Positive Phase 3 Results With Filgotinib for Treatment-Resistant Rheumatoid Arthritis

The following article is part of conference coverage from the 2018 American College of Rheumatology and Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Chicago, Illinois. Rheumatology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in rheumatology. Check back for the latest news from ACR/ARHP 2018 .

CHICAGO – Treatment with filgotinib, an oral Janus kinase 1 inhibitor, for 24 weeks resulted in significant improvements in the signs and symptoms of rheumatoid arthritis (RA) among patients with inadequate response or intolerance to biologic disease-modifying antirheumatic drugs (bDMARDs), according to data presented at the 2018 ACR/ARHP Annual Meeting, held October 19-24, in Chicago, Illinois.

In this phase 3 study (ClinicalTrials.gov identifier: NCT02873936), 448 patients with moderate to severe active RA with inadequate response or intolerance to ≥1 bDMARD were randomly assigned to receive filgotinib 200 mg (n=147), 100 mg (n=153), or placebo (n=148) for 24 weeks.

All participants continued stable conventional synthetic DMARDs.

The primary end point was the percentage of participants who achieved 20% improvement in ACR criteria (ACR20) at 12 weeks. The investigators noted that 80.4% of the participants were women, 23.4% had ≥3 prior bDMARDs, and the mean age was 56 years.

More patients receiving filgotinib 200 mg or 100 mg achieved ACR20 response compared with patients receiving placebo at 12 weeks (66.0% and 57.5% vs 31.1%) and 24 weeks (69.4% and 54.9% vs 34.5%). Results also showed that the reduction from baseline in Health Assessment Questionnaire Disability Index was greater in the filgotinib 200 mg or 100 mg groups compared with the placebo group (-0.55 and -0.48 vs -0.23; both P <.001).

Researchers noted that adverse event rates were similar for filgotinib 200 mg, filgotinib 100 mg, and placebo groups (69.4% and 63.4% vs 67.6%) as were rates of serious adverse events (4.1%, 5.2% and 3.4%). There were 4 cases of herpes zoster, 1 non-serious event of retinal vein occlusion in the filgotinib 200 mg group, and 2 adjudicated major adverse cardiac events. There were no cases of active tuberculosis, malignancy, gastrointestinal perforation, or death.

Investigators concluded that “[filgotinib] may provide a novel treatment option for [patients] who continue to have active RA despite prior biologic therapies.”

This study was sponsored by Gilead Sciences, Inc.

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Reference

Genovese MC, Kalunian KC, Walker D, et al. Safety and efficacy of filgotinib in a phase 3 trial of patients with active rheumatoid arthritis and inadequate response or intolerance to biologic DMARDs. Presented at: 2018 ACR/ARHP Annual Meeting; October 19-24, 2018; Chicago, IL. Abstract L06.

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