The Food and Drug Administration (FDA) has approved Rinvoq® (upadacitinib) for the treatment of refractory, moderate to severe atopic dermatitis in patients 12 years of age and older whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.
The approval was based on data from 3 randomized, double-blind, phase 3 trials (Measure Up 1 [ClinicalTrials.gov Identifier: NCT03569293]; Measure Up 2 [ClinicalTrials.gov Identifier: NCT03607422]; AD Up [ClinicalTrials.gov Identifier: NCT03568318]), which evaluated the efficacy and safety of upadacitinib 15mg and 30mg orally once daily in a total of 2584 patients 12 years of age and older with moderate to severe atopic dermatitis who were candidates for systemic therapy. In Measure Up 1 and 2, upadacitinib was evaluated as monotherapy; in AD Up, upadacitinib was evaluated in combination with topical corticosteroids.
The coprimary endpoints for all of the trials were the proportion of patients achieving at least a 75% improvement in the Eczema Area Severity Index (EASI 75) and a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) of clear or almost clear (0/1) at week 16.
Findings from the Measure Up 1 and Measure Up 2 trials showed that a significantly greater proportion of patients treated with upadacitinib 15mg and 30mg achieved EASI 75 and vIGA-AD 0/1 at week 16 compared with placebo. Moreover, a significantly higher proportion of patients treated with upadacitinib met key secondary endpoints including EASI 90, EASI 100, and at least a 4-point improvement in the Worst Pruritus Numerical Rating Scale (NRS) at week 16. Patients treated with upadacitinib reported a clinically meaningful reduction in itch as early as day 2.
In the AD Up trial, 65% and 77% of patients treated with upadacitinib 15mg and 30mg plus topical corticosteroids, respectively, achieved EASI 75 at week 16 compared with 26% of patients in the placebo plus topical corticosteroids arm. Moreover, 40% and 59% of patients treated with upadacitinib 15mg and 30mg plus topical corticosteroids, respectively, achieved vIGA-AD 0/1 at week 16 compared with 11% of patients who received placebo plus topical corticosteroids. Upadacitinib also met all key secondary endpoints: EASI 90, EASI 100, and at least a 4-point improvement in the Worst Pruritus NRS at week 16.
“This additional approval for Rinvoq provides a once-daily oral option that can significantly improve the debilitating itch and skin symptoms of atopic dermatitis,” said Thomas Hudson, MD, senior vice president, research and development, chief scientific officer, AbbVie.
The most common adverse reactions reported were upper respiratory tract infections, acne, herpes simplex, headache, increased blood creatine phosphokinase, cough, hypersensitivity, folliculitis, nausea, abdominal pain, pyrexia, increased weight, herpes zoster, influenza, fatigue, neutropenia, myalgia, and influenza-like illness.
The labeling for Rinvoq also includes additional warnings on the risks of serious cardiovascular-related events, malignancy, thrombosis, and death. The update follows the FDA’s Drug Safety Communication for certain Janus kinase (JAK) inhibitors issued on September 1, 2021.
Rinvoq is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.
- US FDA approves Rinvoq® (upadacitinib) to treat adults and children 12 years and older with refractory, moderate to severe atopic dermatitis. News release. AbbVie. January 14, 2022. Accessed January 18, 2022. https://www.prnewswire.com/news-releases/us-fda-approves-rinvoq-upadacitinib-to-treat-adults-and-children-12-years-and-older-with-refractory-moderate-to-severe-atopic-dermatitis-301461377.html.
- Rinvoq. Package insert. AbbVie; 2021. Accessed January 18, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s002s005lbl.pdf.