Abstract
Background: Atopic dermatitis (AD) is an inflammatory skin disease characterized by a wide phenotypic variety with a very complex pathophysiological mechanism that has led to the identification of new therapeutic targets, such as janus kinasis (JAK) inhibitors. Objectives: To evaluate the efficacy and safety of baricitinib, the first JAK 1 and 2 inhibitor approved in Europe for the treatment of adult patients with moderate-to-severe AD. Methods: The efficacy and safety data available from the Phase III studies belonging to the BREEZE AD program are presented. Results: Results from BREEZE-AD1, AD2, AD4, and AD7 showed the efficacy of Baricitib 4 mg, administered orally, once daily, as monotherapy or in combination with topical corticosteroid (TCS), with a significant proportion of patients achieving primary endpoints IGA 0–1 (16.4% vs. 4.8%; 13.8% vs. 4.5%; 21.7% vs. 9.7%; 30.6% vs. 14.7%) and EASI75 (24.8% vs. 8.8%; 21.1% vs. 6.1%; 31.5% vs. 17.2%; 47.7% vs. 22.9%) at week 16 (W16) compared to placebo, respectively. Baricitinib showed rapid improvement in symptoms, starting from week 1 of treatment at 4 mg dosage, with a good safety profile. Nasopharyngitis, upper respiratory tract infections (URIs), creatine phosphokinase (CPK) elevations, and headache were the most frequently reported adverse events. Conclusions: Following the efficacy and safety data on W 16 from the phase III BREEZE-AD studies, baricitinib has recently been approved in Europe for the treatment of moderate to severe AD in adult patients. Further data to evaluate long-term efficacy and safety in a real-life setting are needed.
Highlights
16-week studies, and treatment-emergent Adverse Events (TEAEs) were higher for baricitinib 2 mg (57.9%) vs. placebo (51.6%), while serious adverse events, serious infections, and opportunistic infections were low in frequency and similar between baricitinib 2 mg and placebo; results confirmed the absence of occurrences of cancer, gastrointestinal perforations, or major adverse cardiovascular events within the first 16 week of treatment
Pooled safety analyses have been conducted by Bieber et al [43], including 4-mg-treated arms in addition to the analysis of King et al Data were collected for 2531 patients who were given baricitinib for 2247 patient-years
The results showed a statistically significative difference between 4-mg therapeutic dosage regime and placebo in terms of efficacy, measured by two main primary endpoints among all of these trials: the percentage of patients achieving an investigator global assessment (IGA) score 0–1 or an improvement of 75% of Eczema Area Severity Index (EASI) score from baseline (EASI 75) [34,35,36,37]
Summary
Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by itch and eczematous lesions. Atopic dermatitis (AD) is an inflammatory skin disease characterized by a wide phenotypic variety with a very complex pathophysiological mechanism that has led to the identification of new therapeutic targets, such as janus kinasis (JAK) inhibitors. Objectives: To evaluate the efficacy and safety of baricitinib, the first JAK 1 and 2 inhibitor approved in Europe for the treatment of adult patients with moderate-to-severe AD. BREEZE-AD1, AD2, AD4, and AD7 showed the efficacy of Baricitib 4 mg, administered orally, once daily, as monotherapy or in combination with topical corticosteroid (TCS), with a significant proportion of patients achieving primary endpoints IGA 0–1 (16.4% vs 4.8%; 13.8% vs 4.5%; 21.7% vs 9.7%; 30.6% vs 14.7%) and EASI75 (24.8% vs 8.8%; 21.1% vs 6.1%; 31.5% vs 17.2%; 47.7% vs 22.9%) at week 16 (W16) compared to placebo, respectively.
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