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.
N1 - Funding Information:
AW has received grants, personal fees or non‐financial support from AbbVie, Almirall, Beiersdorf, Bioderma, Chugai, Eli Lilly and Company, Galapagos, Galderma, Hans Karrer, Leo Pharma, L'Oreal, Maruho, MedImmune, Novartis, Pfizer, Pierre Fabre, Regeneron, Santen and Sanofi‐Aventis; TN has received speaker's fees from Maruho and Sanofi; CM is an Investigator, Consultant, Advisory Board Member, Speaker for and/or receives honoraria from Aquinox Pharma, Asana BioSciences, AbbVie, Brickell Biotech, Dermavant, Eli Lilly and Company, Galderma, Glenmark, GSK‐Stiefel, Hoffman‐LaRoche Ltd, Hoffman‐LaRoche‐Posay, Leo Pharma, Pfizer, Regeneron‐Sanofi, Valeant and Vitae; KP reports personal fees from Almirall, AbbVie, Biogen, Janssen, Eli Lilly and Company, Celgene, Galderma, Janssen, Leo Pharma, Novartis, Pierre Fabre, Sanofi, Sandoz and Sun Pharma outside the submitted work; PL has served as an investigator for AbbVie and Regeneron/Sanofi‐Genzyme, has served as an advisor/consultant for AbbVie, Arbonne, Amyris, Bodewell, Burt's Bees, Dermavant, Dermira, Eli Lilly and Company, Galderma, Johnson and Johnson, Kiniksa, Leo Pharma, L'Oreal, Micreos, Pfizer, Pierre Fabre, Regeneron/Sanofi‐Genzyme, Theraplex and Verrica; has served as a speaker for Galderma, L'Oreal and Pfizer, and has a patent with Theraplex AIM. MA has served as advisor and/or paid speaker for and/or participated in research projects sponsored by Abbott/AbbVie, ALK Scherax, Almirall, Amgen, Beiersdorf, Biogen Idec, BMS, Boehringer Ingelheim, Celgene, Centocor, Dermira, Eli Lilly and Company, Forward Pharma, Fresenius, Galderma, GSK, Hexal, Incyte, Janssen‐Cilag, LEO Pharma, Medac, Menlo, Merck, MSD, Mylon, Novartis, Pfizer, Regeneron, Sandoz, Sanofi‐Aventis, Stallergenes, Stiefel, Teva, TK, Trevi, UCB and Xenoport; JIS has received honoraria as a consultant and/or advisory board member for Abbvie, Afyx, Arena, Asana, BioMX, Bluefin, Bodewell, Boehringer Ingelheim, Celgene, Dermavant, Dermira, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, Kiniksa, Leo, Luna, Menlo, Novartis, Pfizer, RAPT, Regeneron, Sanofi; speaker for Pfizer, Regeneron, Sanofi; institution received grants from Galderma; MT has been a co‐investigator for AbbVie, Boehringer, Eli Lilly and Company, Galderma, Janssen‐Cilag, Leo Pharma, Pierre Fabre, Sanofi‐Regeneron, and UCB and a speaker for Sanofi‐Regeneron and Janssen‐Cilag; CP has been an investigator and consultant for AbbVie, Almirall, Amgen, Boehringer, Celgene, Eli Lilly and Company, Galderma, Janssen‐Cilag, Leo Pharma, Merck, Novartis, Pfizer, Pierre Fabre, Regeneron, Sanofi (AD) and UCB pharma; MJR, AMD, EP, FEY, LS and SB are employees and shareholders of Eli Lilly and Company.
Publisher Copyright:
© 2021 Eli Lilly and Company. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.
PY - 2021/7
Y1 - 2021/7
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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85107191330&partnerID=8YFLogxK
U2 - 10.1111/jdv.17278
DO - 10.1111/jdv.17278
M3 - Article
C2 - 33834521
AN - SCOPUS:85107191330
SN - 0926-9959
VL - 35
SP - 1543
EP - 1552
JO - Journal of the European Academy of Dermatology and Venereology
JF - Journal of the European Academy of Dermatology and Venereology
IS - 7
ER -