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.