Rapid Improvement in Skin Pain Severity and Its Impact on Quality of Life in Adult Patients With Moderate-to-Severe Atopic Dermatitis From a Double-Blind, Placebo-Controlled Baricitinib Phase 3 Study
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Rapid Improvement in Skin Pain Severity and Its Impact on Quality of Life in Adult Patients With Moderate-to-Severe Atopic Dermatitis From a Double-Blind, Placebo-Controlled Baricitinib Phase 3 Study. / Rosmarin, David; Fretzin, Scott; Strowd, Lindsay; Casillas, Marta; DeLozier, Amy M.; Dawson, Zach; Chen, Sherry; Lu, Na; Thyssen, Jacob P.
I: Journal of Cutaneous Medicine and Surgery, Bind 26, Nr. 4, 2022, s. 377-385.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Rapid Improvement in Skin Pain Severity and Its Impact on Quality of Life in Adult Patients With Moderate-to-Severe Atopic Dermatitis From a Double-Blind, Placebo-Controlled Baricitinib Phase 3 Study
AU - Rosmarin, David
AU - Fretzin, Scott
AU - Strowd, Lindsay
AU - Casillas, Marta
AU - DeLozier, Amy M.
AU - Dawson, Zach
AU - Chen, Sherry
AU - Lu, Na
AU - Thyssen, Jacob P.
N1 - Publisher Copyright: © The Author(s) 2022.
PY - 2022
Y1 - 2022
N2 - Background: Skin pain (discomfort/soreness) is a common symptom associated with atopic dermatitis (AD). Objective: To evaluate rapid changes in skin pain severity with baricitinib, and its impact on patient quality of life (QoL) in adults with moderate-to-severe AD who were inadequate responders to topical therapy. Methods: Adult patients with moderate-to-severe AD who were inadequate responders to topical therapies (N = 440, BREEZE-AD5 [NCT03435081]) were randomized to once-daily placebo, baricitinib 1 mg, or baricitinib 2 mg for 16 weeks. Change in Skin Pain Numeric Rating Scale (NRS) scores were assessed for the randomized population. Skin Pain NRS and Dermatology Life Quality Index (DLQI) scores were assessed for Skin Pain Response groups and patients with Body Surface Area (BSA) 10% to 50%. Results: Skin Pain NRS improvement was significant versus placebo by day 1 baricitinib 2 mg (least squares mean [LSM] difference −4.4%, P =.048) and by day 2 for baricitinib 1 mg (−6.7%, P =.011). As measured weekly, improvement was significant starting at Week 1 and remained significant through Week 16 for both doses. At Week 16, 70.9% of Skin Pain NRS responders vs 10.4% of nonresponders had a clinically meaningful improvement in DLQI (P <.0001). At week 16, LSM DLQI change from baseline was −11.1 for all Skin Pain NRS responders versus −3.5 for nonresponders (P <.0001). Patients with BSA 10% to 50% showed similar trends. Conclusions: Patients with moderate-to-severe AD, treated with baricitinib, reported rapid improvements in skin pain severity by day 1 for baricitinib 2 mg and day 2 for baricitinib 1 mg and remained effective through 16 weeks of treatment, which positively impacted patient QoL.
AB - Background: Skin pain (discomfort/soreness) is a common symptom associated with atopic dermatitis (AD). Objective: To evaluate rapid changes in skin pain severity with baricitinib, and its impact on patient quality of life (QoL) in adults with moderate-to-severe AD who were inadequate responders to topical therapy. Methods: Adult patients with moderate-to-severe AD who were inadequate responders to topical therapies (N = 440, BREEZE-AD5 [NCT03435081]) were randomized to once-daily placebo, baricitinib 1 mg, or baricitinib 2 mg for 16 weeks. Change in Skin Pain Numeric Rating Scale (NRS) scores were assessed for the randomized population. Skin Pain NRS and Dermatology Life Quality Index (DLQI) scores were assessed for Skin Pain Response groups and patients with Body Surface Area (BSA) 10% to 50%. Results: Skin Pain NRS improvement was significant versus placebo by day 1 baricitinib 2 mg (least squares mean [LSM] difference −4.4%, P =.048) and by day 2 for baricitinib 1 mg (−6.7%, P =.011). As measured weekly, improvement was significant starting at Week 1 and remained significant through Week 16 for both doses. At Week 16, 70.9% of Skin Pain NRS responders vs 10.4% of nonresponders had a clinically meaningful improvement in DLQI (P <.0001). At week 16, LSM DLQI change from baseline was −11.1 for all Skin Pain NRS responders versus −3.5 for nonresponders (P <.0001). Patients with BSA 10% to 50% showed similar trends. Conclusions: Patients with moderate-to-severe AD, treated with baricitinib, reported rapid improvements in skin pain severity by day 1 for baricitinib 2 mg and day 2 for baricitinib 1 mg and remained effective through 16 weeks of treatment, which positively impacted patient QoL.
KW - atopic dermatitis
KW - baricitinib
KW - quality of life
KW - skin pain
U2 - 10.1177/12034754221088542
DO - 10.1177/12034754221088542
M3 - Journal article
C2 - 35354410
AN - SCOPUS:85129017315
VL - 26
SP - 377
EP - 385
JO - Journal of Cutaneous Medicine and Surgery
JF - Journal of Cutaneous Medicine and Surgery
SN - 1203-4754
IS - 4
ER -
ID: 321488892