P3636 - Risk Factors for Development of Acne for Patients With Inflammatory Bowel Disease Treated With Upadacitinib

Natalie K. Choi, BA¹, David K.. Choi, PharmD¹, Nicole M. Garcia, BA¹, Scott Friedberg, MD², Russell D.. Cohen, MD¹, David T. Rubin, MD^3
1University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL; ²University of Chicago, Chicago, IL; ³Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL

Introduction: Upadacitinib (UPA) is a novel, highly selective Janus kinase 1 inhibitor that has received regulatory approval for moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). Acne was one of the most frequently reported adverse events (AE) in pivotal trials of UPA for inflammatory bowel disease (IBD) and the most commonly reported AE in our large prospective real-world experience. However, risk factors for acne are not known. Here we present a real-world experience of patient-reported acne as an AE in patients with IBD.

Methods: We performed a prospective, real-world analysis of acne incidence in patients receiving UPA for IBD at our institution. Clinical follow-up to assess effectiveness and safety occurred at predetermined intervals: weeks 0, 2, 4, 8, and 12. This included standard questions about extra-intestinal manifestations or AEs, including acne. Disease-, drug-, and patient-related variables were assessed related to acne occurrence. Analysis of covariance (ANCOVA), Shapiro-Wilk test, Mann-Whitney test, and multivariate logistical regression (MLR) were performed for predictive variables. Time (days) to acne occurrence was analyzed using quartile analysis.

Results: 119 patients with IBD were assessed for the first 3 months on UPA (63 UC, 44 CD, 5 IBD-U, 6 pouchitis (P)); 109 receiving 45 mg/d; 10 receiving 15 mg/d). 35 patients (29%; 23 UC, 10 CD, 1 IBD-U, 1 P all receiving 45 mg/d) reported acne primarily of the face, but also involving the scalp and back. Treatment discontinuation due to the acne occurred in only 2 patients (5.7%). Of acne-reporting patients, the median time from initiation of UPA to occurrence of acne was 31 days (IQR: 18-49). MLR of all examined variables (AUC=0.6737) demonstrated age stratified by decade (P=0.047) significantly correlated younger age with incidence of acne. Female sex (P=0.08), type of IBD (P=0.11), smoking status (P=0.16), and concomitant immunomodulator therapy (P=0.58) or concomitant corticosteroids (P=0.67) were not related to the development of acne on UPA (Table).

Discussion: In our large real-world experience in patients with IBD treated with upadacitinib, we report 29% incidence of acne mostly occurring within the first 31 days of treatment, only with 45 mg/d dose, and in younger patients. Concomitant steroids or immune therapies were not associated with increased risk of acne. These findings are of considerable interest, will assist in patient communication, and inform a prospective prevention trial for this AE.


Disclosures:


Natalie K. Choi, BA¹, David K.. Choi, PharmD¹, Nicole M. Garcia, BA¹, Scott Friedberg, MD², Russell D.. Cohen, MD¹, David T. Rubin, MD³. P3636 - Risk Factors for Development of Acne for Patients With Inflammatory Bowel Disease Treated With Upadacitinib, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.