Efficacy and safety of Sandoz biosimilar rituximab for active rheumatoid arthritis: 52-week results from the randomized controlled ASSIST-RA trial.

Autor:	Smolen JS; Department of Rheumatology, Medical University of Vienna, Vienna, Austria., Cohen SB; Department of Rheumatology, Metroplex Clinical Research Center, Dallas, TX, USA., Tony HP; Department of Internal Medicine, Rheumatology/Clinical Immunology, University Hospital of Wuerzburg, Wuerzburg, Germany., Scheinberg M; Rheumatology Section, Orthopedic Department, Hospital Israelita Albert Einstein, Sao Paulo, Brazil., Kivitz A; Altoona Center for Clinical Research, Altoona Arthritis and Osteoporosis Center, Duncansville, PA, USA., Balanescu A; Sf. Maria Hospital, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania., Gomez-Reino J; Fundacion IDIS, Hospital Clinico Universitario, Santiago, Spain., Cen L; Biostatistics Biosimilars Analytics, Novartis Pharmaceuticals Corp, East Hanover, NJ, USA., Poetzl J; Biosimilar Clinical Development, Hexal AG, Holzkirchen, Germany., Shisha T; Translational Medicine, Novartis Institute of Biomedical Research, Basel, Switzerland., Kollins D; Biosimilar Clinical Development, Hexal AG, Holzkirchen, Germany.
Jazyk:	angličtina
Zdroj:	Rheumatology (Oxford, England) [Rheumatology (Oxford)] 2021 Jan 05; Vol. 60 (1), pp. 256-262.
DOI:	10.1093/rheumatology/keaa234
Abstrakt:	Objectives: This report provides data for the extent of B cell depletion and recovery, efficacy, safety and immunogenicity of Sandoz rituximab (SDZ-RTX; GP2013; Rixathon®) compared with reference rituximab (Ref-RTX) up to week 52 of the ASSIST-RA study. Methods: Patients were randomized to SDZ-RTX or Ref-RTX in combination with methotrexate according to the RTX label. The primary endpoint was analysed at week 24. Responders (28-joint DAS [DAS28] decrease from baseline >1.2) at week 24 with residual disease activity (DAS28 ≥2.6) were eligible for a second treatment course between week 24 and 52. Endpoints after week 24 included change from baseline in peripheral B cells, DAS28, ACR 20% response rate (ACR20), Clinical and Simplified Disease Activity Indexes (CDAI, SDAI) and HAQ disability index (HAQ-DI). Safety and immunogenicity were assessed by the incidence of adverse events and antidrug antibodies. Results: Primary and secondary endpoints up to week 24 were met. Overall, 260/312 randomized patients completed treatment up to week 52. SDZ-RTX resulted in B cell concentrations over time similar to Ref-RTX. The efficacy of SDZ-RTX was similar to Ref-RTX up to week 52, as measured by DAS28, ACR20/50/70, CDAI, SDAI and HAQ-DI. Safety of SDZ-RTX was similar to Ref-RTX regarding frequency, type and severity of adverse events, which were consistent with the known Ref-RTX safety profile. The incidence of antidrug antibodies was low and transient similarly across treatment groups. Conclusion: SDZ-RTX demonstrated similar B cell concentrations over time, efficacy, safety and immunogenicity to Ref-RTX over 52 weeks of the ASSIST-RA study. (© The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
Databáze:	MEDLINE
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