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Impact of baricitinib in combination with topical steroids on atopic dermatitis symptoms, quality of life and functioning in adult patients with moderate-to-severe atopic dermatitis from the BREEZE-AD7 Phase 3 randomized trial.
J Eur Acad Dermatol Venereol. 2021 Jul; 35(7):1543-1552.JE

Abstract

BACKGROUND

Baricitinib is an oral, selective, reversible Janus kinase 1/2 inhibitor approved in the European Union and Japan and under investigation in the United States for treatment of atopic dermatitis (AD).

OBJECTIVES

To evaluate the impact of baricitinib plus background topical corticosteroids (TCS) on health-related quality of life (HRQoL), how AD symptoms impact work productivity and life functioning, and treatment benefit using patient-reported outcome (PRO) assessments in patients with moderate-to-severe AD previously experiencing inadequate response to TCS.

METHODS

Adult patients with AD in BREEZE-AD7, a Phase 3, multicentre, double-blind trial, were randomised 1 : 1 : 1 to daily oral placebo (control) or baricitinib 4- or 2-mg plus TCS. PROs reported Week 1 through Week 16: Dermatology Life Quality Index (DLQI), Work Productivity and Activity Impairment-AD (WPAI-AD); Patient-Reported Outcomes Measurement Information System (PROMIS) Itch and Sleep measures, and Patient Benefit Index (PBI). Data were analysed using logistic regression (categorical) and mixed model repeated measures (continuous). PBI scores were analysed using analysis of variance.

RESULTS

A total of 329 patients were randomised. Treatment with baricitinib 4-mg (N = 111) or 2 mg (N = 109) plus TCS led to rapid, statistically significant improvements [vs. TCS plus placebo (N = 109)] in DLQI ≥4-point improvement starting at Week 2 (4-mg plus TCS, P ≤ 0.001; 2-mg plus TCS P ≤ 0.05), change from baseline in WPAI-AD presenteeism at Week 1 (4-mg plus TCS, P ≤ 0.01; 2-mg plus TCS P ≤ 0.05) and PROMIS itch interference at Week 2 (4-mg plus TCS P ≤ 0.01). Improvements were sustained through Week 16 for baricitinib 4-mg. Statistically significant improvements were observed at Week 16 for PBI global score (4-mg plus TCS, P ≤ 0.001; 2-mg plus TCS P ≤ 0.05).

CONCLUSIONS

Baricitinib plus TCS vs. placebo plus TCS showed significant improvements in treatment benefit at Week 16 and rapid significant improvements in HRQoL and impact of AD symptoms on work productivity and functioning through 16 weeks.

Authors+Show Affiliations

Department of Dermatology and Allergy, Ludwig Maximillian University, Munich, Germany.Department of Dermatology, Kyushu University, Fukuoka, Japan.Division of Dermatology, Innovaderm Research and Montreal University, Montreal, Quebec, Canada.Dermatology, Università Cattolica del Sacro Cuore and Fondazione Policlinico Agostino Gemelli - IRCCS, Rome, Italy.Northwestern University Feinberg School of Medicine, Chicago, IL, USA.University Medical Center Hamburg-Eppendorf, Hamburg, Germany.George Washington University School of Medicine and Health Sciences, Washington, DC, USA.Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.Toulouse University and CHU Larrey, Toulouse, France.Toulouse University and CHU Larrey, Toulouse, France.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

33834521

Citation

Wollenberg, A, et al. "Impact of Baricitinib in Combination With Topical Steroids On Atopic Dermatitis Symptoms, Quality of Life and Functioning in Adult Patients With Moderate-to-severe Atopic Dermatitis From the BREEZE-AD7 Phase 3 Randomized Trial." Journal of the European Academy of Dermatology and Venereology : JEADV, vol. 35, no. 7, 2021, pp. 1543-1552.
Wollenberg A, Nakahara T, Maari C, et al. Impact of baricitinib in combination with topical steroids on atopic dermatitis symptoms, quality of life and functioning in adult patients with moderate-to-severe atopic dermatitis from the BREEZE-AD7 Phase 3 randomized trial. J Eur Acad Dermatol Venereol. 2021;35(7):1543-1552.
Wollenberg, A., Nakahara, T., Maari, C., Peris, K., Lio, P., Augustin, M., Silverberg, J. I., Rueda, M. J., DeLozier, A. M., Pierce, E., Yang, F. E., Sun, L., Ball, S., Tauber, M., & Paul, C. (2021). Impact of baricitinib in combination with topical steroids on atopic dermatitis symptoms, quality of life and functioning in adult patients with moderate-to-severe atopic dermatitis from the BREEZE-AD7 Phase 3 randomized trial. Journal of the European Academy of Dermatology and Venereology : JEADV, 35(7), 1543-1552. https://doi.org/10.1111/jdv.17278
Wollenberg A, et al. Impact of Baricitinib in Combination With Topical Steroids On Atopic Dermatitis Symptoms, Quality of Life and Functioning in Adult Patients With Moderate-to-severe Atopic Dermatitis From the BREEZE-AD7 Phase 3 Randomized Trial. J Eur Acad Dermatol Venereol. 2021;35(7):1543-1552. PubMed PMID: 33834521.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Impact of baricitinib in combination with topical steroids on atopic dermatitis symptoms, quality of life and functioning in adult patients with moderate-to-severe atopic dermatitis from the BREEZE-AD7 Phase 3 randomized trial. AU - Wollenberg,A, AU - Nakahara,T, AU - Maari,C, AU - Peris,K, AU - Lio,P, AU - Augustin,M, AU - Silverberg,J I, AU - Rueda,M J, AU - DeLozier,A M, AU - Pierce,E, AU - Yang,F E, AU - Sun,L, AU - Ball,S, AU - Tauber,M, AU - Paul,C, Y1 - 2021/06/05/ PY - 2020/12/11/received PY - 2021/03/17/accepted PY - 2021/4/10/pubmed PY - 2021/6/22/medline PY - 2021/4/9/entrez SP - 1543 EP - 1552 JF - Journal of the European Academy of Dermatology and Venereology : JEADV JO - J Eur Acad Dermatol Venereol VL - 35 IS - 7 N2 - BACKGROUND: Baricitinib is an oral, selective, reversible Janus kinase 1/2 inhibitor approved in the European Union and Japan and under investigation in the United States for treatment of atopic dermatitis (AD). OBJECTIVES: To evaluate the impact of baricitinib plus background topical corticosteroids (TCS) on health-related quality of life (HRQoL), how AD symptoms impact work productivity and life functioning, and treatment benefit using patient-reported outcome (PRO) assessments in patients with moderate-to-severe AD previously experiencing inadequate response to TCS. METHODS: Adult patients with AD in BREEZE-AD7, a Phase 3, multicentre, double-blind trial, were randomised 1 : 1 : 1 to daily oral placebo (control) or baricitinib 4- or 2-mg plus TCS. PROs reported Week 1 through Week 16: Dermatology Life Quality Index (DLQI), Work Productivity and Activity Impairment-AD (WPAI-AD); Patient-Reported Outcomes Measurement Information System (PROMIS) Itch and Sleep measures, and Patient Benefit Index (PBI). Data were analysed using logistic regression (categorical) and mixed model repeated measures (continuous). PBI scores were analysed using analysis of variance. RESULTS: A total of 329 patients were randomised. Treatment with baricitinib 4-mg (N = 111) or 2 mg (N = 109) plus TCS led to rapid, statistically significant improvements [vs. TCS plus placebo (N = 109)] in DLQI ≥4-point improvement starting at Week 2 (4-mg plus TCS, P ≤ 0.001; 2-mg plus TCS P ≤ 0.05), change from baseline in WPAI-AD presenteeism at Week 1 (4-mg plus TCS, P ≤ 0.01; 2-mg plus TCS P ≤ 0.05) and PROMIS itch interference at Week 2 (4-mg plus TCS P ≤ 0.01). Improvements were sustained through Week 16 for baricitinib 4-mg. Statistically significant improvements were observed at Week 16 for PBI global score (4-mg plus TCS, P ≤ 0.001; 2-mg plus TCS P ≤ 0.05). CONCLUSIONS: Baricitinib plus TCS vs. placebo plus TCS showed significant improvements in treatment benefit at Week 16 and rapid significant improvements in HRQoL and impact of AD symptoms on work productivity and functioning through 16 weeks. SN - 1468-3083 UR - https://www.unboundmedicine.com/medline/citation/33834521/Impact_of_baricitinib_in_combination_with_topical_steroids_on_atopic_dermatitis_symptoms_quality_of_life_and_functioning_in_adult_patients_with_moderate_to_severe_atopic_dermatitis_from_the_BREEZE_AD7_Phase_3_randomized_trial_ L2 - https://doi.org/10.1111/jdv.17278 DB - PRIME DP - Unbound Medicine ER -