Background: Baricitinib demonstrated efficacy in treating adults with moderate-to-severe atopic dermatitis (AD) in Phase 3 clinical trials.
Objective: To examine long-term efficacy of baricitinib combined with topical corticosteroids (TCS) in adult patients from a Phase 3 study, BREEZE-AD7 (NCT03733301), enrolled in ongoing extension study, BREEZE-AD3 (NCT03334435).
Methods: Upon BREEZE-AD7 completion, responders or partial responders (RPR [vIGA-AD™ ≤2]) receiving baricitinib 2-mg or 4-mg + TCS maintained their original treatment doses in BREEZE-AD3. Nonresponders (NR; vIGA-AD 3,4) receiving baricitinib 2-mg were rerandomized 1:1 to baricitinib 2-mg or 4-mg; NR receiving baricitinib 4-mg remained on same dose. Integrated data from all patients (RPR + NR = baricitinib 4-mg intent-to-treat [ITT] cohort) receiving continuous baricitinib 4-mg in BREEZE-AD7 through BREEZE-AD3 were analysed, along with baricitinib 4-mg or 2-mg RPR cohorts. Primary endpoint was proportion of patients with vIGA-AD (0,1) at Weeks 16, 36 and 52 (Weeks 32, 52 and 68 of continuous therapy). Additional outcomes included improvement in EASI75 and Itch NRS (up to Week 32). Missing data were imputed by last observation carried forward.
Results: In baricitinib 4-mg ITT cohort (N = 102), proportions of patients achieving vIGA-AD (0,1) at Week 32, Week 52, and Week 68 were 21.6%, 26.5% and 23.5%; EASI75 were 46.1%, 40.2% and 43.1%, respectively. Itch NRS ≥4-point improvement (Itch ≥4) were 47.3% at Week 16 and 40.6% at Week 32. In baricitinib 4-mg RPR cohort (N = 63), proportions of patients achieving vIGA-AD (0,1) at Week 32, Week 52 and Week 68 were 31.7%, 33.3% 34.9%, respectively; EASI75 were 57.1%, 49.2% and 49.2%, respectively. Itch ≥4 were 53.6% at Week 16 and 46.4% at Week 32. Corresponding proportions for baricitinib 2-mg RPR cohort (N = 53) for vIGA-AD (0,1) were 39.6%, 45.3% and 30.2%; EASI75 were 77.4%, 69.8% and 58.5%, respectively. Itch ≥4 were 56.3% at Week 16 and 47.9% at Week 32.
Conclusion: Baricitinib 4-mg and 2-mg combined with TCS maintained clinically meaningful sustained efficacy over 68 weeks of continuous treatment.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1111/jdv.18816 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Efficacy and safety of baricitinib in rheumatoid arthritis patients with moderate renal impairment: a multicenter propensity score matching study.
BMC Rheumatol
December 2024
Department of Orthopaedic Surgery, Faculty of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.
Background: This study aimed to compare the efficacy and safety of baricitinib in patients with rheumatoid arthritis (RA) receiving different doses based on renal function.
Methods: We conducted a retrospective study within the JAK Study Group, involving 23 facilities in Fukuoka Prefecture, examining patients treated with baricitinib for RA. Patients were categorized into two dose groups: 4 mg with normal/mild renal dysfunction and 2 mg with moderate renal dysfunction.
The efficacy of JAK inhibitors in adult eosinophilic colitis with atopic dermatitis; four cases report.
Clin J Gastroenterol
December 2024
Department of Internal Medicine, Division of Gastroenterology, Kawasaki Medical School, Kurashiki City, Japan.
We herein present four cases of Eosinophilic colitis (EoC) in adult patients who were successfully treated with a Janus kinase (JAK) inhibitor. Case 1 is a 23-year-old female who was treated with baricitinib (BAR, 4 mg, once a day) for atopic dermatitis (AD). Colonoscopy (CS) initially did not reveal any significant abnormalities.
View Article and Find Full Text PDFBaricitinib as monotherapy and with topical corticosteroids in moderate-to-severe atopic dermatitis: a systematic review and meta-analysis of dose-response.
Front Allergy
November 2024
Department of Dermatology, Vayodha Hospitals, Kathmandu, Nepal.
Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin disorder that affects millions worldwide, presenting challenges in managing symptoms and quality of life. Current treatments include topical corticosteroids (TCS), but novel approaches, such as Janus kinase (JAK) inhibitors, show promise. Baricitinib, a selective JAK1 and JAK2 inhibitor, targets cytokines involved in AD and offers potential benefits beyond traditional therapies.
View Article and Find Full Text PDFSystemic Treatment with the Janus Kinase Inhibitor Baricitinib in Ocular Chronic Graft-versus-Host Disease.
Ophthalmol Sci
September 2024
Ophthalmology Consult Services Section, National Eye Institute, NIH, Bethesda, Maryland.
Objective: To investigate the effects of oral baricitinib on ocular surface disease (OSD) in patients with chronic graft-versus-host disease (cGVHD).
Design: Prospective phase 1 to 2 single institution trial.
Subjects: Eighteen patients with ocular graft-versus-host-disease (oGVHD) and systemic steroid-refractory cGVHD.
Safety of baricitinib 24 weeks 4 mg or 2 mg for the treatment of rheumatoid arthritis: A meta-analysis of randomized controlled trials.
Medicine (Baltimore)
November 2024
Department of Pharmacology, Hunan University of Medicine General Hospital, Huaihua, People's Republic of China.
Backgrounds: Baricitinib, an oral selective inhibitor of Janus kinase 1 and 2, is approved for moderate and severe rheumatoid arthritis (RA) with insufficient response to conventional synthetic disease-modifying antirheumatic drugs. The study evaluated the safety of baricitinib 24 weeks 4 mg or 2 mg for the treatment of RA.
Methods: The net change (least squares mean [LSM]) of alanine aminotransferase (ALT), creatinine, low-density lipoprotein cholesterol (LDL-C) levels from baseline with the comparison of baricitinib versus placebo was pooled, respectively.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!