Pfizer announces results from Phase 3 OPAL clinical development program investigating XELJANZ (tofacitinib citrate) for psoriatic arthritis.
Pfizer Inc. announced that new results from the Phase 3 oral psoriatic arthritis trial (OPAL) studies, Broaden and Beyond, will be presented at the 2016 ACR/ARHP Annual Meeting this week in Washington, DC.
OPAL Broaden and OPAL Beyond evaluated the efficacy and safety of XELJANZ (tofacitinib citrate) in adult patients with active psoriatic arthritis (PsA) who had an inadequate response (IR) to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or to tumor necrosis factor inhibitors (TNFis), respectively.
Detailed results from OPAL Broaden will be presented during a plenary session for the first time at ACR/ARHP. Additionally, results from OPAL Beyond will be presented during a late-breaking abstract poster session.
“Psoriatic arthritis is a chronic condition that can have a significant and potentially debilitating impact on people with the disease, who currently have limited treatment options,” said Michael Corbo, chief development officer, inflammation & immunology, Pfizer Global Product Development. “As the only JAK inhibitor being investigated in psoriatic arthritis, tofacitinib, if approved, would provide patients and healthcare professionals the first medicine in a new class to treat this disease. We continue to progress the OPAL clinical development program globally and look forward to possible future regulatory filings.”
OPAL Broaden and OPAL Beyond met their primary efficacy endpoints showing a statistically significant improvement with tofacitinib 5 mg and 10 mg twice daily (BID) compared to treatment with placebo at three months as measured by American College of Rheumatology 20 (ACR20) response (OPAL Broaden: p≤0.05 and p<0.0001; OPAL Beyond: p<0.0001, respectively), and change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score (OPAL Broaden: p≤0.05 and p<0.001; OPAL Beyond: p<0.0001 and p<0.001, respectively).
OPAL Broaden, which was a 12-month duration trial with a three month placebo-controlled period, evaluated the efficacy and safety of tofacitinib 5 mg (n=107) and 10 mg (n=104) BID compared to placebo (n=105) in adult patients with active PsA who had an IR to at least one csDMARD and who were TNFi-naïve. OPAL Broaden included an active control arm of adalimumab 40 mg (n=106) administered subcutaneously every two weeks (q2 wk).
The study was not designed for non-inferiority or superiority comparisons between adalimumab and tofacitinib. OPAL Beyond, a six-month duration trial with a three month placebo-controlled period, evaluated the efficacy and safety of tofacitinib 5 mg (n=131) and 10 mg (n=132) BID compared to placebo (n=131) in adult patients with active PsA who had an IR to at least one TNFi. OPAL Beyond focused exclusively on the TNFi-IR patient population. In both studies, patients who were initially randomized to placebo advanced to tofacitinib 5 or 10 mg BID in a blinded manner at three months.
Efficacy Results
In OPAL Broaden, 50.5% and 60.6% of patients achieved an ACR20 response with tofacitinib 5 mg and 10 mg BID, respectively, compared to 33.3% of patients taking placebo at three months. Patients taking adalimumab 40 mg q2 wk achieved an ACR20 response rate of 51.9%. In OPAL Beyond, 49.6% and 47.0% of patients achieved ACR20 response with tofacitinib 5 mg and 10 mg BID, respectively, compared to 23.7% of patients taking placebo at three months. In both studies, changes from baseline in HAQ-DI score were statistically significantly greater with tofacitinib 5 mg and 10 mg BID compared to placebo at three months.
“The findings from OPAL Broaden and OPAL Beyond showed that treatment with tofacitinib improved symptoms and decreased disease activity in patients with active psoriatic arthritis who do not respond well to currently available therapies, including DMARDs and TNFis,” said Philip Mease, M.D., Swedish Medical Center and University of Washington. “Tofacitinib, if approved, may be an important treatment option for people with active psoriatic arthritis.”
Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic inflammatory multisystem disease. PsA causes joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful tendonitis and irreversible joint damage. An estimated three million people in the U.S. and Europe combined have active PsA. Disease prevalence may even be higher because it is often misdiagnosed or goes undiagnosed altogether.
(Source: Business Wire)
Filed Under: Drug Discovery
