According to Gilead (Nasdaq: GILD) and partner Galapagos NV (Euronext & Nasdaq: GLPG), analysis of two phase 2 human clinical trials evaluating the efficacy of JAK1 inhibitor filgotinib for the treatment of psoriatic arthritis (PsA) in adults found “durable efficacy and consistent safety profile” of the drug in individuals with active disease and demonstrated “rapid and sustained reductions” in markers of inflammation in individuals with moderate-to-severe disease.
The randomized, placebo-controlled, double-blind, 16-week-long Phase 2 EQUATOR study included 124 adults, 122 of whom were enrolled in the open-label extension trial EQUATOR-2 OLE. Among both studies, patients were treated with filgotinib for a median of 66 weeks without the reporting of new safety signals.
Senior Vice President of Inflammation at Gilead Sciences Mark Genovese, MD, stated, “Despite existing treatments, people living with psoriatic arthritis can face challenging long-term symptoms including joint swelling and stiffness, pain and fatigue – all of which can significantly impact patients’ daily lives.”
“These new analyses from the EQUATOR study program showed that patients with PsA who were treated with filgotinib achieved a sustained response. We look forward to advancing the pivotal Phase 3 PENGUIN clinical trial program to confirm the safety and efficacy of filgotinib as a potential treatment option for this patient population,” Dr. Genovese continued.
“The data from the Phase 2 program for filgotinib in psoriatic arthritis add to the growing body of evidence for the efficacy and safety profile of this investigational treatment. We are particularly encouraged by the innovative analysis of the impact of filgotinib at the molecular level, which indicates the drug is acting rapidly to reduce the hallmarks of inflammation in this condition,” stated Chief Medical Officer of Galapagos Walid Abi-Saab, MD.
The efficacy of filgotinib was “generally consistent” regardless of patient characteristics such as sex, baseline disease severity, and history of treatment with tumor necrosis factor inhibitors, among others.
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As compared to patients treated with a placebo, among most patient subgroups, those administered filgotinib were significantly more likely to achieve responses as measured by the Disease Activity Index for Psoriatic Arthritis (DAPSA), the Psoriatic Arthritis Disease Activity Score (PASDAS), or a scoring system of the American College of Rheumatology (ACR).
Patients treated with filgotinib were beared significantly reduced systemic levels of the pro-inflammatory cytokine interleukin-6 (IL-6) and the marker of inflammation serum amyloid A, among others measures of autoimmune pathology.
Filgotinib is being evaluated for the treatment of other autoimmune diseases including rheumatoid arthritis, ulcerative colitis, and Crohn’s disease, among others.