Health Boards
Pfizer have released second phase 3 results on Xeljanz (tofacitinib citrate) for the treatment of psoriatic arthritis.
Source: pfizer.com
Quote:
Pfizer announced today top-line results from Oral Psoriatic Arthritis triaL (OPAL) Beyond, the second Phase 3 study of XELJANZ® (tofacitinib citrate) being investigated in patients with active psoriatic arthritis (PsA). This study evaluated the efficacy and safety of tofacitinib 5 mg and 10 mg twice daily (BID) in adult patients with active PsA who had an inadequate response to at least one tumor necrosis factor inhibitor (TNFi), making it the first PsA study to focus exclusively on TNFi-IR patients.1 OPAL Beyond met its primary efficacy endpoints demonstrating a statistically significant (p<0.0001) improvement with tofacitinib 5 mg BID and 10 mg BID compared to placebo treatment as measured by American College of Rheumatology 20 (ACR20) response and Health Assessment Questionnaire Disability Index (HAQ-DI) score at 3 months.1
“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, Category Development Lead, Inflammation & Immunology, Pfizer Global Innovative Pharmaceuticals Business. “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.”
Overall safety findings in this study were consistent with those observed in the broader rheumatology clinical development program for tofacitinib.
OPAL Beyond is a Phase 3, randomized, double-blind, placebo-controlled, 6-month study investigating the efficacy and safety of tofacitinib 5 mg and 10 mg twice daily in patients with active PsA who had inadequate response to at least one TNFi due to lack of efficacy or an adverse event.1 A total of 395 subjects enrolled in the study and were randomized equally to tofacitinib 5 mg BID, tofacitinib 10 mg BID and placebo. Patients enrolled in the study were required to be on one conventional synthetic disease modifying antirheumatic drug (csDMARD) as background therapy and continue that dose for the duration of the study.
Source: pfizer.com
