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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

Huang, Yanrong; Fan, Yong; Liu, Yang LU ; Xie, Wenhui and Zhang, Zhuoli (2019) In Clinical Rheumatology
Abstract


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... (More)


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.

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author
organization
publishing date
type
Contribution to journal
publication status
epub
subject
keywords
Efficacy and safety, Rheumatoid arthritis, Secukinumab, Tumor necrosis factor inhibitors
in
Clinical Rheumatology
publisher
Springer
external identifiers
  • scopus:85065643643
ISSN
0770-3198
DOI
10.1007/s10067-019-04595-1
language
English
LU publication?
yes
id
8b47129d-eea3-4c5a-acdf-e4c82b4f4752
date added to LUP
2019-06-17 11:54:09
date last changed
2019-06-19 04:16:43
@article{8b47129d-eea3-4c5a-acdf-e4c82b4f4752,
  abstract     = {<p><br>
                                                         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                             <br>
                            <sup>2</sup><br>
                                                          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 &lt; 0.0001; I                             <br>
                            <sup>2</sup><br>
                                                          = 0%), ACR50 (1.88, 95% CI 1.29, 2.72; P = 0.0009; I                             <br>
                            <sup>2</sup><br>
                                                          = 0%), and ACR70 (2.15, 95% CI 1.15, 4.02; P = 0.02; I                             <br>
                            <sup>2</sup><br>
                                                          = 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 &lt; 0.00001; I                             <br>
                            <sup>2</sup><br>
                                                          = 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                             <br>
                            <sup>2</sup><br>
                                                          = 47%; RR 1.81, 95% CI 0.78, 4.21, P = 0.17, I                             <br>
                            <sup>2</sup><br>
                                                          = 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.                         <br>
                        </p>},
  author       = {Huang, Yanrong and Fan, Yong and Liu, Yang and Xie, Wenhui and Zhang, Zhuoli},
  issn         = {0770-3198},
  keyword      = {Efficacy and safety,Rheumatoid arthritis,Secukinumab,Tumor necrosis factor inhibitors},
  language     = {eng},
  publisher    = {Springer},
  series       = {Clinical Rheumatology},
  title        = {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},
  url          = {http://dx.doi.org/10.1007/s10067-019-04595-1},
  year         = {2019},
}