Gilead Sciences, Inc. and Galapagos NV today announced detailed results from the Phase 3 FINCH 2 clinical trial of filgotinib, an investigational, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis and prior inadequate response or intolerance to biologic agents. The data, which are being presented as a late-breaking poster at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Chicago, suggest filgotinib has a potential role in addressing important unmet needs in the treatment of rheumatoid arthritis.
Positive efficacy data from FINCH 2 were previously announced in September 2018. The data show statistically significant improvements in the proportion of patients achieving a range of clinical efficacy endpoints, including the proportion of patients achieving American College of Rheumatology 20 percent (ACR20, primary endpoint), 50 percent (ACR50) and 70 percent (ACR70) responses, low disease activity (defined as DAS28(CRP) ≤ 3.2) and clinical remission (defined as DAS28(CRP) < 2.6) at Weeks 12 and 24.
Additional FINCH 2 data to be presented include positive results across several patient-reported health-related quality of life measures. Patients receiving filgotinib 100mg or 200mg once-daily experienced greater reduction in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 compared with those receiving placebo (-0.46 and -0.50 vs -0.19; both p<0.001). Patients receiving filgotinib 100mg or 200mg also experienced greater improvements on the Short-Form Health Survey (SF-36) Physical Component Score (PCS) at Week 12 (7.6 and 8.4 vs 4.2; both p<0.001) and on the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) at Week 12 (8.4 and 10.2 vs 5.2; p=0.007 and p<0.001) compared with patients receiving placebo.
Filgotinib demonstrated a safety profile consistent with earlier clinical trials. Rates of serious treatment-emergent adverse events were similar for the filgotinib 100mg, 200mg and placebo groups (5.2 percent, 4.1 percent and 3.4 percent, respectively). The proportion of patients who discontinued study drug due to treatment-emergent adverse events was also similar across groups. Serious infections occurred at similar rates across the three study arms (2.0 percent, 0.7 percent and 1.4 percent, respectively). A total of four cases of uncomplicated Herpes zoster occurred in the filgotinib arms, and one non-serious case of retinal vein occlusion was reported in the filgotinib 200 mg group. Two major adverse cardiovascular events were reported, one in the filgotinib 100mg group and one in the placebo group. No deaths occurred during the study.
"Inflammatory diseases are an important area of focus for Gilead's research and development and filgotinib is a cornerstone of this work," said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. "The results of FINCH 2 add further support to the potential role of filgotinib in treating patients with rheumatoid arthritis."
"For many people living with rheumatoid arthritis, the effects of pain, inflammation and fatigue can take a serious toll in their everyday lives. We are encouraged by these data, which suggest filgotinib can improve symptoms of rheumatoid arthritis in patients who have not responded to prior biologic treatment and who need new therapies that are safe and effective," said Dr. Walid Abi-Saab, Chief Medical Officer at Galapagos. "We are committed to developing filgotinib to address the unmet needs of these patients."
Filgotinib is an investigational compound and is not approved anywhere globally. Its efficacy and safety have not been established. For information about the clinical trials with filgotinib: www.clinicaltrials.gov.