New analyses of phase II EQUATOR clinical program support durable efficacy of filgotinib in psoriatic arthritis.- Gilead Sciences, Inc. + Galapagos NV

Gilead Sciences, Inc. and Galapagos NV announced new analyses from two clinical trials evaluating filgotinib, an investigational, oral, selective JAK1 inhibitor, in adults with psoriatic arthritis (PsA).

The data from the double-blind, placebo-controlled, Phase II EQUATOR study and the EQUATOR-2 open-label extension study demonstrate filgotinib’s durable efficacy and consistent safety profile in people with active PsA, and showed rapid and sustained reductions in inflammatory biomarkers in patients with moderate to severe PsA. The new analyses were presented at the European League Against Rheumatism, EULAR, European E-Congress of Rheumatology 2020.

“Efficacy and Safety of Filgotinib in Patients with Active PsA: Subgroup Analyses from a Randomized, Placebo-Controlled, Phase II Trial (EQUATOR)” (Poster #0343)- In a new subgroup analysis of patients with active PsA in the 16-week EQUATOR Phase II trial, the effects of filgotinib on key efficacy endpoints were generally consistent across a range of patient subgroups, including sex, body mass index, disease duration, baseline disease severity, concurrent use of disease-modifying antirheumatic drugs and prior exposure to tumor necrosis factor inhibitors. Filgotinib consistently demonstrated a statistically significant higher proportion of patients achieving ACR20 response compared with placebo across all subgroups. Similarly, filgotinib achieved a higher proportion of ACR50 response and Psoriatic Arthritis Disease Activity Score (PASDAS) low disease activity, compared with placebo, reaching statistical significance in most subgroups. Treatment differences for Disease Activity Index for Psoriatic Arthritis (DAPSA) consistently favored filgotinib, reaching statistical significance in most subgroups, as well. There were no clinically relevant differences when comparing response to filgotinib across subgroups.nbFilgotinib demonstrated a consistent safety profile, and no new safety signals were identified in this study.

“Long-Term Efficacy of Filgotinib in PsA: Week 52 Response Patterns from an Open-Label Extension (OLE) Study (EQUATOR-2) “(Poster #0339)- Nearly all (98.4 percent, 122/124) of the patients who completed the 16-week EQUATOR trial enrolled in the EQUATOR-2 OLE study. The median exposure to filgotinib in both EQUATOR and the OLE study was 66 weeks. An interim analysis at Week 52 demonstrated sustained efficacy with filgotinib across several measures of disease activity and treatment response in patients with active PsA.The majority of patients who achieved minimal disease activity (MDA) and ACR50 response in the original EQUATOR trial maintained MDA and ACR50 at Week 52, and a proportion of non-responders in EQUATOR achieved these responses in the OLE study. In total, at Week 52 of the OLE study, 33.6 percent of patients achieved MDA response and 55.0 percent achieved ACR50 response in this observed case analysis. No new safety signals were observed.

“Effect of Filgotinib on Inflammatory Biomarkers in Patients with Moderate to Severe PsA “(Oral #0224)- Finally, in a new biomarker analysis of samples from the EQUATOR trial, treatment with filgotinib demonstrated significantly greater reductions from baseline in levels of circulating biomarkers associated with PsA disease activity, compared with placebo. Filgotinib treatment reduced cytokines involved in both systemic inflammation, such as IL-6 and SAA, as well as psoriasis-associated pathology, such as IL-17AF and IL-12 p40, reflecting the improvements in clinical scores observed in EQUATOR. These findings are consistent with reduced disease activity in patients with PsA and suggest that filgotinib treatment leads to a sustained reduction of inflammation in PsA. Filgotinib is an investigational agent and is not approved by the FDA or any other regulatory authority.