CHICAGO—Gilead Sciences, Inc. and Galapagos NV have reported today that detailed results from two clinical trials evaluating filgotinib have both been published in The Lancet. Filgotinib is an an investigational, selective JAK1 inhibitor for the treatment of psoriatic arthritis and ankylosing spondylitis. The publication of the Phase 2 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, where it is ACR/ARHP Abstract #1821.
John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences said, “The results of the EQUATOR and TORTUGA studies demonstrate that filgotinib improved the signs and symptoms of patients with psoriatic arthritis whose disease had not responded to prior therapies and independently, for those with ankylosing spondylitis. These findings represent an important step forward in our efforts to improve outcomes for people living with these inflammatory diseases.”
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 EQUATOR 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 EQUATOR 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.
“Effective treatment for psoriatic arthritis is critical for relieving pain and inflammation and helping to prevent joint damage. Unfortunately, not all patients respond to currently available therapies,” mentioned Philip J. Mease, MD, Director of Rheumatology Research, Swedish-Providence-St. Joseph Health Systems and Clinical Professor, University of Washington. “These results indicate that filgotinib has the potential to address the needs of individuals who require additional treatment options.”
In the Phase 2 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 in the TORTUGA study, 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.
“We are pleased that filgotinib demonstrates a consistent safety and efficacy profile across multiple inflammatory conditions, including psoriatic arthritis and ankylosing spondylitis. We look forward to sharing additional updates as we continue to develop this compound for patients in need of additional therapy options,” noted Dr. Walid Abi-Saab, Chief Medical Officer at Galapagos.