Spondyloarthropathies

A 25-year-old man with plaque psoriasis and virtually no hair of any sort now sports a full head of hair plus body hair after treatment with the arthritis drug tofacitinib, according to Dr. Brittany G. Craiglow and Dr. Brett A. King of Yale University, New Haven, Conn.

The treatment has been so successful that Dr. King has submitted a proposal for a clinical trial involving a cream form of tofacitinib as a treatment for alopecia areata, according to a statement from the university.

Tofacitinib is approved only for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate, but it is in clinical development for the treatment of psoriasis.

Dr. Craiglow and Dr. King began treating the patient with 10 mg oral tofacitinib (Xeljanz) daily. At baseline, the patient had been diagnosed with plaque psoriasis and alopecia universalis. His only body hair was a small amount of hair within the psoriasis plaques on his head, the researchers said (J. Invest. Dermatol. 2014 June 18 [doi:10.1038/jid.2014.260]). 

After 2 months of tofacitinib dosed at 5 mg twice daily, the psoriasis on the patient’s scalp, torso, and elbows showed some improvement, and there was some hair growth on his face and scalp. The researchers increased the dose to 10 mg in the morning and 5 mg at night. After 3 more months, the patient had complete regrowth of scalp hair, as well as some growth of eyebrows, eyelashes, armpit hair, and pubic hair. After 8 months, the patient had full regrowth of all body hair, with the exception of hair on the arms and legs (which had been sparse prior to his alopecia diagnosis, the researchers said).

Although the hair growth has been dramatic, improvements in the patient’s psoriasis have been slower, likely because of the dosage.

“While we considered increasing the dose of tofacitinib, the patient is so pleased with the regrowth of his hair (and is not particularly bothered by the remaining psoriasis) that he has chosen to continue at the present dose,” the researchers noted.

The researchers considered using tofacitinib to treat the patient’s alopecia universalis based on the research of Angela M. Christiano, Ph.D., of Columbia University, New York, in which the drug reversed hair loss in a mouse model of alopecia areata.

The patient has reported no side effects, and lab testing has shown no abnormalities in complete blood count, serum creatinine, electrolytes, liver function, glucose, or lipids, the researchers noted.
The researchers had no financial conflicts to disclose.

hsplete@frontlinemedcom.com

A 25-year-old man with plaque psoriasis and virtually no hair of any sort now sports a full head of hair plus body hair after treatment with the arthritis drug tofacitinib, according to Dr. Brittany G. Craiglow and Dr. Brett A. King of Yale University, New Haven, Conn.

The treatment has been so successful that Dr. King has submitted a proposal for a clinical trial involving a cream form of tofacitinib as a treatment for alopecia areata, according to a statement from the university.

Tofacitinib is approved only for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate, but it is in clinical development for the treatment of psoriasis.

Dr. Craiglow and Dr. King began treating the patient with 10 mg oral tofacitinib (Xeljanz) daily. At baseline, the patient had been diagnosed with plaque psoriasis and alopecia universalis. His only body hair was a small amount of hair within the psoriasis plaques on his head, the researchers said (J. Invest. Dermatol. 2014 June 18 [doi:10.1038/jid.2014.260]). 

After 2 months of tofacitinib dosed at 5 mg twice daily, the psoriasis on the patient’s scalp, torso, and elbows showed some improvement, and there was some hair growth on his face and scalp. The researchers increased the dose to 10 mg in the morning and 5 mg at night. After 3 more months, the patient had complete regrowth of scalp hair, as well as some growth of eyebrows, eyelashes, armpit hair, and pubic hair. After 8 months, the patient had full regrowth of all body hair, with the exception of hair on the arms and legs (which had been sparse prior to his alopecia diagnosis, the researchers said).

Although the hair growth has been dramatic, improvements in the patient’s psoriasis have been slower, likely because of the dosage.

“While we considered increasing the dose of tofacitinib, the patient is so pleased with the regrowth of his hair (and is not particularly bothered by the remaining psoriasis) that he has chosen to continue at the present dose,” the researchers noted.

The researchers considered using tofacitinib to treat the patient’s alopecia universalis based on the research of Angela M. Christiano, Ph.D., of Columbia University, New York, in which the drug reversed hair loss in a mouse model of alopecia areata.

The patient has reported no side effects, and lab testing has shown no abnormalities in complete blood count, serum creatinine, electrolytes, liver function, glucose, or lipids, the researchers noted.
The researchers had no financial conflicts to disclose.

hsplete@frontlinemedcom.com

A 25-year-old man with plaque psoriasis and virtually no hair of any sort now sports a full head of hair plus body hair after treatment with the arthritis drug tofacitinib, according to Dr. Brittany G. Craiglow and Dr. Brett A. King of Yale University, New Haven, Conn.

The treatment has been so successful that Dr. King has submitted a proposal for a clinical trial involving a cream form of tofacitinib as a treatment for alopecia areata, according to a statement from the university.

Tofacitinib is approved only for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate, but it is in clinical development for the treatment of psoriasis.

Dr. Craiglow and Dr. King began treating the patient with 10 mg oral tofacitinib (Xeljanz) daily. At baseline, the patient had been diagnosed with plaque psoriasis and alopecia universalis. His only body hair was a small amount of hair within the psoriasis plaques on his head, the researchers said (J. Invest. Dermatol. 2014 June 18 [doi:10.1038/jid.2014.260]). 

After 2 months of tofacitinib dosed at 5 mg twice daily, the psoriasis on the patient’s scalp, torso, and elbows showed some improvement, and there was some hair growth on his face and scalp. The researchers increased the dose to 10 mg in the morning and 5 mg at night. After 3 more months, the patient had complete regrowth of scalp hair, as well as some growth of eyebrows, eyelashes, armpit hair, and pubic hair. After 8 months, the patient had full regrowth of all body hair, with the exception of hair on the arms and legs (which had been sparse prior to his alopecia diagnosis, the researchers said).

Although the hair growth has been dramatic, improvements in the patient’s psoriasis have been slower, likely because of the dosage.

“While we considered increasing the dose of tofacitinib, the patient is so pleased with the regrowth of his hair (and is not particularly bothered by the remaining psoriasis) that he has chosen to continue at the present dose,” the researchers noted.

The researchers considered using tofacitinib to treat the patient’s alopecia universalis based on the research of Angela M. Christiano, Ph.D., of Columbia University, New York, in which the drug reversed hair loss in a mouse model of alopecia areata.

The patient has reported no side effects, and lab testing has shown no abnormalities in complete blood count, serum creatinine, electrolytes, liver function, glucose, or lipids, the researchers noted.
The researchers had no financial conflicts to disclose.

hsplete@frontlinemedcom.com

The metabolic syndrome and insulin resistance are not just common among patients with psoriatic arthritis, but both also correlate with the severity of the inflammatory musculoskeletal disease, according to a single-center, cross-sectional cohort study.

In the study of 283 consecutive white patients with longstanding psoriatic arthritis who attended a rheumatology clinic during a 1-year period, 44% were found to have the metabolic syndrome and 16% to have insulin resistance. "Our findings are novel and support our pretest hypothesis that the risk of metabolic syndrome and insulin resistance increases with the severity of underlying psoriatic arthritis, probably reflecting the increasing burden of inflammation," said Dr. Muhammad Haroon of the department of rheumatology and his associates at St. Vincent’s University Hospital, Dublin.

Psoriatic arthritis is known to be associated with heightened cardiovascular risk, and CV diseases are the leading causes of death in patients with psoriatic arthritis. Until now, however, the prevalences of these two major CV risk factors have not been well studied in patients with psoriatic arthritis. "We hypothesized, therefore, that there might be a greater burden of metabolic syndrome and insulin resistance in psoriatic arthritis, and consequently of cardiovascular diseases because of a greater inflammatory load," Dr. Haroon and his colleagues wrote (J. Rheumatol. 2014;41:1357-65).

The patients had psoriatic arthritis for a duration of at least 10 years (mean of 19 years), and just over half of the patients were women. Their mean age was 54.6 years.

A total of 124 patients (44%) were found to have the metabolic syndrome. "Even more alarming was the finding that about 50% of these newly diagnosed patients with metabolic syndrome had a combination of 4 or 5 of these risk features," the investigators said. In particular, elevated blood pressure (74%), greater waist circumference (56%), and elevated triglycerides (44%) were common among these psoriatic arthritis patients.

On multivariate analysis, metabolic syndrome was significantly associated with more severe disease, higher smoking pack-years, and worse EuroQol-5 dimension (EQ-5D). Metabolic syndrome was significantly associated with severe disease, even after adjustment for the presence of insulin resistance.

A total of 41 patients (16%) had insulin resistance of the 263 for whom insulin resistance data were available, which on multivariate analysis was significantly associated more severe disease, older age at the onset of psoriasis, and higher body-mass index, even after adjusting for the presence of metabolic syndrome.

Both the metabolic syndrome and insulin resistance were more frequent among patients with the most severe psoriatic arthritis, as measured by current and previous skin assessments; inflammatory markers; measures of disease activity; the number of deformed joints; and the presence of dactylitis, enthesitis, peripheral joint erosions, osteolysis, and sacroiliitis, the investigators said.

The study findings suggest, but do not establish, that "the higher burden of inflammatory arthritis or the combination of severe psoriatic disease features play major roles in the development of the metabolic syndrome and/or insulin resistance," Dr. Haroon and his associates said.

Their observations "can also help inform risk stratification" of patients with psoriatic arthritis, they added.

No disclosures were provided.

The metabolic syndrome and insulin resistance are not just common among patients with psoriatic arthritis, but both also correlate with the severity of the inflammatory musculoskeletal disease, according to a single-center, cross-sectional cohort study.

In the study of 283 consecutive white patients with longstanding psoriatic arthritis who attended a rheumatology clinic during a 1-year period, 44% were found to have the metabolic syndrome and 16% to have insulin resistance. "Our findings are novel and support our pretest hypothesis that the risk of metabolic syndrome and insulin resistance increases with the severity of underlying psoriatic arthritis, probably reflecting the increasing burden of inflammation," said Dr. Muhammad Haroon of the department of rheumatology and his associates at St. Vincent’s University Hospital, Dublin.

Psoriatic arthritis is known to be associated with heightened cardiovascular risk, and CV diseases are the leading causes of death in patients with psoriatic arthritis. Until now, however, the prevalences of these two major CV risk factors have not been well studied in patients with psoriatic arthritis. "We hypothesized, therefore, that there might be a greater burden of metabolic syndrome and insulin resistance in psoriatic arthritis, and consequently of cardiovascular diseases because of a greater inflammatory load," Dr. Haroon and his colleagues wrote (J. Rheumatol. 2014;41:1357-65).

The patients had psoriatic arthritis for a duration of at least 10 years (mean of 19 years), and just over half of the patients were women. Their mean age was 54.6 years.

A total of 124 patients (44%) were found to have the metabolic syndrome. "Even more alarming was the finding that about 50% of these newly diagnosed patients with metabolic syndrome had a combination of 4 or 5 of these risk features," the investigators said. In particular, elevated blood pressure (74%), greater waist circumference (56%), and elevated triglycerides (44%) were common among these psoriatic arthritis patients.

On multivariate analysis, metabolic syndrome was significantly associated with more severe disease, higher smoking pack-years, and worse EuroQol-5 dimension (EQ-5D). Metabolic syndrome was significantly associated with severe disease, even after adjustment for the presence of insulin resistance.

A total of 41 patients (16%) had insulin resistance of the 263 for whom insulin resistance data were available, which on multivariate analysis was significantly associated more severe disease, older age at the onset of psoriasis, and higher body-mass index, even after adjusting for the presence of metabolic syndrome.

Both the metabolic syndrome and insulin resistance were more frequent among patients with the most severe psoriatic arthritis, as measured by current and previous skin assessments; inflammatory markers; measures of disease activity; the number of deformed joints; and the presence of dactylitis, enthesitis, peripheral joint erosions, osteolysis, and sacroiliitis, the investigators said.

The study findings suggest, but do not establish, that "the higher burden of inflammatory arthritis or the combination of severe psoriatic disease features play major roles in the development of the metabolic syndrome and/or insulin resistance," Dr. Haroon and his associates said.

Their observations "can also help inform risk stratification" of patients with psoriatic arthritis, they added.

No disclosures were provided.

The metabolic syndrome and insulin resistance are not just common among patients with psoriatic arthritis, but both also correlate with the severity of the inflammatory musculoskeletal disease, according to a single-center, cross-sectional cohort study.

In the study of 283 consecutive white patients with longstanding psoriatic arthritis who attended a rheumatology clinic during a 1-year period, 44% were found to have the metabolic syndrome and 16% to have insulin resistance. "Our findings are novel and support our pretest hypothesis that the risk of metabolic syndrome and insulin resistance increases with the severity of underlying psoriatic arthritis, probably reflecting the increasing burden of inflammation," said Dr. Muhammad Haroon of the department of rheumatology and his associates at St. Vincent’s University Hospital, Dublin.

Psoriatic arthritis is known to be associated with heightened cardiovascular risk, and CV diseases are the leading causes of death in patients with psoriatic arthritis. Until now, however, the prevalences of these two major CV risk factors have not been well studied in patients with psoriatic arthritis. "We hypothesized, therefore, that there might be a greater burden of metabolic syndrome and insulin resistance in psoriatic arthritis, and consequently of cardiovascular diseases because of a greater inflammatory load," Dr. Haroon and his colleagues wrote (J. Rheumatol. 2014;41:1357-65).

The patients had psoriatic arthritis for a duration of at least 10 years (mean of 19 years), and just over half of the patients were women. Their mean age was 54.6 years.

A total of 124 patients (44%) were found to have the metabolic syndrome. "Even more alarming was the finding that about 50% of these newly diagnosed patients with metabolic syndrome had a combination of 4 or 5 of these risk features," the investigators said. In particular, elevated blood pressure (74%), greater waist circumference (56%), and elevated triglycerides (44%) were common among these psoriatic arthritis patients.

On multivariate analysis, metabolic syndrome was significantly associated with more severe disease, higher smoking pack-years, and worse EuroQol-5 dimension (EQ-5D). Metabolic syndrome was significantly associated with severe disease, even after adjustment for the presence of insulin resistance.

A total of 41 patients (16%) had insulin resistance of the 263 for whom insulin resistance data were available, which on multivariate analysis was significantly associated more severe disease, older age at the onset of psoriasis, and higher body-mass index, even after adjusting for the presence of metabolic syndrome.

Both the metabolic syndrome and insulin resistance were more frequent among patients with the most severe psoriatic arthritis, as measured by current and previous skin assessments; inflammatory markers; measures of disease activity; the number of deformed joints; and the presence of dactylitis, enthesitis, peripheral joint erosions, osteolysis, and sacroiliitis, the investigators said.

The study findings suggest, but do not establish, that "the higher burden of inflammatory arthritis or the combination of severe psoriatic disease features play major roles in the development of the metabolic syndrome and/or insulin resistance," Dr. Haroon and his associates said.

Their observations "can also help inform risk stratification" of patients with psoriatic arthritis, they added.

No disclosures were provided.

The National Psoriasis Foundation has relaunched its psoriatic arthritis program to aggressively address the disparities in diagnosis and treatment for psoriatic arthritis patients in the United States.

"There are significantly fewer resources for people with psoriatic arthritis than for those with rheumatoid arthritis," despite similar symptoms and prevalence, according to a press release issued by the foundation June 26.

The National Psoriasis Foundation PsA Project states four goals: Reduce the time to diagnosis of PsA; improve clinician understanding of PsA symptoms, treatment options, and the effect of the disease on quality of life; reduce barriers to treatment; and help patients better manage their disease.

Specifically, the foundation aims to reduce from 4 years to 1 year the average time to diagnosis for PsA patients, reduce from 50% to 30% the percentage of patients who report PsA is a problem in their everyday lives; and double the number of PsA patients receiving proper treatment, the number of National Institutes of Health scientists studying psoriatic disease, and the health resources available for PsA patients.

hsplete@frontlinemedcom.com

The National Psoriasis Foundation has relaunched its psoriatic arthritis program to aggressively address the disparities in diagnosis and treatment for psoriatic arthritis patients in the United States.

"There are significantly fewer resources for people with psoriatic arthritis than for those with rheumatoid arthritis," despite similar symptoms and prevalence, according to a press release issued by the foundation June 26.

The National Psoriasis Foundation PsA Project states four goals: Reduce the time to diagnosis of PsA; improve clinician understanding of PsA symptoms, treatment options, and the effect of the disease on quality of life; reduce barriers to treatment; and help patients better manage their disease.

Specifically, the foundation aims to reduce from 4 years to 1 year the average time to diagnosis for PsA patients, reduce from 50% to 30% the percentage of patients who report PsA is a problem in their everyday lives; and double the number of PsA patients receiving proper treatment, the number of National Institutes of Health scientists studying psoriatic disease, and the health resources available for PsA patients.

hsplete@frontlinemedcom.com

The National Psoriasis Foundation has relaunched its psoriatic arthritis program to aggressively address the disparities in diagnosis and treatment for psoriatic arthritis patients in the United States.

"There are significantly fewer resources for people with psoriatic arthritis than for those with rheumatoid arthritis," despite similar symptoms and prevalence, according to a press release issued by the foundation June 26.

The National Psoriasis Foundation PsA Project states four goals: Reduce the time to diagnosis of PsA; improve clinician understanding of PsA symptoms, treatment options, and the effect of the disease on quality of life; reduce barriers to treatment; and help patients better manage their disease.

Specifically, the foundation aims to reduce from 4 years to 1 year the average time to diagnosis for PsA patients, reduce from 50% to 30% the percentage of patients who report PsA is a problem in their everyday lives; and double the number of PsA patients receiving proper treatment, the number of National Institutes of Health scientists studying psoriatic disease, and the health resources available for PsA patients.

hsplete@frontlinemedcom.com

Median starting doses of infliximab in psoriatic arthritis patients in two nationwide registries were below the recommended dose of 5 mg/kg every 8 weeks, but outcomes suggest that a low starting dose with subsequent step-up is an effective treatment strategy, according to an observational cohort study based on the registries.

In 376 Danish patients in the Danish Rheumatologic Database (DANBIO) registry and 86 Icelandic patients in the Center for Rheumatology Research (ICEBIO) registry, starting infliximab doses were less than 3 mg/kg in 29% and 74%, respectively, 3-5 mg/kg in 42% and 27%, respectively, and greater than 5 mg/kg in 10% and 0%, respectively (starting doses in the remaining patients were not registered). In those cohorts, median starting doses were 3.1 mg/kg and 2.3 mg/kg, respectively, Dr. Bente Glintborg of the Copenhagen Center for Arthritis Research and Glostrup (Denmark) Hospital and her colleagues reported (Rheumatology 2014 June 17 [doi:10.1093/rheumatology/keu252]).

Treatment was maintained after 12 months in 58% and 66% of the Danish and Icelandic patients, respectively (and was highest in those taking concomitant methotrexate). At 12 months, the median doses were 3.3 and 2.9 mg/kg, respectively, and time until dose escalation, response rates, drug survival, and disease activity at 12 months did not differ based on starting dose. Dosing was sustained at below the recommended level in more than 70% of the patients, the investigators found.

Recommended starting doses of infliximab are higher for psoriatic arthritis than for rheumatoid arthritis (5 mg/kg vs. 3 mg/kg) based on randomized trial data, but data on the effectiveness of lower doses are lacking. The current findings suggest that the approach often used in RA – a lower starting dose with gradual escalation – is also effective in psoriatic arthritis, they concluded.

Dr. Glintborg reported having no disclosures. Other study authors reported receiving research grants, serving on a speakers’ bureau, providing consultancy, or serving as an adviser or investigator to a variety of manufacturers of biologic drugs.

Median starting doses of infliximab in psoriatic arthritis patients in two nationwide registries were below the recommended dose of 5 mg/kg every 8 weeks, but outcomes suggest that a low starting dose with subsequent step-up is an effective treatment strategy, according to an observational cohort study based on the registries.

In 376 Danish patients in the Danish Rheumatologic Database (DANBIO) registry and 86 Icelandic patients in the Center for Rheumatology Research (ICEBIO) registry, starting infliximab doses were less than 3 mg/kg in 29% and 74%, respectively, 3-5 mg/kg in 42% and 27%, respectively, and greater than 5 mg/kg in 10% and 0%, respectively (starting doses in the remaining patients were not registered). In those cohorts, median starting doses were 3.1 mg/kg and 2.3 mg/kg, respectively, Dr. Bente Glintborg of the Copenhagen Center for Arthritis Research and Glostrup (Denmark) Hospital and her colleagues reported (Rheumatology 2014 June 17 [doi:10.1093/rheumatology/keu252]).

Treatment was maintained after 12 months in 58% and 66% of the Danish and Icelandic patients, respectively (and was highest in those taking concomitant methotrexate). At 12 months, the median doses were 3.3 and 2.9 mg/kg, respectively, and time until dose escalation, response rates, drug survival, and disease activity at 12 months did not differ based on starting dose. Dosing was sustained at below the recommended level in more than 70% of the patients, the investigators found.

Recommended starting doses of infliximab are higher for psoriatic arthritis than for rheumatoid arthritis (5 mg/kg vs. 3 mg/kg) based on randomized trial data, but data on the effectiveness of lower doses are lacking. The current findings suggest that the approach often used in RA – a lower starting dose with gradual escalation – is also effective in psoriatic arthritis, they concluded.

Dr. Glintborg reported having no disclosures. Other study authors reported receiving research grants, serving on a speakers’ bureau, providing consultancy, or serving as an adviser or investigator to a variety of manufacturers of biologic drugs.

Median starting doses of infliximab in psoriatic arthritis patients in two nationwide registries were below the recommended dose of 5 mg/kg every 8 weeks, but outcomes suggest that a low starting dose with subsequent step-up is an effective treatment strategy, according to an observational cohort study based on the registries.

In 376 Danish patients in the Danish Rheumatologic Database (DANBIO) registry and 86 Icelandic patients in the Center for Rheumatology Research (ICEBIO) registry, starting infliximab doses were less than 3 mg/kg in 29% and 74%, respectively, 3-5 mg/kg in 42% and 27%, respectively, and greater than 5 mg/kg in 10% and 0%, respectively (starting doses in the remaining patients were not registered). In those cohorts, median starting doses were 3.1 mg/kg and 2.3 mg/kg, respectively, Dr. Bente Glintborg of the Copenhagen Center for Arthritis Research and Glostrup (Denmark) Hospital and her colleagues reported (Rheumatology 2014 June 17 [doi:10.1093/rheumatology/keu252]).

Treatment was maintained after 12 months in 58% and 66% of the Danish and Icelandic patients, respectively (and was highest in those taking concomitant methotrexate). At 12 months, the median doses were 3.3 and 2.9 mg/kg, respectively, and time until dose escalation, response rates, drug survival, and disease activity at 12 months did not differ based on starting dose. Dosing was sustained at below the recommended level in more than 70% of the patients, the investigators found.

Recommended starting doses of infliximab are higher for psoriatic arthritis than for rheumatoid arthritis (5 mg/kg vs. 3 mg/kg) based on randomized trial data, but data on the effectiveness of lower doses are lacking. The current findings suggest that the approach often used in RA – a lower starting dose with gradual escalation – is also effective in psoriatic arthritis, they concluded.

Dr. Glintborg reported having no disclosures. Other study authors reported receiving research grants, serving on a speakers’ bureau, providing consultancy, or serving as an adviser or investigator to a variety of manufacturers of biologic drugs.

PARIS – Patients with ankylosing spondylitis who worked at more physically-demanding jobs showed greater radiographic progression than did patients who performed more sedentary jobs in a prospective cohort study with 136 patients.

The findings immediately raised questions about "our commonly given advice to patients with spondylarthritis to strenuously exercise. Should physically demanding labor be discouraged?" asked Dr. Sofia Ramiro at the annual European Congress of Rheumatology.

© CandyBoxImages/Thinkstock

Dr. Ramiro stressed that the finding needs confirmation from studies in other cohorts of patients with ankylosing spondylitis (AS), but it raises the possibility that certain stresses and loads on the spine, from work or exercise, can worsen disease severity.

"If we can confirm that mechanical stress has an impact on radiographic progression, then I think we would have to analyze further and identify the type of activity having this impact, and then recommend the activity not be done," said Dr. Ramiro, a researcher at the Amsterdam Rheumatology Center, University of Amsterdam.

"I’m not saying that we would stop recommending exercise and that patients with AS should stay quiet at home, but perhaps we will advise against certain types of exercise," Dr. Ramiro said in an interview.

Dr. Ramiro and her associates previously reported this year that disease activity contributed longitudinally to radiographic AS progression during up to 12 years of follow-up (Ann. Rheum. Dis. 2014 [doi:10.1136/annrheumdis-2014-205178]). They further evaluated patients in the same cohort, 184 AS patients enrolled in OASIS (the Outcome in AS International Study), for additional factors that might affect radiographic progression either directly or indirectly. In addition to documenting a link between disease activity and radiographic progression, the report earlier this year had identified sex and disease duration as modifiers of the impact of disease activity. This impact on radiographic progression was greater in men, and early during the course of AS.

The new analysis looked for possible effects from smoking, and for chronic activity patterns using the surrogate marker of job type. The 184 patients in OASIS were sorted by their type of regular work, which identified 65 people with physically demanding (blue collar) jobs and 71 with relatively sedentary (white collar) jobs. The other 48 patients had either missing employment data or jobs with less clear links to activity levels, such as students or homemakers.

The findings showed that neither smoking nor job type appeared to have a direct influence on radiographic progression, but that smoking and a physically demanding job each had significant indirect effects. A physically demanding job linked with a 1.19-U increase in a measure of radiographic progression (the modified Stoke AS Spine Score, or mSASSS) for every 1-U increase in a measure of disease activity (the AS disease activity score, or ASDAS) during 2 years of follow-up, Dr. Ramiro reported. In contrast, the impact of a sedentary job was a 0.20-U rise in mSASSS for each 1-U rise in ASDAS. Smoking produced a 1.95-U rise in the mSASSS for each 1-U rise in ASDAS, significantly more than the 0.35 rate among nonsmokers.

Personal income, family income, and education each showed no statistically significant link with radiographic progression.

When the investigators analyzed job activity in subgroups divided by sex, they found that the relationship between a more physically demanding job and increased radiographic progression remained statistically significant in men, but the relationship was no longer significant in women.

The researchers could not include leisure activity or sports participation in their analysis as these data were not available. In addition, analysis by leisure activity may pose problems because baseline data on leisure activity may not extrapolate long-term, and patients can also have recall bias when reporting leisure activity, Dr. Ramiro said.

Dr. Ramiro said that she had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

PARIS – Patients with ankylosing spondylitis who worked at more physically-demanding jobs showed greater radiographic progression than did patients who performed more sedentary jobs in a prospective cohort study with 136 patients.

The findings immediately raised questions about "our commonly given advice to patients with spondylarthritis to strenuously exercise. Should physically demanding labor be discouraged?" asked Dr. Sofia Ramiro at the annual European Congress of Rheumatology.

© CandyBoxImages/Thinkstock

Dr. Ramiro stressed that the finding needs confirmation from studies in other cohorts of patients with ankylosing spondylitis (AS), but it raises the possibility that certain stresses and loads on the spine, from work or exercise, can worsen disease severity.

"If we can confirm that mechanical stress has an impact on radiographic progression, then I think we would have to analyze further and identify the type of activity having this impact, and then recommend the activity not be done," said Dr. Ramiro, a researcher at the Amsterdam Rheumatology Center, University of Amsterdam.

"I’m not saying that we would stop recommending exercise and that patients with AS should stay quiet at home, but perhaps we will advise against certain types of exercise," Dr. Ramiro said in an interview.

Dr. Ramiro and her associates previously reported this year that disease activity contributed longitudinally to radiographic AS progression during up to 12 years of follow-up (Ann. Rheum. Dis. 2014 [doi:10.1136/annrheumdis-2014-205178]). They further evaluated patients in the same cohort, 184 AS patients enrolled in OASIS (the Outcome in AS International Study), for additional factors that might affect radiographic progression either directly or indirectly. In addition to documenting a link between disease activity and radiographic progression, the report earlier this year had identified sex and disease duration as modifiers of the impact of disease activity. This impact on radiographic progression was greater in men, and early during the course of AS.

The new analysis looked for possible effects from smoking, and for chronic activity patterns using the surrogate marker of job type. The 184 patients in OASIS were sorted by their type of regular work, which identified 65 people with physically demanding (blue collar) jobs and 71 with relatively sedentary (white collar) jobs. The other 48 patients had either missing employment data or jobs with less clear links to activity levels, such as students or homemakers.

The findings showed that neither smoking nor job type appeared to have a direct influence on radiographic progression, but that smoking and a physically demanding job each had significant indirect effects. A physically demanding job linked with a 1.19-U increase in a measure of radiographic progression (the modified Stoke AS Spine Score, or mSASSS) for every 1-U increase in a measure of disease activity (the AS disease activity score, or ASDAS) during 2 years of follow-up, Dr. Ramiro reported. In contrast, the impact of a sedentary job was a 0.20-U rise in mSASSS for each 1-U rise in ASDAS. Smoking produced a 1.95-U rise in the mSASSS for each 1-U rise in ASDAS, significantly more than the 0.35 rate among nonsmokers.

Personal income, family income, and education each showed no statistically significant link with radiographic progression.

When the investigators analyzed job activity in subgroups divided by sex, they found that the relationship between a more physically demanding job and increased radiographic progression remained statistically significant in men, but the relationship was no longer significant in women.

The researchers could not include leisure activity or sports participation in their analysis as these data were not available. In addition, analysis by leisure activity may pose problems because baseline data on leisure activity may not extrapolate long-term, and patients can also have recall bias when reporting leisure activity, Dr. Ramiro said.

Dr. Ramiro said that she had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

PARIS – Patients with ankylosing spondylitis who worked at more physically-demanding jobs showed greater radiographic progression than did patients who performed more sedentary jobs in a prospective cohort study with 136 patients.

The findings immediately raised questions about "our commonly given advice to patients with spondylarthritis to strenuously exercise. Should physically demanding labor be discouraged?" asked Dr. Sofia Ramiro at the annual European Congress of Rheumatology.

© CandyBoxImages/Thinkstock

Dr. Ramiro stressed that the finding needs confirmation from studies in other cohorts of patients with ankylosing spondylitis (AS), but it raises the possibility that certain stresses and loads on the spine, from work or exercise, can worsen disease severity.

"If we can confirm that mechanical stress has an impact on radiographic progression, then I think we would have to analyze further and identify the type of activity having this impact, and then recommend the activity not be done," said Dr. Ramiro, a researcher at the Amsterdam Rheumatology Center, University of Amsterdam.

"I’m not saying that we would stop recommending exercise and that patients with AS should stay quiet at home, but perhaps we will advise against certain types of exercise," Dr. Ramiro said in an interview.

Dr. Ramiro and her associates previously reported this year that disease activity contributed longitudinally to radiographic AS progression during up to 12 years of follow-up (Ann. Rheum. Dis. 2014 [doi:10.1136/annrheumdis-2014-205178]). They further evaluated patients in the same cohort, 184 AS patients enrolled in OASIS (the Outcome in AS International Study), for additional factors that might affect radiographic progression either directly or indirectly. In addition to documenting a link between disease activity and radiographic progression, the report earlier this year had identified sex and disease duration as modifiers of the impact of disease activity. This impact on radiographic progression was greater in men, and early during the course of AS.

The new analysis looked for possible effects from smoking, and for chronic activity patterns using the surrogate marker of job type. The 184 patients in OASIS were sorted by their type of regular work, which identified 65 people with physically demanding (blue collar) jobs and 71 with relatively sedentary (white collar) jobs. The other 48 patients had either missing employment data or jobs with less clear links to activity levels, such as students or homemakers.

The findings showed that neither smoking nor job type appeared to have a direct influence on radiographic progression, but that smoking and a physically demanding job each had significant indirect effects. A physically demanding job linked with a 1.19-U increase in a measure of radiographic progression (the modified Stoke AS Spine Score, or mSASSS) for every 1-U increase in a measure of disease activity (the AS disease activity score, or ASDAS) during 2 years of follow-up, Dr. Ramiro reported. In contrast, the impact of a sedentary job was a 0.20-U rise in mSASSS for each 1-U rise in ASDAS. Smoking produced a 1.95-U rise in the mSASSS for each 1-U rise in ASDAS, significantly more than the 0.35 rate among nonsmokers.

Personal income, family income, and education each showed no statistically significant link with radiographic progression.

When the investigators analyzed job activity in subgroups divided by sex, they found that the relationship between a more physically demanding job and increased radiographic progression remained statistically significant in men, but the relationship was no longer significant in women.

The researchers could not include leisure activity or sports participation in their analysis as these data were not available. In addition, analysis by leisure activity may pose problems because baseline data on leisure activity may not extrapolate long-term, and patients can also have recall bias when reporting leisure activity, Dr. Ramiro said.

Dr. Ramiro said that she had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

Spondyloarthritis patients with microscopic gut inflammation had to start anti–tumor necrosis factor treatment sooner in the course of their disease than patients without gut inflammation in a prospective, observational study of 63 Belgian patients with the axial form of spondyloarthritis, the peripheral form, or both.

The finding "is in line with the hypothesis that in SpA [spondyloarthritis] gut inflammation may drive disease," Dr. Heleen Cypers said at the annual European Congress of Rheumatology.

SpA patients with microscopic gut inflammation initiated anti–tumor necrosis factor (TNF) therapy roughly twice as quickly as those without gut inflammation at each time period examined – at 6, 12, and 18 months after their initial diagnosis. After 18 months, 56% of patients with inflammation were on treatment with an anti-TNF agent, compared with almost 29% of the followed patients without microscopic gut inflammation, said Dr. Cypers, a rheumatologist at Ghent (Belgium) University.

The link between microscopic gut inflammation and a faster need to start on biologic treatment occurred at nearly identical rates in both the subset of 11 patients with acute gut inflammation and the subset of 21 patients with chronic inflammation.

Previous research by Dr. Cypers’ group had shown that chronic inflammation in the gut was associated with more extensive bone marrow edema of the sacroiliac joints, a higher risk of progression to ankylosing spondylitis, and a higher risk of developing Crohn’s disease. No information existed on the impact of gut inflammation on therapeutic decision-making in SpA, however.

The current study followed the Ghent Inflammatory Arthritis and Spondylitis Cohort (GIANT) of 63 newly diagnosed patients who underwent an ileocolonoscopy at baseline. Patients were not taking anti-TNF agents and were followed for 18 months. The decision to start anti-TNF treatment was made by a rheumatologist who was unaware of the patient’s gut history.

SpA patients who had microscopic gut inflammation at baseline were more likely to start anti-TNF treatment sooner than were patients without gut inflammation. During follow-up, just under a third of patients (9 of 31) with normal gut histology started anti-TNFs, compared with over half (18 of 32) of the patients with gut inflammation at baseline.

In most cases, anti-TNF drugs were started because first-line therapy had failed, Dr. Cypers reported. Her analysis also showed that initiation of an anti-TNF drug during follow-up was significantly linked with a higher level of C-reactive protein at baseline.

According to Dr. Cypers, the findings support the hypothesis that bowel inflammation in SpA induces a more chronic, persevering disease.

"The findings identify gut inflammation as a marker of a poor prognosis and have relevance for therapeutic decision-making in daily clinical practice. It is conceivable that assessment of gut inflammation will be included in future models for risk stratification of SpA," she said in an interview.

The underlying mechanisms explaining the link are still under investigation, but several studies have suggested that inflammation in the gut may be a triggering factor for SpA development. Interactions in the intestinal immune system also may play an important role, she said.

Future research by the group will focus on ruling out the interdependency of all of these factors, predicting response to biologic therapy based on gut histology, and determining whether therapies aiming at treating microscopic gut inflammation can affect the evolution of the disease.

Dr. Cypers said that she and her associates had no disclosures.

mzoler@frontlinemedcom.com

Spondyloarthritis patients with microscopic gut inflammation had to start anti–tumor necrosis factor treatment sooner in the course of their disease than patients without gut inflammation in a prospective, observational study of 63 Belgian patients with the axial form of spondyloarthritis, the peripheral form, or both.

The finding "is in line with the hypothesis that in SpA [spondyloarthritis] gut inflammation may drive disease," Dr. Heleen Cypers said at the annual European Congress of Rheumatology.

SpA patients with microscopic gut inflammation initiated anti–tumor necrosis factor (TNF) therapy roughly twice as quickly as those without gut inflammation at each time period examined – at 6, 12, and 18 months after their initial diagnosis. After 18 months, 56% of patients with inflammation were on treatment with an anti-TNF agent, compared with almost 29% of the followed patients without microscopic gut inflammation, said Dr. Cypers, a rheumatologist at Ghent (Belgium) University.

The link between microscopic gut inflammation and a faster need to start on biologic treatment occurred at nearly identical rates in both the subset of 11 patients with acute gut inflammation and the subset of 21 patients with chronic inflammation.

Previous research by Dr. Cypers’ group had shown that chronic inflammation in the gut was associated with more extensive bone marrow edema of the sacroiliac joints, a higher risk of progression to ankylosing spondylitis, and a higher risk of developing Crohn’s disease. No information existed on the impact of gut inflammation on therapeutic decision-making in SpA, however.

The current study followed the Ghent Inflammatory Arthritis and Spondylitis Cohort (GIANT) of 63 newly diagnosed patients who underwent an ileocolonoscopy at baseline. Patients were not taking anti-TNF agents and were followed for 18 months. The decision to start anti-TNF treatment was made by a rheumatologist who was unaware of the patient’s gut history.

SpA patients who had microscopic gut inflammation at baseline were more likely to start anti-TNF treatment sooner than were patients without gut inflammation. During follow-up, just under a third of patients (9 of 31) with normal gut histology started anti-TNFs, compared with over half (18 of 32) of the patients with gut inflammation at baseline.

In most cases, anti-TNF drugs were started because first-line therapy had failed, Dr. Cypers reported. Her analysis also showed that initiation of an anti-TNF drug during follow-up was significantly linked with a higher level of C-reactive protein at baseline.

According to Dr. Cypers, the findings support the hypothesis that bowel inflammation in SpA induces a more chronic, persevering disease.

"The findings identify gut inflammation as a marker of a poor prognosis and have relevance for therapeutic decision-making in daily clinical practice. It is conceivable that assessment of gut inflammation will be included in future models for risk stratification of SpA," she said in an interview.

The underlying mechanisms explaining the link are still under investigation, but several studies have suggested that inflammation in the gut may be a triggering factor for SpA development. Interactions in the intestinal immune system also may play an important role, she said.

Future research by the group will focus on ruling out the interdependency of all of these factors, predicting response to biologic therapy based on gut histology, and determining whether therapies aiming at treating microscopic gut inflammation can affect the evolution of the disease.

Dr. Cypers said that she and her associates had no disclosures.

mzoler@frontlinemedcom.com

Spondyloarthritis patients with microscopic gut inflammation had to start anti–tumor necrosis factor treatment sooner in the course of their disease than patients without gut inflammation in a prospective, observational study of 63 Belgian patients with the axial form of spondyloarthritis, the peripheral form, or both.

The finding "is in line with the hypothesis that in SpA [spondyloarthritis] gut inflammation may drive disease," Dr. Heleen Cypers said at the annual European Congress of Rheumatology.

SpA patients with microscopic gut inflammation initiated anti–tumor necrosis factor (TNF) therapy roughly twice as quickly as those without gut inflammation at each time period examined – at 6, 12, and 18 months after their initial diagnosis. After 18 months, 56% of patients with inflammation were on treatment with an anti-TNF agent, compared with almost 29% of the followed patients without microscopic gut inflammation, said Dr. Cypers, a rheumatologist at Ghent (Belgium) University.

The link between microscopic gut inflammation and a faster need to start on biologic treatment occurred at nearly identical rates in both the subset of 11 patients with acute gut inflammation and the subset of 21 patients with chronic inflammation.

Previous research by Dr. Cypers’ group had shown that chronic inflammation in the gut was associated with more extensive bone marrow edema of the sacroiliac joints, a higher risk of progression to ankylosing spondylitis, and a higher risk of developing Crohn’s disease. No information existed on the impact of gut inflammation on therapeutic decision-making in SpA, however.

The current study followed the Ghent Inflammatory Arthritis and Spondylitis Cohort (GIANT) of 63 newly diagnosed patients who underwent an ileocolonoscopy at baseline. Patients were not taking anti-TNF agents and were followed for 18 months. The decision to start anti-TNF treatment was made by a rheumatologist who was unaware of the patient’s gut history.

SpA patients who had microscopic gut inflammation at baseline were more likely to start anti-TNF treatment sooner than were patients without gut inflammation. During follow-up, just under a third of patients (9 of 31) with normal gut histology started anti-TNFs, compared with over half (18 of 32) of the patients with gut inflammation at baseline.

In most cases, anti-TNF drugs were started because first-line therapy had failed, Dr. Cypers reported. Her analysis also showed that initiation of an anti-TNF drug during follow-up was significantly linked with a higher level of C-reactive protein at baseline.

According to Dr. Cypers, the findings support the hypothesis that bowel inflammation in SpA induces a more chronic, persevering disease.

"The findings identify gut inflammation as a marker of a poor prognosis and have relevance for therapeutic decision-making in daily clinical practice. It is conceivable that assessment of gut inflammation will be included in future models for risk stratification of SpA," she said in an interview.

The underlying mechanisms explaining the link are still under investigation, but several studies have suggested that inflammation in the gut may be a triggering factor for SpA development. Interactions in the intestinal immune system also may play an important role, she said.

Future research by the group will focus on ruling out the interdependency of all of these factors, predicting response to biologic therapy based on gut histology, and determining whether therapies aiming at treating microscopic gut inflammation can affect the evolution of the disease.

Dr. Cypers said that she and her associates had no disclosures.

mzoler@frontlinemedcom.com

Thanks to anti–tumor necrosis factor inhibitors and other highly effective biologic therapies, rheumatologists are increasingly embracing treat to target, a strategy in which patients are closely monitored and medications adjusted until a patient has the least disease activity possible.

Ample evidence from randomized, controlled trials has shown treat to target – sometimes referred to as tight control – to result in better outcomes than standard therapy in rheumatoid arthritis patients.

But in psoriatic arthritis (PsA), a more heterogeneous disorder with skin and nail manifestations as well as joint and connective tissue involvement, remission has historically been less well defined. Only in recent years have endpoints been developed and validated for minimal disease activity in PsA, and evidence in support of a treat-to-target approach is now slowly trickling in.

Mary Jo M. Dales/Frontline Medical News

At the annual European Congress of Rheumatology, Dr. Arthur Kavanaugh of the University of California, San Diego, presented results from a 5-year extension of a randomized, controlled trial of golimumab in patients with PsA that showed better long-term outcomes in those able to achieve minimal disease activity (MDA) through a treat-to-target strategy.

"I think [the study] does provide some evidence suggesting that treat to target could well be a valuable goal for PsA, Dr. Kavanaugh said. "Right now, RA has the advantage of more studies showing this."

Dr. Kavanaugh and his colleagues’ study used data from an open-label extension of a clinical trial in which about 400 patients were randomized to receive golimumab at 50 mg or 100 mg, or placebo; all placebo patients were crossed over to golimumab treatment at 24 weeks and during the long-term, open-label extension of the trial, were followed for as long as 252 weeks. Patients were assessed at 14, 24, and 52 weeks, then yearly until week 252. The investigators used a validated composite endpoint that included measures of skin, joint, and enthesis involvement.

About half of the patients (44.2% of those randomized to placebo and 51.7% of those randomized to active treatment) achieved persistent MDA over three or more consecutive time points during follow-up, and investigators saw significantly better clinically meaningful Health Assessment Questionnaire improvement and less radiographic progression in patients who had achieved MDA, regardless of treatment allocation.

Patients who achieved MDA after crossing over had improvements that were similar to those who started on golimumab at baseline, suggesting that delayed treatment initiation does not result in a worsening of physical function or radiographic progression.

"When it comes to patients, we cannot always control when we will see them in the course of disease," Dr. Kavanaugh said. "These data suggest that even though a patient may show up with months of uncontrolled disease, it is still a viable goal to treat them to try to get MDA."

Dr. Kavanaugh said that further studies in PsA patients were needed to confirm that treat-to-target strategies resulted in better long-term disease outcomes. "As always in medicine, it is important to have verification from multiple studies. It would be helpful to have data from studies using medications with other mechanisms of action to support treat to target," he added.

Dr. Kavanaugh disclosed research and grant support from Abbott, Amgen, Janssen, and UCB. His coauthors on the study disclosed financial support from additional manufacturers, and three were employees of Janssen.

Thanks to anti–tumor necrosis factor inhibitors and other highly effective biologic therapies, rheumatologists are increasingly embracing treat to target, a strategy in which patients are closely monitored and medications adjusted until a patient has the least disease activity possible.

Ample evidence from randomized, controlled trials has shown treat to target – sometimes referred to as tight control – to result in better outcomes than standard therapy in rheumatoid arthritis patients.

But in psoriatic arthritis (PsA), a more heterogeneous disorder with skin and nail manifestations as well as joint and connective tissue involvement, remission has historically been less well defined. Only in recent years have endpoints been developed and validated for minimal disease activity in PsA, and evidence in support of a treat-to-target approach is now slowly trickling in.

Mary Jo M. Dales/Frontline Medical News

At the annual European Congress of Rheumatology, Dr. Arthur Kavanaugh of the University of California, San Diego, presented results from a 5-year extension of a randomized, controlled trial of golimumab in patients with PsA that showed better long-term outcomes in those able to achieve minimal disease activity (MDA) through a treat-to-target strategy.

"I think [the study] does provide some evidence suggesting that treat to target could well be a valuable goal for PsA, Dr. Kavanaugh said. "Right now, RA has the advantage of more studies showing this."

Dr. Kavanaugh and his colleagues’ study used data from an open-label extension of a clinical trial in which about 400 patients were randomized to receive golimumab at 50 mg or 100 mg, or placebo; all placebo patients were crossed over to golimumab treatment at 24 weeks and during the long-term, open-label extension of the trial, were followed for as long as 252 weeks. Patients were assessed at 14, 24, and 52 weeks, then yearly until week 252. The investigators used a validated composite endpoint that included measures of skin, joint, and enthesis involvement.

About half of the patients (44.2% of those randomized to placebo and 51.7% of those randomized to active treatment) achieved persistent MDA over three or more consecutive time points during follow-up, and investigators saw significantly better clinically meaningful Health Assessment Questionnaire improvement and less radiographic progression in patients who had achieved MDA, regardless of treatment allocation.

Patients who achieved MDA after crossing over had improvements that were similar to those who started on golimumab at baseline, suggesting that delayed treatment initiation does not result in a worsening of physical function or radiographic progression.

"When it comes to patients, we cannot always control when we will see them in the course of disease," Dr. Kavanaugh said. "These data suggest that even though a patient may show up with months of uncontrolled disease, it is still a viable goal to treat them to try to get MDA."

Dr. Kavanaugh said that further studies in PsA patients were needed to confirm that treat-to-target strategies resulted in better long-term disease outcomes. "As always in medicine, it is important to have verification from multiple studies. It would be helpful to have data from studies using medications with other mechanisms of action to support treat to target," he added.

Dr. Kavanaugh disclosed research and grant support from Abbott, Amgen, Janssen, and UCB. His coauthors on the study disclosed financial support from additional manufacturers, and three were employees of Janssen.

Thanks to anti–tumor necrosis factor inhibitors and other highly effective biologic therapies, rheumatologists are increasingly embracing treat to target, a strategy in which patients are closely monitored and medications adjusted until a patient has the least disease activity possible.

Ample evidence from randomized, controlled trials has shown treat to target – sometimes referred to as tight control – to result in better outcomes than standard therapy in rheumatoid arthritis patients.

But in psoriatic arthritis (PsA), a more heterogeneous disorder with skin and nail manifestations as well as joint and connective tissue involvement, remission has historically been less well defined. Only in recent years have endpoints been developed and validated for minimal disease activity in PsA, and evidence in support of a treat-to-target approach is now slowly trickling in.

Mary Jo M. Dales/Frontline Medical News

At the annual European Congress of Rheumatology, Dr. Arthur Kavanaugh of the University of California, San Diego, presented results from a 5-year extension of a randomized, controlled trial of golimumab in patients with PsA that showed better long-term outcomes in those able to achieve minimal disease activity (MDA) through a treat-to-target strategy.

"I think [the study] does provide some evidence suggesting that treat to target could well be a valuable goal for PsA, Dr. Kavanaugh said. "Right now, RA has the advantage of more studies showing this."

Dr. Kavanaugh and his colleagues’ study used data from an open-label extension of a clinical trial in which about 400 patients were randomized to receive golimumab at 50 mg or 100 mg, or placebo; all placebo patients were crossed over to golimumab treatment at 24 weeks and during the long-term, open-label extension of the trial, were followed for as long as 252 weeks. Patients were assessed at 14, 24, and 52 weeks, then yearly until week 252. The investigators used a validated composite endpoint that included measures of skin, joint, and enthesis involvement.

About half of the patients (44.2% of those randomized to placebo and 51.7% of those randomized to active treatment) achieved persistent MDA over three or more consecutive time points during follow-up, and investigators saw significantly better clinically meaningful Health Assessment Questionnaire improvement and less radiographic progression in patients who had achieved MDA, regardless of treatment allocation.

Patients who achieved MDA after crossing over had improvements that were similar to those who started on golimumab at baseline, suggesting that delayed treatment initiation does not result in a worsening of physical function or radiographic progression.

"When it comes to patients, we cannot always control when we will see them in the course of disease," Dr. Kavanaugh said. "These data suggest that even though a patient may show up with months of uncontrolled disease, it is still a viable goal to treat them to try to get MDA."

Dr. Kavanaugh said that further studies in PsA patients were needed to confirm that treat-to-target strategies resulted in better long-term disease outcomes. "As always in medicine, it is important to have verification from multiple studies. It would be helpful to have data from studies using medications with other mechanisms of action to support treat to target," he added.

Dr. Kavanaugh disclosed research and grant support from Abbott, Amgen, Janssen, and UCB. His coauthors on the study disclosed financial support from additional manufacturers, and three were employees of Janssen.

Psoriatic arthritis patients treated with brodalumab improved by approximately 20%, compared with those on placebo, achieving the primary endpoint in a phase II trial, investigators reported online June 11 in the New England Journal of Medicine.

Brodalumab is a human monoclonal antibody targeting the interleukin-17 receptor A (IL-17RA). At week 12 of the 40-week randomized trial, 37%-39% of brodalumab patients had improved by at least 20% based on the American College of Rheumatology response criteria (ACR 20), compared with only 18% of the placebo patients (P = .03 and .02, respectively), reported Dr. Philip J. Mease of the Swedish Medical Center and the University of Washington, both in Seattle, and his associates.

Rates of 50% improvement in response criteria, or ACR 50, also exceeded placebo in both treatment arms (14%, compared with 4% for placebo; P = .05).

The researchers randomized 168 adults with psoriatic arthritis, of whom 159 finished the double-blind phase and 134 completed 40 weeks of the open-label extension (N. Engl. J. Med. 2014;370:2295-306 [doi: 10.1056/NEJMoa1315231]). By week 24, ACR 20 response rates were 51% for the 140-mg group, 64% for the 280-mg group, and 44% in placebo patients who switched to open-label brodalumab, said the researchers. Patients improved similarly whether they were treatment naive or had received previous biologic therapy, the investigators added.

Adverse events were comparable between the treatment and placebo groups, with no opportunistic infections or deaths, the investigators reported. Two patients tested positive for antibodies to brodalumab. "No significant neutropenic events were reported – an important safety outcome, since interleukin-17 is involved in neutrophil homeostasis," the researchers said. They noted, however, that larger trials would be needed to detect rare adverse events.

Amgen, a maker of brodalumab, funded the study. Dr. Mease and his coauthors reported employment with or receiving grants from Amgen.

The study findings also were scheduled for presentation in a poster at EULAR 2014.

Psoriatic arthritis patients treated with brodalumab improved by approximately 20%, compared with those on placebo, achieving the primary endpoint in a phase II trial, investigators reported online June 11 in the New England Journal of Medicine.

Brodalumab is a human monoclonal antibody targeting the interleukin-17 receptor A (IL-17RA). At week 12 of the 40-week randomized trial, 37%-39% of brodalumab patients had improved by at least 20% based on the American College of Rheumatology response criteria (ACR 20), compared with only 18% of the placebo patients (P = .03 and .02, respectively), reported Dr. Philip J. Mease of the Swedish Medical Center and the University of Washington, both in Seattle, and his associates.

Rates of 50% improvement in response criteria, or ACR 50, also exceeded placebo in both treatment arms (14%, compared with 4% for placebo; P = .05).

The researchers randomized 168 adults with psoriatic arthritis, of whom 159 finished the double-blind phase and 134 completed 40 weeks of the open-label extension (N. Engl. J. Med. 2014;370:2295-306 [doi: 10.1056/NEJMoa1315231]). By week 24, ACR 20 response rates were 51% for the 140-mg group, 64% for the 280-mg group, and 44% in placebo patients who switched to open-label brodalumab, said the researchers. Patients improved similarly whether they were treatment naive or had received previous biologic therapy, the investigators added.

Adverse events were comparable between the treatment and placebo groups, with no opportunistic infections or deaths, the investigators reported. Two patients tested positive for antibodies to brodalumab. "No significant neutropenic events were reported – an important safety outcome, since interleukin-17 is involved in neutrophil homeostasis," the researchers said. They noted, however, that larger trials would be needed to detect rare adverse events.

Amgen, a maker of brodalumab, funded the study. Dr. Mease and his coauthors reported employment with or receiving grants from Amgen.

The study findings also were scheduled for presentation in a poster at EULAR 2014.

Psoriatic arthritis patients treated with brodalumab improved by approximately 20%, compared with those on placebo, achieving the primary endpoint in a phase II trial, investigators reported online June 11 in the New England Journal of Medicine.

Brodalumab is a human monoclonal antibody targeting the interleukin-17 receptor A (IL-17RA). At week 12 of the 40-week randomized trial, 37%-39% of brodalumab patients had improved by at least 20% based on the American College of Rheumatology response criteria (ACR 20), compared with only 18% of the placebo patients (P = .03 and .02, respectively), reported Dr. Philip J. Mease of the Swedish Medical Center and the University of Washington, both in Seattle, and his associates.

Rates of 50% improvement in response criteria, or ACR 50, also exceeded placebo in both treatment arms (14%, compared with 4% for placebo; P = .05).

The researchers randomized 168 adults with psoriatic arthritis, of whom 159 finished the double-blind phase and 134 completed 40 weeks of the open-label extension (N. Engl. J. Med. 2014;370:2295-306 [doi: 10.1056/NEJMoa1315231]). By week 24, ACR 20 response rates were 51% for the 140-mg group, 64% for the 280-mg group, and 44% in placebo patients who switched to open-label brodalumab, said the researchers. Patients improved similarly whether they were treatment naive or had received previous biologic therapy, the investigators added.

Adverse events were comparable between the treatment and placebo groups, with no opportunistic infections or deaths, the investigators reported. Two patients tested positive for antibodies to brodalumab. "No significant neutropenic events were reported – an important safety outcome, since interleukin-17 is involved in neutrophil homeostasis," the researchers said. They noted, however, that larger trials would be needed to detect rare adverse events.

Amgen, a maker of brodalumab, funded the study. Dr. Mease and his coauthors reported employment with or receiving grants from Amgen.

The study findings also were scheduled for presentation in a poster at EULAR 2014.

LIVERPOOL, ENGLAND – Further evidence that apremilast has multiple and sustained effects in psoriatic arthritis for at least 1 year were reported at the British Society for Rheumatology annual conference.

Data from two of the phase III studies that make up the PALACE (Psoriatic Arthritis Long-term Assessment of Clinical Efficacy) clinical trials program showed that the oral phosphodiesterase 4 inhibitor continued to suppress disease activity and improved pain and physical functioning associated with the skin and joint condition.

In the PALACE 1 (Psoriatic Arthritis Long-term Assessment of Clinical Efficacy 1) trial, 75 of 119 (63%) patients treated with apremilast 20 mg twice daily and 71 of 130 (55%) patients treated with apremilast 30 mg twice daily still had an American College of Rheumatology 20% (ACR20) response at 52 weeks.

Corresponding 52-week data from the PALACE 3 trial showed ACR20 responses in 56% of 116 patients and 62% of 127 patients for the two doses of apremilast, respectively. ACR50 and ACR70 were achieved by 25%-30% of patients, and 9%-10% achieved an ACR70.

Apremilast is marketed by Celgene as Otezla and gained approval from the Food and Drug Administration for the treatment of adults with active psoriatic arthritis in March. The FDA approval came with a caution that patients’ weight should be monitored regularly and that there had been increased reports of depression.

The long-term safety data from these two PALACE trials, however, showed no new safety concerns, according to the studies’ authors. The most common side effects seen were as reported previously and included diarrhea, nausea, and headache.

PALACE 1 and PALACE 3 were designed to assess the efficacy and safety of apremilast versus placebo in patients who had active psoriatic arthritis despite treatment with conventional nonbiologic disease-modifying antirheumatic drugs (nbDMARDs) with or without additional biologic treatment.

For inclusion in the trials, patients had to have disease duration of at least 6 months, meet Classification of Psoriatic Arthritis (CASPAR) criteria, and have three or more tender or swollen joints involved. Patients enrolled in PALACE 3 also had to have skin involvement, with at least plaque psoriasis of 2 cm in size or larger.

A total of 504 patients were enrolled into PALACE 1 (Ann. Rheum. Dis. 2013;72[Suppl. 3]:163) and 505 into PALACE 3 and initially randomized to twice-daily treatment with placebo or one of two doses of apremilast for 24 weeks. At this point, all patients in the placebo arm who had not already been rerandomized to active treatment were randomized to apremilast 20 mg or 30 mg. Patients originally randomized to active therapy continued with their treatment if they continued to respond.

"I think what comes out of these [data], and looking over time, is that the effect is sustained with all the caveats that go with that because, of course, people only stay on [the drug] if they are doing well," PALACE 3 investigator Dr. Christopher Edwards observed in an interview.

Dr. Edwards, who is a clinical rheumatologist at University Hospital Southampton, England, noted that the statistical power of long-term extension studies is perhaps a little less robust than the initial study phases, but that these long-term data from the PALACE trials do seem to show that the effects of treatment with apremilast are sustained and maybe even that the effect size improves slightly over time.

Physical function, assessed via the Health Assessment Questionnaire–Disability Index (HAQ-DI), was improved with apremilast treatment in both the PALACE 1 and PALACE 3 trials. In the latter trial, mean change in HAQ-DI scores at 16 weeks declined by 0.13 and 0.19, compared with baseline values in the apremilast 20-mg and 30-mg groups. In contrast, scores increased by 0.07 in the placebo group. Over the following year, HAQ-DI scores continued to improve, with the mean change in scores from baseline crossing the threshold of –0.30, which many think signifies a clinically meaningful change, Dr. Edwards explained.

HAQ-DI scores in PALACE 1 at 52 weeks were a respective –0.369 and –0.318 in the 20-mg and 30-mg groups, and at the 16-week assessment point, they had been –0.20 and –0.24, respectively, and –0.09 for placebo.

Furthermore, in the PALACE 3 trial, 29%-39% of patients treated with apremilast achieved a 75% improvement in skin involvement, assessed via the Psoriasis Area and Severity Index (PASI) at 1 year. PASI50 was achieved in 49%-54%.

Dr. Edwards observed that some of the additional data now available from PALACE 3 showed that there was a beneficial effect of apremilast on enthesitis and dactylitis – two unique features of psoriatic arthritis that are often not treated by the use of the nbDMARDS, such as methotrexate and sulfasalazine.

At 24 weeks, he noted that in other comparisons of patients treated with apremilast or placebo, active therapy yielded significant improvements in pain (assessed using a visual analog scale), improved Functional Assessment of Chronic Illness Therapy-Fatigue scores, a higher rate of achieving ‘good’ or ‘moderate’ European League Against Rheumatism responses, and greater modified Psoriatic Arthritis Response Criteria results.

Dr. Edwards has acted as a consultant to Celgene, the company that sponsored the studies. He has also received research support from Pfizer and honoraria from Roche, Abbott, and GlaxoSmithKline.

LIVERPOOL, ENGLAND – Further evidence that apremilast has multiple and sustained effects in psoriatic arthritis for at least 1 year were reported at the British Society for Rheumatology annual conference.

Data from two of the phase III studies that make up the PALACE (Psoriatic Arthritis Long-term Assessment of Clinical Efficacy) clinical trials program showed that the oral phosphodiesterase 4 inhibitor continued to suppress disease activity and improved pain and physical functioning associated with the skin and joint condition.

In the PALACE 1 (Psoriatic Arthritis Long-term Assessment of Clinical Efficacy 1) trial, 75 of 119 (63%) patients treated with apremilast 20 mg twice daily and 71 of 130 (55%) patients treated with apremilast 30 mg twice daily still had an American College of Rheumatology 20% (ACR20) response at 52 weeks.

Corresponding 52-week data from the PALACE 3 trial showed ACR20 responses in 56% of 116 patients and 62% of 127 patients for the two doses of apremilast, respectively. ACR50 and ACR70 were achieved by 25%-30% of patients, and 9%-10% achieved an ACR70.

Apremilast is marketed by Celgene as Otezla and gained approval from the Food and Drug Administration for the treatment of adults with active psoriatic arthritis in March. The FDA approval came with a caution that patients’ weight should be monitored regularly and that there had been increased reports of depression.

The long-term safety data from these two PALACE trials, however, showed no new safety concerns, according to the studies’ authors. The most common side effects seen were as reported previously and included diarrhea, nausea, and headache.

PALACE 1 and PALACE 3 were designed to assess the efficacy and safety of apremilast versus placebo in patients who had active psoriatic arthritis despite treatment with conventional nonbiologic disease-modifying antirheumatic drugs (nbDMARDs) with or without additional biologic treatment.

For inclusion in the trials, patients had to have disease duration of at least 6 months, meet Classification of Psoriatic Arthritis (CASPAR) criteria, and have three or more tender or swollen joints involved. Patients enrolled in PALACE 3 also had to have skin involvement, with at least plaque psoriasis of 2 cm in size or larger.

A total of 504 patients were enrolled into PALACE 1 (Ann. Rheum. Dis. 2013;72[Suppl. 3]:163) and 505 into PALACE 3 and initially randomized to twice-daily treatment with placebo or one of two doses of apremilast for 24 weeks. At this point, all patients in the placebo arm who had not already been rerandomized to active treatment were randomized to apremilast 20 mg or 30 mg. Patients originally randomized to active therapy continued with their treatment if they continued to respond.

"I think what comes out of these [data], and looking over time, is that the effect is sustained with all the caveats that go with that because, of course, people only stay on [the drug] if they are doing well," PALACE 3 investigator Dr. Christopher Edwards observed in an interview.

Dr. Edwards, who is a clinical rheumatologist at University Hospital Southampton, England, noted that the statistical power of long-term extension studies is perhaps a little less robust than the initial study phases, but that these long-term data from the PALACE trials do seem to show that the effects of treatment with apremilast are sustained and maybe even that the effect size improves slightly over time.

Physical function, assessed via the Health Assessment Questionnaire–Disability Index (HAQ-DI), was improved with apremilast treatment in both the PALACE 1 and PALACE 3 trials. In the latter trial, mean change in HAQ-DI scores at 16 weeks declined by 0.13 and 0.19, compared with baseline values in the apremilast 20-mg and 30-mg groups. In contrast, scores increased by 0.07 in the placebo group. Over the following year, HAQ-DI scores continued to improve, with the mean change in scores from baseline crossing the threshold of –0.30, which many think signifies a clinically meaningful change, Dr. Edwards explained.

HAQ-DI scores in PALACE 1 at 52 weeks were a respective –0.369 and –0.318 in the 20-mg and 30-mg groups, and at the 16-week assessment point, they had been –0.20 and –0.24, respectively, and –0.09 for placebo.

Furthermore, in the PALACE 3 trial, 29%-39% of patients treated with apremilast achieved a 75% improvement in skin involvement, assessed via the Psoriasis Area and Severity Index (PASI) at 1 year. PASI50 was achieved in 49%-54%.

Dr. Edwards observed that some of the additional data now available from PALACE 3 showed that there was a beneficial effect of apremilast on enthesitis and dactylitis – two unique features of psoriatic arthritis that are often not treated by the use of the nbDMARDS, such as methotrexate and sulfasalazine.

At 24 weeks, he noted that in other comparisons of patients treated with apremilast or placebo, active therapy yielded significant improvements in pain (assessed using a visual analog scale), improved Functional Assessment of Chronic Illness Therapy-Fatigue scores, a higher rate of achieving ‘good’ or ‘moderate’ European League Against Rheumatism responses, and greater modified Psoriatic Arthritis Response Criteria results.

Dr. Edwards has acted as a consultant to Celgene, the company that sponsored the studies. He has also received research support from Pfizer and honoraria from Roche, Abbott, and GlaxoSmithKline.

LIVERPOOL, ENGLAND – Further evidence that apremilast has multiple and sustained effects in psoriatic arthritis for at least 1 year were reported at the British Society for Rheumatology annual conference.

Data from two of the phase III studies that make up the PALACE (Psoriatic Arthritis Long-term Assessment of Clinical Efficacy) clinical trials program showed that the oral phosphodiesterase 4 inhibitor continued to suppress disease activity and improved pain and physical functioning associated with the skin and joint condition.

In the PALACE 1 (Psoriatic Arthritis Long-term Assessment of Clinical Efficacy 1) trial, 75 of 119 (63%) patients treated with apremilast 20 mg twice daily and 71 of 130 (55%) patients treated with apremilast 30 mg twice daily still had an American College of Rheumatology 20% (ACR20) response at 52 weeks.

Corresponding 52-week data from the PALACE 3 trial showed ACR20 responses in 56% of 116 patients and 62% of 127 patients for the two doses of apremilast, respectively. ACR50 and ACR70 were achieved by 25%-30% of patients, and 9%-10% achieved an ACR70.

Apremilast is marketed by Celgene as Otezla and gained approval from the Food and Drug Administration for the treatment of adults with active psoriatic arthritis in March. The FDA approval came with a caution that patients’ weight should be monitored regularly and that there had been increased reports of depression.

The long-term safety data from these two PALACE trials, however, showed no new safety concerns, according to the studies’ authors. The most common side effects seen were as reported previously and included diarrhea, nausea, and headache.

PALACE 1 and PALACE 3 were designed to assess the efficacy and safety of apremilast versus placebo in patients who had active psoriatic arthritis despite treatment with conventional nonbiologic disease-modifying antirheumatic drugs (nbDMARDs) with or without additional biologic treatment.

For inclusion in the trials, patients had to have disease duration of at least 6 months, meet Classification of Psoriatic Arthritis (CASPAR) criteria, and have three or more tender or swollen joints involved. Patients enrolled in PALACE 3 also had to have skin involvement, with at least plaque psoriasis of 2 cm in size or larger.

A total of 504 patients were enrolled into PALACE 1 (Ann. Rheum. Dis. 2013;72[Suppl. 3]:163) and 505 into PALACE 3 and initially randomized to twice-daily treatment with placebo or one of two doses of apremilast for 24 weeks. At this point, all patients in the placebo arm who had not already been rerandomized to active treatment were randomized to apremilast 20 mg or 30 mg. Patients originally randomized to active therapy continued with their treatment if they continued to respond.

"I think what comes out of these [data], and looking over time, is that the effect is sustained with all the caveats that go with that because, of course, people only stay on [the drug] if they are doing well," PALACE 3 investigator Dr. Christopher Edwards observed in an interview.

Dr. Edwards, who is a clinical rheumatologist at University Hospital Southampton, England, noted that the statistical power of long-term extension studies is perhaps a little less robust than the initial study phases, but that these long-term data from the PALACE trials do seem to show that the effects of treatment with apremilast are sustained and maybe even that the effect size improves slightly over time.

Physical function, assessed via the Health Assessment Questionnaire–Disability Index (HAQ-DI), was improved with apremilast treatment in both the PALACE 1 and PALACE 3 trials. In the latter trial, mean change in HAQ-DI scores at 16 weeks declined by 0.13 and 0.19, compared with baseline values in the apremilast 20-mg and 30-mg groups. In contrast, scores increased by 0.07 in the placebo group. Over the following year, HAQ-DI scores continued to improve, with the mean change in scores from baseline crossing the threshold of –0.30, which many think signifies a clinically meaningful change, Dr. Edwards explained.

HAQ-DI scores in PALACE 1 at 52 weeks were a respective –0.369 and –0.318 in the 20-mg and 30-mg groups, and at the 16-week assessment point, they had been –0.20 and –0.24, respectively, and –0.09 for placebo.

Furthermore, in the PALACE 3 trial, 29%-39% of patients treated with apremilast achieved a 75% improvement in skin involvement, assessed via the Psoriasis Area and Severity Index (PASI) at 1 year. PASI50 was achieved in 49%-54%.

Dr. Edwards observed that some of the additional data now available from PALACE 3 showed that there was a beneficial effect of apremilast on enthesitis and dactylitis – two unique features of psoriatic arthritis that are often not treated by the use of the nbDMARDS, such as methotrexate and sulfasalazine.

At 24 weeks, he noted that in other comparisons of patients treated with apremilast or placebo, active therapy yielded significant improvements in pain (assessed using a visual analog scale), improved Functional Assessment of Chronic Illness Therapy-Fatigue scores, a higher rate of achieving ‘good’ or ‘moderate’ European League Against Rheumatism responses, and greater modified Psoriatic Arthritis Response Criteria results.

Dr. Edwards has acted as a consultant to Celgene, the company that sponsored the studies. He has also received research support from Pfizer and honoraria from Roche, Abbott, and GlaxoSmithKline.

Inflammation in ankylosing spondylitis was associated with new spinal bone formation in a 12-year follow-up study of 184 patients in the Outcome in AS International Study (OASIS).

"We have demonstrated here for the first time that the effect of disease activity on radiographic damage is actually rather impressive and longitudinal: Per one ASDAS unit increase a 0.7 mSASSS (modified Stoke Ankylosing Spondylitis Spine Score) units progression in 2 years can be expected. This longitudinal relationship was pertinent over the entire 12 years of follow-up," said Dr. Sofia Ramiro of the Amsterdam Rheumatology Center, University of Amsterdam.

The effect was more pronounced in men and in the earlier phases of the disease, Dr. Ramiro and her associates wrote in an article published online May 7 in Annals of the Rheumatic Diseases (doi:10.1136/annrheumdis-2014-205178).

For the study, all patients had biennial clinical and radiographic assessments and two readers independently scored the x-rays according to the mSASSS. Disease activity measures included the Bath AS Disease Activity Index (BASDAI), AS Disease Activity Index (ASDAS)-C-reactive protein (CRP), CRP, erythrocyte sedimentation rate (ESR), patient’s global assessment, and spinal pain.

As a disease activity measure, ASDAS outperformed the models with all other disease activity measures. The finding importantly adds to the validity of ASDAS as the disease activity measure of choice, the researchers said.

Patients with an ASDAS less than 1.3 at baseline had an average progression of 0.71 mSASSS units/2-years. Those with an ASDAS of more than 3.5 at baseline had a progression of 3.1 mSASSS units/2-year progression. A similar relationship was found for BASDAI: patients with a BASDAI less than 4 at baseline had an average progression of 1.4 mSASSS units/2 years, while patients with a BASDAI of 4 or more at baseline had an average progression of 2.7 mSASSS units/2 years.

However, inflammation "by far does not fully explain radiographic damage in AS: Even without measurable disease activity there is still considerable radiographic progression," they said. Patients who have inactive disease for the entire 12 years still can expect a progression of 5 mSASSS units on average. It seems as if increased bone formation in AS is partly constitutive and partly inflammation dependent.

The effect of disease activity on radiographic progression seems to be stronger in men, who had an additional progression of about 1 mSASSS unit per 2-year interval per additional unit of ASDAS. The researchers also found a stronger effect of disease activity on radiographic progression in the early phase of AS.

The models with ASDAS as the disease activity measure fitted the data better than did models with BASDAI, CRP, or BASDAI+CRP. An increase of one ASDAS unit led to an increase of 0.72 mSASSS units/2 years. An ASDAS exceeding 3.5 compared with an ASDAS of less than 1.3 resulted in an additional 2-year progression of 2.31 mSASSS units.

Dr. Romero was supported by the Fundação para a Ciência e Tecnologia (FCT) grant SFRH/BD/68684/2010.

mdales@frontlinemedcom.com

Inflammation in ankylosing spondylitis was associated with new spinal bone formation in a 12-year follow-up study of 184 patients in the Outcome in AS International Study (OASIS).

"We have demonstrated here for the first time that the effect of disease activity on radiographic damage is actually rather impressive and longitudinal: Per one ASDAS unit increase a 0.7 mSASSS (modified Stoke Ankylosing Spondylitis Spine Score) units progression in 2 years can be expected. This longitudinal relationship was pertinent over the entire 12 years of follow-up," said Dr. Sofia Ramiro of the Amsterdam Rheumatology Center, University of Amsterdam.

The effect was more pronounced in men and in the earlier phases of the disease, Dr. Ramiro and her associates wrote in an article published online May 7 in Annals of the Rheumatic Diseases (doi:10.1136/annrheumdis-2014-205178).

For the study, all patients had biennial clinical and radiographic assessments and two readers independently scored the x-rays according to the mSASSS. Disease activity measures included the Bath AS Disease Activity Index (BASDAI), AS Disease Activity Index (ASDAS)-C-reactive protein (CRP), CRP, erythrocyte sedimentation rate (ESR), patient’s global assessment, and spinal pain.

As a disease activity measure, ASDAS outperformed the models with all other disease activity measures. The finding importantly adds to the validity of ASDAS as the disease activity measure of choice, the researchers said.

Patients with an ASDAS less than 1.3 at baseline had an average progression of 0.71 mSASSS units/2-years. Those with an ASDAS of more than 3.5 at baseline had a progression of 3.1 mSASSS units/2-year progression. A similar relationship was found for BASDAI: patients with a BASDAI less than 4 at baseline had an average progression of 1.4 mSASSS units/2 years, while patients with a BASDAI of 4 or more at baseline had an average progression of 2.7 mSASSS units/2 years.

However, inflammation "by far does not fully explain radiographic damage in AS: Even without measurable disease activity there is still considerable radiographic progression," they said. Patients who have inactive disease for the entire 12 years still can expect a progression of 5 mSASSS units on average. It seems as if increased bone formation in AS is partly constitutive and partly inflammation dependent.

The effect of disease activity on radiographic progression seems to be stronger in men, who had an additional progression of about 1 mSASSS unit per 2-year interval per additional unit of ASDAS. The researchers also found a stronger effect of disease activity on radiographic progression in the early phase of AS.

The models with ASDAS as the disease activity measure fitted the data better than did models with BASDAI, CRP, or BASDAI+CRP. An increase of one ASDAS unit led to an increase of 0.72 mSASSS units/2 years. An ASDAS exceeding 3.5 compared with an ASDAS of less than 1.3 resulted in an additional 2-year progression of 2.31 mSASSS units.

Dr. Romero was supported by the Fundação para a Ciência e Tecnologia (FCT) grant SFRH/BD/68684/2010.

mdales@frontlinemedcom.com

Inflammation in ankylosing spondylitis was associated with new spinal bone formation in a 12-year follow-up study of 184 patients in the Outcome in AS International Study (OASIS).

"We have demonstrated here for the first time that the effect of disease activity on radiographic damage is actually rather impressive and longitudinal: Per one ASDAS unit increase a 0.7 mSASSS (modified Stoke Ankylosing Spondylitis Spine Score) units progression in 2 years can be expected. This longitudinal relationship was pertinent over the entire 12 years of follow-up," said Dr. Sofia Ramiro of the Amsterdam Rheumatology Center, University of Amsterdam.

The effect was more pronounced in men and in the earlier phases of the disease, Dr. Ramiro and her associates wrote in an article published online May 7 in Annals of the Rheumatic Diseases (doi:10.1136/annrheumdis-2014-205178).

For the study, all patients had biennial clinical and radiographic assessments and two readers independently scored the x-rays according to the mSASSS. Disease activity measures included the Bath AS Disease Activity Index (BASDAI), AS Disease Activity Index (ASDAS)-C-reactive protein (CRP), CRP, erythrocyte sedimentation rate (ESR), patient’s global assessment, and spinal pain.

As a disease activity measure, ASDAS outperformed the models with all other disease activity measures. The finding importantly adds to the validity of ASDAS as the disease activity measure of choice, the researchers said.

Patients with an ASDAS less than 1.3 at baseline had an average progression of 0.71 mSASSS units/2-years. Those with an ASDAS of more than 3.5 at baseline had a progression of 3.1 mSASSS units/2-year progression. A similar relationship was found for BASDAI: patients with a BASDAI less than 4 at baseline had an average progression of 1.4 mSASSS units/2 years, while patients with a BASDAI of 4 or more at baseline had an average progression of 2.7 mSASSS units/2 years.

However, inflammation "by far does not fully explain radiographic damage in AS: Even without measurable disease activity there is still considerable radiographic progression," they said. Patients who have inactive disease for the entire 12 years still can expect a progression of 5 mSASSS units on average. It seems as if increased bone formation in AS is partly constitutive and partly inflammation dependent.

The effect of disease activity on radiographic progression seems to be stronger in men, who had an additional progression of about 1 mSASSS unit per 2-year interval per additional unit of ASDAS. The researchers also found a stronger effect of disease activity on radiographic progression in the early phase of AS.

The models with ASDAS as the disease activity measure fitted the data better than did models with BASDAI, CRP, or BASDAI+CRP. An increase of one ASDAS unit led to an increase of 0.72 mSASSS units/2 years. An ASDAS exceeding 3.5 compared with an ASDAS of less than 1.3 resulted in an additional 2-year progression of 2.31 mSASSS units.

Dr. Romero was supported by the Fundação para a Ciência e Tecnologia (FCT) grant SFRH/BD/68684/2010.

mdales@frontlinemedcom.com