Filgotinib reduced corticosteroid use and maintained corticosteroid-free clinical remission over an 8-month period in almost one-quarter of patients with moderate to severe ulcerative colitis (UC), according to findings published in the Journal of Crohn’s and Colitis.
Researchers across the globe conducted several posthoc analyses, analyzing data obtained during a 58-week, placebo-controlled, phase 2b/3 trial (SELECTION; ClinicalTrials.gov Identifier: NCT02914522). They assessed the rate of corticosteroid-free clinical remission of moderate to severe UC at 1, 3, 6, and 8 months following tapering of corticosteroid use, starting at week 14 until patients no longer used them.
At baseline, the researchers enrolled 199 patients taking 200 mg of filgotinib and 98 receiving a placebo. Of the 199 patients taking filgotinib, 30.4%, 29.3%, 27.2%, and 21.7% remained corticosteroid-free at 1, 3, 6, and 8 months compared with the 6.4% in the placebo group (P <.05). For patients who still required corticosteroids, the median daily prednisone-equivalent dose decreased from 17.5 to 10.0 mg/day while on filgotinib.
Next, the researchers compared corticosteroid-free clinical remission rates in the SELECTION maintenance study to results from trials of other treatments used for UC, such as GEMINI 1 for intravenous vedolizumab, VISIBLE 1 for subcutaneous vedolizumab, and OCTAVE SUSTAIN for tofacitinib.
Filgotinib associated with higher chances of corticosteroid-free clinical remission when compared with intravenous vedolizumab (odds ratio [OR], 15.2; 95% CI, 1.6-139.9; P <.05). Similar probabilities of corticosteroid-free clinical remission occurred when comparing filgotinib with subcutaneous vedolizumab in biologic-naïve patients (OR, 3.8; 95% CI, 0.2-63.8; P =.36] and tofacitinib [OR, 2.0; 95% CI, 0.4-9.1; P =.39].
“The present findings suggest FIL [filgotinib] 200 mg could facilitate early corticosteroid tapering and reduce cumulative corticosteroid burden, even in treatment-resistant patients,” the study authors noted.
Study limitations include lack of standardization of time required to reach corticosteroid-free status during tapering, potentially different tapering times and protocols used among drug comparison trials, and potential artificially inflated results from the placebo group, which had received 11 weeks of induction therapy with filgotinib prior to the switch to placebo for the maintenance study.
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
This article originally appeared on Gastroenterology Advisor
Loftus EV, Vermeire S, Feagan BG, et al. Corticosteroid-sparing effects of filgotinib in moderate to severely active ulcerative colitis: data from the phase 2b/3 selection study. J Crohns Colitis. Published online August 25, 2022:jjac122. doi:10.1093/ecco-jcc/jjac122