Emery P, Keystone E, Tony HP, Cantagrel A, van Vollenhoven R, Sanchez A, Alecock E, Lee J, Kremer J.
Ann Rheum Dis 2008; 67:1516–1523.
The RADIATE study was a 24-week double-blind, randomised, placebo-controlled, Phase III study designed to examine the efficacy and safety of tocilizumab (TCZ) in combination with methotrexate (MTX) in patients with active RA who have had an inadequate response to treatment with at least one anti-TNF. Patients were randomised to receive TCZ 8 mg/kg (n=170), 4 mg/kg (n=163) or placebo (n=160), each in combination with MTX.
Key study results are summarised below.
- Both TCZ 8 mg/kg (50.0%) and 4 mg/kg (30.4%) groups exhibited superior ACR20 responses compared with control (10.1%; p<0.001 for both comparisons) at Week 24.
- ACR50 and ACR70 responses at Week 24 were greater in both TCZ 8 mg/kg (28.8%; p<0.001 and 12.4%; p<0.001, respectively) and 4 mg/kg (16.8%; p<0.001 and 5.0%; p=0.1, respectively) groups compared with control (3.8% and 1.3%, respectively).
- Improvements in ACR20/50/70 responses were rapid, occurring within 2–4 weeks of initiation of TCZ treatment.
- DAS28 remission (<2.6) was achieved by 30.1%, 7.6% and 1.6% of TCZ 8 mg/kg, 4 mg/kg and control patients, respectively, at Week 24.
- TCZ 8 mg/kg was superior to 4 mg/kg in achieving improvements from baseline in swollen joint count, tender joint count and Health Assessment Questionnaire (HAQ) scores.
- C-reactive protein (CRP) levels decreased markedly in both TCZ groups at Week 2; however, only the TCZ 8 mg/kg group had normalised CRP levels by Week 24.
- The incidence of adverse events and serious adverse events was comparable across treatment groups and most adverse events were mild or moderate in severity.
In summarising their findings, the authors highlight that the efficacy data support the use of TCZ 8 mg/kg + MTX in this patient population, and together with improvements in HAQ and a manageable safety profile, provide evidence that changing therapy to TCZ can improve signs and symptoms in inadequate responders to anti-TNF therapy.
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