Phase 3 data confirms safety, efficacy of filgotinib for RA
CHICAGO – Filgotinib improved the signs and symptoms of rheumatoid arthritis among previously treated patients with highly active disease, according to findings presented at the ACR/ARHP 2018 Annual Meeting.
In addition, the safety profile observed in this global phase 3 study was consistent with previously published data.
“Filgotinib [Galapagos NV], an oral, selective JAK1 inhibitor, was effective in phase 2 studies of active RA in patients with insufficient response to methotrexate, warranting further evaluation,” the researchers wrote.
Mark C. Genovese, MD, James W. Raitt Professor of Medicine and director of the rheumatology clinic in the division of immunology and rheumatology at Stanford University Medical Center, and colleagues enrolled 448 patients with moderate to severe disease in the study. Participants either responded ineffectively to, or were intolerant of, one or more biologic DMARDs. The researchers reported the following baseline characteristics: mean age (56 years), sex (80.4% female), disease duration (12.4 years) and prior treatment with three or more biologic DMARDs (23.4%). Also at baseline, the tender joint count and swollen joint count for all patients were 27 out of 68 and 17 out of 66, respectively; the DAS 28 and C-Reactive Protein (DAS28-CRP) score was 5.9 among all patients at baseline.
Patients were randomly assigned 1:1:1 to receive filgotinib 200 mg once daily (n = 147), filgotinib 100 mg once daily (n = 153) or placebo (n = 148) for 24 weeks. Participants were also required to continue treatment with DMARDs.
More patients in the 200 mg (66%) and 100 mg (57.5%) arms reached an ACR 20 response by Week 12, which served as the study’s primary endpoint, when compared with placebo (31.1%). The results were statistically significant (P < .001) in both filgotinib arms.
The decrease from baseline in the health assessment questionnaire disability index was also statistically significant for patients in both the 200 mg and 100 mg filgotinib arms at week 12 when compared with the placebo arm (-0.55 and -0.48, respectively, vs. -0.23; both P < .001).
Adverse events occurred at comparable rates in the filgotinib 200 mg and 100 mg arms when compared with the placebo group (69.4% and 63.4%, respectively, vs. 67.6%), as did serious adverse events (4.1%, 5.2% and 3.4%, respectively). Four cases of uncomplicated herpes zoster occurred, two in each filgotinib group. One non-serious adverse event, a retinal vein occlusion, was noted in the filgotinib 200 mg group; no other venous thrombotic events were noted. Two adjudicated major adverse cardiovascular events occurred: myocardial ischemia in the filgotinib 100 mg group and a subarachnoid hemorrhage in the placebo group. No cases of opportunistic infections/active tuberculosis, malignancy or gastrointestinal perforation were reported and there were no deaths.
“Filgotinib may provide a novel treatment option for patients who continue to have active RA despite prior biologic therapies,” the researchers wrote. - by Julia Ernst, MS
Genovese MC, et al. Abstract L06. Presented at: ACR/ARHP Annual Meeting, Oct. 20-24, 2018; Chicago.
Disclosures: The study was funded by Gilead Sciences. Genovese reports receiving research grants, consulting fees and other remunerations from AbbVie, Eli Lilly and Company, Galapagos, Gilead Sciences and Pfizer.