- Fecal Incontinence
|Long-Term Safety and Efficacy of Risankizumab Treatment in Patients with Crohn's Disease: Results from the Phase 2 Open-Label Extension Study
J Crohns Colitis. 2021 Dec 18;15(12):2001-2010. doi: 10.1093/ecco-jcc/jjab093.
Marc Ferrante 1, Brian G Feagan 2, Julián Panés 3, Filip Baert 4, Edouard Louis 5, Olivier Dewit 6, Arthur Kaser 7, W Rachel Duan 8, Yinuo Pang 8, Wan-Ju Lee 8, Dawn Gustafson 8, Xiaomei Liao 8, Kori Wallace 8, Jasmina Kalabic 9, Geert R D'Haens 10
1University Hospitals Leuven, KU Leuven, Leuven, Belgium.
2University of Western Ontario, London, ON, Canada.
3Hospital Clinic Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
4AZ Delta Roeselare-Menen, Roeselare, Belgium.
5University of Liège and CHU, Liège, Belgium.
6Cliniques Universitaires Saint-Luc, Brussels, Belgium.
7University of Cambridge and Cambridge University Hospitals - Addenbrooke's Hospital, Cambridge, UK.
8AbbVie Inc., North Chicago, IL, USA.
9AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.
10Amsterdam University Medical Center, Amsterdam, Netherlands.
Background and aims: Risankizumab, an interleukin-23 antibody, demonstrated efficacy and acceptable safety in a phase 2 study of patients with moderate-to-severe refractory Crohn's disease. This open-label extension investigated the long-term safety, pharmacokinetics, immunogenicity and efficacy of risankizumab in responders to risankizumab in the parent phase 2 study.
Methods: Enrolled patients had achieved clinical response [decrease in Crohn's Disease Activity Index from baseline ≥100] without clinical remission [Crohn's Disease Activity Index <150] at Week 26, or clinical response and/or remission at Week 52 in the parent phase 2 study and received open-label subcutaneous risankizumab 180 mg every 8 weeks.
Results: Sixty-five patients were enrolled, including four who had lost response in the parent study and were first reinduced with risankizumab 600 mg every 4 weeks [three infusions]. Patients received risankizumab for a median of 33 months [total: 167.0 patient-years]. The rate of serious adverse events was 24.6 events/100 patient-years; the majority were gastrointestinal in nature. Rates of serious infections, opportunistic infections and fungal infections were 4.2, 1.8, and 6.6 events/100 patient-years, respectively. No deaths, malignancies, adjudicated major adverse cardiovascular events, latent/active tuberculosis or herpes zoster were reported. Treatment-emergent anti-drug antibodies developed in eight patients [12.3%]; none were neutralizing. Efficacy outcomes were maintained during the study, including the proportions of patients [observed analysis] with clinical remission [>71%] and endoscopic remission [>42%].
Conclusions: Long-term maintenance treatment with subcutaneous risankizumab 180 mg every 8 weeks was well tolerated by patients with Crohn's disease, with no new safety signals. Clinical trial registration number: NCT02513459.