PMID- 31777801
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220411
IS  - 2578-5745 (Electronic)
IS  - 2578-5745 (Linking)
VI  - 1
IP  - 4
DP  - 2019 Jun
TI  - Safety of Abatacept Versus Placebo in Rheumatoid Arthritis: Integrated Data 
      Analysis of Nine Clinical Trials.
PG  - 251-257
LID - 10.1002/acr2.1034 [doi]
AB  - OBJECTIVE: To assess the safety of abatacept treatment in rheumatoid arthritis 
      (RA) using integrated data from multiple clinical trials. METHODS: Data from nine 
      double-blind, placebo-controlled studies of abatacept treatment (seven 
      intravenous, two subcutaneous) in patients with RA were pooled, focusing on 
      safety events in the double-blind treatment period of each study. Incidence rates 
      (IRs) of adverse events (AEs) per 100 patient-years of exposure were calculated 
      for abatacept- and placebo-treated patients. AEs in abatacept-treated patients 
      were combined regardless of dose and formulation. RESULTS: In total, 2653 
      patients received abatacept and 1485 received placebo, with 2357 and 1254 
      patient-years of exposure, respectively. The mean (SD) durations of exposure in 
      the abatacept and placebo groups were 10.8 (3.3) and 10.3 (3.5) months, 
      respectively. The IRs (95% confidence interval [CI]) for serious AEs were 14.8 
      (13.3, 16.5) and 14.6 (12.5, 17.0) in the abatacept and placebo groups, 
      respectively. Death occurred in 12 (0.5%) and 12 (0.8%) patients in the abatacept 
      and placebo groups, respectively, and was most commonly caused by cardiac 
      disorders. Malignancies were observed in 31 patients (1.2%) treated with 
      abatacept (IR: 1.32 [95% CI: 0.90, 1.87]) versus 14 (0.9%; IR: 1.12 [0.61, 1.88]) 
      who received placebo. Solid organ tumor was the most frequent malignancy reported 
      in both groups (abatacept: 1.0%; IR: 1.11 [95% CI: 0.72, 1.62]; placebo: 0.8%; 
      0.96 [0.50, 1.67]). CONCLUSION: In this integrated analysis, the IRs of safety 
      events in the abatacept and placebo groups were similar with no new safety 
      concerns identified.
CI  - (c) 2019 Bristol Myers Squibb. ACR Open Rheumatology published by Wiley 
      Periodicals, Inc. on behalf of American College of Rheumatology.
FAU - Simon, Teresa A
AU  - Simon TA
AUID- ORCID: 0000-0003-4042-0715
AD  - Bristol-Myers Squibb Princeton New Jersey.
FAU - Soule, Benjamin P
AU  - Soule BP
AD  - Bristol-Myers Squibb Princeton New Jersey.
FAU - Hochberg, Marc
AU  - Hochberg M
AD  - University of Maryland Baltimore.
FAU - Fleming, Douglas
AU  - Fleming D
AD  - Bristol-Myers Squibb Princeton New Jersey.
FAU - Torbeyns, Anne
AU  - Torbeyns A
AD  - Bristol-Myers Squibb Braine-l'Alleud Belgium.
FAU - Banerjee, Subhashis
AU  - Banerjee S
AD  - Bristol-Myers Squibb Princeton New Jersey.
FAU - Boers, Maarten
AU  - Boers M
AUID- ORCID: 0000-0002-6969-283X
AD  - Amsterdam University Medical Centers Vrije Universiteit Amsterdam Netherlands.
LA  - eng
PT  - Journal Article
DEP - 20190529
PL  - United States
TA  - ACR Open Rheumatol
JT  - ACR open rheumatology
JID - 101740025
PMC - PMC6858048
EDAT- 2019/11/30 06:00
MHDA- 2019/11/30 06:01
PMCR- 2019/05/29
CRDT- 2019/11/29 06:00
PHST- 2019/11/29 06:00 [entrez]
PHST- 2019/11/30 06:00 [pubmed]
PHST- 2019/11/30 06:01 [medline]
PHST- 2019/05/29 00:00 [pmc-release]
AID - ACR21034 [pii]
AID - 10.1002/acr2.1034 [doi]
PST - epublish
SO  - ACR Open Rheumatol. 2019 May 29;1(4):251-257. doi: 10.1002/acr2.1034. eCollection 
      2019 Jun.