Irish health authorities have approved reimbursement for upadacitinib for use in moderate to severe atopic dermatitis patients, for both adults and adolescents
AbbVie has announced the availability in Ireland of upadacitinib, an oral, selective and reversible Janus Kinase (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.
This is now available to prescribe via the HSE-Medicines Management Programme under a HSE-managed access protocol. On August 24, 2021, the European Commission (EC) approved a recommended dose of upadacitinib for atopic dermatitis in adults of 15mg or 30mg once daily based on individual patient presentation, and 15mg once daily for adolescents (12-17 years of age) and adults 65 years and older. Upadacitinib can be used with or without topical corticosteroids (TCS).
The EC approval was 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 evaluated the efficacy and safety of upadacitinib 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 per cent improvement in the Eczema Area and Severity Index (EASI 75) and validated Investigatorâ€™s Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 (clear or almost clear) at week 16. Alan Irvine, Professor of Dermatology, Trinity College, Dublin, who was a upadacitinib clinical study investigator, welcomed the availability of a new treatment option for Irish patients with atopic dermatitis.
He stated: â€œEczema is a chronic relapsing inflammatory skin disease, characterised by intense itch, dry skin and typically distributed skin lesions. The burden experienced by patients and their care-givers is significant, with chronic itch and sleep disturbance, negatively affecting overall quality of life.
â€œClinicians need more tools to help them treat and manage this complex disease. It is very welcome to now have an additional treatment option in upadacitinib available for moderate to severe atopic dermatitis patients in Ireland.
The degree and early onset of skin clearance and itch relief in the upadacitinib Phase 3 clinical studies are very encouraging.
AbbVieâ€™s Irish General Manager Andres Rodrigo added: â€œI very much welcome the HSEâ€™s timely approval of upadacitinib for patients with atopic dermatitis, which is a highly debilitating condition with limited therapeutic options currently. Ireland will be among the first European countries to provide access to upadacitinib for atopic dermatitis, which was approved by the EMA in August 2021.
â€œIt will provide significant improvement to patientâ€™s quality of life, impacting positively on both their physical and psychological well-being. Our companyâ€™s Irish employees support the manufacture of upadacitinib for global supply, and it is very encouraging that locally made innovation is being made available to Irish citizens.â€