P2117 - A Nationwide Comparison of Risankizumab-rzaa, Vedolizumab, and Adalimumab on Infection and Neuromusculoskeletal Adverse Events in Crohn’s Disease Patients: A Pharmacovigilance Investigation

Yash P. Ashara, MBBS¹, Clive J. Miranda, DO, MS², Murad H. Ali, MD², Gregory D. Gudleski, PhD², Bhavtosh Dedania, MD^3
1Mayo Clinic, Rochester, MN; ²University at Buffalo, Buffalo, NY; ³HCA Florida Brandon Hospital, Brandon, FL

Introduction: Crohn’s disease (CD) is chronic inflammation of the gut mucosa due to dysregulated immune responses. Biologics, a novel therapy revolutionized CD management. However, these medications have not been without adverse reactions, and comprehensive patient education is thereby imperative when starting it. In this study, we investigate the adverse events associated with the biologic agents risankizumab-rzaa, adalimumab, and vedolizumab in a nationwide cohort of CD patients.

Methods: The US Food and Drug Administration’s Adverse Event Reports System (FAERS) was queried for risankizumab-rzaa, vedolizumab and adalimumab in CD on February 5, 2023. Patient demographics were recorded along with rates of infection and neuromusculoskeletal adverse reactions on these drugs. Analysis was performed using reported odds ratios (ROR) with 95% confidence interval (CI) and statistical significance p < 0.05

Results: A dataset of 93,056 reported adverse event cases of CD patients treated with risankizumab-rzaa, vedolizumab and adalimumab until December 31, 2022, was extracted from the FAERS database. 34,647 (37.2%) patients were male. Patients on vedolizumab were 1.56 times more likely to be hospitalized than those on adalimumab [95% CI 1.50-1.58, p < 0.05]. Whereas patients on risankizumab-rzaa were significantly 44% less likely to be hospitalized than those on adalimumab [95% CI 0.40-0.77, p < 0.05]. The risk of contracting an infection was 1.35 times higher for patients on vedolizumab than those on adalimumab [95% CI 1.31-1.40, p < 0.001]. Notably the risk for nervous system disorders was almost twice as high for patients on risankizumab than those on adalimumab [OR 1.97, 95% CI 1.57-2.47, p < 0.001]. Incorporating musculoskeletal adverse events, patients on risankizumab had 1.69 times a risk of developing a neuromusculoskeletal disorder over those patients on adalimumab [95% CI 1.46-1.97, p < 0.001]. There was no statistical significance between rates of neuromusculoskeletal adverse reactions between patients on vedolizumab and those on adalimumab. Incorporating gender and age did not yield any statistical significance.

Discussion: Patients with Crohn’s disease on risankizumab-rzaa had significantly higher rates of neuromusculoskeletal adverse events but less hospitalization than patients with CD being treated with adalimumab while patients with CD on vedolizumab have significantly higher rates of infections and hospitalization than patients with CD on adalimumab.



Disclosures:


Yash P. Ashara, MBBS¹, Clive J. Miranda, DO, MS², Murad H. Ali, MD², Gregory D. Gudleski, PhD², Bhavtosh Dedania, MD³. P2117 - A Nationwide Comparison of Risankizumab-rzaa, Vedolizumab, and Adalimumab on Infection and Neuromusculoskeletal Adverse Events in Crohn’s Disease Patients: A Pharmacovigilance Investigation, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.