The European Commission ( EC ) has approved Rinvoq ( Upadacitinib ), an oral, selective and reversible JAK inhibitor, for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.
The recommended dose of Rinvoq for atopic dermatitis in adults is 15 mg or 30 mg once daily based on individual patient presentation, and 15 mg once daily for adolescents ( 12-17 years of age ) and adults 65 years and older.
Rinvoq can be used with or without topical corticosteroids.
The EC approval is supported by data from one of the largest registrational phase 3 programs in atopic dermatitis with more than 2,500 adults and adolescents with moderate to severe disease. These studies have evaluated the efficacy and safety of Rinvoq monotherapy ( Measure Up 1 [ MU1 ] and Measure Up 2 [ MU2 ] ) and with topical corticosteroids ( AD Up [ AU ] ) compared to placebo.
In all three studies, the co-primary endpoints were at least a 75% improvement in the EASI 75 ( Eczema Area and Severity Index ) and vIGA-AD ( validated Investigator's Global Assessment for Atopic Dermatitis ) score of 0/1 ( clear or almost clear ) at week 16.
Across the phase 3 studies, all primary and secondary endpoints were met with 15 mg and 30 mg doses of Rinvoq compared to placebo.
a) significantly more patients have achieved EASI 75 at week 16 in the Rinvoq 15 mg group ( MU1: 70%; MU2: 60%; AU: 65% ) and the Rinvoq 30 mg group ( MU1: 80%; MU2: 73%; AU: 77% ), compared to placebo ( MU1: 16%; MU2: 13%; AU: 26% );
b) significantly more patients have achieved vIGA-AD 0/1 at week 16 in the Rinvoq 15 mg group ( MU1: 48%; MU2: 39%; 40: 31% ) and the Rinvoq 30 mg group ( MU1: 62%; MU2: 52%; AU: 59% ) compared to placebo ( MU1: 8%; MU2: 5%; AU: 11% );
c) significantly more patients have achieved clinically meaningful itch reduction ( improvement in Worst Pruritus NRS greater 4 or more ) in the Rinvoq 15 mg group ( MU1: 52%; MU2: 42%; AU: 52% ) and the Rinvoq 30 mg group ( MU1: 60%; MU2: 60%; AU: 64% ) compared to placebo ( MU1: 12%; MU2: 9%; AU: 15% ) at week 16;
d) clinically meaningful itch reduction ( improvement in Worst Pruritus NRS 4 or more ) and skin clearance ( EASI 75 ) were observed as early as week 1 and week 2, respectively, in patients treated with either dose of Rinvoq compared to those treated with placebo.
Results at week 16 continued to be maintained through week 52 in patients treated with either dose of Rinvoq.
The most commonly reported adverse reactions ( greater than or equal to 5% of patients ) with Rinvoq 15 mg or 30 mg were upper respiratory tract infection ( 25.4% ), acne ( 15.1% ), herpes simplex ( 8.4% ), headache ( 6.3% ) and increased blood creatine phosphokinase ( CPK; 5.5% ).
The most common serious adverse reactions were serious infections ( less than 1.0% ).
Rinvoq is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.
In human cellular assays, Rinvoq preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.
Rinvoq 15 mg is also approved by the U.S. Food and Drug Administration ( FDA ) for adults with moderately to severely active rheumatoid arthritis, and by the European Commission for adults with moderate to severe active rheumatoid arthritis, adults with active psoriatic arthritis ( PsA ) and adults with active ankylosing spondylitis ( AS ). ( Xagena )
Source: Abbvie, 2021