Gilead and Galapagos Announce Long-Term Efficacy and Safety of JAK1 Inhibitor Filgotinib in Rheumatoid Arthritis Through 52 Weeks

Recently, Gilead Sciences and Galapagos announced that the 52-week results from two Phase 3 clinical trials of filgotinib, an oral JAK1 inhibitor co-developed by the two companies, in patients with moderate to severe rheumatoid arthritis (RA), support the efficacy, safety, and tolerability profile demonstrated in the previously reported 12- and 24-week data. In March this year, the companies released the 12- and 24-week data from these trials, stating that filgotinib had met the primary endpoints. These data support their plan to submit a New Drug Application to the FDA before the end of the year. The 52-week data from both trials will be presented at future medical conferences.

Rheumatoid arthritis is a chronic inflammatory autoimmune disease. The immune system attacks the synovium in the patient’s own joints, leading to inflammation and synovial thickening, which ultimately results in damage to the cartilage and bone within the joints. Rheumatoid arthritis may impair the function of multiple joints in patients. It affects approximately 23.7 million people worldwide. Methotrexate (MTX) is typically the first-line therapy for this condition; however, many patients are intolerant to or respond poorly to MTX, necessitating new therapies to mitigate disease progression in these patients.

Filgotinib is a highly selective JAK1 inhibitor jointly developed by Gilead Sciences and Galapagos. JAKs belong to the cytoplasmic tyrosine kinase family and function to mediate signaling pathways activated by cytokines (such as interferons); there are four JAK subtypes. Inhibitors of this kinase family have demonstrated efficacy in treating certain inflammatory and autoimmune diseases. Previously, filgotinib has been evaluated in multiple clinical trials for the treatment of various inflammatory conditions.

▲Filgotinib Development Pipeline (Image source: Gilead Sciences official website)

The complete data from two Phase 3 trials released this time present the results of filgotinib in treating patient populations with different types of rheumatoid arthritis. In the FINCH 1 trial, a total of 1,759 patients who had previously received methotrexate (MTX) treatment but exhibited an inadequate response were enrolled. Previously reported results showed that after 12 weeks of treatment, the proportion of patients receiving filgotinib who achieved ACR20 (one of the American College of Rheumatology criteria for treatment assessment) was significantly higher than that in the placebo group, thereby meeting the primary endpoint of the trial.

In another 52-week FINCH 3 trial, filgotinib was evaluated as monotherapy or in combination with methotrexate (MTX) in patients who had never previously received MTX. Previously reported results demonstrated that at 24 weeks, the combination of filgotinib and MTX significantly increased the proportion of patients achieving an ACR20 response compared with MTX alone, thereby meeting the primary endpoint of the trial.

“We are pleased to observe the durable efficacy and safety of filgotinib in the treatment of patients with rheumatoid arthritis in these trials,” said John Sundy, M.D., Senior Vice President of Inflammation and Respiratory Diseases at Gilead Sciences. “If approved, filgotinib could provide a new effective treatment option for patients with rheumatoid arthritis.”

References:

[1] Gilead and Galapagos Announce Efficacy and Safety Results of Filgotinib Through 52 Weeks in FINCH 1 and FINCH 3 Studies in Rheumatoid Arthritis, Retrieved October 11, 2019, from https://www.businesswire.com/news/home/20191010005875/en/Gilead-Galapagos-Announce-Efficacy-Safety-Results-Filgotinib

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