P0649 Acceptability and Tolerance of Risankizumab Treatment Administered via On-Body Injector in Patients with Crohn’s Disease: Results of the Nationwide ACCEPT-OBI Study
Abstract Background Risankizumab (RZB) has been available in our country for Crohn’s disease (CD) patients through an early access program and is now administered using an innovative medical device known as an on-body injector (OBI). We assessed the acceptability and the tolerance of RZB administration via OBI and compare its acceptability with other modalities of CD treatments, and searched for factors associated with the OBI acceptability. Methods This was a prospective, multicenter longitudinal study. All CD patients from the early access cohort treated with RZB via OBI starting in February 2024 were assessed at the time of the switch to OBI (week 0 = W0) and at W8, W16, and W24. The primary endpoint was acceptability, evaluated using a acceptability numerical scale (ANS) ranging from 0 (completely unacceptable) to 10 (perfectly acceptable). Results A total of 58 multi-refractory patients were included (mean age : 42.8 ± 13.8 years; 57.9% were women, 17.3% were smokers, 64.7% had a history of intestinal resection, and 78.2% were in PRO2-clinical remission). Therapeutic education sessions were conducted concurrently for 36.2% (21/58) of patients. OBI was applied to abdomen, thigh, or another site in 43.9%, 52.6%, and 3.5% of patients, respectively. RZB administration via OBI was well tolerated in 57.4%, with possible mild application-site pain (20.4%, mild in 90% of cases), localized erythema (22.2%), pruritus (16.7%), edema (16.7%). No factors affected the acceptability of risankizumab administration via OBI in more than 15% of patients. RZB acceptability via OBI was very high (9.5 ± 1.2) at W0, significantly better than RZB subcutaneous injections (6.98 ± 2.57; p < 0.0001). OBI acceptability remained stable over time: 9.6 ± 1.2 at W8, 9.6 ± 1.4 at W16, and 9.6 ± 0.8 at W24 (p = 0.97). OBI acceptability as a medical device was better than other injectable administration modalities for IBD treatments: IV infusions (p < 0.0001), pen injectors (p < 0.001), and syringes (p < 0.001). Overall, patients preferred OBI (64.0%), followed by oral administration (28.0%), subcutaneous injections (6.0%), and IV infusions (2.0%). When adjusted for administration frequency, RZB every 8 weeks via OBI was the most preferred method (ANS = 9.2 ± 2.0), compared to long interval subcutaneous injections (every 12, 8, or 4 weeks), more frequent injections (weekly or eow), and IV infusions every 4–8 weeks (p < 0.001 for all comparisons). Conclusion In this cohort of refractory patients, the administration of risankizumab via OBI was highly acceptable to CD patients with excellent tolerance, suggesting that this new medical device could promote the use of risankizumab in clinical practice.
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