Introduction
We aimed to evaluate the real-world effectiveness and safety of ustekinumab for the treatment of both bio-naïve and bio-exposed ulcerative colitis (UC) patients in a real-world setting.
Aims & Methods
Retrospective, Canadian multicenter cohort study. Standardized data collection was performed on consecutive adult UC outpatients treated with ustekinumab in 4 large IBD centers. The primary outcomes were clinical remission and endoscopic remission. Key secondary outcomes included composite clinical and endoscopic response, safety, and persistence. A multivariable Cox proportional hazards model was used to explore associations between baseline factors and endpoints. For multivariable model selection, backwards elimination was used with a threshold P < 0.05.
Results
A total of 198 patients were included, of whom 47.5% were female and 85.9% under 65 years. The majority had severe endoscopic activity at baseline (47.5%, n=87) and were bio-exposed (88.8%, n=176; 33%, n=66 prior failure of 3 or more biologics. Patients were followed for a median of 12.8 (IQR 8.2 to 22.1) months after induction. Clinical remission rates were 43.7% (69/198), 43.8% (56/128), and 62.4% (58/93) at 3, 6 and 12 months respectively. Endoscopic remission rates were 11.3% (7/62), 24.7% (23/93), and 23.4% (11/43) at 3, 6 and 12 months respectively. Bio-naive patients were more likely to achieve clinical and endoscopic remission compared to bio-exposed (HR=1.71, 95% CI: 1.02–2.88, and HR=7.33, 95% CI: 2.15–25.01, respectively). Adverse events were reported in 14.1% (18/198), with colectomies exclusively observed in bio-exposed individuals (8.6%; 17/198).
Conclusion
In a highly refractory and largely bio exposed population more than half of patients with UC treated with ustekinumab achieved clinical remission and one-third achieved endoscopic remission. Prior biologic exposure was independently associated with clinical and endoscopic remission. Safety profile was consistent with interleukin (IL)-12-23 blockade.
Disclosure
VS, AN, KES, AZ, LG have no conflict of interest
NN has been a speaker or advisor for Janssen, Abbvie, Takeda, Pfizer, Merck, Sandoz, Fresenius Kabi, Innomar, Iterative Scopes, Bristol Myers Squibb, Viatris and Ferring
TB has received consulting or speaker fees for Abbvie, Alimentiv, Amgen, Bristol Myers Squibb, Ferring, Janssen, Merck, Pfizer, Roche, Sandoz, Takeda, Gilead, Viatris, Fresenius, Kabi
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 consulting/advisory board fees from AbbVie, Alimentiv Inc, Arena pharmaceuticals, Asahi Kasei Pharma, Asieris, Astra Zeneca, Avoro Capital, Bristol Myers Squibb, Celltrion, Eli Lilly, Endpoint Health, Enthera, Ferring, Flagship Pioneering, Fresenius Kabi, Galapagos, Gilde Healthcare, GlaxoSmithKline, Genentech, Gilead, Innomar, JAMP, Janssen, Merck, Metacrine, Mylan, Pandion, Pendopharm, Pfizer, Protagonist, Prometheus Biosciences, Reistone Biopharma, Roche, Roivant, Sandoz, SCOPE, Second Genome, Sorriso, Takeda, TD Securities, Teva, Topivert, Ventyx, Vividion; speaker’s fees from, Abbvie, Ferring, Bristol Myers Squibb, Galapagos, Janssen Pfizer Shire, Takeda, Fresenius Kabi.