PMID- 31087226
OWN - NLM
STAT- MEDLINE
DCOM- 20200501
LR  - 20200501
IS  - 1434-9949 (Electronic)
IS  - 0770-3198 (Linking)
VI  - 38
IP  - 10
DP  - 2019 Oct
TI  - Efficacy and safety of secukinumab in active rheumatoid arthritis with an 
      inadequate response to tumor necrosis factor inhibitors: a meta-analysis of phase 
      III randomized controlled trials.
PG  - 2765-2776
LID - 10.1007/s10067-019-04595-1 [doi]
AB  - OBJECTIVES: To address the efficacy and safety of secukinumab in comparison with 
      placebo in active rheumatoid arthritis (RA) patients who had an inadequate 
      response to tumor necrosis factor (TNF) inhibitors. METHODS: Databases of PubMed, 
      Embase, and Web of Science were searched to identify the relevant randomized 
      controlled trials (RCTs). Risk ratio (RR) and 95% confidence interval (95% CI) 
      were calculated with the Mantel-Haenszel random effects method. Statistical 
      heterogeneity was assessed using the Cochran Q and I(2) tests. RESULTS: A total 
      of 1292 patients from three phase III RCT studies were included. Compared with 
      placebo, secukinumab 150 mg was superior at 24 weeks in terms of ACR20 with RR 
      (1.66, 95% CI 1.33, 2.08; P < 0.0001; I(2) = 0%), ACR50 (1.88, 95% CI 1.29, 2.72; 
      P = 0.0009; I(2) = 0%), and ACR70 (2.15, 95% CI 1.15, 4.02; P = 0.02; I(2) = 0%). 
      Consistent effects were also observed in pooled group of 150 mg and 75 mg 
      secukinumab. For secukinumab 75 mg alone, ACR20 response rate was significantly 
      higher compared with placebo (RR 1.62, 95% CI 1.29, 2.03; P < 0.00001; 
      I(2) = 0%). Although ACR50 and ACR70 response rates showed a favorable trend to 
      be higher, no statistical difference was observed (RR 1.68, 95% CI 0.99, 2.85, 
      P = 0.05, I(2) = 47%; RR 1.81, 95% CI 0.78, 4.21, P = 0.17, I(2) = 34%, 
      respectively). Compared with the placebo group, there was no increased risk of 
      adverse effects (AEs) and serious AEs at 16 weeks in the pooled secukinumab 
      group. CONCLUSIONS: In active RA patients with an inadequate response to TNF 
      inhibitors, secukinumab may be a therapeutic option. Secukinumab 150 mg showed 
      significantly better clinical efficacy with no increased risk of AEs and serious 
      AEs compared with placebo. TRIAL REGISTRATION: Clinical Trials.gov identifier: 
      NCT01770379, NCT01350804, NCT01377012 Key Points * Secukinumab 150 mg showed 
      significantly better clinical efficacy in active RA patients with an inadequate 
      response to TNF inhibitors. * No increased risk of AEs and serious AEs in 
      secukinumab group compared with placebo.
FAU - Huang, Yanrong
AU  - Huang Y
AD  - Department of Rheumatology and Clinical Immunology, Peking University First 
      Hospital, No.8, Xishiku Street, West District, Beijing, 100034, China.
FAU - Fan, Yong
AU  - Fan Y
AD  - Department of Rheumatology and Clinical Immunology, Peking University First 
      Hospital, No.8, Xishiku Street, West District, Beijing, 100034, China.
FAU - Liu, Yang
AU  - Liu Y
AD  - Department of Orthopedics, Clinical Sciences, Lund University, 22185, Lund, 
      Sweden.
FAU - Xie, Wenhui
AU  - Xie W
AD  - Department of Rheumatology and Clinical Immunology, Peking University First 
      Hospital, No.8, Xishiku Street, West District, Beijing, 100034, China.
FAU - Zhang, Zhuoli
AU  - Zhang Z
AD  - Department of Rheumatology and Clinical Immunology, Peking University First 
      Hospital, No.8, Xishiku Street, West District, Beijing, 100034, China. 
      zhuoli.zhang@126.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT01770379
SI  - ClinicalTrials.gov/NCT01350804
SI  - ClinicalTrials.gov/NCT01377012
GR  - 81771740/National Natural Science Foundation of China/
GR  - 2010CB529100/National Science Technology Pillar Program of China/
GR  - 2011-4021-03/Capital Health Research and Development of Special Fund Program/
GR  - PUCRP201305/Peking University Clinical Research Program/
PT  - Comparative Study
PT  - Journal Article
PT  - Meta-Analysis
PT  - Systematic Review
DEP - 20190514
PL  - Germany
TA  - Clin Rheumatol
JT  - Clinical rheumatology
JID - 8211469
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Biological Products)
RN  - 0 (Tumor Necrosis Factor Inhibitors)
RN  - DLG4EML025 (secukinumab)
SB  - IM
MH  - Antibodies, Monoclonal, Humanized/adverse effects/*therapeutic use
MH  - Antirheumatic Agents/therapeutic use
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Biological Products/therapeutic use
MH  - Clinical Trials, Phase III as Topic
MH  - Humans
MH  - Patient Safety
MH  - Randomized Controlled Trials as Topic
MH  - Risk
MH  - Treatment Outcome
MH  - Tumor Necrosis Factor Inhibitors/adverse effects/*therapeutic use
OTO - NOTNLM
OT  - Efficacy and safety
OT  - Rheumatoid arthritis
OT  - Secukinumab
OT  - Tumor necrosis factor inhibitors
EDAT- 2019/05/16 06:00
MHDA- 2020/05/02 06:00
CRDT- 2019/05/16 06:00
PHST- 2019/01/16 00:00 [received]
PHST- 2019/05/06 00:00 [accepted]
PHST- 2019/04/21 00:00 [revised]
PHST- 2019/05/16 06:00 [pubmed]
PHST- 2020/05/02 06:00 [medline]
PHST- 2019/05/16 06:00 [entrez]
AID - 10.1007/s10067-019-04595-1 [pii]
AID - 10.1007/s10067-019-04595-1 [doi]
PST - ppublish
SO  - Clin Rheumatol. 2019 Oct;38(10):2765-2776. doi: 10.1007/s10067-019-04595-1. Epub 
      2019 May 14.