PMID- 33090385
OWN - NLM
STAT- MEDLINE
DCOM- 20210629
LR  - 20210629
IS  - 2284-0729 (Electronic)
IS  - 1128-3602 (Linking)
VI  - 24
IP  - 19
DP  - 2020 Oct
TI  - The comparative safety of biological treatment in patients with axial 
      spondylarthritis: a meta-analysis of randomized controlled trials with placebo.
PG  - 9824-9836
LID - 23192 [pii]
LID - 10.26355/eurrev_202010_23192 [doi]
AB  - OBJECTIVE: To evaluate the comparative safety of biological treatment in patients 
      with axial spondyloarthritis (axSpA) enrolled in randomized controlled trials 
      (RCTs) with placebo. MATERIALS AND METHODS: Studies were systematically retrieved 
      from the Web of Science, PubMed, Cochrane Library, and Embase databases. The last 
      search was performed on 8 June 2020. The primary outcome measures were adverse 
      events (AEs), serious AEs, infection, serious infection, and discontinuation due 
      to AEs. This study was performed in accordance with the Preferred Reporting Items 
      for Systematic Reviews and Meta-Analyses guidelines. RESULTS: A total of 
      twenty-two trials, including 2599 participants treated with biologics and 1547 
      participants treated with placebo, met the inclusion criteria. There was a 
      significantly higher risk of infection, AEs, and discontinuation due to AEs in 
      the biologics groups compared to the placebo groups [risk ratio (RR) = 1.38, 95% 
      confidence interval (95% CI) = 1.22-1.57, p < 0.01; RR = 1.17, 95% CI = 
      1.10-1.25, p < 0.01; and RR = 1.72, 95% CI = 1.03-2.87, p = 0.04, respectively], 
      and low heterogeneity was found among the included studies (I2 = 0%, p = 0. 49; 
      I2 = 29%, p = 0.10; and I2 = 0%, p = 0.79, respectively). The risk of serious 
      infection and serious AEs was not significantly different between axSpA patients 
      treated with biologics and those treated with placebo [RR = 1.62, 95% CI = 
      0.54-4.90, p = 0.39 and RR = 1.17, 95% CI = 0.79-1.73, p = 0.44]. Low 
      heterogeneity was found among the included studies (I2 = 0%, p = 0.94 and I2 = 
      0%, p = 0.69). The subgroup analyses based on tumour necrosis factor inhibitors 
      and interleukin antagonists did not yield significant differences. CONCLUSIONS: 
      This meta-analysis is the first comprehensive assessment of the safety of various 
      biological agents in axSpA patients. The use of biological agents in axSpA is 
      generally safe and tolerable.
FAU - Sun, W-T
AU  - Sun WT
AD  - Graduate School, Beijing University of Chinese Medicine, Beijing, China. 
      fanson@pku.edu.cn.
FAU - He, Y-H
AU  - He YH
FAU - Dong, M-M
AU  - Dong MM
FAU - Zhang, Y-N
AU  - Zhang YN
FAU - Peng, K-X
AU  - Peng KX
FAU - Zhang, Y-M
AU  - Zhang YM
FAU - Lin, Y-D
AU  - Lin YD
FAU - Yang, C
AU  - Yang C
FAU - Peng, P-X
AU  - Peng PX
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Meta-Analysis
PL  - Italy
TA  - Eur Rev Med Pharmacol Sci
JT  - European review for medical and pharmacological sciences
JID - 9717360
RN  - 0 (Biological Factors)
SB  - IM
MH  - Biological Factors/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Randomized Controlled Trials as Topic
MH  - Software
MH  - Spondylarthritis/*drug therapy
EDAT- 2020/10/23 06:00
MHDA- 2021/06/30 06:00
CRDT- 2020/10/22 12:19
PHST- 2020/10/22 12:19 [entrez]
PHST- 2020/10/23 06:00 [pubmed]
PHST- 2021/06/30 06:00 [medline]
AID - 23192 [pii]
AID - 10.26355/eurrev_202010_23192 [doi]
PST - ppublish
SO  - Eur Rev Med Pharmacol Sci. 2020 Oct;24(19):9824-9836. doi: 
      10.26355/eurrev_202010_23192.