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Cimzia is the first and only biologic approved in Europe with the option for a reduced maintenance dose for patients across the full axial spondyloarthritis spectrum- UCB.

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Published:8th Aug 2020
UCB announced that the European Medicines Agency (EMA) has approved a label extension for Cimzia (certolizumab pegol) for use in adult patients with axial spondyloarthritis (axSpA) at a reduced maintenance dose of 200 mg every four weeks (Q4W), once sustained remission is achieved after one year of Cimzia 200 mg every two weeks (Q2W) or 400 mg Q4W. The approval makes Cimzia the only biologic in Europe with a dose reduction option in its label for patients in the broad axSpA population. Clinical remission is recommended as a major treatment target in the Assessment of SpondyloArthritis international Society (ASAS)/European League Against Rheumatism (EULAR) recommendations for axSpA and treat-to-target recommendations for spondyloarthritis. Additionally, strategies for the maintenance of remission are necessary to prevent future deterioration in disease status. Maintenance dose reduction supports the long-term management of patients with axSpA, when sustained disease remission has been achieved. This approach offers an additional option that preserves the clinical benefits to patients of remaining on treatment, while responding to specific patient needs, and can optimise the cost of their therapy. The extension of Cimzia's label in Europe addresses an under-recognised unmet need by providing the first validated dose reduction strategy for patients across the broad axSpA spectrum who have achieved sustained remission.
Condition: Axial Spondyloarthritis
Type: drug

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