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Filgotinib effective in patients with PsA
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CHICAGO — Filgotinib, an oral, selective JAK1 inhibitor in development for inflammatory diseases, demonstrated efficacy compared with placebo in patients with psoriatic arthritis, with no new safety concerns, according to Philip J. Mease, MD, of the University of Washington School of Medicine.
“JAK inhibitors mediate pro-inflammatory cytokine signaling,” Mease said, addressing attendees at the ACR/ARHP 2018 Annual Meeting. “JAK2 in addition mediates certain hematologic parameters and JAK3 on lymphocyte function. By using a selective JAK1 inhibitor, we are looking to see if there is any differentiation, either in efficacy or safety, from less selective JAK inhibitors. Filgotinib has a 30-fold selective inhibition of JAK1 over JAK2 in whole blood assay.”
To analyze the efficacy and safety of filgotinib (Galapagos NV) in patients with active psoriatic arthritis, Mease and colleagues conducted a randomized, placebo-controlled, multicenter phase 2 study of 131 participants during a period of 16 weeks, known as the EQUARTOR trial. Patients included in the trial had PsA for 12 or more weeks, active arthritis and prior or current plaque psoriasis, with inadequate response to one or more conventional disease-modifying antirheumatic drugs and prior exposure to no more than one TNF inhibitor. Participants were permitted to continue treatment with conventional DMARDs during the study.
All participants were randomly selected to receive either a 200-mg daily dose of filgotinib or placebo. The researchers evaluated disease activity at screening, baseline and at weeks 1, 2, 4, 8, 12 and 16. The primary endpoint was the percentage of patients who achieved a ACR20 response at week 16. Secondary endpoints included the proportion of patients who achieved ACR50/70 responses, improvement from baseline in health assessment questionnaire disability index (HAQ-DI) measures, minimal disease activity, 75% reduction in the psoriasis area and severity index (PASI75), the Leeds Enthesitis Index (LEI) and the Leeds Dactylitis Index (LDI).
According to Mease, 124 patients completed the study. Of those, 80% of patients treated with filgotinib achieved ACR20 response at week 16, compared with 33.3% in the placebo group (P < .0001). In addition, minimal disease activity was achieved by 23.1% of participants in the filgotinib group, compared to 9.1% of patients who received placebo. HAQ-DI change from baseline was –0.57 for the filgotinib group and –0.28 among those who received the placebo (P = .0009), and PASI75 was achieved by 45.2% of those who received the treatment, compared with 15% of the placebo group (P = .0034).
Rates of adverse events, infection and discontinuation were similar between the two groups. Among the patients treated with filgotinib, there was one case of pneumonia, which represented the group’s only serious infection and death. One patient discontinued filgotinib due to safety concerns over endometrial hypertrophy.
“The adverse events tended to be mild or moderate in severity,” Mease said. “There was one case of fatal pneumonia and one nonserious case of herpes zoster, with no malignancies, major adverse cardiovascular events, venous thromboembolism, opportunistic infections or active tuberculosis. Thus, this positive proof-of-concept study of filgotinib in patients with active psoriatic arthritis is a promising first step in the further study of this agent in this disease.” – by Jason Laday
Disclosure: Mease reports professional relationships with Abbvie, Amgen, BMS, Celgene, Galapagos, Genentech, Gilead, Janssen, Eli Lilly, Merck, Novartis, Pfizer, SUN and UCB.
Reference :
Mease PJ. Abstract 1821 Presented at ACR/ARHP Annual Meeting, Oct. 20-24, 2018; Chicago.