Acceptability and tolerability of risankizumab maintenance therapy administered via on-body injector in patients with Crohn's disease: Results of the ACCEPT-OBI study.

BACKGROUND: Risankizumab is administered via a new modality, so-called on-body injector (OBI). OBJECTIVES: To assess the acceptability and the tolerability of OBI-risankizumab therapy, and compare its acceptability with other available modalities in Crohn's disease (CD). DESIGN: Longitudinal multicenter prospective study. METHODS: All CD patients from an early access cohort treated with OBI-risankizumab were assessed from the first OBI use (week 0 = W0), W8, W16, and W24. The primary endpoint was acceptability (acceptability numerical scale = ANS). Patients were asked to grade the acceptability of OBI-risankizumab and other modalities of therapeutic maintenance regimen. RESULTS: Among 58 CD patients (79.4% with at least four prior advanced therapies), OBI-risankizumab acceptability was 9.5±1.2 at W0 and remained stable until W24 (p=0.97). OBI-risankizumab acceptability showed a higher acceptability than intravenous infusions (p<0.0001), pen injectors (p<0.001), and syringes (p<0.001), and ranked as the preferred route in 64% of patients. OBI-risankizumab Q8 was the most accepted maintenance regimen (ANS = 9.2 ± 2.0), compared to long interval subcutaneous injections (Q12, Q8 or Q4), more frequent injections (weekly or eow), or intravenous infusions every 4-8 weeks (p < 0.05 for all comparisons). While 57.4% of patients did not experience any adverse event within 24 weeks, the two most frequent adverse events were mild application-site pain (19.0%) and localized erythema (20.7%) with no need for risankizumab discontinuation. CONCLUSION: OBI-risankizumab therapy is highly accepted and could be the most preferred maintenance regimen in patients with CD.