Baricitinib: The First Jak Inhibitor Approved in Europe for the Treatment of Moderate to Severe Atopic Dermatitis in Adult Patients

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.

Patient preferences for atopic dermatitis medications in the UK, France and Spain: a discrete choice experiment

“…Treatment attributes and levels included in the DCE were identified through a targeted literature review of Embase and MEDLINE for quantitative and qualitative preference studies and a review of product labels for AD treatments (search conducted 10 September 2018; see online supplemental methods and table 1 for details). The attribute levels included in the DCE (eg, likelihood of achieving clear or almost clear skin at week 16) were informed by clinical data from product labels for AD treatments (where available), including both baricitinib and dupilumab, reflecting the range of potential experiences that patients may have 19 20. Attributes included the following: chance of achieving clear or almost clear skin at week 16, chance of achieving a meaningful reduction in itch at week 16, risk of eye inflammation, risk of serious infections, administration, flare management, long-term disease management, monitoring and speed of onset (table 1).…”

A Systematic Literature Review of Economic Evaluations and Cost Studies of the Treatment of Psoriasis, Atopic Dermatitis, and Chronic Urticaria

“…Moreover, tralokinumab received approval in the US at the end of 2021 [ 54 ]. For AD, orally administered Janus kinase (JAK) inhibitors are also available in many countries and typically involve treatments that are similar to biologic treatments [ 55 – 57 ]. So, future studies that reveal the economic value and cost of treatment of AD may consider the impacts of biologics and similar high-cost treatments such as JAK inhibitors.…”

Treatment-resistant atopic dermatitis: novel therapeutics, digital tools, and precision medicine

“…Baricitinib is an oral selective Janus kinase (JAK)1/JAK2 inhibitor studied for moderate-to-severe AD in children and adolescents (aged 2–17 years) and in adults [ 17 18 19 ], with U.S. Food and Drug Administration (FDA) approval for the treatment of AD anticipated in near future. However, Baricitinib is already approved by many regulatory bodies and countries including European Medicines Agency (EMA), Korea, and Japan for adult cases with moderate-to-severe AD who are candidates for systemic therapy.…”

“…However, Baricitinib is already approved by many regulatory bodies and countries including European Medicines Agency (EMA), Korea, and Japan for adult cases with moderate-to-severe AD who are candidates for systemic therapy. It is already FDA approved for moderately to severely active rheumatoid arthritis in adults [ 17 18 19 ].…”