Abstract Background Guselkumab (GUS) is an IgG1 monoclonal antibody targeting the p19 subunit of interleukin-23 (IL-23), a key cytokine in the inflammatory cascade of inflammatory bowel disease (IBD). GUS has demonstrated efficacy in inducing and maintaining remission in patients with moderately to severely active Crohn’s disease (CD) in clinical trials. We report real-world data on the effectiveness and safety of GUS in CD from a large tertiary IBD center. Methods Patients with CD who initiated GUS therapy at our center were prospectively followed. Participants were contacted at weeks 0, 2, 4, 8, and 12, and data were collected regarding clinical disease activity (Harvey–Bradshaw Index HBI), corticosteroid use, and adverse events. Efficacy analyses included all patients who completed 12 weeks of therapy. HBI values are presented as medians with interquartile ranges (IQRs). Laboratory assessments, including C-reactive protein (CRP) and fecal calprotectin (FCP), were obtained at baseline and at weeks 4, 8, and 12. Patients with ostomies were excluded from efficacy analyses. Results Seventy-seven patients completed 12 weeks of follow-up and were included in the analysis. Of these, 53 (68.9%) had prior exposure to ≥ 2 advanced therapies. Among patients with active disease at baseline, HBI decreased from 8 IQR 7–12 to 6.5 IQR 0.75–8. Among patients with elevated baseline CRP, median CRP decreased from 8 IQR 6.95–30 mg/L to 3 IQR 1.5-10.5 mg/L at week 12. Among patients with baseline FCP 150 µg/g, 60% were in biochemical remission (FCP150 µg/g) at week 12. Steroid-free clinical remission increased from 56.6% at baseline to 68.6% at week 12. No treatment-related adverse events were observed. Conclusion In this first real-world cohort of patients with moderately to severely active Crohn’s disease treated with GUS, many of whom were resistant to 2 or more advanced therapies prior to GUS initiation, GUS demonstrated meaningful clinical and biochemical improvement with an excellent safety profile. 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: D.C. 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, and 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.
Shafrir et al. (Thu,) studied this question.