Abstract

Abstract Background Three Janus kinase (JAK) inhibitors, tofacitinib (TFC), filgotinib (FIL) and upadacitinib (UPA), have been approved for treatment of Crohn’s disease (CD) and/or ulcerative colitis (UC). During the IBD registrational trials, acne was reported as adverse event (AE) in 5-7% of UPA treated patients, but not in the FIL and TFC programs. Hence, we assessed the prevalence of JAK inhibitor associated acne in a real-life cohort. Methods All patients initiating JAK inhibitors for active moderate-to-severe CD or UC at our center were included. Patients were prospectively monitored at prespecified timepoints, and specifically assessed for AEs including acne. Affected patients completed a visual analogue scale (VAS) to assess the impact of acne on their quality of life. All pictures of skin lesions were assessed by a dermatologist specialized in inflammatory skin diseases. Results In total, 46 patients initiated TFC, 40 FIL and 79 UPA. None of the TFC or FIL treated patients reported new onset of acne. Instead, 17 (21.5%) patients (9 CD, 8 UC; median [IQR] age 28.2 [25.2-45.0]; 47.1% female) spontaneously reported acne during UPA therapy. Most (89.5%) reported new onset of acne, while 2 (10.5%) mentioned a deterioration of existing acne during UPA induction. Previous acne during adolescence was reported by 46.2%. Lesions were present in the face (82.3%), back (23.5%), chest (23.5%) and scalp (11.8%). The acne phenotype included inflammatory papules in all patients, but also pustules (66.7%), nodules (33.3%), cysts (11.1%) and comedones (11.1%) were observed. A median VAS score of 5.5 [5.0-7.0] highlighted the impact on the patient’s quality of life, though no patient interrupted UPA due to acne. Six (35.2%) patients were referred to a dermatologist for acne. Most patients (82.4%) received topical skin therapy during UPA induction based on a standard operation procedure approved by the dermatologist and communicated via the IBD nurses. Three patients (17.6%) received antibiotics during UPA induction because of acne. During UPA maintenance, 5 patients (29.4%) reported resolution of skin problems with only 1 requiring continued skin therapy. Ten patients (58.7%) continued topical skin therapy during maintenance, with 4 of them requiring continued antibiotic treatment for at least 3 months. A single patient was deescalated from UPA 30mg to 15mg QD because of severe acne, with little improvement. Conclusion In this real-world experience, JAK inhibitor associated acne was uniquely linked to UPA, occurring in one fifth of patients. This is more prevalent than observed in the registrational trials. Awareness and patient education are therefore important, as well as early referral to the dermatologist for appropriate treatment.

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