Gilead Sciences (GILD) and Galapagos NV (GLPG) have announced positive topline results from a Phase 2b/3 trial evaluating the efficacy and safety of the selective JAK1 inhibitor filgotinib in 1,348 patients with moderately to severely active ulcerative colitis (UC).
UC is a chronic, idiopathic inflammatory disease affecting the colon and often involves periods of remission interspersed with periods of active disease.
Filgotinib 200 mg achieved all primary endpoints in the placebo-controlled trial, inducing clinical remission at Week 10 and maintaining clinical remission at Week 58 in a significantly higher proportion of patients compared with placebo.
However Filgotinib 100 mg did not achieve statistically significant clinical remission at Week 10.
Rates of adverse events were low and comparable across treatment groups.
“Patients with moderate to severe ulcerative colitis can struggle to effectively manage their disease. These topline data suggest that filgotinib could play a role in helping more patients achieve a meaningful and sustained improvement in treatment response with an oral therapy.” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.
In this trial, clinical remission was defined as an endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, and ≥ 1 point decrease in stool frequency from baseline to achieve a subscore of 0 or 1.
Among biologic-naïve patients, a statistically significant higher proportion of patients achieved clinical remission at Week 10 when treated with filgotinib 200 mg (26.1%) compared with placebo (15.3%). Among biologic-experienced patients, a statistically significant higher proportion of patients achieved clinical remission at Week 10 when treated with filgotinib 200 mg (11.5%) compared with placebo (4.2%).
Patients who achieved clinical response or remission after 10 weeks of treatment with filgotinib 100 mg or 200 mg were subsequently re-treated. At Week 58, 37.2% of biologic-naïve and biologic-experienced patients receiving filgotinib 200 mg achieved clinical remission, compared with 11.2% treated with placebo.
Of patients receiving filgotinib 100 mg, 23.8% achieved clinical remission at Week 58, compared with 13.5% treated with placebo.
As for safety, the serious adverse events rate in biologic-naïve patients came out as 4.7% (100mg), 1.2% (200mg) and 2.9% (control arm). For biologic-experienced patients the rates for the 100mg, 200mg, and control arm were 5.3%, 7.3% and 6.3%, respectively.
Two deaths were observed in the filgotinib 200 mg treatment group in the maintenance trial but neither was assessed as related to the study drug by the investigator.
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