Upadacitinib Receives EU Approval as First JAK Inhibitor for Moderate to Severe Atopic Dermatitis
AbbVie
Innovative Drug Developer
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
On August 24, 2021, AbbVie announced that the European Commission (EC) has approved an expanded indication for its oral JAK inhibitor upadacitinib (marketed under the trade name Rinvoq) for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents aged 12 years and older who are candidates for systemic therapy, with or without concomitant topical corticosteroids (TCS). In multiple Phase 3 clinical trials, upadacitinib met all primary and secondary endpoints. Compared with placebo, patients in the upadacitinib groups demonstrated rapid and significant improvements in skin clearance and itch relief, whether used as monotherapy or in combination with TCS (p<0.001). The press release noted that this is the first JAK inhibitor approved for the treatment of atopic dermatitis.
Upadacitinib is a selective and reversible oral JAK inhibitor currently under investigation for several immune-mediated inflammatory diseases. The JAK protein family mediates the signaling of multiple inflammatory cytokines. In cellular assays, upadacitinib preferentially inhibits JAK1 or JAK1/3 signal transduction. In August 2019, it received US FDA approval for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to or are intolerant of methotrexate. Upadacitinib has demonstrated positive results in Phase 3 clinical trials for the treatment of various inflammatory diseases, including rheumatoid arthritis, atopic dermatitis, ulcerative colitis, and psoriatic arthritis.
The Phase 3 trial enrolled over 2,500 adult and adolescent patients with moderate-to-severe atopic dermatitis to evaluate the efficacy and safety of upadacitinib as monotherapy or in combination with TCS compared with placebo. Both the 15 mg and 30 mg doses of upadacitinib met all primary and secondary endpoints. At Week 16, significantly more patients in the upadacitinib groups achieved a ≥75% improvement in the Eczema Area and Severity Index (EASI 75) and clear or almost clear skin (vIGA-AD 0/1) compared with the placebo group. Additionally, the proportion of patients achieving a clinically meaningful reduction in itch (≥4-point improvement in NRS) was significantly higher in the upadacitinib groups than in the placebo group.
Regarding safety, the most frequently reported adverse reactions (≥5%) in the 15 mg or 30 mg upadacitinib groups were upper respiratory tract infection (25.4%), acne (15.1%), herpes simplex (8.4%), headache (6.3%), and elevated blood creatine phosphokinase (CPK; 5.5%). The most common serious adverse re
References:
[1] 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. Retrieved August 24, 2021, from https://news.abbvie.com/news/press-releases/european-commission-approves-rinvoq-upadacitinib-as-first-jak-inhibitor-in-european-union-for-treatment-both-adults-and-adolescents-with-moderate-to-severe-atopic-dermatitis.htm
(Original text abridged)
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