P2658 - Safety of Ustekinumab Across Approved Adult Indications: Pooled Safety Analysis in Crohn’s Disease, Ulcerative Colitis, Psoriasis, and Psoriatic Arthritis Through up to 5 Years

Millie D. Long, MD, MPH, FACG¹, Silvio Danese, MD, PhD², Elyssa Ott, MPH³, Christopher Gasink, MD³, Ye Miao, MS⁴, Thomas Baker, MD⁴, Ilia Tikhonov, MD, PhD⁴, Proton Rahman, MD⁵, Bruce Strober, MD, PhD⁶, Edward V. Loftus, MD, FACG^7
1University of North Carolina Chapel Hill, Chapel Hill, NC; ²Inflammatory Bowel Diseases Center, Humanitas Clinical and Research Center IRCCS and Hunimed, Milan, Lombardia, Italy; ³Janssen Scientific Affairs, LLC, Horsham, PA; ⁴Janssen R&D, LLC, Spring House, PA; ⁵Eastern Health, St. John’s, NF, Canada; ⁶Central CT Dermatology, Avon, CT; ⁷Mayo Clinic, Rochester, MN

Introduction: Ustekinumab (UST) is a well-established therapy and was approved for treatment of adults with psoriasis (PsO) in 2009, psoriatic arthritis (PsA) in 2013, Crohn’s disease (CD) in 2016, and ulcerative colitis (UC) in 2019. An integrated analysis of safety data through 1 year¹ and the more recently presented 2020 IBD Pooled Safety Dataset showed a favorable safety profile for UST across indications that was generally similar to placebo (PBO). Here, we present an integrated analysis of the pooled safety data incorporating phase 2/3 long-term safety data from IBD studies through up to 5 years in CD and 2 years in UC and psoriatic disease studies through up to 5 years in PsO and 1 year in PsA.

Methods: Data from 13 phase 2/3 studies in approved indications were pooled. Concomitant immunomodulators and corticosteroids were permitted for IBD and PsA pts, but not PsO pts. All pts who received ≥1 dose of UST were included in this analysis. Safety outcomes are presented as events per 100 patient-years (PY) of follow-up and 95% confidence interval (CIs). Of note, the PBO-controlled period in most PsO studies was 12 wks, and 16 wks in PSA.

Results: Across all indications, 2501 pts were treated with PBO with 1244 PYs of follow-up and 6710 pts were treated with UST with 13807 PYs of follow-up.

Rates of key events per 100 PYs and corresponding 95% CIs were generally similar between UST and PBO groups (Table 1). In pooled indications in the PBO and UST groups, respectively, the most frequent adverse events (AEs; excluding preferred terms of CD and UC) were nasopharyngitis (20.83 vs 20.87), upper respiratory tract infection (13.51 vs 14.53), arthralgia (13.99 vs 7.01), abdominal pain (10.77 vs 4.01), and diarrhea (6.67 vs 3.88). Anal abscess (PBO 0.72 vs UST 0.17), pneumonia (PBO 0.32 vs UST 0.14), and cellulitis (PBO 0.16 vs UST 0.11) were the most frequently reported serious infections. Events of malignancy and death were less frequently reported, particularly in the PBO group and as such, CIs were wide.

Discussion: The safety profile of UST across pooled indications was favorable through up to 5 yrs, confirming the well-established safety profile of UST in psoriatic and IBD indications.



Disclosures:


Millie D. Long, MD, MPH, FACG¹, Silvio Danese, MD, PhD², Elyssa Ott, MPH³, Christopher Gasink, MD³, Ye Miao, MS⁴, Thomas Baker, MD⁴, Ilia Tikhonov, MD, PhD⁴, Proton Rahman, MD⁵, Bruce Strober, MD, PhD⁶, Edward V. Loftus, MD, FACG⁷. P2658 - Safety of Ustekinumab Across Approved Adult Indications: Pooled Safety Analysis in Crohn’s Disease, Ulcerative Colitis, Psoriasis, and Psoriatic Arthritis Through up to 5 Years, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.