Long-term clinical effectiveness of ustekinumab in patients with Crohn’s disease who failed biological therapies: a national cohort study.
J Crohns Colitis. 2019 Apr 16;:
Authors: Liefferinckx C, Verstockt B, Gils A, Noman M, Van Kemseke C, Macken E, De Vos M, Van Moerkercke W, Rahier JF, Bossuyt P, Dutré J, Humblet E, Staessen D, Peeters H, Van Hootegem P, Louis E, Franchimont D, Baert F, Vermeire S, Belgian Inflammatory Bowel Disease Research and Development Group (BIRD group)
BACKGROUND: Ustekinumab (UST) was recently approved in Europe for the treatment of moderate to severe Crohn’s disease (CD). Long-term real-world data are currently scarce in CD patients previously exposed to several biologics.
METHODS: This is an observational, national, retrospective multicenter study. Patients received intravenous UST ~ 6mg/kg at baseline, with 90mg subcutaneously thereafter every 8 weeks. Response and remission rates were assessed at week 8, 16 and 52.
RESULTS: Data from 152 patients were analysed. All patients were exposed at least one anti-TNFα agent, with 69.7 % even two anti-TNFα and vedolizumab. After one year, 42.1 % and 25.7% experienced clinical response and clinical remission, respectively; 38.8% and 24.3% achieved steroid-free clinical response and remission, respectively at one year. Thirty-eight point eight per cent of patients discontinued therapy during the 12 months of follow-up. Colonic location was predictive of clinical response at one year, while low BMI at baseline was a negative predictor of clinical remission. Resolution of arthralgia was associated with clinical response over time. De novo arthralgia were reported by 17.9% of patients at week 8 and 13.5% at week 52. No impact of ustekinumab on arthralgia was observed in patients with concomitant ankylosing spondyloarthritis (n=17). Others adverse events were reported in 7.2% of patients.
CONCLUSIONS: This real-world cohort study confirms the effectiveness of ustekinumab in CD patients previously exposed to several biologics. Ustekinumab was well tolerated with adverse events.
PMID: 30989232 [PubMed – as supplied by publisher]