Treatment with the Janus kinase inhibitor upadacitinib for 48 weeks was safe and effective in patients with moderate to severe atopic dermatitis (AD), according to study results published in the American Journal of Clinical Dermatology.
Researchers sought to assess the effectiveness and safety of upadacitinib during 48 weeks of observation in a real-world population of adults with AD in a multicenter prospective study. The patients included in the study were treated at 15 dermatologic centers in Italy from October 2020 to September 2022.
The study included prospective data on adult patients 18 years of age and older with moderate to severe AD (as defined by an Eczema Area and Severity Index [EASI] score of 16 or higher). Eligible participants were unresponsive to, intolerant of, or had contraindications to the approved therapies for moderate to severe AD at protocol definition in June 2020 (with cyclosporine and dupilumab being the only agents indicated for AD in Italy). During the study period, they received upadacitinib at a dose of either 15 mg or 30 mg, at the discretion of the treating physician.
At baseline, disease severity was assessed using EASI, skin involvement was evaluated according to the affected body surface area (BSA), itch severity was determined by a 0 to 10 numeric rating scale (itch-NRS), and pain intensity was monitored by the pain-NRS. Patients were reassessed at approximately every 16 weeks. Sleep disturbances/sleeplessness were evaluated by an NRS scale (sleep-NRS), quality of life was assessed using the Dermatology Life Quality Index (DLQI), and global patient-oriented disease severity was determined by the Patient-Oriented Eczema Measure (POEM).
The cohort included 146 patients (mean age, 37.83±14.4 years; 61% male). A total of 125 patients received 16 weeks of treatment, 113 were treated for 32 weeks, and 97 were treated for 48 weeks. Upadacitinib was initially prescribed at a dosage of 30-mg daily in 118 patients (80.8%) and at 15-mg daily in 28 patients (19.2%). Over the 48-week treatment period, dose variation occurred in 38 patients (26%).
Responses of EASI75, EASI90, and EASI100 were achieved by 78.2%, 47.6%, and 28.2% of patients, respectively, at week 16; and by 87.6%, 69.1%, and 44.3% of patients, respectively, at week 48. A significant decrease from baseline was observed in mean sleeplessness, skin pain, and itch-NRS ratings at weeks 16, 32, and 48 (all P <.001).
The 15-mg and 30-mg doses of upadacitinib were associated with decreased disease severity, with significant reductions observed in mean EASI, DLQI, BSA, POEM, itch-NRS, pain-NRS, and sleep-NRS. Response to treatment was comparable between participants who received the 15-mg vs the 30-mg dose without any statistical difference between the 2 groups.
Adverse events (AEs) occurred in 26 patients (17.8%) during the treatment period; most of these were mild to moderate, but in 4 cases they led to drug discontinuation. The most common AE was infections (in 30.0% of patients), including 3 cases of SARS-CoV-2 infection.
Regarding study limitations, the researchers noted that in their interim analysis only 66.4% of patients received 48 weeks of therapy, scheduled visits may have varied among treatment centers, and a smaller percentage of participants received the 15-mg dose of upadacitinib than those who received 30 mg.
“This study provides strong evidence of a sustained response obtained by upadacitinib in AD patients, through 48 weeks of observation,” the authors concluded. “This satisfactory response was also obtained in patients who had failed to respond to conventional or biological systemic agents, preserving an acceptable safety profile.”
References:
Chiricozzi A, Ortoncelli M, Schena D, et al. Long‑term effectiveness and safety of upadacitinib for atopic dermatitis in a real‑world setting: an interim analysis through 48 weeks of observation. Am J Clin Dermatol. Published online June 15, 2023. doi:10.1007/s40257-023-00798-0
