Baricitinib improves symptoms in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: patient-reported outcomes from two randomized monotherapy phase III trials.

Autor: Reich K; Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Skinflammation® Center, Hamburg and Dermatologikum Berlin, Berlin, Germany., DeLozier AM; Eli Lilly and Company, Indianapolis, IN, USA., Nunes FP; Eli Lilly and Company, Indianapolis, IN, USA., Thyssen JP; Department of Dermatology and Allergy, Herlev and Gentofte Hospital and University of Copenhagen, Copenhagen, Denmark., Eichenfield LF; Departments of Dermatology and Pediatrics, University of California, San Diego and Rady Children's Hospital, San Diego, CA, USA., Wollenberg A; Department of Dermatology and Allergology, Ludwig Maximilian University, Munich, Germany., Ross Terres JA; Eli Lilly and Company, Indianapolis, IN, USA., Watts SD; Eli Lilly and Company, Indianapolis, IN, USA., Chen YF; Eli Lilly and Company, Indianapolis, IN, USA., Simpson EL; Department of Dermatology, Oregon Health and Science University, Portland, OR, USA., Silverberg JI; Department of Dermatology, George Washington University School of Medicine, Washington, DC, USA.
Jazyk: angličtina
Zdroj: The Journal of dermatological treatment [J Dermatolog Treat] 2022 May; Vol. 33 (3), pp. 1521-1530. Date of Electronic Publication: 2020 Nov 22.
DOI: 10.1080/09546634.2020.1839008
Abstrakt: Background: Itch, skin pain, and sleep disturbance are burdensome symptoms in atopic dermatitis (AD) that negatively influence a patient's quality of life (QoL).
Objective: To evaluate the impact of baricitinib on patient-reported outcomes (PROs) in adult patients with moderate-to-severe AD, and explore the association between improvement in key signs and symptoms of AD with improvements in QoL and patient's assessment of disease severity.
Methods: Data were analyzed from two phase III monotherapy trials (BREEZE-AD1/BREEZE-AD2) in which patients were randomized 2:1:1:1 to once-daily placebo, baricitinib 1-mg, 2-mg, or 4-mg for 16 weeks and assessed using PRO measures.
Results: At week 16, baricitinib 4-mg and 2-mg significantly reduced itch severity (Itch Numeric Rating Scale (NRS) (BREEZE-AD1: percent change from baseline -36.6% and -29.4% vs. placebo (-12.0%), p ≤.001 and p ≤.05; BREEZE-AD2: -47.2% and -46.9% vs. placebo (-16.6%), p ≤.001). Baricitinib significantly reduced SCORing AD (SCORAD) pruritus (4-mg in BREEZE-AD1 and 2-mg in BREEZE-AD2) and Patient Oriented Eczema Measure (POEM) itch (both doses). Improvements in skin pain severity and sleep disturbance were also observed. Improvements in AD symptoms showed higher correlations with patients' assessment of AD severity and QoL than improvements in skin inflammation.
Conclusions: Baricitinib significantly improved symptoms in patients with moderate-to-severe AD.
Clinicaltrials.gov Identifiers: NCT03334396 (BREEZE-AD1) and NCT03334422 (BREEZE-AD2).
Databáze: MEDLINE
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