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  3. Comparison of tocilizumab as monotherapy or with add-on disease-modifying antirheumatic drugs in patients with rheumatoid arthritis and inadequate responses to previous treatments: an open-label study close to clinical practice

Comparison of tocilizumab as monotherapy or with add-on disease-modifying antirheumatic drugs in patients with rheumatoid arthritis and inadequate responses to previous treatments: an open-label study close to clinical practice

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Bykerk, VP
  • Ostor, AJK
  • Alvaro-Gracia, J
  • Pavelka, K
  • Graninger, W
  • Bensen, W
  • Nurmohamed, MT
  • Krause, A
  • Bernasconi, C
  • Aassi, M
  • Sibilia, J

Grupos

Abstract

This was an exploratory analysis comparing the safety and efficacy of tocilizumab monotherapy with those of tocilizumab in combination with disease-modifying anti-rheumatic drugs (DMARDs). Data were from a single-arm, nonrandomized, open-label, 24-week study in patients with rheumatoid arthritis in which patients with inadequate responses to DMARDs or tumor necrosis factor-alpha inhibitors received tocilizumab 8 mg/kg intravenously every 4 weeks plus methotrexate/other DMARD(s) combination therapy. If they were intolerant of methotrexate/other DMARD, patients received tocilizumab monotherapy. Effectiveness endpoints included American College of Rheumatology (ACR) responses (ACR20/50/70/90) and disease activity score using 28 joints (DAS28). Of 1,681 patients, 239 received tocilizumab monotherapy, and 1,442 received combination therapy. Methotrexate was the most common DMARD (79 %) used in combination therapy. The frequency of adverse events (AEs), serious AEs, and AEs leading to withdrawal were similar between tocilizumab monotherapy (82.4, 7.9, and 5.4 %, respectively) and combination therapy (76.6, 7.8, and 5.1 %, respectively). No differences in ACR20/50/70/90 responses were observed between treatment groups (66.9 %/43.5 %/23.8 %/10.0 % vs 66.9 %/47.2 %/26.8 %/8.5 %, respectively; p > 0.12 for all individual comparisons, including ACR50 propensity score analyses). The decrease in DAS28 was also similar between treatment groups (mean +/- standard deviation: -3.41 +/- 1.49 for tocilizumab monotherapy vs -3.43 +/- 1.43 for combination therapy; p > 0.33 all analyses, including propensity score analyses). Tocilizumab had a comparable safety profile, and was similarly effective, when used as monotherapy or in combination with DMARDs in a broad population of patients with rheumatoid arthritis.

Datos de la publicación

ISSN/ISSNe:
0770-3198, 1434-9949

CLINICAL RHEUMATOLOGY  SPRINGER LONDON LTD

Tipo:
Article
Páginas:
563-571
PubMed:
25604316
Factor de Impacto:
0,838 SCImago ℠
Cuartil:
Q2 SCImago ℠

Citas Recibidas en Web of Science: 35

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Keywords

  • Disease activity; DMARDs (biologic); DMARDs (synthetic); Monotherapy; Open-label; Rheumatoid arthritis; Tocilizumab; Tumor necrosis factor-alpha inhibitor

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