– Approval supported by data from one of the largest registrational Phase 3 programs in atopic dermatitis evaluating RINVOQ (upadacitinib) monotherapy or with topical corticosteroids
– RINVOQ met all primary and secondary endpoints, demonstrating rapid and significant improvement in skin clearance and itch reduction compared to placebo at week 16 and earlier time points (p<0.001)
– Results at week 16 continued to be maintained through week 52
– RINVOQ has a safety profile supported by clinical programs evaluating more than 10,500 patients* across approved indications, and on-market experience in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis[2-9]
– Milestone marks the fourth EC-approved indication for RINVOQ
NORTH CHICAGO, Ill., Aug. 24, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced the European Commission (EC) 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.1 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.1 RINVOQ can be used with or without topical corticosteroids (TCS).1
“This is a significant milestone for AbbVie in our pursuit to transform care in atopic dermatitis,” said Michael Severino, M.D., vice chairman and president, AbbVie. “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 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.1 These studies 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.1 In all three studies, the co-primary endpoints were at least a 75 percent improvement in the Eczema Area and Severity Index (EASI 75) and validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 (clear or almost clear) at week 16.1
“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, M.D., D.Sc., 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.”
Highlights From the Global Phase 3 Atopic Dermatitis Clinical Trial Program1
Across the Phase 3 studies, all primary and secondary endpoints were met with 15 mg and 30 mg doses of RINVOQ compared to placebo. Highlights include:
- Significantly more patients 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%).
- Significantly more patients 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%).
- Significantly more patients achieved clinically meaningful itch reduction (improvement in Worst Pruritus NRS ?4) 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.
- Clinically meaningful itch reduction (improvement in Worst Pruritus NRS ?4) 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 (?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%).1 The most common serious adverse reactions were serious infections (<1.0%).1
The Marketing Authorization means that RINVOQ is approved in all member states of the European Union, as well as Iceland, Liechtenstein, Norway and Northern Ireland. RINVOQ is already approved for the treatment of moderate to severe atopic dermatitis in Russia, Saudi Arabia, United Arab Emirates, New Zealand and Chile, and is currently under review in the U.S. by the Food and Drug Administration (FDA).
*10,500 patients includes all patients across all arms (active treatment and placebo) in 8 Phase 3 trials in rheumatoid arthritis, 2 in psoriatic arthritis, 1 in ankylosing spondylitis and 5 in atopic dermatitis.2-9 This includes 344 adolescent patients (aged 12 to 17 years) in the Phase 3 Measure Up 1, Measure Up 2 and, AD Up studies in atopic dermatitis.1,2,5 Of the total number of patients included in these trials, 6,280 were randomized to receive RINVOQ at either dose.2-9