P0732Guselkumab Efficacy and Safety in Moderately to Severely Active Ulcerative Colitis: Real-World Data from a Large Tertiary Center

Background Guselkumab (GUS) is an IgG1 antibody targeting the p19 subunit of interleukin-23, a cytokine involved in the pathogenesis of inflammatory bowel disease (IBD). GUS has demonstrated efficacy for induction and maintenance of remission in moderately to severely active ulcerative colitis (UC). We report real-world effectiveness and safety outcomes of GUS in UC from a large tertiary IBD centre. Methods All patients prescribed GUS at our centre were prospectively followed and contacted at weeks 0, 2, 4, 8, and 12. Disease activity (Simple Clinical Colitis Index [SCCAI]), corticosteroid use, adverse events, and laboratory markers were collected at baseline and at weeks 4, 8, and 12. Patients with ≥12 weeks of follow-up were included. Results Sixty-one patients started treatment (mean age 42.95 ± 16.29 years; 66.1% female). At week 12, 59 (97%) remained on GUS. Median SCCAI decreased from 3.5 (IQR 1–6) at baseline to 0.5 (IQR 0–1) at week 12. At baseline, 46.4% (26/56) were in clinical remission (SCCAI ≤ 2), increasing to 88.9% (48/54) at week 12. Among 30 patients with active disease at baseline, 25 (83%) achieved remission at week 12. Steroid-free remission increased from 45.5% at baseline to 71.7% at week 12. Among patients with elevated baseline CRP (n = 12), median CRP decreased from 6.75 mg/L to < 3 mg/L at week 12. Median faecal calprotectin decreased from 977 µg/g to 322 µg/g. Remission rates with GUS treatment were comparable between ustekinumab (UST)-naïve and UST-exposed patients. No treatment-related serious adverse events were observed. In univariate analysis, age, sex, and prior TNF or UST therapy were not associated with steroid-free remission at weeks 8 or 12. Conclusion In this real-world analysis of GUS in moderately to severely active UC, GUS demonstrated marked clinical effectiveness and a favourable safety profile, including in patients previously exposed to UST. Conflict of interest: Shafrir, Asher: No conflict of interest Mr. Mathew, Alex: No conflict of interest Tanouye, Jessica M: No conflict of interest Hannett, Alexandra R: No conflict of interest Choi, David: David Choi has served on the speaker bureau for Janssen Pharmaceuticals, AbbVie, Eli Lilly and as a consultant for Bristol Myers Squibb, Boehringer Ingelheim, AbbVie, Eli Lilly, Janssen Pharmaceuticals, Pfizer Cohen, Russell: Personal Fees: Abbvie, Celgene, Eli Lilly, Hospira, Janssen, Pfizer, Sandoz Biopharma, Takeda, UCB Pharma Non-financial Support: Abbvie Rubin, David T.: Grant support: Takeda Pharmaceuticals Consultant: Abbvie, Abivax SA, Altrubio, Athos Therapeutics, Inc, Bristol-Myers Squibb, Celltrion, Connect BioPharma, Eli Lilly & Co., Genentech (Roche) Inc., Iterative Health, Janssen Pharmaceuticals, Johnson & Johnson, Merck & Co., Mirador, Odyssey Therapeutics, Pfizer, Sanofi, Spyre, Takeda Pharmaceuticals, Vedanta Biosciences, and Ventyx.