Longer-term safety and efficacy of baricitinib for atopic dermatitis in pediatric patients 2 to <18 years old: a randomized clinical trial of extended treatment to 3.6 years
Background Baricitinib, an oral selective Janus kinase inhibitor, improved clinical signs and symptoms of moderate-to-severe atopic dermatitis (AD) at week 16 in the phase 3 pediatric study BREEZE-AD-PEDS.Objective To assess longer-term efficacy and safety of baricitinib in pediatric patients aged 2...
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Taylor & Francis Group
2024-12-01
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| Series: | Journal of Dermatological Treatment |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/09546634.2024.2411834 |
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| author | Andreas Wollenberg Masanori Ikeda Chia-Yu Chu Lawrence F. Eichenfield Marieke M. B. Seyger Apurva Prakash Robinette Angle Danting Zhu Marco Pontes Amy S. Paller |
| author_facet | Andreas Wollenberg Masanori Ikeda Chia-Yu Chu Lawrence F. Eichenfield Marieke M. B. Seyger Apurva Prakash Robinette Angle Danting Zhu Marco Pontes Amy S. Paller |
| author_sort | Andreas Wollenberg |
| collection | DOAJ |
| description | Background Baricitinib, an oral selective Janus kinase inhibitor, improved clinical signs and symptoms of moderate-to-severe atopic dermatitis (AD) at week 16 in the phase 3 pediatric study BREEZE-AD-PEDS.Objective To assess longer-term efficacy and safety of baricitinib in pediatric patients aged 2 to <18 years.Methods In BREEZE-AD-PEDS long-term extension, responders and partial responders (validated Investigator Global Assessment-Atopic Dermatitis [vIGA-AD®] 0/1/2) at Week 16 remained on double-blind treatment to which they were randomized (placebo, baricitinib [1-mg equivalent, 2-mg equivalent, or 4-mg equivalent); non-responders (vIGA-AD 3 or 4) at Week 16 transitioned to open-label baricitinib 4-mg equivalent. Safety was summarized for all randomized patients who received ≥1 dose of study treatment.Results In total 467 patients received baricitinib for 750.7 patient-years. Proportion of responders/partial responders (at Week 16) who achieved vIGA-AD 0/1 at Week 52 was greater for baricitinib 4-mg equivalent (56.8%) versus all other treatment groups (42.2%, 47.7%, and 39.7% for 2-mg equivalent, 1-mg equivalent, and placebo, respectively). Most treatment-emergent adverse events were mild/moderate in severity. No deaths, pulmonary emboli, deep vein thromboses or arterial thrombotic events, major adverse cardiovascular events, malignancies, tuberculosis events, or gastrointestinal perforations were reported.Conclusions Baricitinib demonstrated sustained long-term efficacy. No new safety signals were identified.Trial Registration ClinicalTrials.gov Identifier: NCT03952559 |
| format | Article |
| id | doaj-art-60c95020afe746ab9bb7dbef4c3fa42d |
| institution | Kabale University |
| issn | 0954-6634 1471-1753 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Journal of Dermatological Treatment |
| spelling | doaj-art-60c95020afe746ab9bb7dbef4c3fa42d2025-01-09T22:43:02ZengTaylor & Francis GroupJournal of Dermatological Treatment0954-66341471-17532024-12-0135110.1080/09546634.2024.2411834Longer-term safety and efficacy of baricitinib for atopic dermatitis in pediatric patients 2 to <18 years old: a randomized clinical trial of extended treatment to 3.6 yearsAndreas Wollenberg0Masanori Ikeda1Chia-Yu Chu2Lawrence F. Eichenfield3Marieke M. B. Seyger4Apurva Prakash5Robinette Angle6Danting Zhu7Marco Pontes8Amy S. Paller9Department of Dermatology and Allergy, University Hospital Augsburg, Augsburg, GermanyOkayama University School of Medicine, Okayama and Department of Pediatrics, Fukuyama City Hospital, Fukuyama, JapanDepartment of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, TaiwanDepartments of Dermatology and Pediatrics, University of California San Diego and Rady Children’s Hospital, San Diego, CA, USADepartment of Dermatology, Radboud University Medical Center, Nijmegen, NetherlandsEli Lilly and Company, Indianapolis, IN, USAEli Lilly and Company, Indianapolis, IN, USAEli Lilly and Company, Indianapolis, IN, USAEli Lilly and Company, Indianapolis, IN, USADepartments of Dermatology and Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USABackground Baricitinib, an oral selective Janus kinase inhibitor, improved clinical signs and symptoms of moderate-to-severe atopic dermatitis (AD) at week 16 in the phase 3 pediatric study BREEZE-AD-PEDS.Objective To assess longer-term efficacy and safety of baricitinib in pediatric patients aged 2 to <18 years.Methods In BREEZE-AD-PEDS long-term extension, responders and partial responders (validated Investigator Global Assessment-Atopic Dermatitis [vIGA-AD®] 0/1/2) at Week 16 remained on double-blind treatment to which they were randomized (placebo, baricitinib [1-mg equivalent, 2-mg equivalent, or 4-mg equivalent); non-responders (vIGA-AD 3 or 4) at Week 16 transitioned to open-label baricitinib 4-mg equivalent. Safety was summarized for all randomized patients who received ≥1 dose of study treatment.Results In total 467 patients received baricitinib for 750.7 patient-years. Proportion of responders/partial responders (at Week 16) who achieved vIGA-AD 0/1 at Week 52 was greater for baricitinib 4-mg equivalent (56.8%) versus all other treatment groups (42.2%, 47.7%, and 39.7% for 2-mg equivalent, 1-mg equivalent, and placebo, respectively). Most treatment-emergent adverse events were mild/moderate in severity. No deaths, pulmonary emboli, deep vein thromboses or arterial thrombotic events, major adverse cardiovascular events, malignancies, tuberculosis events, or gastrointestinal perforations were reported.Conclusions Baricitinib demonstrated sustained long-term efficacy. No new safety signals were identified.Trial Registration ClinicalTrials.gov Identifier: NCT03952559https://www.tandfonline.com/doi/10.1080/09546634.2024.2411834Atopic dermatitispediatricbaricitinib |
| spellingShingle | Andreas Wollenberg Masanori Ikeda Chia-Yu Chu Lawrence F. Eichenfield Marieke M. B. Seyger Apurva Prakash Robinette Angle Danting Zhu Marco Pontes Amy S. Paller Longer-term safety and efficacy of baricitinib for atopic dermatitis in pediatric patients 2 to <18 years old: a randomized clinical trial of extended treatment to 3.6 years Journal of Dermatological Treatment Atopic dermatitis pediatric baricitinib |
| title | Longer-term safety and efficacy of baricitinib for atopic dermatitis in pediatric patients 2 to <18 years old: a randomized clinical trial of extended treatment to 3.6 years |
| title_full | Longer-term safety and efficacy of baricitinib for atopic dermatitis in pediatric patients 2 to <18 years old: a randomized clinical trial of extended treatment to 3.6 years |
| title_fullStr | Longer-term safety and efficacy of baricitinib for atopic dermatitis in pediatric patients 2 to <18 years old: a randomized clinical trial of extended treatment to 3.6 years |
| title_full_unstemmed | Longer-term safety and efficacy of baricitinib for atopic dermatitis in pediatric patients 2 to <18 years old: a randomized clinical trial of extended treatment to 3.6 years |
| title_short | Longer-term safety and efficacy of baricitinib for atopic dermatitis in pediatric patients 2 to <18 years old: a randomized clinical trial of extended treatment to 3.6 years |
| title_sort | longer term safety and efficacy of baricitinib for atopic dermatitis in pediatric patients 2 to 18 years old a randomized clinical trial of extended treatment to 3 6 years |
| topic | Atopic dermatitis pediatric baricitinib |
| url | https://www.tandfonline.com/doi/10.1080/09546634.2024.2411834 |
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