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. 2024 Sep;14(9):2621-2630.
doi: 10.1007/s13555-024-01242-9. Epub 2024 Aug 7.

More Time Spent with Clear Skin and No Itch with Upadacitinib versus Dupilumab for Atopic Dermatitis

Andrew Blauvelt  1 , Kilian Eyerich  2 , Alan D Irvine  3 , Marjolein de Bruin-Weller  4 , Shawn G Kwatra  5 , Melinda Gooderham  6   7   8 , Brian Kim  9   10   11   12 , Brian M Calimlim  13 , Wan-Ju Lee  13 , Eliza M Raymundo  13 , Yingyi Liu  13 , Sarah Ofori  13 , Andrew M Platt  13 , Jonathan I Silverberg  14
Affiliations

More Time Spent with Clear Skin and No Itch with Upadacitinib versus Dupilumab for Atopic Dermatitis

Andrew Blauvelt et al. Dermatol Ther (Heidelb). 2024 Sep.

Abstract

Introduction: Atopic dermatitis (AD), with its hallmark symptoms of pruritus and skin lesions, often impairs patients' quality of life. We assessed time spent with clear/almost clear skin and no/minimal itch during upadacitinib treatment versus placebo or dupilumab among patients with moderate-to-severe AD.

Methods: This analysis consisted of a post hoc analysis of Measure Up 1 (NCT03569293), Measure Up 2 (NCT03607422), and Heads Up (NCT03738397). Measure Up 1 and 2 were replicate, randomized, double-blind, placebo-controlled phase 3 studies with patients randomized (1:1:1) to once-daily oral upadacitinib 15 mg, upadacitinib 30 mg, or placebo for 16 weeks. Heads Up was a head-to-head, randomized, double-blind, double-dummy, phase 3b study with patients randomized (1:1) to upadacitinib 30 mg or subcutaneous dupilumab 300 mg for 24 weeks. Skin clearance was assessed with the Eczema Area and Severity Index (EASI) at baseline, weeks 1, 2, and 4, and every 4 weeks thereafter. Itch was assessed using the Worst Pruritus Numerical Rating Scale (WP-NRS) daily over 16 weeks and every 2 weeks thereafter to week 24 in Heads Up.

Results: This analysis included 1683 patients in Measure Up 1 and 2 and 673 patients in Heads Up. Through 16 weeks in Measure Up 1 and 2, patients receiving upadacitinib spent 9.8-13.4 times as many days with an EASI 90 response and 7.0-10.3 times as many days with a WP-NRS 0/1 response versus placebo. In Heads Up, patients receiving upadacitinib spent 2.0 and 1.7 times as many days through 16 and 24 weeks, respectively, with an EASI 90 response versus dupilumab. Through 16 and 24 weeks, patients receiving upadacitinib spent 3.0 and 2.6 times as many days, respectively, with a WP-NRS 0/1 response versus dupilumab.

Conclusions: Patients with moderate-to-severe AD spent more time with clear/almost clear skin and no/minimal itch with upadacitinib versus placebo or dupilumab.

Trial registration: ClinicalTrials.gov identifier, Measure Up 1 (NCT03569293), Measure Up 2 (NCT03607422), Heads Up (NCT03738397).

Keywords: Atopic dermatitis; Dupilumab; Itch response; Janus kinase inhibitors; Skin clearance; Upadacitinib.

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Conflict of interest statement

Andrew Blauvelt has served as a speaker (received honoraria) for Lilly and UCB; has 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, Celldex, CTI BioPharma, Dermavant, EcoR1, Escient, Evelo, Evommune, Forte, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, LEO Pharma, Lilly, Lipidio, Microbion, Merck, Monte Rosa Therapeutics, Nektar, Novartis, Overtone Therapeutics, Paragon, Pfizer, Q32 Bio, Rani, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, TrialSpark, UCB Pharma, Union, Ventyx, Vibliome, and Xencor; 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, DermBiont, Evelo, Evommune, Galderma, Incyte, Janssen, LEO Pharma, Lilly, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, Takeda, UCB Pharma, and Ventyx; and owns stock in Lipidio and Oruka. Kilian Eyerich has received grants and personal fees from AbbVie; has received personal fees from Almirall, Bristol Myers Squibb, LEO Pharma, Lilly, Janssen, Novartis, UCB, and Sanofi; and has received grants from Lilly, LEO Pharma, Janssen, Novartis, and UCB. Alan D. Irvine has received personal fees as a consultant/speaker from AbbVie, Arena, Eli Lilly, LEO Pharma, Novartis, Pfizer, and Sanofi Regeneron. He has been an investigator for AbbVie and Regeneron/Sanofi. Marjolein de Bruin-Weller has served as a consultant, advisory board member, and/or speaker for AbbVie, Almirall, Amgen, Aslan, Galderma, Janssen, LEO Pharma, Lilly, Pfizer, Regeneron, Sanofi‐Genzyme, and UCB. Shawn G. Kwatra has served as an advisory board member/consultant for AbbVie, Amgen, Arcutis, Aslan, Cara, Castle Biosciences, Celldex, Galderma, Genzada, Incyte, Johnson & Johnson, LEO Pharma, Novartis, Pfizer, Regeneron, and Sanofi. He has served as an investigator for Galderma, Incyte, Pfizer, and Sanofi. He is currently affiliated with the Department of Dermatology, University of Maryland School of Medicine, Baltimore, MD, and the Maryland Itch Center, University of Maryland School of Medicine, Baltimore, MD. Melinda Gooderham is or has been an investigator, adviser, and/or speaker for AbbVie, Akros, Amgen, AnaptysBio, Arcutis, Aristea, Bausch, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Coherus BioSciences, Dermira, Dermavant, Galderma, GlaxoSmithKline, Janssen, Kyowa Kirin, LEO, Lilly, Medimmune, Merck, Meiji, Moonlake, Nimbus, Novartis, Pfizer, Regeneron, Reistone, Roche, Sanofi-Genzyme, Sun Pharma, UCB, and Ventyx. Brian Kim has served as a consultant for AbbVie, Almirall, Amagma, Argenx, AstraZeneca, Bellus Health, Blueprint Medicines, Boehringer Ingelheim Corporation, Bristol Myers Squibb, Cara Therapeutics, Daewoong Pharmaceutical, Guidepoint Global, Janssen Pharmaceuticals, Incyte Corporation, Kiniksa Pharmaceuticals, LectureLinx, LEO Pharma, Lilly, Maruho, Novartis, OM Pharma, Pfizer, Sanofi Genzyme, Shaperon, Third Rock Ventures, and Trevi Therapeutics; is a stockholder of RecensMedical and Locus Biosciences; serves on the scientific advisory boards for Abrax Japan, Granular Therapeutics, RecensMedical, National Eczema Association, Cell Reports Medicine, and Journal of Allergy and Clinical Immunology; and holds a patent for the use of JAK inhibitors for chronic pruritus. Brian M. Calimlim, Wan-Ju Lee, Eliza M. Raymundo, Yingyi Liu, Sarah Ofori, and Andrew M. Platt are full-time employees of AbbVie Inc., and may hold AbbVie stock, stock options, and/or patents. Jonathan I. Silverberg has received honoraria as a consultant, advisory board member, and/or speaker for AbbVie, AObiome, Arcutis, Alamar, Amgen, Arena, Arcutis, Asana, ASLAN, Boehringer Ingelheim, BioMX, Biosion, Bodewell, Cara, Castle, Celgene, Connect, Dermavant, Dermira, Dermtech, Galderma, GlaxoSmithKline, Incyte, Kiniksa, LEO Pharma, Lilly, Menlo, Novartis, Optum, Pfizer, RAPT, Regeneron, Sanofi-Genzyme, Shaperon, and Union. His institution has received grants from Galderma and Pfizer.

Figures

Fig. 1
Fig. 1
Time spent in skin clearance and itch response states through 16 weeks of treatment with upadacitinib (Measure Up 1 and Measure Up 2 studies). a Mean number of days spent with an EASI 90 response. b Mean number of days spent with no/minimal itch for patients with WP-NRS > 1 at baseline, defined as a WP-NRS 0/1 response. c Mean number of days spent in an itch-improved state for patients with WP‑NRS ≥ 4 at baseline, defined as WP‑NRS improvement ≥ 4 from baseline. EASI 90 ≥ 90% improvement from baseline in the Eczema Area and Severity Index, WP-NRS Worst Pruritus Numerical Rating Scale
Fig. 2
Fig. 2
Time spent in skin clearance and itch response states through 16 weeks of treatment with upadacitinib versus dupilumab (Heads Up study). a Mean number of days spent with an EASI 90 response. b Mean number of days spent with no/minimal itch for patients with WP‑NRS > 1 at baseline, defined as a WP‑NRS 0/1 response. c Mean number of days spent in an itch‑improved state for patients with WP‑NRS ≥ 4 at baseline, defined as WP‑NRS improvement ≥ 4 from baseline. EASI 90 ≥ 90% improvement from baseline in the Eczema Area and Severity Index, WP-NRS Worst Pruritus Numerical Rating Scale
Fig. 3
Fig. 3
Time spent in skin clearance and itch response states through 24 weeks of treatment with upadacitinib versus dupilumab (Heads Up study). a Mean number of days spent with an EASI 90 response. b Mean number of days spent with no/minimal itch for patients with WP‑NRS > 1 at baseline, defined as a WP‑NRS 0/1 response. c Mean number of days spent in an itch‑improved state for patients with WP‑NRS ≥ 4 at baseline, defined as WP‑NRS improvement ≥ 4 from baseline. EASI 90 ≥ 90% improvement from baseline in the Eczema Area and Severity Index, WP-NRS Worst Pruritus Numerical Rating Scale
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