PMID- 32699904
OWN - NLM
STAT- MEDLINE
DCOM- 20210416
LR  - 20210416
IS  - 1462-0332 (Electronic)
IS  - 1462-0324 (Linking)
VI  - 60
IP  - 1
DP  - 2021 Jan 5
TI  - Efficacy and safety of Sandoz biosimilar rituximab for active rheumatoid 
      arthritis: 52-week results from the randomized controlled ASSIST-RA trial.
PG  - 256-262
LID - 10.1093/rheumatology/keaa234 [doi]
AB  - 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(R)) 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.
CI  - (c) 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.
FAU - Smolen, Josef S
AU  - Smolen JS
AD  - Department of Rheumatology, Medical University of Vienna, Vienna, Austria.
FAU - Cohen, Stanley B
AU  - Cohen SB
AD  - Department of Rheumatology, Metroplex Clinical Research Center, Dallas, TX, USA.
FAU - Tony, Hans-Peter
AU  - Tony HP
AD  - Department of Internal Medicine, Rheumatology/Clinical Immunology, University 
      Hospital of Wuerzburg, Wuerzburg, Germany.
FAU - Scheinberg, Morton
AU  - Scheinberg M
AD  - Rheumatology Section, Orthopedic Department, Hospital Israelita Albert Einstein, 
      Sao Paulo, Brazil.
FAU - Kivitz, Alan
AU  - Kivitz A
AD  - Altoona Center for Clinical Research, Altoona Arthritis and Osteoporosis Center, 
      Duncansville, PA, USA.
FAU - Balanescu, Andra
AU  - Balanescu A
AD  - Sf. Maria Hospital, Carol Davila University of Medicine and Pharmacy, Bucharest, 
      Romania.
FAU - Gomez-Reino, Juan
AU  - Gomez-Reino J
AD  - Fundacion IDIS, Hospital Clinico Universitario, Santiago, Spain.
FAU - Cen, Liyi
AU  - Cen L
AD  - Biostatistics Biosimilars Analytics, Novartis Pharmaceuticals Corp, East Hanover, 
      NJ, USA.
FAU - Poetzl, Johann
AU  - Poetzl J
AD  - Biosimilar Clinical Development, Hexal AG, Holzkirchen, Germany.
FAU - Shisha, Tamas
AU  - Shisha T
AD  - Translational Medicine, Novartis Institute of Biomedical Research, Basel, 
      Switzerland.
FAU - Kollins, Dmitrij
AU  - Kollins D
AD  - Biosimilar Clinical Development, Hexal AG, Holzkirchen, Germany.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Rheumatology (Oxford)
JT  - Rheumatology (Oxford, England)
JID - 100883501
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 4F4X42SYQ6 (Rituximab)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Antirheumatic Agents/adverse effects/immunology/*therapeutic use
MH  - Arthritis, Rheumatoid/*drug therapy/immunology
MH  - B-Lymphocytes/cytology
MH  - Biosimilar Pharmaceuticals/adverse effects/*therapeutic use
MH  - Drug Therapy, Combination/methods
MH  - Humans
MH  - Methotrexate/therapeutic use
MH  - Remission Induction
MH  - Rituximab/adverse effects/immunology/*therapeutic use
MH  - Therapeutic Equivalency
MH  - Time Factors
OTO - NOTNLM
OT  - bioequivalence
OT  - biosimilar
OT  - efficacy
OT  - immunogenicity
OT  - pharmacodynamics
OT  - rheumatoid arthritis
OT  - rituximab
OT  - safety
EDAT- 2020/07/24 06:00
MHDA- 2021/04/17 06:00
CRDT- 2020/07/24 06:00
PHST- 2019/11/20 00:00 [received]
PHST- 2020/04/03 00:00 [revised]
PHST- 2020/07/24 06:00 [pubmed]
PHST- 2021/04/17 06:00 [medline]
PHST- 2020/07/24 06:00 [entrez]
AID - 5875396 [pii]
AID - 10.1093/rheumatology/keaa234 [doi]
PST - ppublish
SO  - Rheumatology (Oxford). 2021 Jan 5;60(1):256-262. doi: 
      10.1093/rheumatology/keaa234.