New Clinical Trial Results: Safety and Efficacy of Tofacitinib in PsA

Results were announced from a phase 3 trials assessing safety and efficacy of tofacitinib citrate for active psoriatic arthritis

Pfizer anounced results from a phase 3 study of tofacitnib (Xeljanz®, tofacitinib citrate) for the treatment of adults with active psoriatic arthritis (PsA) who failed treatment with previously administered tumor necrosis factor (TNF) inhibitor.

Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors (“OPAL Beyond”), a randomized, double-blind, placebo-controlled, 6-month trial ( Identifier NCT01882439) is part of the OPAL global clinical development program consisting of two Phase 3 studies and one long-term extension trial. 

This study evaluated the efficacy and safety of tofacitinib 5mg and 10mg twice daily as compared to placebo in 395 adult patients with active PsA who had inadequate or intolerable response to ≥1 TNF inhibitor. The primary efficacy endpoint was improvement in symptoms as measured by American College of Rheumatology 20 response and Health Assessment Questionnaire Disability Index scores at 3 months.

Results from OPAL Beyond showed that treatment with tofacitinib 5mg and 10mg twice daily demonstrated a statistically significant improvement vs placebo based on ACR20 and HAQ-DI scores at 3 months, meeting the study’s primary endpoint. Overall adverse events rates were consistent with those observed in broader tofacitinib rheumatology studies. 

Tofacitinib is a Janus kinase (JAK) inhibitor. It is currently available as Xeljanz® and Xeljanz XR® for the treatment of moderate to severe rheumatoid arthritis in adults who have had an inadequate response or intolerance to methotrexate, as monotherapy or in combination with MTX or other nonbiologic disease-modifying anti-rheumatic drugs.

Summary and Clinical Applicability

“There is a significant need for additional PsA treatment options as many people living with the condition do not respond well to available therapies,” said Michael Corbo of Pfizer.

“The positive results of both Phase 3 PsA studies, OPAL Broaden in DMARD-IR patients and OPAL Beyond in TNFi-IR patients, demonstrate that tofacitinib, if approved, may have potential to be an important treatment option to help address unmet needs for patients with PsA.”


Pfizer Announces Positive Top-Line Results From Second Phase 3 Trial Of Oral XELJANZ® (Tofacitinib Citrate) In Adults With Psoriatic Arthritis [news release].  Pfizer press release office.  Published online June 7, 2016. Source Code.

This article originally appeared on MPR