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Two new JAK-1 inhibitors are in the pipeline for rheumatoid arthritis. It has been proposed that inhibiting JAK-1 only will lead to suppression of inflammation, with fewer side effects than inhibiting other JAK pathways.
The first of these, called filgotinib, is being developed by Galapagos Pharma in Belgium. During this ACR, Galapagos presented 7 abstracts, including results from the DARWIN 1 and 2 studies in RA, which are phase 2b dose-finding studies. DARWIN 1 looked at filgotinib + MTX in DMARD-IR rheumatoid arthritis patients and found a significant improvement in clinical response with a favourable safety profile. DARWIN 2 evaluated filgotinib monotherapy in DMARD-IR rheumatoid arthritis patients and showed similar efficacy as in DARWIN 1 with favourable safety. At the higher doses of 100mg and 200mg daily, average ACR 20/50/70 responses were 60/40/20, as expected. Interestingly, filgotinib was originally licensed by Abbvie for co-development and distribution. In September 2015, Abbvie dropped filgotinib and has decided to focus on its own JAK-1 inhibitor, ABT-494.
Results from a Phase 2b, 12-week, double-blind placebo-controlled trial of ABT-494 (with MTX) in RA patients with an inadequate response to ≥ 1 TNFi were presented on Tuesday morning at the ACR. Results showed significant improvement in ACR20 responses with all doses evaluated, and significant LDAS/remission with doses higher than 12mg BID, with an acceptable safety profile. In this TNF-IR population, very high ACR responses were reported, particularly in doses greater than 12mg BID with ACR 20/50/70 responses of 71/42/22.
These are two molecules to watch for in the future, as they enter into Phase 3 studies. Now that Galapapos Pharma's filgotinib was dropped by Abbvie, watch for partnership with another competitor!
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About the Author
Dr. Shahin Jamal
Dr. Jamal is a Clinical Associate Professor at the University of British Columbia and an active staff physician at Vancouver Coastal Health. Her interests include diagnosis and prognosis of early inflammatory arthritis, and timely assessment and access to care for patients with rheumatoid arthritis.
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