Therapy with upadacitinib through 140 weeks led to robust clinical efficacy and itch relief in adolescents and adults (12–75 years) with moderate-to-severe atopic dermatitis (AD) in 3 ongoing phase 3 trials. Reassuringly, no increases in side effects or new safety signals were observed during this period.
Dr Jonathan Silverberg (George Washington University School of Medicine and Health Sciences, Washington DC, USA) presented the week 140 data of 3 ongoing randomised, double-blind, multicentre phase 3 studies (Measure Up 1 NCT03569293, Measure Up 2 NCT03607422, and AD UP NCT03568318) [1]. In these trials, adolescents and adults with moderate-to-severe AD were randomised to receive upadacitinib in 2 doses (15 mg and 30 mg) or placebo once daily. At week 16, placebo-treated participants were re-randomised to receive upadacitinib in either of 2 doses.
All efficacy results were sustained from week 16 up to week 140: in the 4 groups (upadacitinib 15 mg, upadacitinib 30 mg, placebo/upadacitinib 15 mg, and placebo/upadacitinib 30 mg) EASI75 responses were achieved by 83.5% up to 89.4% of participants. In addition, between 60.4% (placebo/upadacitinib 15 mg) and 75.5% (placebo/upadacitinib 30 mg) gained clear or almost clear skin according to the assessment of the investigators. “The EASI90 responses show a similar result,” Dr Silverberg said. Participants treated with placebo in the double-blind phase achieved similar results after the switch to upadacitinib compared with those receiving upadacitinib continuously. The JAK1 inhibitor also led to a sustained itch relief. At week 140, between 68.0% and 81.3% of participants achieved a ≥4-point reduction on the Worst Pruritus Metric Rating Scale.
“Safety is especially important long time. Overall, we see there is a slightly higher rate of adverse events in the higher dose group, such as for serious infection herpes zoster and acne – but the rates are overall low and consistent with data we had in previous data sets,” Dr Silverberg said.
- Silverberg J, et al. Efficacy and safety of upadacitinib through 140 weeks in adolescents and adults with moderate-to-severe atopic dermatitis: phase 3 randomized clinical trial results. D1T01.1B, EADV Congress 2023, 11–14 October, Berlin, Germany.
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Table of Contents: EADV 2023
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