Objectives: The Phase III RADIATE study examined efficacy and safety of tocilizumab, an anti-interleukin-6 receptor monoclonal antibody in patients with rheumatoid arthritis (RA) refractory to TNF-antagonist therapy.
Methods: 499 patients with inadequate response to >1 TNF-antagonist were randomised to receive 8 mg/kg or 4 mg/kg tocilizumab or placebo (control) intravenously every 4 weeks with stable methotrexate for 24 weeks. ACR20 responses, secondary efficacy and safety endpoints were assessed.
Results: ACR20 was achieved at 24 weeks by 50.0%, 30.4% and 10.1% of patients in the 8 mg/kg, 4 mg/kg and control groups, respectively (p<0.0001 both tocilizumab groups vs. control). At Week 4 more patients achieved ACR20 in 8 mg/kg tocilizumab vs. controls (p=0.0008). Patients responded regardless of most-recently failed anti-TNF or the number of failed treatments. DAS28 remission (DAS28 <2.6) rates at Week 24 were clearly dose-related, being achieved by 30.1%, 7.6% and 1.6% of 8 mg/kg, 4 mg/kg and control groups (p=0.0001 for 8 mg/kg and p=0.053 for 4 mg/kg vs. control). Most adverse events (AEs) were mild or moderate with overall incidences of 84.0%, 87.1% and 80.6%, respectively. The most common AEs with higher incidence in tocilizumab groups were infections, GI symptoms, rash, and headache. Serious AE incidence was higher in controls (11.3%) than 8 mg/kg (6.3%) and 4 mg/kg (7.4%) groups.
Conclusion: Tocilizumab + MTX is effective in achieving rapid and sustained improvements in signs and symptoms of RA in patients with inadequate response to TNF antagonists and has a manageable safety profile. ClinicalTrials.gov identifier: NCT00106522.
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