The European Medicines Agency (EMA) has approved a label extension for UCB’s Cimzia (certolizumab pegol) for adult patients with axial spondyloarthritis (axSpA) at a reduced maintenance dose.
This means that axSpA patients can now reduce the dose to 200mg every four weeks once sustained remission is achieved after one year of treatment with Cimzia taken every two weeks, or 400mg every four weeks.
According to UCB, this label extension makes Cimzia the only biologic in Europe with a dose reduction option in its label for axSpA patients.
The approval was based on data from the Phase IIIb C-OPTIMISE trial of Cimzia in adults with early active axSpA. At week 48 of the induction period, 43.9% of patients achieved sustained remission and at week 96, 84%, 79% and 20% of patients receiving the full maintenance dose, reduced maintenance dose or placebo, respectively, remained flare-free.
“AxSpA patients typically experience symptom onset in their mid-twenties and may therefore be concerned about lifelong continuation of therapy,” said Robert Landewé, Amsterdam Rheumatology & Clinical Immunology Center, and lead author of the C-OPTIMISE study.
“The CIMZIA label extension now offers healthcare providers a validated dose reduction strategy that can meet the needs of patients. Furthermore, the option to reduce the maintenance dose may provide cost reductions, benefiting the wider healthcare system,” he added.
Maintenance dose reduction supports the long-term management of patients with axSpA when sustained disease remission has been achieved.
The Cimzia label extension addresses an unmet medical need by providing the first validated dose reduction for patients across the axSpA spectrum, said UCB.