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Abatacept Improves Patient-reported Outcomes in Psoriatic Arthritis
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Weekly doses of abatacept 125 mg for 24 weeks improved patient-reported outcomes in psoriatic arthritis, with better results among patients with elevated C-reactive protein at baseline and those who were not exposed to TNF inhibitors, according to data published in Arthritis Care & Research.
“In the phase 3 Active Psoriatic Arthritis Randomized Trial (ASTRAEA), subcutaneous (SC) abatacept 125 mg weekly significantly increased the proportion of patients achieving 20% improvement in the American College of Rheumatology criteria (ACR20) compared with placebo at week 24 and was well tolerated in patients with active PsA,” Vibeke Strand, MD, of the Stanford University School of Medicine, and colleagues wrote. “A numerically higher proportion of patients with [Health Assessment Questionnaire–Disability Index (HAQ-DI)] responses was evident with abatacept versus placebo.”
The researchers added: “However, due to the hierarchical testing procedure employed, it was not possible to attribute significance to endpoints ranked below HAQ-DI responses in the hierarchical testing.”
To determine the effect of abatacept treatment on patient-reported outcomes in PsA, Strand and colleagues conducted a phase 3, double-blind, placebo-controlled, multicenter study of 424 participants with PsA. The patients were randomly assigned to abatacept (Orencia, Bristol-Myers Squibb) 125 mg weekly for 24 weeks (n = 213) or placebo (n = 211). An early escape to open-label abatacept was available at week 16. A total of 76 patients in the abatacept group and 89 in the placebo group qualified for early escape.
The researchers analyzed adjusted mean changes from baseline to weeks 16 and 24 among participants do did not qualify for early escape. They used multiple measures, including HAQ-DI, Short Form-36, Dermatology Life Quality Index and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). In addition, the researchers evaluated subpopulations through C-reactive protein level and prior exposure to TNF inhibitors at baseline.
According to the researchers, participants in the treatment group demonstrated numerically higher improvements in most patient-reported outcomes, compared with placebo, at both time points (P>.05). Higher proportions of participants who received abatacept, compared with placebo, reported improvements equal or greater minimal clinically important difference as well as normative values at week 16.
Also at week 16, all patient-reported-outcome improvements were numerically greater (P>.05) in participants with baseline C-reactive protein levels that were greater than the upper limit of normal, compared with levels that were at the upper limit or below (95% CI); improvements in Short Form-36 component summaries and FACIT-F were greater in patients who were TNF inhibitor-naive, compared with those who had been exposed to the treatments.
“These results demonstrate that clinical improvements in PsA signs and symptoms previously reported with abatacept treatment also result in clinically meaningful improvements in [patient-reported outcomes],” Strand and colleagues wrote. – by Jason Laday
Disclosure: Strand reports consulting fees from AbbVie, Amgen Corporation, AstraZeneca, Biogen, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Celltrion, Corrona, Crescendo/Myriad Genetics, EMD Serono, Genentech/Roche, GlaxoSmithKline, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi and UCB. Please see the study for all other authors’ relevant financial disclosures.
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