Long-term clinical effectiveness of ustekinumab in patients with Crohn's disease who failed biological therapies: a national cohort study

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.

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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.

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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.

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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.