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

Abstract

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. J Drugs Dermatol. 2021;20(8):855-860. doi:10.36849/JDD.6216 THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

• Authors: Peter Foley, Kristian Reich, Andrew Blauvelt, Jerry Bagel, Richard G Langley, Megan Miller, Paraneedharan Ramachandran, Ya Wen Yang, Yaung-Kaung Shen, Yin You, Mark Lebwohl, Christopher E M Griffiths
• Journal: Journal of drugs in dermatology : JDD (J Drugs Dermatol) Vol. 20 Issue 8 Pg. 855-860 (Aug 01 2021) ISSN: 1545-9616 [Print] United States
• PMID: 34397205 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)

Chemical References

• Antibodies, Monoclonal, Humanized
• guselkumab

Topics

• Antibodies, Monoclonal, Humanized (adverse effects)
• Double-Blind Method
• Humans
• Psoriasis (diagnosis, drug therapy, epidemiology)
• Severity of Illness Index
• Treatment Outcome