Wirksamkeit und Sicherheit von Methotrexat plus Certolizumab Pegol vs. MTX plus Placebo bei aktiver rheumatoider Arthritis: Metaanalyse randomisierter kontrollierter Studien

Translated title of the contribution: Efficacy and safety of methotrexate plus certolizumab pegol or placebo in active rheumatoid arthritis: Meta-analysis of randomized controlled trials

Young Ho Lee, S. C. Bae

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Objectives: This study aimed to assess the relative efficacy and safety of certolizumab pegol (CZP) 200 and 400 mg + methotrexate (MTX) compared to placebo + MTX in patients with active rheumatoid arthritis (RA). Methods: We performed a Bayesian network meta-analysis to combine the direct and indirect evidence from randomized controlled trials (RCTs) examining the efficacy and safety of CZP 200 and 400 mg + MTX and placebo + MTX (MTX group) in patients with active RA despite receiving MTX or a disease-modifying antirheumatic drug (DMARD). Results: Six RCTs (30349 patients) met the inclusion criteria. The ACR20 response rate was significantly higher in the CZP 200 and 400 mg + MTX group than in the MTX group (OR 7.30, 95 % credible interval [CrI] 3.31–16.92 and OR 5.48, 95 % CrI 2.98–10.30, respectively). CZP 400 mg + MTX tended to be more efficacious than CZP 200 mg + MTX (OR 1.33, 95 % CrI 0.61–2.97). A surface under the cumulative ranking curve (SUCRA)-based ranking probability indicated that CZP 400 mg + MTX had the highest probability of achieving the ACR20 response rate, followed by CZP 200 mg + MTX and MTX (SUCRA = 0.9007, 0.7156, and 0.0002, respectively). The ACR20, 50, and 70 response rate distributions were comparable. However, the safety based on the number of adverse event (AE)-related withdrawals did not differ significantly among the three interventions. Conclusions: CZP, at dosages of 200 and 400 mg, in combination with MTX, was the efficacious intervention for active RA without causing a significant risk of AE-related withdrawals.

Original languageGerman
Pages (from-to)528-534
Number of pages7
JournalZeitschrift fur Rheumatologie
Volume76
Issue number6
DOIs
Publication statusPublished - 2017 Aug 1

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Methotrexate
Meta-Analysis
Rheumatoid Arthritis
Randomized Controlled Trials
Placebos
Safety
Antirheumatic Agents
Certolizumab Pegol

Keywords

  • Bayesian network meta-analysis
  • Drug side effects
  • Evidence-based medicine
  • Immunosuppressive agents
  • Placebo effect

ASJC Scopus subject areas

  • Rheumatology

Cite this

@article{702dc69cd8864115b03e4988c0f6c8c5,
title = "Wirksamkeit und Sicherheit von Methotrexat plus Certolizumab Pegol vs. MTX plus Placebo bei aktiver rheumatoider Arthritis: Metaanalyse randomisierter kontrollierter Studien",
abstract = "Objectives: This study aimed to assess the relative efficacy and safety of certolizumab pegol (CZP) 200 and 400 mg + methotrexate (MTX) compared to placebo + MTX in patients with active rheumatoid arthritis (RA). Methods: We performed a Bayesian network meta-analysis to combine the direct and indirect evidence from randomized controlled trials (RCTs) examining the efficacy and safety of CZP 200 and 400 mg + MTX and placebo + MTX (MTX group) in patients with active RA despite receiving MTX or a disease-modifying antirheumatic drug (DMARD). Results: Six RCTs (30349 patients) met the inclusion criteria. The ACR20 response rate was significantly higher in the CZP 200 and 400 mg + MTX group than in the MTX group (OR 7.30, 95 {\%} credible interval [CrI] 3.31–16.92 and OR 5.48, 95 {\%} CrI 2.98–10.30, respectively). CZP 400 mg + MTX tended to be more efficacious than CZP 200 mg + MTX (OR 1.33, 95 {\%} CrI 0.61–2.97). A surface under the cumulative ranking curve (SUCRA)-based ranking probability indicated that CZP 400 mg + MTX had the highest probability of achieving the ACR20 response rate, followed by CZP 200 mg + MTX and MTX (SUCRA = 0.9007, 0.7156, and 0.0002, respectively). The ACR20, 50, and 70 response rate distributions were comparable. However, the safety based on the number of adverse event (AE)-related withdrawals did not differ significantly among the three interventions. Conclusions: CZP, at dosages of 200 and 400 mg, in combination with MTX, was the efficacious intervention for active RA without causing a significant risk of AE-related withdrawals.",
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T1 - Wirksamkeit und Sicherheit von Methotrexat plus Certolizumab Pegol vs. MTX plus Placebo bei aktiver rheumatoider Arthritis

T2 - Metaanalyse randomisierter kontrollierter Studien

AU - Lee, Young Ho

AU - Bae, S. C.

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Y1 - 2017/8/1

N2 - Objectives: This study aimed to assess the relative efficacy and safety of certolizumab pegol (CZP) 200 and 400 mg + methotrexate (MTX) compared to placebo + MTX in patients with active rheumatoid arthritis (RA). Methods: We performed a Bayesian network meta-analysis to combine the direct and indirect evidence from randomized controlled trials (RCTs) examining the efficacy and safety of CZP 200 and 400 mg + MTX and placebo + MTX (MTX group) in patients with active RA despite receiving MTX or a disease-modifying antirheumatic drug (DMARD). Results: Six RCTs (30349 patients) met the inclusion criteria. The ACR20 response rate was significantly higher in the CZP 200 and 400 mg + MTX group than in the MTX group (OR 7.30, 95 % credible interval [CrI] 3.31–16.92 and OR 5.48, 95 % CrI 2.98–10.30, respectively). CZP 400 mg + MTX tended to be more efficacious than CZP 200 mg + MTX (OR 1.33, 95 % CrI 0.61–2.97). A surface under the cumulative ranking curve (SUCRA)-based ranking probability indicated that CZP 400 mg + MTX had the highest probability of achieving the ACR20 response rate, followed by CZP 200 mg + MTX and MTX (SUCRA = 0.9007, 0.7156, and 0.0002, respectively). The ACR20, 50, and 70 response rate distributions were comparable. However, the safety based on the number of adverse event (AE)-related withdrawals did not differ significantly among the three interventions. Conclusions: CZP, at dosages of 200 and 400 mg, in combination with MTX, was the efficacious intervention for active RA without causing a significant risk of AE-related withdrawals.

AB - Objectives: This study aimed to assess the relative efficacy and safety of certolizumab pegol (CZP) 200 and 400 mg + methotrexate (MTX) compared to placebo + MTX in patients with active rheumatoid arthritis (RA). Methods: We performed a Bayesian network meta-analysis to combine the direct and indirect evidence from randomized controlled trials (RCTs) examining the efficacy and safety of CZP 200 and 400 mg + MTX and placebo + MTX (MTX group) in patients with active RA despite receiving MTX or a disease-modifying antirheumatic drug (DMARD). Results: Six RCTs (30349 patients) met the inclusion criteria. The ACR20 response rate was significantly higher in the CZP 200 and 400 mg + MTX group than in the MTX group (OR 7.30, 95 % credible interval [CrI] 3.31–16.92 and OR 5.48, 95 % CrI 2.98–10.30, respectively). CZP 400 mg + MTX tended to be more efficacious than CZP 200 mg + MTX (OR 1.33, 95 % CrI 0.61–2.97). A surface under the cumulative ranking curve (SUCRA)-based ranking probability indicated that CZP 400 mg + MTX had the highest probability of achieving the ACR20 response rate, followed by CZP 200 mg + MTX and MTX (SUCRA = 0.9007, 0.7156, and 0.0002, respectively). The ACR20, 50, and 70 response rate distributions were comparable. However, the safety based on the number of adverse event (AE)-related withdrawals did not differ significantly among the three interventions. Conclusions: CZP, at dosages of 200 and 400 mg, in combination with MTX, was the efficacious intervention for active RA without causing a significant risk of AE-related withdrawals.

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KW - Immunosuppressive agents

KW - Placebo effect

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