Risankizumab Self-Administration a Positive Experience in Patients With Crohn Disease

Patients with Crohn disease find self-administering risankizumab to be a positive experience and can achieve sustained clinical remission with the On Body Injector.

Patients with moderate to severe Crohn disease who self-administer risankizumab achieve stable clinical remission at 16 weeks, according to study results presented at the Advances in Inflammatory Bowel Diseases (AIBD) 2022 conference, held from December 5 to 7, 2022, in Orlando, Florida.

Researchers reported on the efficacy, safety, usability, and experience of self-administering risankizumab with the On Body Injector (OBI) among patients with CD. All study participants received maintenance therapy in the phase 3 FORTIFY study (ClinicalTrials.gov Identifier: NCT03105102).

The substudy in the open-label extension included 46 US patients who were trained how to inject risankizumab with the OBI. The patients self-administered risankizumab 360 mg (2.4 mL, 150 mg/mL) or 180 mg (1.2 mL, 150 mg/mL) on the abdomen or thigh at weeks 0, 8 (at home), and 16. The injections were observed by staff at weeks 0 and 16.

Endpoints included the proportion of participants who were in clinical remission (CD Activity Index <150), OBI usability according to observer rating of successful self-administration, hazard-free self-injection (all endpoints at weeks 0 and 16), and rating of patient experience with use of the Self-Injection Assessment Questionnaire (SIAQ) at weeks 0, 8, and 16.

Performance data indicated a pattern of successful sequential administrations likely to be represented in real-world use.

All patients (46/46) had successful self-administration at week 0, and 44/44 patients had successful self-administration at week 16. At week 0, 1 participant had an incomplete cartridge insertion that led to dosing failure of the first OBI, and another patient had an improper skin attachment of the OBI that resulted in dampness at the injection site.

The participants had a favorable experience of self-injection of risankizumab, as the OBI was rated by 93.2% as easy or very easy to use after the first injection, by 97.4% at week 8, and by 97.7% at week 16. The patients had stable clinical remission with risankizumab 180 mg and 360 mg.

Injection site reactions unrelated to the OBI occurred in 2 patients. Device-related adverse events related to topical adhesive reactions were observed in 2 patients but were mild and resolved. No new safety risks occurred.

“SIAQ feedback indicated a positive patient experience with the OBI throughout the study,” the study authors noted. “Performance data indicated a pattern of successful sequential administrations likely to be represented in real-world use. Results did not reveal any unanticipated clinical concerns or harms associated with the use of the OBI.”

References:

Loftus Jr E, Griffith J, Neimark E, et al. On-body injector administration of risankizumab for treatment of moderate-to-severe Crohn’s disease: data from the FORTIFY open-label longitudinal real-life handling substudy. Abstract presented at: AIBD 2022; December 5-7, 2022; Orlando, FL. Abstract 38.