Phase II TORTUGA study of filgotinib to treat ankylosing spondyliti 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.

In the Phase II TORTUGA study, adults with moderately to severely active ankylosing spondylitis who were treated with filgotinib 200mg once-daily achieved significantly greater improvements in AS Disease Activity Score (ASDAS), the primary endpoint, at Week 12. The mean change from baseline in ASDAS was -1.5 for patients treated with filgotinib versus -0.6 for those treated with placebo (p<0.0001). asas20 and asas40 responses at week 12 were also significantly higher for filgotinib compared with placebo asas20: 76 percent for filgotinib vs 40 percent for placebo p><0.0001; asas40: 38 percent vs 19 percent p><0.05).>

Adverse events were generally mild or moderate in severity and were reported in an equal proportion of patients in the filgotinib and placebo groups (31 percent). Laboratory changes were consistent with those previously reported for filgotinib, and no new safety signals were observed in the study. There was one treatment-emergent serious adverse event of pneumonia reported for a patient receiving filgotinib who recovered after hospital-based antibiotic treatment. One patient with an inherited risk for thrombosis who was randomized to filgotinib experienced a non-serious deep venous thrombosis after completing the course of study drug. No deaths, malignancies, hepatic events, 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 ankylosing spondylitis (TORTUGA): results from a randomised, placebo-controlled, phase 2 trial"- Prof D�sir�e van der Heijde, MD Xenofon Baraliakos, MD Lianne S Gensler, MD et al. Published:October 22, 2018DOI:https://doi.org/10.1016/S0140-6736(18)32463-2.