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Rituximab biosimilar shows promise in patients with rheumatoid arthritis
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Equivalent pharmacokinetics and similar efficacy, safety, pharmacodynamics and immunogenicity were observed in patients with rheumatoid arthritis treated with CT-P10, a candidate biosimilar for rituximab, or innovator rituximab, recently published findings indicate.
In this multicenter, randomized controlled trial, researchers randomly assigned 103 patients with rheumatoid arthritis to IV CT-P10 (Celltrion) and 51 patients to innovator rituximab (Rituxan; Genentech, Biogen Idec) at 0 and 2 weeks, with data reported up to 24 weeks. The primary endpoints investigators observed included area under the serum concentration and the maximum serum concentration after the second infusion. Data also assessed included pharmacokinetic parameters, efficacy, pharmacodynamics, immunogenicity and safety.
Results showed for both of the primary endpoints, the ration of geometric means were within the 80% bioequivalence range. Investigators noted the two treatment groups were similar with regard to the pharmacodynamics and efficacy. At week 24, in each treatment group, 17.6% of patients had antidrug antibodies. Similar safety profiles were found with CT-P10 and innovator rituximab. ‒ by Monica Jaramillo
Disclosure: The study was sponsored by Celltrion, and many of the researchers report financial ties to Celltrion. Please see the full study for a list of all the authors’ relevant financial disclosures.
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