Phase II EQUATOR trial of filgotinib to treat psoriatic arthritis is published in The Lancet.- Gilead + Galapagos.

Gilead Sciences, Inc.and Galapagos NV announced that detailed results from two clinical trials evaluating filgotinib, an investigational, selective JAK1 inhibitor, for the treatment of psoriatic arthritis and ankylosing spondylitis were both published in The Lancet. The publication of the Phase II EQUATOR data also coincides with a plenary session presentation at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting.

Phase II EQUATOR Study in Psoriatic Arthritis [ACR/ARHP Abstract #1821]: Data from EQUATOR a placebo-controlled trial of 131 adults with moderately to severely active psoriatic arthritis who had an inadequate response or were intolerant to at least one conventional disease-modifying anti-rheumatic drug (cDMARD), demonstrated the efficacy of filgotinib in this patient population. The study achieved its primary endpoint at Week 16, with 80 percent of patients on filgotinib 200mg once-daily achieving ACR20, compared with 33 percent on placebo (p<0.001). acr50 and acr70 responses at week 16 were also significantly higher for filgotinib compared with placebo (acr50: 48 percent for filgotinib vs 15 percent for placebo, p><0.001; acr70: 23 percent vs 6 percent, p><0.01). these data were previously announced in may 2018 . the study also found greater improvement in disease signs and symptoms for patients receiving filgotinib 200mg once-daily compared with placebo at week 16, as measured by minimal disease activity (mda) (23 percent vs 9 percent, p><0.05) and the psoriasis area and severity index 75 percent improvement from baseline (pasi75) (45 percent vs 15 percent, p><0.01). the data showed greater improvement from baseline in the health assessment questionnaire disability index (haq-di) for those receiving filgotinib compared with placebo (-0.57 vs -0.28, p><0.001).>

Safety-related outcomes were similar between the filgotinib and placebo arms of the study, including rates of treatment-emergent adverse events (57 percent and 59 percent, respectively) and infections and infestations (22 percent and 21 percent). Two serious treatment-emergent adverse events were reported: one hip fracture in the placebo group and one case of fatal pneumonia in the filgotinib treatment group, which was the only serious infection and the only death in the study. No deep venous thrombosis, pulmonary embolism, malignancies, gastrointestinal perforations, opportunistic infections/active tuberculosis or cases of Herpes zoster were reported.

See- "Efficacy and safety of filgotinib, a selective Janus kinase 1 inhibitor, in patients with active psoriatic arthritis (EQUATOR): results from a randomised, placebo-controlled, phase 2 trial".- Philip Mease, MD Laura C Coates, MBChB Prof Philip S Helliwell, MD Prof Mykola Stanislavchuk, MD et al. Published:October 22, 2018DOI:https://doi.org/10.1016/S0140-6736(18)32483-8.