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Long-term Efficacy of Baricitinib in Adults With Moderate to Severe Atopic Dermatitis Who Were Treatment Responders or Partial Responders: An Extension Study of 2 Randomized Clinical Trials.
JAMA Dermatol. 2021 Jun 01; 157(6):691-699.JD

Abstract

IMPORTANCE

Baricitinib, an oral selective Janus kinase inhibitor, improved the clinical signs and symptoms of moderate to severe atopic dermatitis in the 16-week, phase 3 monotherapy studies, BREEZE-AD1 and BREEZE-AD2. Long-term efficacy has not yet been examined.

OBJECTIVE

To evaluate the long-term (68-week) efficacy of baricitinib in adults with moderate to severe atopic dermatitis who were treatment responders or partial responders in BREEZE-AD1 and BREEZE-AD2.

DESIGN, SETTING, AND PARTICIPANTS

Patients completing BREEZE-AD1/BREEZE-AD2 entered the ongoing, multicenter, double-blind, long-term extension study BREEZE-AD3. The study was initiated on March 28, 2018. Data were analyzed on December 13, 2019.

INTERVENTIONS

Responders and partial responders (patients achieving validated Investigator Global Assessment for Atopic Dermatitis [vIGA-AD] score of 0 or 1 [0,1], or 2) at BREEZE-AD1/BREEZE-AD2 completion remained on originally assigned treatment for 52 weeks (68 total weeks of continuous therapy).

MAIN OUTCOMES AND MEASURES

The primary end point was the proportion of patients achieving a vIGA-AD score of 0,1 at weeks 16, 36, and 52 of BREEZE-AD3. Secondary end points included the proportion of patients achieving 75% or more improvement in the Eczema Area and Severity Index [EASI75] score and 4-point or more improvement in the itch numeric rating scale (NRS), using originating study baseline data. Itch data were collected during the first 16 weeks in BREEZE-AD3. The last originating study visit was the first BREEZE-AD3 visit; therefore, data are presented for continuous weeks of therapy, including the 16-week originating study period. Missing data were imputed by last observation carried forward. Modified intention-to-treat analysis was used.

RESULTS

Of the responder/partial responder population, the proportion of patients treated with baricitinib, 4 mg (n = 70) (mean [SD] age, 36.7 [15.5] years; 42 [60%] were men), achieving vIGA-AD (0,1) at week 16 was 45.7% (BREEZE-AD3 baseline) and, at week 68, 47.1%. Improvement of 75% or more in the EASI score was 70.0% at week 16 and 55.7% at week 68. The proportion of patients achieving an itch NRS improvement greater than or equal to 4 points at week 16 was 52.5% and, at week 32, 45.9%. Of the responder/partial responder population, the proportion of patients treated with baricitinib, 2 mg (n = 54) (mean [SD] age, 32.8 [12.7] years; 28 [51.9%] were men), achieving vIGA-AD (0,1) at week 16 was 46.3% and, at week 68, 59.3%. Improvement in the EASI75 score was 74.1% at week 16 and 81.5% at week 68. The proportion of patients achieving an itch NRS improvement greater than or equal to 4 points at week 16 was 44.2% and, at week 32, 39.5%.

CONCLUSIONS AND RELEVANCE

In this long-term double-blind extension study of 2 randomized clinical trials, baricitinib, 4 and 2 mg, demonstrated sustained long-term efficacy in patients with moderate to severe atopic dermatitis.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03334435.

Authors+Show Affiliations

Department of Dermatology, George Washington University School of Medicine, Washington, DC.Department of Dermatology, Oregon Health & Science University, Portland.Department of Dermatology and Allergy, Ludwig Maximillian University, Munich, Germany.Innovaderm Research, Montreal, Quebec, Canada.Department of Dermatology, Kyoto University, Graduate School of Medicine, Kyoto, Japan. Skin Research Institute of Singapore and Singapore Immunology Network, A*Star, Singapore.Eli Lilly and Company, Indianapolis, Indiana.Eli Lilly and Company, Indianapolis, Indiana.Eli Lilly and Company, Indianapolis, Indiana.now with Janssen, Titusville, New Jersey. at the time of the trial, Eli Lilly and Company, Indianapolis, Indiana.Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

33978711

Citation

Silverberg, Jonathan I., et al. "Long-term Efficacy of Baricitinib in Adults With Moderate to Severe Atopic Dermatitis Who Were Treatment Responders or Partial Responders: an Extension Study of 2 Randomized Clinical Trials." JAMA Dermatology, vol. 157, no. 6, 2021, pp. 691-699.
Silverberg JI, Simpson EL, Wollenberg A, et al. Long-term Efficacy of Baricitinib in Adults With Moderate to Severe Atopic Dermatitis Who Were Treatment Responders or Partial Responders: An Extension Study of 2 Randomized Clinical Trials. JAMA Dermatol. 2021;157(6):691-699.
Silverberg, J. I., Simpson, E. L., Wollenberg, A., Bissonnette, R., Kabashima, K., DeLozier, A. M., Sun, L., Cardillo, T., Nunes, F. P., & Reich, K. (2021). Long-term Efficacy of Baricitinib in Adults With Moderate to Severe Atopic Dermatitis Who Were Treatment Responders or Partial Responders: An Extension Study of 2 Randomized Clinical Trials. JAMA Dermatology, 157(6), 691-699. https://doi.org/10.1001/jamadermatol.2021.1273
Silverberg JI, et al. Long-term Efficacy of Baricitinib in Adults With Moderate to Severe Atopic Dermatitis Who Were Treatment Responders or Partial Responders: an Extension Study of 2 Randomized Clinical Trials. JAMA Dermatol. 2021 Jun 1;157(6):691-699. PubMed PMID: 33978711.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term Efficacy of Baricitinib in Adults With Moderate to Severe Atopic Dermatitis Who Were Treatment Responders or Partial Responders: An Extension Study of 2 Randomized Clinical Trials. AU - Silverberg,Jonathan I, AU - Simpson,Eric L, AU - Wollenberg,Andreas, AU - Bissonnette,Robert, AU - Kabashima,Kenji, AU - DeLozier,Amy M, AU - Sun,Luna, AU - Cardillo,Tracy, AU - Nunes,Fabio P, AU - Reich,Kristian, PY - 2021/5/13/pubmed PY - 2022/3/26/medline PY - 2021/5/12/entrez SP - 691 EP - 699 JF - JAMA dermatology JO - JAMA Dermatol VL - 157 IS - 6 N2 - IMPORTANCE: Baricitinib, an oral selective Janus kinase inhibitor, improved the clinical signs and symptoms of moderate to severe atopic dermatitis in the 16-week, phase 3 monotherapy studies, BREEZE-AD1 and BREEZE-AD2. Long-term efficacy has not yet been examined. OBJECTIVE: To evaluate the long-term (68-week) efficacy of baricitinib in adults with moderate to severe atopic dermatitis who were treatment responders or partial responders in BREEZE-AD1 and BREEZE-AD2. DESIGN, SETTING, AND PARTICIPANTS: Patients completing BREEZE-AD1/BREEZE-AD2 entered the ongoing, multicenter, double-blind, long-term extension study BREEZE-AD3. The study was initiated on March 28, 2018. Data were analyzed on December 13, 2019. INTERVENTIONS: Responders and partial responders (patients achieving validated Investigator Global Assessment for Atopic Dermatitis [vIGA-AD] score of 0 or 1 [0,1], or 2) at BREEZE-AD1/BREEZE-AD2 completion remained on originally assigned treatment for 52 weeks (68 total weeks of continuous therapy). MAIN OUTCOMES AND MEASURES: The primary end point was the proportion of patients achieving a vIGA-AD score of 0,1 at weeks 16, 36, and 52 of BREEZE-AD3. Secondary end points included the proportion of patients achieving 75% or more improvement in the Eczema Area and Severity Index [EASI75] score and 4-point or more improvement in the itch numeric rating scale (NRS), using originating study baseline data. Itch data were collected during the first 16 weeks in BREEZE-AD3. The last originating study visit was the first BREEZE-AD3 visit; therefore, data are presented for continuous weeks of therapy, including the 16-week originating study period. Missing data were imputed by last observation carried forward. Modified intention-to-treat analysis was used. RESULTS: Of the responder/partial responder population, the proportion of patients treated with baricitinib, 4 mg (n = 70) (mean [SD] age, 36.7 [15.5] years; 42 [60%] were men), achieving vIGA-AD (0,1) at week 16 was 45.7% (BREEZE-AD3 baseline) and, at week 68, 47.1%. Improvement of 75% or more in the EASI score was 70.0% at week 16 and 55.7% at week 68. The proportion of patients achieving an itch NRS improvement greater than or equal to 4 points at week 16 was 52.5% and, at week 32, 45.9%. Of the responder/partial responder population, the proportion of patients treated with baricitinib, 2 mg (n = 54) (mean [SD] age, 32.8 [12.7] years; 28 [51.9%] were men), achieving vIGA-AD (0,1) at week 16 was 46.3% and, at week 68, 59.3%. Improvement in the EASI75 score was 74.1% at week 16 and 81.5% at week 68. The proportion of patients achieving an itch NRS improvement greater than or equal to 4 points at week 16 was 44.2% and, at week 32, 39.5%. CONCLUSIONS AND RELEVANCE: In this long-term double-blind extension study of 2 randomized clinical trials, baricitinib, 4 and 2 mg, demonstrated sustained long-term efficacy in patients with moderate to severe atopic dermatitis. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03334435. SN - 2168-6084 UR - https://www.unboundmedicine.com/medline/citation/33978711/Long_term_Efficacy_of_Baricitinib_in_Adults_With_Moderate_to_Severe_Atopic_Dermatitis_Who_Were_Treatment_Responders_or_Partial_Responders:_An_Extension_Study_of_2_Randomized_Clinical_Trials_ L2 - https://jamanetwork.com/journals/jamadermatology/fullarticle/10.1001/jamadermatol.2021.1273 DB - PRIME DP - Unbound Medicine ER -