Filgotinib maintains remission, improves quality of life over 4 years in UC
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Key takeaways:
- Filgotinib 200 mg increased markers of disease remission and health-related quality of life in previous non-responders.
- Researchers identified no new safety signals.
Long-term filgotinib induced and maintained symptomatic remission and improved health-related quality of life in ulcerative colitis, with no new safety signals reported, according to interim analysis of the SELECTION extension study.
“Filgotinib is an oral, once-daily, JAK1 preferential inhibitor approved for the treatment of moderately to severely active UC and moderate to severe rheumatoid arthritis in the European Union, Japan and the U.K.,” Brian G. Feagan, MD, FRCPC, scientific director at Alimentiv, and colleagues wrote in Alimentary Pharmacology & Therapeutics. “Approval for the treatment of UC was based on the phase 2b/3 SELECTION trial, in which filgotinib provided rapid improvements in UC symptoms and was effective in inducing and maintaining clinical remission and improving HRQoL compared with placebo over 58weeks of treatment.”
In a long-term extension of the SELECTION trial, Feagan and colleagues investigated the safety and efficacy of continued filgotinib for up to 336weeks. They enrolled 250 patients who achieved clinical remission or response at week 10 and completed SELECTION to week 58 (completers) as well as 372 patients who did not achieve remission or response and discontinued the trial (induction non-responders).
Completers continued open-label filgotinib 100 mg (n = 102; mean age, 43.1 years; 46.1% women) or 200 mg (n = 148; mean age, 44.3 years; 56.1% women) while non-responders received the maximum possible dose permitted in their country (100-200 mg: n = 212; mean age, 43.2 years; 34.9% women; 200-200 mg: n = 160; mean age, 43.2 years; 34.4% women).
The primary endpoint was safety, assessed via adverse events, while secondary efficacy outcomes included change from baseline in partial Mayo Clinic Score (pMCS); health-related quality of life (HRQoL), measured by the Inflammatory Bowel Disease Questionnaire; and inflammatory biomarkers.
According to analysis at up to 202 weeks of treatment, occurrence of adverse events was low and similar between treatment groups, with no new safety signals identified.
In the filgotinib 200 mg group, the proportion of completers in pMCS remission rose from 72.4% at baseline to 80% at week 144, with HRQoL and biomarker remission also remaining high (86.4% and 86%, respectively). In addition, the researchers reported increases among non-responders at week 192 (62.1%, 76.7% and 59.3%, respectively).
Further, results demonstrated a higher rate of comprehensive disease control among completers vs. non-responders up to week 96.
“Filgotinib was efficacious in maintaining achievement of remission, reductions in inflammatory biomarkers and improvements in HRQoL for up to approximately 4years, resulting in an acceptable long-term benefit-risk profile,” Feagan and colleagues wrote. “SELECTION LTE is continuing, and full assessment of the safety and efficacy of filgotinib over the entire 336-week LTE study period will be performed upon study completion, followed by further real-world assessment of filgotinib.”
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