Tofacitinib exhibits shorter timeline to initial clinical response in PsA vs. placebo
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Tofacitinib for psoriatic arthritis is efficacious in most patient-reported and clinical endpoints over time, and shows shorter initial and meaningful response times versus switching from placebo to the drug at month 3, noted researchers.
“The efficacy and safety of oral tofacitinib 5 mg or 10mg twice daily (BID) or adalimumab (40mg administered subcutaneously once every 2weeks [Q2W]) have been demonstrated in patients with active PsA and a previous inadequate response to conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) (OPAL Broaden) or tumor necrosis factor inhibitors (TNFi) (OPAL Beyond) and were investigated in a long-term extension study (OPAL Balance),” Dafna D. Gladman, MD, FRCPC, of the University of Toronto, and colleagues wrote. “Tofacitinib was more effective than placebo over 3months in reducing disease activity.
“The long-term success of a particular treatment for PsA may be predictable as early as 3months following treatment initiation, emphasizing the importance of the timely assessment and adjustment of the disease management approach, if necessary, to optimize patient outcomes by reducing disease activity,” they added. “Clarification of the time frame over which a meaningful response to treatment can be expected, and availability of comparative data between drug classes, would be of considerable value to clinicians when considering treatment options in PsA.”
To examine the time to clinically meaningful response among patients with active PsA who receive tofacitinib (Xeljanz, Pfizer), adalimumab (Humira, AbbVie) or placebo before switching to tofacitinib, Gladman and colleagues conducted a post-hoc analysis of data from the OPAL Broaden and OPAL Beyond studies. Both studies were randomized, double-blind, placebo-controlled, phase 3 trials of adults with active PsA, with Broaden assessing 422 patients over 12 months, while OPAL analyzed 394 participants through 6 months.
Participants in OPAL Broaden had a prior inadequate response to at least one conventional synthetic DMARD and were TNF-inhibitor-naïve. Those in OPAL Beyond, meanwhile, had a prior inadequate response to at least one TNF-inhibitor. Participants in both studies were randomly assigned treatment with tofacitinib 5 mg or 10mg twice daily, adalimumab 40mg once every 2weeks — in the OPAL Broaden only — or placebo. Those who received placebo switched to tofacitinib 5 mg or 10mg twice daily at month 3.
For their post-hoc analysis, Gladman and colleagues assessed the time from baseline to initial treatment response using pre-defined criteria for “clinically meaningful.” These criteria were based on a Health Assessment Questionnaire-Disability Index (HAQ-DI) improvement of at least 0.35 points, a Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) improvement of at least 4 points, a Psoriatic Arthritis Disease Activity Score (PASDAS) post-baseline score of 3.2 or less and a greater than 1.6-point PASDAS improvement from baseline, and a minimal disease activity meeting at least five of seven criteria.
According to the researchers, the median time to initial HAQ-DI score response in OPAL Broaden was 29, 53 and 30days in participants treated with tofacitinib 5mg, tofacitinib 10mg, or adalimumab, respectively, compared with 162 and 112days in those who received placebo and switched to tofacitinib 5 mg or 10mg at month 3, respectively.
The median time to initial FACIT-F total score response across both studies was 31 days in participants receiving tofacitinib 5mg, compared with 84 to 91 days in other groups. In OPAL Broaden, the median time to initial response was approximately 11 months for MDA, and 6 to 9months for PASDAS, in patients who received tofacitinib or adalimumab.
“This post hoc analysis of data from the OPAL Broaden and OPAL Beyond studies demonstrates the efficacy of tofacitinib 5 mg and 10mg BID on various patient-reported and clinical endpoints over time and shows a shorter time to initial, clinically meaningful response in patients receiving tofacitinib vs. patients switching from placebo to tofacitinib at month 3,” Gladman and colleagues wrote. “Numerical similarity was observed between tofacitinib and adalimumab in OPAL Broaden.
“Our findings provide an estimate for physicians of when a clinically meaningful response can be expected with tofacitinib,” they added. “Considering the limitations noted above, the results of this analysis should be considered exploratory and, therefore, future research is needed for confirmation.”
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