Upadacitinib Improves Night-time Itch and Sleep Disturbance: Study
Results from a new analysis presented at Maui Derm 2024 indicated that upadacitinib improves night-time itch and sleep disturbance.
Researchers publishing the poster at Maui Derm 2024 analyzed integrated data from the Measure Up 1 and Measure Up 2 phase-3 randomized, double-blinded studies looking the safety and efficacy of upadacitinib 15 mg (UPA 15) and 30 mg (UPA 30) vs. placebo in patients with moderate-to-severe AD. The researchers used Atopic Dermatitis Symptom Scale (ADerm-SS) and Atopic Dermatitis Impact Scale (ADerm-IS) for the evaluation of night-time itch and overall sleep disturbance, respectively. They asked patients to rate their worst itch during sleep hours and also the overall impact of their condition during sleep hours. There was a 24-hour recall period, and 11-point numeric ratings scale was used, with higher scores suggesting worse outcomes. The study period was 28 days. Chochran-Mantal-Haenszel tests were used to compare proportions of patients with a reduction ≥4 from baseline scores (and those with a 0 or 1 score on both night-time itch and sleep disturbance) between the UPA treatment arms and placebo. A total of 1,638 patients were randomly assigned to UPA 15 (n=557), UPA 30 (n=567), or placebo (n=559).
According to the study results, greater proportions of patients in the UPA 15 and UPA 30 arms saw improvements ≥4 from baseline vs. placebo for night-time itch as early as night 1 following treatment, at the end of week 1, and at the end of month 1. Similar findings were reported for improved overall impact on sleep.
"Night-time itch and associated sleep disturbances are a major problem for patients with AD," Andy Blauvelt, MD, MBA, a researcher on the study and an investigator at the Oregon Medical Research Center, told Practical Dermatology. "When we studied data from phase 3 trials, we found that upadacitinib treatment markedly improved night-time itch and sleep disturbances, providing direct improvements to the lives of patients."
Source: Blauvelt A, Prajpati V, Ständer S, et al. Upadacitinib Rapidly Improves Atopic Dermatitis-Related Night-time Itch and Sleep Disturbance: An Integrated Daily Analysis from Two Phase 3 Trials (Measure Up 1 & 2). Abstract 12638. Presented at: Maui Derm, January 22-26, 2024.
Disclosures
Dr. Blauvelt has served as a speaker (received honoraria) for AbbVie, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, Regeneron, and Sanofi, served as a scientific adviser (received honoraria) for AbbVie, Abcentra, Aclaris, Affibody, Aligos, Almirall, Alumis, Amgen, Anaptysbio, Apogee, Arcutis, Arena, Aslan, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, CTI BioPharma, Dermavant, EcoR1, Eli Lilly and Company, Escient, Evelo, Evommune, Forte, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, Leo, Merck, Novartis, Pfizer, Rani, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, TrialSpark, UCB Pharma, Union, Ventyx, Vibliome, and Xencor, and has acted as a clinical study investigator (institution has received clinical study funds) for AbbVie, Acelyrin, Allakos, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Concert, Dermavant, Eli Lilly and Company, Evelo, Evommune, Galderma, Incyte, Janssen, Leo, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, UCB Pharma, and Ventyx.
Dr. Prajapati has served as an advisor, consultant, and/or speaker for AbbVie, Actelion, Amgen, Apogee Therapeutics, Aralez, Arcutis, Aspen, Bausch Health, BioScript Solutions, Boehringer Ingelheim, Bristol Myers Squibb, Canadian Psoriasis Network, Celgene, Cipher, Concert, Eczema Society of Canada, Eli Lilly, Galderma, GlaxoSmithKline, Homeocan, Incyte, Janssen, LEO Pharma, Medexus, Novartis, Pediapharm, Pfizer, , Sanofi Genzyme, Sun Pharma, Tribute, UCB, and Valeant; investigator for AbbVie, AnaptysBio, Arcutis, Arena, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Pharma, Nimbus Lakshmi, Novartis, Pfizer, Regeneron, Reistone, Sanofi Genzyme, and UCB; received grants from AbbVie, Bausch Health, Janssen, LEO Pharma, Novartis, and Sanofi Genzyme.
Dr. Ständer was speaker and/or consultant and/or Investigator and/or has received research funding from Abbvie, Almirall, Beiersdorf, BMS, Clexio, Eli Lilly, FomF, Galderma, German Research Foundation (DFG), Integrity CE, Kiniksa, Leo Pharma, L'Oréal, MEDahead, Moroscience, NACCME, Novartis, Omnicuris, P.G. Unna Academy, Pfizer, Sanofi, TouchIME, UCB, Vifor, and WebMD.
Dr. Pink acted as investigator, advisor, lecturer or received educational or research support from Sanofi, Lilly, Abbvie, Pfizer, Leo, Galderma, Almirall, Janssen, Novartis, BMs, UCB, Celgene, Amgen, La Roche Posay, BI
Dr. Herranz reports a disclosure for Pinto.
Dr. Yosipovitch reports disclosures for Abbvie, Arcutis, Escient Health, Eli Lilly, Galderma, LEO Pharma, Novartis, Pfizer, Pierre Fabre, Regeneron Pharmaceuticals, Inc., Sanofi, Trevi Therapeutics, Vifor (advisory board member); Eli Lilly, LEO Pharma, Novartis, Pfizer, Galderma, Escient, Sanofi Regeneron, Celldex (grants/research funding); and Regeneron Pharmaceuticals, Inc., Sanofi (investigator).
Drs. Lee, Calimlim, Li, Platt, and Vigna are full-time employees of AbbVie Inc and may hold AbbVie stock and/or stock options.
Dr. Silverberg has served as an advisor, speaker, or consultant for AbbVie, Asana Biosciences, Dermavant, Galderma, GlaxoSmithKline, Glenmark, Kiniksa, LEO Pharma, Lilly, Menlo Therapeutics, Novartis, Pfizer, Realm Pharma, Sanofi/Regeneron, and as a researcher for GlaxoSmithKline.
AbbVie funded the Measure Up 1 and Measure Up 2 studies, contributed to study design, and participated in data collection. All authors had access to relevant data and participated in the drafting, review, and approval.