Long-Term Safety and Efficacy of Risankizumab Treatment in Patients with Crohn's Disease: Results from the Phase 2 Open-Label Extension Study
| Autor: | Marc Ferrante, Arthur Kaser, Geert R. D'Haens, Wan-Ju Lee, Julián Panés, Xiaomei Liao, Olivier Dewit, Brian G. Feagan, Filip Baert, Jasmina Kalabic, W. Rachel Duan, Kori Wallace, Yinuo Pang, Dawn Gustafson, Edouard Louis |
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| Přispěvatelé: | Gastroenterology and Hepatology, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, UCL - SSS/IREC/GAEN - Pôle d'Hépato-gastro-entérologie, UCL - (SLuc) Service de gastro-entérologie, Feagan, Brian, Panés, Julian, Baert, Filip, Louis, Edouard, Dewit, Olivier, Kaser, Arthur, Duan W., Rachel, Pang, Yinuo, Lee, Wan-Ju, Gustafson, Dawn, Liao, Xiaomei, Wallace, Kori, Kalabic, Jasmina |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Adult
Male Crohn’s disease medicine.medical_specialty Adolescent Injections Subcutaneous Phases of clinical research Disease Opportunistic Infections 030226 pharmacology & pharmacy Young Adult 03 medical and health sciences Eccojc/1040 0302 clinical medicine Crohn Disease Gastrointestinal Agents Internal medicine medicine Humans open-label extension Ileitis Adverse effect AcademicSubjects/MED00260 Aged Crohn's disease Risankizumab Surrogate endpoint business.industry Gastroenterology Antibodies Monoclonal Original Articles General Medicine Middle Aged medicine.disease Crohn's Disease Activity Index Treatment Outcome Female 030211 gastroenterology & hepatology business long-term safety |
| Zdroj: | Journal of Crohn's & colitis, 15(12), 2001-2010. Elsevier Journal of Crohn's & colitis, Vol. 15, no.12, p. 2001-2010 (2021) Journal of Crohn's & Colitis |
| ISSN: | 1873-9946 |
| Popis: | 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 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 |
| Databáze: | OpenAIRE |
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