FITZROY: Filgotinib induces clinical remission in moderate-to-severe Crohn’s disease
Filgotinib safely and effectively induced clinical remission and response in patients with moderate-to-severe Crohn’s disease, according to interim results from the FITZROY trial presented at the European Crohn’s and Colitis Organization’s Congress.
Filgotinib (Galapagos), an oral, selective Janus kinase 1 (JAK1) inhibitor, has previously shown efficacy in patients with rheumatoid arthritis in the DARWIN trials.
In the FITZROY study, Séverine Vermeire, MD, PhD, from Leuven University Hospital in Belgium, and colleagues randomly assigned 175 patients with moderate-to-severe Crohn’s disease to receive 200 mg filgotinib or placebo for 10 weeks. The results presented at ECCO were from this period of the study, with a primary endpoint of clinical remission. Afterward, patients continued to receive 200 mg or 100 mg filgotinib or placebo for another 10 weeks.
Baseline characteristics between groups were comparable. Patients were either anti-TNF–naive or -nonresponders, and any patient receiving immunosuppressant therapy stopped.
At week 10, 48% of patients achieved clinical remission with filgotinib vs. 28% with placebo (P = .0067), 60% achieved clinical response with filgotinib vs. 41% with placebo (P = .0386), 30% achieved normalization of C-reactive protein with filgotinib vs. 14% with placebo, and significantly more patients in the filgotinib group experienced improved quality of life compared with the placebo group (P = .0045).
Filgotinib was safe and well tolerated in general, with comparable incidence of early discontinuation, adverse events (including infections) and serious adverse events (most related to worsening of Crohn’s disease) between groups. Hemoglobin concentration also increased in both groups, mean neutrophil counts or liver function test results did not significantly change from baseline, and filgotinib demonstrated a favorable lipid profile.
“Filgotinib is the first [JAK] inhibitor showing efficacy in moderate-to-severe Crohn’s disease patients,” the researchers wrote. “The efficacy and safety data of [filgotinib] suggest a favorable risk/benefit profile, showing its potential as an oral treatment with a novel mechanism of action for the treatment of IBD.” – by Adam Leitenberger
Vermeire S, et al. Abstract OP020. Presented at: ECCO Congress; March 16-19, 2016. Amsterdam.
Disclosure: Vermeire reports grant support from AbbVie, MSD and Takeda, lecture fees from AbbVie, MSD, Takeda, Ferring, Falk Pharma, Hospira and Tillotts, and consultancy relationships with AbbVie, MSD, Takeda, Ferring, Genentech/Roche, Shire, Pfizer, Galapagos, Mundipharma, Hospira, Celgene, Second Genome and Johnson & Johnson. Please see the ECCO disclosures database for all other researchers’ relevant financial disclosures.