Tocilizumab in patients with active rheumatoid arthritis and inadequate responses to DMARDs and/or TNF inhibitors: a large, open-label study close to clinical practice. Academic Article Article uri icon

Overview

MeSH

  • Adult
  • Aged
  • Drug Resistance
  • Female
  • Humans
  • Male
  • Middle Aged
  • Remission Induction
  • Severity of Illness Index
  • Treatment Outcome

MeSH Major

  • Antibodies, Monoclonal, Humanized
  • Antirheumatic Agents
  • Arthritis, Rheumatoid
  • Tumor Necrosis Factor-alpha

abstract

  • To evaluate the safety and efficacy of tocilizumab in clinical practice in patients with rheumatoid arthritis (RA) with inadequate responses (IR) to disease-modifying antirheumatic drugs (DMARDs) or both DMARDs and tumour necrosis factor α inhibitors (TNFis). Patients-categorised as TNFi-naive, TNFi-previous (washout) or TNFi-recent (no washout) -received open-label tocilizumab (8 mg/kg) every 4 weeks ± DMARDs for 24 weeks. Adverse events (AEs) and treatment discontinuations were monitored. Efficacy end points included American College of Rheumatology (ACR) responses, 28-joint disease activity score (DAS28) and European League Against Rheumatism responses. Overall, 1681 (976 TNF-naive, 298 TNFi-previous and 407 TNFi-recent) patients were treated; 5.1% discontinued treatment because of AEs. The AE rate was numerically higher in TNFi-recent (652.6/100 patient-years (PY)) and TNFi-previous (653.6/100PY) than in TNFi-naive (551.1/100PY) patients. Serious AE rates were 18.0/100PY, 28.0/100PY and 18.6/100PY; serious infection rates were 6.0/100PY, 6.8/100PY and 4.2/100PY, respectively. At week 4, 36.5% of patients achieved ACR20 response and 14.9% DAS28 remission (<2.6); at week 24, 66.9%, 46.6%, 26.4% and 56.8% achieved ACR20/ACR50/ACR70 responses and DAS28 remission, respectively. Overall, 61.6% (TNFi-naive), 48.5% (TNFi-previous) and 50.4% (TNFi-recent) patients achieved DAS28 remission. In patients with RA who were DMARD-IR/TNFi-IR, tocilizumab ± DMARDs provided rapid and sustained efficacy without unexpected safety concerns.

publication date

  • December 2012

has subject area

  • Adult
  • Aged
  • Antibodies, Monoclonal, Humanized
  • Antirheumatic Agents
  • Arthritis, Rheumatoid
  • Drug Resistance
  • Female
  • Humans
  • Male
  • Middle Aged
  • Remission Induction
  • Severity of Illness Index
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha

Research

keywords

  • Clinical Trial, Phase III
  • Journal Article
  • Multicenter Study

Identity

Language

  • eng

PubMed Central ID

  • PMC3595980

Digital Object Identifier (DOI)

  • 10.1136/annrheumdis-2011-201087

PubMed ID

  • 22615456

Additional Document Info

start page

  • 1950

end page

  • 1954

volume

  • 71

number

  • 12