Serious Gastrointestinal-Related Adverse Events Among Psoriasis Patients Treated With Guselkumab in VOYAGE 1 and VOYAGE 2

Background: Anti-interleukin (IL)-17 biologic agents used to treat psoriasis are associated with onset/exacerbation of inflammatory bowel disease (IBD). Objectives: To determine the incidence of IBD or serious gastrointestinal-related adverse events (GI SAEs) in patients with moderate-to-severe psoriasis treated with guselkumab, an IL-23p19 inhibitor that indirectly inhibits IL-17, through 4 years in the phase 3 VOYAGE 1 and VOYAGE 2 trials. Methods: Patients were randomized to guselkumab 100 mg every-8-weeks or placebo -> guselkumab (week 16), or adalimumab. In VOYAGE 1, all patients received open-label guselkumab starting at week 52. In VOYAGE 2, eligible patients were treated with guselkumab or placebo based on clinical response starting at week 28 and received open-label guselkumab starting at week 76. Cumulative incidence rates of IBD and other GI SAEs were calculated as events per 100 patient-years (PY) through week 204. IBD was defined as AEs of Crohn's disease or ulcerative colitis. Data were summarized for all guselkumab-treated patients for years 1-4. Results: Of 1721 guselkumab-treated patients, 1612 were exposed for >= 1 year, 1545 for >= 2 years, 1454 for >= 3 years, and 661 for >= 4 years. For all patients through week 204, the cumulative rate of GI SAEs was 0.45/100PY. Event rates remained stable with longer duration of exposure, ranging from 0.36 to 0.57/100PY. No new or exacerbated cases of IBD were reported. Conclusions: No cases of IBD were observed and rates of GI SAEs were low through 4 years of treatment with guselkumab in two large trials of patients with psoriasis.