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Evidence supports
the approval of biosimilar CT-P10 in terms of
efficacy and safety for long term use in the treatment of patients with rheumatoid
arthritis.
The biosimilar CT-P10 presents similar pharmacodynamics, immunogenicity, pharmacokinetics, long-term efficacy and safety as of US-RTX and EU-RTX (Rituximab) and can be used for rheumatoid arthritis and other CD20+ B-cell-related diseases, apparent from the finding of a recently done 48-week multinational, randomized, double-blind trial.
Three hundred seventy-two participants with active RA were selected and categorized into two groups . The groups were administered either with two intravenous infusions of CT-P10 or 1000 mg US-RTX, or EU-RTX two weeks apart. Afterwards, patients went through a second course regardless of the clinical response. American College of Rheumatology (ACR) response rates and Disease Activity Score 28-joint count (DAS28) were estimated as the efficacy endpoints. Patients were also evaluated for safety, immunogenicity, pharmacodynamics, and pharmacokinetics.
A total of 330
participants out of 372 went for the second treatment course. CT-P10 group
showed similar improvements in DAS28-C-reactive protein, Health Assessment
Questionnaire Disability Index, Short Form 36-Item Health Survey at week 48 as
of US-RTX, and EU-RTX groups. The pharmacokinetic, pharmacodynamic and safety
profiles were also similar between the groups. In the case of immunogenicity,
9.4%, 8.6%, and 4.9% of patients from US-RTX, EU-RTX, and CT-P10 groups were
found to have anti-drug antibodies at week 48. The findings of all the groups
were similar which exhibits CT-P10 as a potential treatment.
BioDrugs
Long-Term Efficacy and Safety of Biosimilar CT-P10 Versus Innovator Rituximab in Rheumatoid Arthritis: 48-Week Results from a Randomized Phase III Trial.
Chang-Hee Suh et al.
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