1. Real-world effectiveness and safety of ustekinumab in bio-naive patients with moderate-to-severe Crohn's disease: A Canadian multi-center study.
- Author
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Bessissow T, Narula N, Ma C, In TSH, Eberg M, Karra K, and Jairath V
- Subjects
- Humans, Retrospective Studies, Remission Induction, Canada, Treatment Outcome, Ustekinumab adverse effects, Crohn Disease drug therapy
- Abstract
Background: Clinical practice guidelines recommend ustekinumab as a first-line biological treatment option for moderately-to-severely active Crohn's disease (CD). However, there is limited real-world effectiveness and safety data in bio-naïve patients., Aims: To assess ustekinumab effectiveness and safety in bio-naïve CD patients., Methods: Medical charts were reviewed retrospectively at seven Canadian centers. The primary outcome was the proportion of patients achieving clinical remission at Month 6 following ustekinumab initiation. Secondary outcomes included clinical, biochemical, and endoscopic response, and remission at Months 4, 6 and 12. Ustekinumab safety was assessed over the one-year follow-up period., Results: 158 charts were reviewed. Clinical remission was achieved by 50.0% (36/72), 67.7% (105/155), and 73.7% (84/114) of patients at Months 4, 6, and 12, respectively. At these study timepoints, biochemical remission was observed in 65.2% (43/66), 71.6% (63/88), and 73.9% (68/92) of patients. At Months 6 and 12, endoscopic remission was observed in 40.5% (15/37) and 56.3% (27/48) of patients, respectively. Most participants (93.5%; 145/155) persisted on ustekinumab through Month 12. No serious adverse drug reactions were reported., Conclusion: In this real-world study, ustekinumab presents as an effective first-line biologic for induction and maintenance of remission among bio-naïve Canadian patients with moderately-to-severely active CD., Competing Interests: Conflict of interest This study was funded by Janssen Inc. The sponsor was involved in the design, interpretation, and reporting of study results. TB acted as a speaker or advisor for AbbVie, Alimentiv (formerly Robarts Inc.), Amgen, Bristol-Myers-Squibb, Ferring, Gilead, Janssen, Merck, Pentax, Pfizer, Roche, Sandoz, Takeda, Viatris. NN has received honoraria from Janssen, AbbVie, Takeda, Pfizer, Merck, Sandoz, Novartis, and Ferring. CM has received consulting fees from AbbVie, Alimentiv, Amgen, AVIR Pharma Inc, BioJAMP, Bristol Myers Squibb, Celltrion, Ferring, Fresenius Kabi, Janssen, McKesson, Mylan, Takeda, Pendopharm, Pfizer, Roche; speaker's fees from AbbVie, Amgen, AVIR Pharma Inc, Alimentiv, Ferring, Janssen, Takeda, and Pfizer; research support from Ferring, Pfizer. VJ served on advisory boards, consulted or was an investigator for AbbVie, Alimentiv Inc. (formerly Robarts Clinical Trials Inc.), Amgen, Applied Strategic, Arena Pharmaceuticals, Asahi Kasei Pharma, Asieris, Astra Zeneca, BioJamp. Celgene/BMS, Celltrion, Eli Lilly, Ferring, F. Hoffman-La Roche Ltd., Flagship Pioneering, Fresenius Kabi, Galapagos, Genentech, Gilead, GlaxoSmithKline, Janssen, Organon (Merck), Landos BioPharma, Mylan, Pandion, Pendopharm, Pfizer, Protagonist Therapeutics, Reistone Biopharma, Roche, Sandoz, Second Genome, Takeda, Teva, Topivert, Ventyx Biosciences, and Vividion Therapeutics. VJ acted as a speaker for AbbVie, Ferring, Galapagos, Janssen, Pfizer, and Takeda and is an employee of Western University. KK was full time employees of Janssen Inc. at the time of the study. TI is a full-time employee of Janssen Inc. ME is a full-time employee of IQVIA Solutions Canada Inc. (IQVIA). Janssen Inc. contracted with IQVIA to manage the study., (Copyright © 2023. Published by Elsevier Ltd.)
- Published
- 2024
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