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 1Brian G Feagan 2Julián Panés 3Filip Baert 4Edouard Louis 5Olivier Dewit 6Arthur Kaser 7W Rachel Duan 8Yinuo Pang 8Wan-Ju Lee 8Dawn Gustafson 8Xiaomei Liao 8Kori Wallace 8Jasmina Kalabic 9Geert R D'Haens 10


Author information

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.

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