Abstract Background Upadacitinib (UPA) is increasingly used for IBD, with acne reported more frequently in real-world cohorts than in trials. Evidence suggests this adverse event is relatively specific to UPA rather than other JAK inhibitors, yet its clinical course and management remain insufficiently defined. We evaluated the prevalence, characteristics and outcomes of UPA-associated acne in a large single-centre cohort. Methods All patients initiating UPA for moderate-to-severe Crohn’s disease (CD) or ulcerative colitis (UC) were prospectively followed at prespecified visits. Demographic, disease and treatment data were collected; acne cases were further assessed for timing, distribution, therapy, dose adjustment, dermatology referral and outcome. Logistic regression evaluated predictors of acne development and treatment needs. Uni and multivariate analyses were performed. Results We included 186 patients (63% male; median age 40.3 IQR 29.3–50.7 years; 55% CD, (Table 1), with median follow-up of 0.59 0.33–1.35 years. Acne occurred in 38.7% of patients. Patients with acne were numerically younger (37.3 vs 41.3 years; p = 0.14), had shorter disease duration (9.3 vs 13.6 years; p = 0.074) and slightly higher BMI (25.1 vs 24.2 kg/m²; p = 0.23). Nicotine use was associated with lower acne risk (p = 0.027). In multivariable analysis, age, disease duration, sex, IBD subtype, Montreal behaviour and location, and prior advanced therapy showed no significant association. Acne developed predominantly during induction (87.5%). Facial involvement was common (68.1%), and truncal lesions (back and/or chest) occurred in 30.6%; neither distribution pattern was associated with treatment intensity or resolution. A structured dermatology protocol allowed on-demand treatment, with referral required in only 22.2% of patients. Topical therapy was required in 58.3% and systemic antibiotics in 20.8%. Maintenance dermatologic therapy (topical and/or systemic) was needed in 43.1%, and was strongly associated with female sex (72.4% vs 23.3%; p 0.001). Resolution of acne during maintenance UPA dose was observed in 37.9%, with markedly higher rates in patients without need for ongoing dermatologic treatment beyond induction (48.8% vs 16.1%; p = 0.006). Only one patient (1.4%) discontinued UPA because of acne. Conclusion In the largest single-centre cohort reported, UPA-associated acne was substantially more common than in trials, but was usually manageable and rarely treatment-limiting. BMI modestly increased risk, and female sex predicted prolonged treatment need, while IBD phenotype and lesion distribution did not. These findings refine the clinical profile of JAKne and support proactive but reassuring monitoring during UPA therapy. Conflict of interest: Mrs. Desmedt, Valérie: Speaker fee Abbvie De Dycker, Els: Other: Speaker at Pfizer IBD Preceptorship, 5 June 2019 Speaker at N-ECCO Netwerk meeting 2021 03/07/2021 Lambrechts, Tessy: No conflict of interest Geens, Patricia: No conflict of interest Brödel, Sarah: No conflict of interest Loddewijkx, Elien: No conflict of interest Guedelha Sabino, João: Speaker’s fees: Lilly, Pfizer, Abbvie, Ferring, Falk, Takeda, Janssen, Fresenius, and Galapagos. Consultancy fees: Takeda, Pfizer, Janssen, Ferring, Fresenius, Abbvie, Galapagos, Celltrion, Pharmacosmos, and Pharmanovia. Research support: Galapagos, Viatris, and Eurogenerics. JS is supported by a Senior Clinical researcher grant from the Research foundation – Flanders. Ferrante, Marc: Research grants from AbbVie, EG Pharma, Celltrion, Janssen, Pfizer, Takeda and Viatris Consultancy fees from AbbVie, AgomAb Therapeutics, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Janssen-Cilag, MRM Health, Merck Sharp and Dohme, Pfizer, Takeda and ThermoFisher Speakers’ fees from AbbVie, Biogen, Boehringer Ingelheim, Dr Falk Pharma, Ferring, Janssen-Cilag, Merck Sharp and Dohme, Pfizer, Takeda, Truvion Healthcare and Viatris Hillary, Tom: No conflict of interest Verstockt, Bram: Research support from AbbVie, Biora Therapeutics, Celltrion, Landos, Pfizer, Sanofi, Sossei Heptares/Nxera and Takeda. Speaker’s fees from Abbvie, Agomab, Alfasigma, Biogen, Bristol Myers Squibb, Celltrion, Eli Lily, Falk, Ferring, Galapagos, Materia Prima, Johnson and Johnson, Pfizer, Sandoz, Takeda, Tillots Pharma, Truvion and Viatris. Consultancy fees from Abbvie, Alfasigma, Alimentiv, Anaptys Bio, Applied Strategic, Astrazeneca, Atheneum, BenevolentAI, Biora Therapeutics, Boxer Capital, Bristol Myers Squibb, Domain Therapeutics, Eli Lily, Galapagos, Guidepont, Landos, Merck, Mirador Therapeutics, Mylan, Nxera, Inotrem, Ipsos, Johnson and Johnson, Pfizer, Sandoz, Sanofi, Santa Ana Bio, Sapphire Therapeutics, Sosei Heptares, Takeda, Tillots Pharma and Viatris. Stock options Vagustim and Thethis Pharma.
Desmedt et al. (Thu,) studied this question.