OP39 Safety of ustekinumab in IBD: Final pooled long-term safety analysis through 5 years in CD and 4 years in UC

Abstract Background Long-term efficacy of ustekinumab (UST) has been reported in Crohn’s disease (CD) through 5 years (yrs)1 and ulcerative colitis (UC) 4 yrs.2 A previous pooled analysis long-term safety data a favorable UST treatment profile for inflammatory bowel (IBD).3 Here, we present results the final cumulative from studies up to yrs CD UC. Methods Data 6 phase 2/3 IBD were pooled. In 3, patients (pts) received single IV placebo (PBO) or (130mg ~6mg/kg) induction dose followed by SC maintenance doses PBO (90mg q8w q12w). Concomitant immunomodulators corticosteroids permitted. All pts who ≥1 included. Safety outcomes are summarized presented using number events per 100 patient-years (PY) follow-up corresponding 95% confidence interval (CI). Results this data, 2575 treated with 4826 PYs follow-up. Rates key events, including MACE malignancies, similar between not higher (Table 1). The most frequently occurring adverse (AEs) either group (excluding diseases under study) headache (PBO 16.66 vs. 11.60), arthralgia 15.91 11.23), abdominal pain 13.79 9.86), nausea 11.35 7.13), pyrexia 5.91); infections nasopharyngitis 17.82 vs 19.10) upper respiratory tract infection 11.78 9.80). serious anal abscess, pneumonia, cellulitis, abscess no than PBO, except gastroenteritis 0.11 0.25). No lymphomas reported. Nine deaths UST-treated (0.00 [0.00, 0.32] 0.19 [0.09, 0.35] UST), 3 UC (all considered unrelated study agent). Conclusion compilation showed that continued be supports well-established experience across all approved indications. References: 1. Sandborn WJ, et al. Five-Year Efficacy Ustekinumab Treatment Crohn's Disease: IM-UNITI Trial. Clin Gastroenterol Hepatol. 2022;20(3):578-590.e4. 2. Afif W, Ulcerative Colitis Through Years: Final UNIFI Extension. UEGW 2023. 3. 129 IBD: Pooled Analysis 2 Years Gastroenterology. 2021;Supplement:S-35-S-36.