% vs. 2.5%), and their hospital costs were lower.

The researchers acknowledged that study limitations include lack of information about marijuana type (smoked, edible, medicinal, or recreational) or dose, as well as the time from marijuana use to cardiac event.
 

In-Hospital outcomes after PCI

Dr. Yoo and colleagues analyzed data from patients who underwent PCI from Jan. 1, 2013, to Oct. 1, 2016, at Michigan’s 48 nonfederal hospitals, which are part of the Blue Cross Blue Shield Michigan Cardiovascular Consortium PCI registry.

In this cohort, 3,970 patients (3.5%) had smoked or vaped marijuana in the month prior to PCI, and 109,507 patients had not done so. The marijuana users were younger (mean age, 54 vs. 66 years) and were more likely to be male (79% vs. 67%) and to smoke cigarettes (73% vs. 27%).

They were less likely to have hypertension, type 2 diabetes, dyslipidemia, cerebrovascular disease, or prior CABG and were equally likely to have had a prior MI (36%).

Compared with nonusers, marijuana users were more likely to present with non–ST-elevation MI (30% vs. 23%) or ST-elevation MI (27% vs. 16%) and were less likely to present with angina.

Using propensity score matching, the researchers matched 3,803 marijuana users with the same number of nonusers.

In the matched cohort, patients who used marijuana had a greater risk of in-hospital bleeding (adjusted odds ratio, 1.54; 95% confidence interval, 1.20-1.97; P < .001) or stroke (aOR, 11.01; 95% CI, 1.32-91.67; P = .026) following PCI.

Marijuana users had a lower risk for acute kidney injury (2.2% vs. 2.9%; P = .007). Transfusion and mortality rates were similar in both groups.

The researchers acknowledged study limitations, including the fact that it did not include marijuana edibles, that the results may not be generalizable, and that marijuana use is now likely more common in Michigan following legalization of recreational marijuana in 2018.

Dr. Bhuva, Dr. Yoo, and Dr. DeFilippis have disclosed no relevant financial relationships.

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

Some patients with photosensitivity disorders present with a rash, while others report a history of reactivity, said Vincent DeLeo, MD, of the University of Southern California, Los Angeles.

“When a patient comes in who makes you suspect a photosensitivity, there will be two different presentations,” he said in a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

In some cases, the patient presents with a reaction they believe is sun related, although they don’t have a rash currently, he said. In other cases, “you as a good clinician suspect photosensitivity because the eruption is in a photo distribution,” although the patient may or may not relate it to sun exposure, he added.

Dr. DeLeo noted a few key points to include when taking the history in patients with likely photosensitivity, whether or not they present with a rash.

“I always ask patients when did the episode occur? Is it chronic?” Also ask about timing: Does the reaction occur in the sun, or later? Does it occur quickly and go away within hours, or occur within days or weeks of exposure?

“Always take a good drug history, as photosensitivity can often be related to drugs,” Dr. DeLeo noted. For example, approximately 50% of individuals on amiodarone will have some type of photosensitivity, he said.

Other drug-induced photosensitive conditions include drug-induced subacute cutaneous lupus and pseudoporphyria from NSAIDs, as well as hyperpigmentation from diltiazem, which most often occurs in Black women, he said.

“Photodrug reactions are usually related to UVA radiation, and that is important because you can develop it through the window while driving in your car”: The car windows do not protect against UVA, Dr. DeLeo said. If you have a patient who tells you about a photosensitivity or has a rash and they are on a photosensitizing drug, first rule out connective tissue disease, then discontinue the drug in collaboration with the patient’s internist and wait for the reaction to disappear, and it should, he said.

Some photosensitivity rashes have characteristic patterns, notably connective tissue disease patterns in lupus and dermatomyositis patients, bullous eruptions in cases of porphyria or phototoxic contact dermatitis, and eczematous eruptions, Dr. DeLeo noted.

Patients who present without a rash, but report a history of a reaction that they believe is related to sun exposure, fall into two categories: some had a rash that occurred while in the sun and disappeared quickly, and some had one that occurred hours or days after exposure and lasted a few days to weeks, said Dr. DeLeo.

The differential diagnosis in the patient with immediate photosensitivity is fairly clear: These patients usually have solar urticaria, he said. However, some lupus patients may report this reaction so it is important to rule out connective tissue disease. The diagnosis can be made with phototesting or do a simple test by having the patient sit out in the sunshine, he said.

For the patient who has a delayed reactivity after sun exposure, and doesn’t have the reaction when they come to the office, the differential diagnosis in a simply applied way is that, if the reaction spared the face, it is likely polymorphous light eruption (PMLE); but if the face is involved, the patient likely has photoallergic contact dermatitis, Dr. DeLeo explained. However, always consider the alternatives of connective tissue disease, drug reactions, and contact dermatitis that is not photoallergic, he noted.

PMLE “is the most common photosensitivity reaction that we see in the United States,” and it almost always occurs when people are away from home, usually on vacation, said Dr. DeLeo. The differential diagnosis for patients with recurrent or delayed rash involving the face could be photoallergic contact dermatitis, but rule out airborne contact dermatitis, personal care product contact dermatitis, and chronic actinic dermatitis, he said. A work-up for these patients could include a photo test, photopatch test, or patch test.

Dr. DeLeo disclosed serving as a consultant for Estee Lauder.

MedscapeLive and this news organization are owned by the same parent company.

Some patients with photosensitivity disorders present with a rash, while others report a history of reactivity, said Vincent DeLeo, MD, of the University of Southern California, Los Angeles.

“When a patient comes in who makes you suspect a photosensitivity, there will be two different presentations,” he said in a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

In some cases, the patient presents with a reaction they believe is sun related, although they don’t have a rash currently, he said. In other cases, “you as a good clinician suspect photosensitivity because the eruption is in a photo distribution,” although the patient may or may not relate it to sun exposure, he added.

Dr. DeLeo noted a few key points to include when taking the history in patients with likely photosensitivity, whether or not they present with a rash.

“I always ask patients when did the episode occur? Is it chronic?” Also ask about timing: Does the reaction occur in the sun, or later? Does it occur quickly and go away within hours, or occur within days or weeks of exposure?

“Always take a good drug history, as photosensitivity can often be related to drugs,” Dr. DeLeo noted. For example, approximately 50% of individuals on amiodarone will have some type of photosensitivity, he said.

Other drug-induced photosensitive conditions include drug-induced subacute cutaneous lupus and pseudoporphyria from NSAIDs, as well as hyperpigmentation from diltiazem, which most often occurs in Black women, he said.

“Photodrug reactions are usually related to UVA radiation, and that is important because you can develop it through the window while driving in your car”: The car windows do not protect against UVA, Dr. DeLeo said. If you have a patient who tells you about a photosensitivity or has a rash and they are on a photosensitizing drug, first rule out connective tissue disease, then discontinue the drug in collaboration with the patient’s internist and wait for the reaction to disappear, and it should, he said.

Some photosensitivity rashes have characteristic patterns, notably connective tissue disease patterns in lupus and dermatomyositis patients, bullous eruptions in cases of porphyria or phototoxic contact dermatitis, and eczematous eruptions, Dr. DeLeo noted.

Patients who present without a rash, but report a history of a reaction that they believe is related to sun exposure, fall into two categories: some had a rash that occurred while in the sun and disappeared quickly, and some had one that occurred hours or days after exposure and lasted a few days to weeks, said Dr. DeLeo.

The differential diagnosis in the patient with immediate photosensitivity is fairly clear: These patients usually have solar urticaria, he said. However, some lupus patients may report this reaction so it is important to rule out connective tissue disease. The diagnosis can be made with phototesting or do a simple test by having the patient sit out in the sunshine, he said.

For the patient who has a delayed reactivity after sun exposure, and doesn’t have the reaction when they come to the office, the differential diagnosis in a simply applied way is that, if the reaction spared the face, it is likely polymorphous light eruption (PMLE); but if the face is involved, the patient likely has photoallergic contact dermatitis, Dr. DeLeo explained. However, always consider the alternatives of connective tissue disease, drug reactions, and contact dermatitis that is not photoallergic, he noted.

PMLE “is the most common photosensitivity reaction that we see in the United States,” and it almost always occurs when people are away from home, usually on vacation, said Dr. DeLeo. The differential diagnosis for patients with recurrent or delayed rash involving the face could be photoallergic contact dermatitis, but rule out airborne contact dermatitis, personal care product contact dermatitis, and chronic actinic dermatitis, he said. A work-up for these patients could include a photo test, photopatch test, or patch test.

Dr. DeLeo disclosed serving as a consultant for Estee Lauder.

MedscapeLive and this news organization are owned by the same parent company.

Some patients with photosensitivity disorders present with a rash, while others report a history of reactivity, said Vincent DeLeo, MD, of the University of Southern California, Los Angeles.

“When a patient comes in who makes you suspect a photosensitivity, there will be two different presentations,” he said in a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

In some cases, the patient presents with a reaction they believe is sun related, although they don’t have a rash currently, he said. In other cases, “you as a good clinician suspect photosensitivity because the eruption is in a photo distribution,” although the patient may or may not relate it to sun exposure, he added.

Dr. DeLeo noted a few key points to include when taking the history in patients with likely photosensitivity, whether or not they present with a rash.

“I always ask patients when did the episode occur? Is it chronic?” Also ask about timing: Does the reaction occur in the sun, or later? Does it occur quickly and go away within hours, or occur within days or weeks of exposure?

“Always take a good drug history, as photosensitivity can often be related to drugs,” Dr. DeLeo noted. For example, approximately 50% of individuals on amiodarone will have some type of photosensitivity, he said.

Other drug-induced photosensitive conditions include drug-induced subacute cutaneous lupus and pseudoporphyria from NSAIDs, as well as hyperpigmentation from diltiazem, which most often occurs in Black women, he said.

“Photodrug reactions are usually related to UVA radiation, and that is important because you can develop it through the window while driving in your car”: The car windows do not protect against UVA, Dr. DeLeo said. If you have a patient who tells you about a photosensitivity or has a rash and they are on a photosensitizing drug, first rule out connective tissue disease, then discontinue the drug in collaboration with the patient’s internist and wait for the reaction to disappear, and it should, he said.

Some photosensitivity rashes have characteristic patterns, notably connective tissue disease patterns in lupus and dermatomyositis patients, bullous eruptions in cases of porphyria or phototoxic contact dermatitis, and eczematous eruptions, Dr. DeLeo noted.

Patients who present without a rash, but report a history of a reaction that they believe is related to sun exposure, fall into two categories: some had a rash that occurred while in the sun and disappeared quickly, and some had one that occurred hours or days after exposure and lasted a few days to weeks, said Dr. DeLeo.

The differential diagnosis in the patient with immediate photosensitivity is fairly clear: These patients usually have solar urticaria, he said. However, some lupus patients may report this reaction so it is important to rule out connective tissue disease. The diagnosis can be made with phototesting or do a simple test by having the patient sit out in the sunshine, he said.

For the patient who has a delayed reactivity after sun exposure, and doesn’t have the reaction when they come to the office, the differential diagnosis in a simply applied way is that, if the reaction spared the face, it is likely polymorphous light eruption (PMLE); but if the face is involved, the patient likely has photoallergic contact dermatitis, Dr. DeLeo explained. However, always consider the alternatives of connective tissue disease, drug reactions, and contact dermatitis that is not photoallergic, he noted.

PMLE “is the most common photosensitivity reaction that we see in the United States,” and it almost always occurs when people are away from home, usually on vacation, said Dr. DeLeo. The differential diagnosis for patients with recurrent or delayed rash involving the face could be photoallergic contact dermatitis, but rule out airborne contact dermatitis, personal care product contact dermatitis, and chronic actinic dermatitis, he said. A work-up for these patients could include a photo test, photopatch test, or patch test.

Dr. DeLeo disclosed serving as a consultant for Estee Lauder.

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