Upadacitinib has been approved by the European Commision and becomes the first Janus kinase (JAK) inhibitor approved in the European Union for the treatment of moderate to severe atopic dermatitis in adult and pediatric patients.
AbbVie announced that the European Commission (EC) has approved upadacitinib (Rinvoq; AbbVie), an oral, selective, and reversible Janus kinase (JAK) inhibitor, for the treatment of moderate to severe atopic dermatitis (AD) in patients 12 years or older who are candidates for systemic therapy.1
The recommended dose of upadacitinib for adult patients less than 65 years of age is 15 mg or 30 mg once a day or 15 mg a day in pediatric patients and adult patients 65 years and older. It can also be used with or without topical corticosteroids (TCS).
"This is a significant milestone for AbbVie in our pursuit to transform care in atopic dermatitis," said Michael Severino, MD, vice chairman and president, AbbVie, Chicago, Illinois. "We are excited to provide an additional treatment option in Europe to help alleviate the burden of unrelenting itch and rash that many of these patients struggle with in daily life, despite available treatment options."
The approval is based on data from 3 phase 3 trials, Measure Up 1 [MU1] (NCT03569293), Measure Up 2 [MU2] (NCT03607422), and AD Up [AU] (NCT03568318), that compared the safety and efficacy of monotherapy upadacitinib (MU1 and MU2) and with topical corticosteroids (AU) compared to placebo. In all the studies, the coprimary endpoints were a 75% or greater improvement in the Eczema Area and Severity Index (EASI 75) and the Investigator Global Assessment (IGA) of 0/1 (clear or almost clear) of atopic dermatitis.
"As a dermatologist researching and treating atopic dermatitis for more than 25 years, I've seen first-hand the debilitating impact this disease can have on a person's daily life," said Alan Irvine, MD, DSc, professor of dermatology, Trinity College Dublin, Ireland, and Rinvoq clinical study investigator. "Clinicians need more tools to help them treat and manage this complex disease. The degree and early onset of skin clearance and itch relief in the Rinvoq phase 3 clinical studies are very encouraging. The outcomes have the potential to advance treatment goals for patients with moderate to severe atopic dermatitis."
All the primary and secondary endpoints were met with the 15 mg and 30 mg doses of upadacitinib compared to placebo in all of the studies. The following results were found:
Of the adverse events (AEs) that occurred, which were reported in less than 5% of patients, in either the 15 mg pr the 30 mg treatment arms were upper respiratory tract infection (25.4%), acne (15.1%), herpes simplex (8.4%), headache (6.3%), and increase blood creatine phosphokinase (CPK; 5.5%). The most common serious AEs were serious infections.
This Marketing Authorization means that upadacitinib is approved in all members of the EU and Iceland, Liechtenstein, Norway, and Northern Ireland.
1. AbbVie. European commission approves Rinvoq® (Upadacitinib) as first JAK inhibitor in the European Union for the treatment of both adults and adolescents with moderate to severe atopic dermatitis. Accessed August 24, 2021. https://www.prnewswire.com/news-releases/european-commission-approves-rinvoq-upadacitinib-as-first-jak-inhibitor-in-the-european-union-for-the-treatment-of-both-adults-and-adolescents-with-moderate-to-severe-atopic-dermatitis-301361058.html