ACTEMRA in combination
with MTX is effective in
reducing signs and
symptoms in TNF-IR
patients.
RADIATE
RheumAtoiD arthritIs study in Anti-TNF failurEs
The RADIATE trial evaluated 499 patients who had an inadequate clinical response or were intolerant to one or more TNF antagonist therapies. The tumour necrosis factor (TNF) antagonist therapy was discontinued prior to randomisation. Doses of 4 or 8 mg/kg ACTEMRA/RoACTEMRA or placebo were given every four weeks in combination with stable methotrexate (MTX) (10 mg to 25 mg weekly).
Summary of results
Compared with controls treated with placebo plus MTX, patients in the ACTEMRA/RoACTEMRA 8 mg/kg arm plus MTX arm had superior American College of Rheumatology (ACR) 20 (50.0% vs. 10.1%; p<0.0001), ACR50 (28.8% vs. 3.8%; p<0.0001) and ACR70 (12.4% vs. 1.3%; p=0.0002) responses and more patients achieved Disease Activity Score (DAS) 28 remission at 24 weeks (30.1% vs. 1.6%, p=0.0001). Patients in the ACTEMRA/RoACTEMRA 8 mg/kg plus MTX arm exhibited a drop in C-reative protein (CRP) levels within 2 weeks, with levels normalising by Week 24.
ACTEMRA/RoACTEMRA in combination with MTX was effective in achieving rapid and sustained improvements in signs and symptoms of rheumatoid arthritis (RA) in patients with inadequate response to TNF antagonists and has a manageable safety profile.
Emery P, et al. Ann Rheum Dis 2008; 67:1616-23.