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Rituximab biosimilar shows pharmacokinetic bioequivalence in patients with RA

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GP2013, a proposed rituximab biosimilar, demonstrated pharmacokinetic bioequivalence to rituximab in patients with rheumatoid arthritis, according to results presented at the EULAR Annual Congress.

Researchers randomly assigned 173 patients with active rheumatoid arthritis (RA) refractory or intolerant to standard disease-modifying antirheumatic drugs and tumor necrosis factor inhibitors to GP2013 (Sandoz) or rituximab (Genentech/Biogen Idec). After week 24, 67.4% of patients in the GP2013 group and 64.4% of patients in the rituximab group received a second treatment course, results showed.

Josef Smolen, MD, of the department of rheumatology and internal medicine at University Hospital in Wien, Austria, and colleagues collected efficacy and pharmacodynamics data at week 52, whereas safety follow-up ended 24 weeks after the last infusion of study medication. Researchers applied a validated in-house enzyme-linked immunosorbent assay (ELISA) method for binding antidrug antibodies for antidrug antibody assessment.

Results showed GP2013 and rituximab demonstrated pharmacokinetic bioequivalence, as well as equivalence of peripheral B-cell depletion. At week 24, researchers noted DAS28 demonstrated noninferiority to reference rituximab change from baseline. Both groups experienced a similar number of adverse events, serious adverse events and potential infusion-related reactions, according to results. Researchers found 11% of patients in the GP2013 group developed antidrug antibodies vs. 21.4% of patients in the rituximab group. – by Casey Tingle

Reference:

Smolen J, et al. Abstract #FRI0222. Presented at: EULAR Annual Congress; June 8-11, 2016; London.

Disclosure: Smolen receives grant or research support from AbbVie, Janssen, Lilly, Merck, Pfizer and Roche; and is a consultant for AbbVie, Amgen, AstraZeneca, Astro, Celgene, Celtrion, Glaxo, ILTOO, Janssen, Lilly, Medimmune, Merck, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi and UCB. Please see the full study for a list of all other authors’ relevant financial disclosures.