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
Annals of Rheumatic Diseases, 06/06/2012
Bykerk VP et al. – In patients with rheumatoid arthritis (RA) who were DMARD–IR/TNFi–IR, tocilizumab ± DMARDs provided rapid and sustained efficacy without unexpected safety concerns.Methods
- 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.