P1069 Safety of guselkumab in patients aged ≥60 years with immune-mediated inflammatory diseases: a pooled analysis of registrational trials in UC, CD, PsA and PsO

A S Faye; S Sebastian; V McCaffrey; I Bravatà; M Nazar; D Piscitelli; S D Chakravarty; S Adsul; J Yee; T Baker; B E Sands

doi:10.1093/ecco-jcc/jjaf231.1250

Abstract Background Adults aged ≥60 years are a rapidly growing segment of the global population, accounting for nearly one-third of individuals with immune-mediated inflammatory diseases.1,2 Despite being at higher risk for both disease- and treatment-related complications, the safety of advanced therapies in this population remains poorly characterized.3 To bridge this gap, we evaluated the safety of guselkumab (GUS), a fully human, dual-acting selective anti-interleukin (IL)-23/p19 subunit antibody, approved for use in Crohn’s disease (CD), ulcerative colitis (UC), psoriasis (PsO) and psoriatic arthritis (PsA),4 using pooled data (up to 1 year) from 14 phase 2/3 studies in patients aged ≥60 years. Methods Pooled data from 14 phase 2/3 trials in approved indications were analyzed. Non-biologic immunomodulators (including disease-modifying anti-rheumatic drugs) and corticosteroids were permitted in inflammatory bowel disease (IBD) and PsA, but not in PsO. Analysis included all patients who received ≥1 dose of GUS. Safety results are expressed as treatment-emergent adverse events (TEAE), per 100 patient-years (PY) with 95% confidence intervals (CIs) for IBD and all combined indications. Results Among patients aged ≥60 years with IBD, 98 received placebo (PBO), with a total follow-up of 47.9 PY (mean: 25.5 weeks), and 238 received GUS, with a total follow-up of 175.5 PY (mean: 38.5 weeks). Across all combined indications, 212 received PBO (90.5 PY of follow-up; mean: 22.3 weeks) and 618 received GUS (496.8 PY of follow-up; mean: 41.9 weeks) (Table). The TEAE/100 PY (95% CI), for any TEAE, serious adverse event, infection, opportunistic infection, major adverse cardiac event or venous thromboembolism was numerically lower with GUS compared with PBO in both the IBD and all combined indications groups. The TEAE/100 PY (95% CI) of malignancies (including non-melanoma skin cancer), was similar between GUS and PBO for patients with IBD (GUS: 4.6 [2.0–9.0]; PBO: 4.2 [0.5–15.1]). For all combined indications, malignancies (TEAE/100 PY [95%CI]) were numerically higher with GUS compared with PBO; CIs broadly overlapped (GUS: 4.0 [2.5–6.2]; PBO: 2.2 [0.3–8.0]). No active tuberculosis or deaths were reported with GUS in either the IBD or all indications groups. Similar TEAE/100 PY were observed in the overall population as in the aged ≥60 years population across all safety outcomes (data not shown). Conclusion Safety outcomes for GUS in this older population with IBD and all combined indications were comparable to or lower than those for PBO. Overall, the safety profile of GUS in patients aged ≥60 years, based on pooled data across approved indications, was favourable and aligned with its established safety profile. Reference: 1. Su QY, et al. Front Public Health. 2025;13:1527680. 2. Caron B, et al. J Crohns Colitis. 2024;18:ii3–15. 3. Zazzara MB, et al. Eur Geriatr Med. 2021;12:463–73. 4. Tremfya (guselkumab) Product Information. Available from: https://www.ema.europa.eu/en/documents/overview/tremfya-epar-medicine-overview_en.pdf. Accessed October 2025 Conflict of interest: Faye, Adam: Consulting/Educational funding from: AbbVie, Takeda, Eli Lilly Sebastian, Shaji: Grant: Takeda, Tillots pharma, Biogen, Pfizer, Abbvie, Johnson & Johnson, Olympus -Odin Vision Personal Fees: Tillots, Johnson & Johnson, Olympus Odin Vision, AbbVie, Takeda, Merck, Pharmacosmos, Amgen, Eli Lilly, BMS, Odin Vision Non-financial Support: Tillots, Takeda, AbbVie, Celltrion, Johnson & Johnson, Eli Lilly, Alphasigma, Ferring Pharma McCaffrey, Victoria: Employed by Johnson & Johnson and may hold stock/stock options. Bravatà, Ivana: Johnson and Johnson employee Nazar, Maciek: Employed by Johnson & Johnson and may hold stock/stock options. Piscitelli, Darren: Employed by Johnson & Johnson and may hold stock/stock options. Chakravarty, Soumya D.: Employed by Johnson & Johnson and may hold stock/stock options. Adsul, Shashi: Employed by Johnson & Johnson and may hold stock/stock options. Yee, Jacqueline: Employed by Johnson & Johnson and may hold stock/stock options. Baker, Thomas: Employed by Johnson & Johnson and may hold stock/stock options. Sands, Bruce E: Grant: Janssen Personal Fees: Abivax SA Abbvie Adiso Therapeutics Agomab Therapeutics Alimentiv Amgen AnaptysBio AstraZeneca Biora Therapeutics Boehringer-Ingeleim Bristol Myers Squibb Celltrion, Inc. ClostraBio Cytoki Pharma EcoR1 Capital Eli Lilly and Company Enthera Equilium, Inc. Ensho Therapeutics Evommune Ferring Galapagos Genentech, Inc. Gilead Sciences GlaxoSmithKline Gossamer Bio Imhotex Immunyx Pharma Ltd. Index Pharmaceuticals Innovation Pharmaceuticals Janssen Janssen Biotech Janssen Pharmaceutica NV Janssen Research & Development, LLC Janssen Scientific Affairs, LLC Janssen-Cilag PTY, Ltd. Johnson & Johnson Kaleido Kallyope Kyowa Kirin, Inc. Merck & Co. Microba Microbiotica Limited Mirador Therapeutics Morphic Therapeutic MRM Health NV Palisade Therapeutics Pfizer, Inc. Prometheus Biosciences Prometheus Laboratories Protagonist Therapeutics, Inc. Q32 Bio Sanofi Sorriso Therapeutics Surrozen Takeda Target RWE Teva TLL Pharmaceutical Tr1x Union Therapeutics Ventyx Biosciences Non-financial Support: Janssen, Pfizer, Lilly, Takeda, Bristol Myers Squibb Other: Stock/Stock Options from Ventyx Biosciences

P1069 Safety of guselkumab in patients aged ≥60 years with immune-mediated inflammatory diseases: a pooled analysis of registrational trials in UC, CD, PsA and PsO

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P1069 Safety of guselkumab in patients aged ≥60 years with immune-mediated inflammatory diseases: a pooled analysis of registrational trials in UC, CD, PsA and PsO

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