PMID- 31446557
OWN - NLM
STAT- MEDLINE
DCOM- 20200217
LR  - 20200217
IS  - 1179-190X (Electronic)
IS  - 1173-8804 (Linking)
VI  - 33
IP  - 5
DP  - 2019 Oct
TI  - Comparative Efficacy and Safety of Biosimilar Rituximab and Originator Rituximab 
      in Rheumatoid Arthritis and Non-Hodgkin's Lymphoma: A Systematic Review and 
      Meta-analysis.
PG  - 469-483
LID - 10.1007/s40259-019-00376-z [doi]
AB  - BACKGROUND: Rituximab is a biologic medicine widely used for the treatment of 
      autoimmune diseases and lymphoma. Several biosimilars of rituximab have been 
      developed and marketed with the expiration of the originator rituximab's patent; 
      thus, systematic combination and analysis of the latest data on the efficacy and 
      safety of biosimilars and the demonstration of the interchangeability of 
      biosimilar agents are required. OBJECTIVE: The objective of this study was to 
      collate available data from head-to-head randomized controlled trials (RCTs) and 
      evaluate the efficacy and safety of biosimilar rituximab compared with the 
      reference drug in patients with rheumatoid arthritis (RA) and non-Hodgkin's 
      lymphoma (NHL). METHODS: The PubMed, EMBASE, Cochrane Library, and Google Scholar 
      databases were searched to identify head-to-head RCTs that directly compare the 
      efficacy and safety of biosimilar rituximab and its originator. The efficacy 
      outcome for RA was the American College of Rheumatology (ACR) response rates and 
      the outcome for NHL was the response rate. The occurrence of adverse events (AEs) 
      and anti-drug antibodies (ADAs) were evaluated for the safety outcome. Data on 
      the pharmacokinetic profile were also included as a secondary outcome. RESULTS: 
      Eleven head-to-head RCTs with 3163 patients were included (1744 patients with RA 
      and 1419 patients with NHL). Biosimilars of rituximab showed similar efficacy in 
      the clinical response in both RA and NHL. The pooled risk ratio (RR) of the ACR 
      20% response rate (ACR20) response in patients with RA at weeks 24 and 48 was 
      0.99 (p = 0.70, 95% confidence interval [CI] 0.92-1.06) and 1.04 (p = 0.73, 95% 
      CI 0.83-1.31), respectively. The pooled RR of the overall response at week 24 in 
      NHL patients was 1.02 (p = 0.31, 95% CI 0.98-1.07). No significant differences 
      were found in the formation of ADAs (RR 0.86, p = 0.20, 95% CI 0.68-1.08) or AEs 
      (RR 1.04, p = 0.30, 95% CI 0.97-1.12). CONCLUSION: This systematic review and 
      conventional meta-analysis demonstrated the overall similarity of the long-term 
      efficacy and safety of biosimilar rituximab to those of originator rituximab in 
      RA and NHL patients by combining direct evidence from head-to-head trials. 
      PROSPERO registration No. CRD42019125138.
FAU - Lee, Soohyun
AU  - Lee S
AUID- ORCID: 0000-0002-4798-2545
AD  - Department of Health, Social and Clinical Pharmacy, College of Pharmacy, 
      Chung-Ang University, 84, Heukseokro, Dongjak-gu, Seoul, 156-756, South Korea.
FAU - Lee, Heeyoung
AU  - Lee H
AD  - College of Pharmacy, Gachon University, Inchon, South Korea.
FAU - Kim, EunYoung
AU  - Kim E
AUID- ORCID: 0000-0003-3525-8805
AD  - Department of Health, Social and Clinical Pharmacy, College of Pharmacy, 
      Chung-Ang University, 84, Heukseokro, Dongjak-gu, Seoul, 156-756, South Korea. 
      eykimjcb777@cau.ac.kr.
LA  - eng
GR  - NRF-2018R1D1A1B07046564/Ministry of Education/
PT  - Comparative Study
PT  - Journal Article
PT  - Meta-Analysis
PT  - Systematic Review
PL  - New Zealand
TA  - BioDrugs
JT  - BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy
JID - 9705305
RN  - 0 (Antineoplastic Agents, Immunological)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 4F4X42SYQ6 (Rituximab)
SB  - IM
MH  - Antineoplastic Agents, Immunological/adverse effects/pharmacokinetics/therapeutic 
      use
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Biosimilar Pharmaceuticals/adverse effects/pharmacokinetics/*therapeutic use
MH  - Humans
MH  - Lymphoma, Non-Hodgkin/*drug therapy
MH  - Randomized Controlled Trials as Topic
MH  - Rituximab/adverse effects/pharmacokinetics/*therapeutic use
MH  - Treatment Outcome
EDAT- 2019/08/26 06:00
MHDA- 2020/02/18 06:00
CRDT- 2019/08/26 06:00
PHST- 2019/08/26 06:00 [pubmed]
PHST- 2020/02/18 06:00 [medline]
PHST- 2019/08/26 06:00 [entrez]
AID - 10.1007/s40259-019-00376-z [pii]
AID - 10.1007/s40259-019-00376-z [doi]
PST - ppublish
SO  - BioDrugs. 2019 Oct;33(5):469-483. doi: 10.1007/s40259-019-00376-z.