PMID- 30295429
OWN - NLM
STAT- MEDLINE
DCOM- 20191014
LR  - 20191014
IS  - 2151-4658 (Electronic)
IS  - 2151-464X (Linking)
VI  - 71
IP  - 1
DP  - 2019 Jan
TI  - Brief Report: Safety and Immunogenicity of Rituximab Biosimilar GP 2013 After 
      Switch From Reference Rituximab in Patients With Active Rheumatoid Arthritis.
PG  - 88-94
LID - 10.1002/acr.23771 [doi]
AB  - OBJECTIVE: Comparable clinical efficacy of the rituximab (RTX) biosimilar GP2013 
      and reference RTX has been established in blinded randomized trials. However, 
      when switching from a reference biologic to a biosimilar, potential safety 
      implications are often an important consideration. Therefore, the aim of this 
      study was to evaluate the safety of switching from reference RTX to RTX 
      biosimilar GP2013 compared with treatment continuation with reference RTX in 
      patients with rheumatoid arthritis (RA). METHODS: In this multinational, 
      randomized, double-blind, parallel-group safety study, 107 patients with RA who 
      had previously received treatment (of any duration) with reference RTX as part of 
      routine practice and who required continuation of treatment were randomized to 
      receive either GP2013 or to continue treatment with reference RTX. All patients 
      received a stable dosage of methotrexate and folic acid during the study. Study 
      assessments included the incidence of hypersensitivity, infusion-related and 
      anaphylactic reactions, immunogenicity (antidrug antibodies), and general safety. 
      RESULTS: Regardless of whether patients switched to GP2013 or continued treatment 
      with reference RTX, the incidences of hypersensitivity (9.4% and 11.1%, 
      respectively) and infusion-related reactions (11.3% and 18.5%, respectively) were 
      similarly low. Only 1 patient (in the reference RTX group) developed antidrug 
      antibodies to RTX after starting study treatment. No neutralizing antidrug 
      antibodies were observed. Antidrug antibodies were not associated with adverse 
      events (AEs). No clinically meaningful differences in the rate of AEs were 
      observed between treatment groups. CONCLUSION: No safety risks were detected when 
      patients switched from reference RTX to GP2013. The safety profiles of patients 
      in both treatment groups were similar, although the study was not powered for 
      statistical testing of equivalence in safety.
CI  - (c) 2018, American College of Rheumatology.
FAU - Tony, Hans-Peter
AU  - Tony HP
AD  - University of Wuerzburg, Wuerzburg, Germany.
FAU - Kruger, Klaus
AU  - Kruger K
AD  - Rheumatologisches Praxiszentrum, Munich, Germany.
FAU - Cohen, Stanley B
AU  - Cohen SB
AD  - Metroplex Clinical Research Center, Dallas, Texas.
FAU - Schulze-Koops, Hendrik
AU  - Schulze-Koops H
AD  - Ludwig Maximilian University of Munich, Munich, Germany.
FAU - Kivitz, Alan J
AU  - Kivitz AJ
AD  - Altoona Center for Clinical Research, Duncansville, Pennsylvania.
FAU - Jeka, Slawomir
AU  - Jeka S
AD  - University Hospital, Bydgoszcz, Poland.
FAU - Vereckei, Edit
AU  - Vereckei E
AD  - The National Institute of Rheumatology and Physiotherapy, Budapest, Hungary.
FAU - Cen, Liyi
AU  - Cen L
AD  - Sandoz (a Novartis Division), Holzkirchen, Germany.
FAU - Kring, Laura
AU  - Kring L
AD  - Sandoz (a Novartis Division), Holzkirchen, Germany.
FAU - Kollins, Dmitrij
AU  - Kollins D
AD  - Sandoz (a Novartis Division), Holzkirchen, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT02514772
GR  - Hexal AG, a Sandoz Company/International
GR  - Sandoz (US)/International
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Arthritis Care Res (Hoboken)
JT  - Arthritis care & research
JID - 101518086
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 4F4X42SYQ6 (Rituximab)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anaphylaxis/chemically induced
MH  - Antirheumatic Agents/*administration & dosage/adverse effects
MH  - Arthritis, Rheumatoid/*drug therapy/epidemiology
MH  - Biosimilar Pharmaceuticals/*administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Drug Substitution/adverse effects/*methods/trends
MH  - Female
MH  - Humans
MH  - Immunogenetic Phenomena/drug effects/physiology
MH  - Infusions, Intravenous
MH  - *Internationality
MH  - Male
MH  - Middle Aged
MH  - Rituximab/*administration & dosage/adverse effects
MH  - Young Adult
EDAT- 2018/10/09 06:00
MHDA- 2019/10/15 06:00
CRDT- 2018/10/09 06:00
PHST- 2018/05/21 00:00 [received]
PHST- 2018/09/25 00:00 [accepted]
PHST- 2018/10/09 06:00 [pubmed]
PHST- 2019/10/15 06:00 [medline]
PHST- 2018/10/09 06:00 [entrez]
AID - 10.1002/acr.23771 [doi]
PST - ppublish
SO  - Arthritis Care Res (Hoboken). 2019 Jan;71(1):88-94. doi: 10.1002/acr.23771.