Safety Profile of Filgotinib Highlighted in Pooled Phase 3 Analysis


John Sundy, MD, PhD, senior vice president of Inflammation and Respiratory Disease with Gilead Sciences, discusses the results of a pooled safety analysis examining phase 3 studies of filgotinib.

Results of a pooled analyses examining safety data from the phase 3 FINCH program are highlighting the safety and tolerability profile of filgotinib in patients with rheumatoid arthritis.

Data presented at the 2019 American College of Rheumatology annual meeting in Atlanta, GA, demonstrated filgotinib had a favorable safety and tolerability profile, regardless if used as monotherapy or in conjunction with methotrexate and conventional synthetic DMARDs (csDMARDs).

To further assess the safety profile of filgotinib, investigators conducted a pooled safety analysis across phase 3 FINCH 1, 2, and 3 studies, which examined filgotinib in 100 and 200 mg doses. From the FINCH program, investigators obtained safety data on a cohort of 3452 patients with moderately to severe rheumatoid arthritis who had inadequate response to methotrexate, who were receiving csDMARDs and had an inadequate response to biologic DMARDs, or who were methotrexate-naive. Of this cohort, 2088 patients received filgotinib.

Incidence of major cardiovascular event during the study were 0.2% in patients receiving both doses of filgotinib, 0.3% in adalimumab-treated groups, and 0.5% in patients receiving placebo plus methotrexate or csDMARDs. Investigators also noted deep vein thrombosis and pulmonary embolism were less than 0.1% in filgotinib 200 mg monotherapy, filgotinib 100 mg and 200 mg plus methotrexate or csDMARD treatments group. In comparison, the rate was 0% in the adalimumab group and 0.3% in the placebo plus methotrexate or csDMARD group.

The rate of patient death in the pooled analyses was 0.2% in the placebo plus methotrexate or csDMARD group and in the 100 mg and 200 mg filgotinib plus methotrexate or csDMARD combination groups.

For more perspective what results of the study add to filgotinib’s safety profile in the treatment of rheumatoid arthritis, MD Magazine® sat down with John Sundy, MD, PhD, senior vice president of Inflammation and Respiratory Disease with Gilead Sciences, at ACR 2019.

MD Mag: What were the results from the pooled analysis of phase 3 trials of filgotinib?

Sundy: So, I think that when you looked at each of the results of the results of the phase 3 programs—FINCH 1, 2, and 3—each study by itself demonstrated a very good safety profile, in our opinion. The thing that we really wanted to do with the pooled analysis was to be able to look at a much larger data set by pooling all that patient experience together, looking at that in the context of some of the active comparator therapies that were used during the course of these trials.

And, again, it's the same takeaway, similar to what I told you with regard to the DARWIN 3 study. When you begin to look at the adverse events of interest—like serious infections, herpes zoster rates, thromboembolism—what we're seeing is that these are demonstrating a profile that I think would be attractive to physicians and to patients who are treating patients with rheumatoid arthritis.

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