ACTEMRA/RoACTEMRA in combination with
MTX is effective in reducing signs and
symptoms in TNF-IR patients
RADIATE: ACTEMRA/RoACTEMRA in RA Patients with an Inadequate Response to Anti-TNFs
The RADIATE trial enrolled patients who had an inadequate clinical response or were intolerant to one or more tumour necrosis factor antagonist (anti-TNF) therapies. The anti-TNF was discontinued prior to randomisation. ACTEMRA/RoACTEMRA 8 mg/kg or placebo were given every 4 weeks in combination with stable methotrexate (MTX) (10 mg to 25 mg weekly). At the end of the 24-week study period, patients who met the inclusion criteria could continue in an ongoing, long-term, open-label follow-up study.
Demographic and disease characteristics at baseline were similar between the treatment groups.
Compared with those who participated in the OPTION and TOWARD trials, the RADIATE patient population generally had an increased disease duration and had received a higher number of DMARDs prior to study entry, reflecting the difficult to treat nature of patients with RA refractory to anti-TNFs.
|
Placebo plus MTX n=158 |
ACTEMRA/ RoACTEMRA 4mg/kg plus MTX n=161 |
ACTEMRA/ RoACTEMRA 8mg/kg plus MTX n=170 |
|
|---|---|---|---|
| Demographics and treatment history | |||
| Female, % |
79 | 81 | 84 |
| Age, years | 53.4 (13.3) | 50.9 (12.5) | 53.9 (12.7) |
| RA duration years | 11.4 (9.2) | 11.0 (8.5) | 12.6 (9.3) |
| Rheumatoid factor positive, % | 75 | 73 | 79 |
| Number of DMARDs used before study | 2.1 (1.6) | 2.0 (1.6) | 1.9 (1.6) |
| Disease activity | |||
| Swollen joint count |
18.9 (11.1) | 19.5 (10.4) | 18.9 (10.9) |
| Tender joint count | 30.4 (16.8) | 31.3 (15.1) | 31.7 (15.4) |
| HAQ-DI | 1.7 (0.6) | 1.7 (0.6) | 1.7 (0.6) |
| CRP, mg/dl | 3.7 (4.1) | 3.1 (3.6) | 2.8 (3.4) |
| DAS28 | 6.8 (1.1) | 6.8 (1.0) | 6.8 (1.0) |
| Haemoglobin |
36 | 32 | 35 |
|
Data are mean (SD) except where indicated. LLN for men is 13.0 g/dl and for women (non-pregnant) is 12.0 g/dl |
|||
ACTEMRA/RoACTEMRA in combination with MTX was 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.
Detailed results of the RADIATE study can be found in the Efficacy and Safety and Tolerability sections of the website.
Reference:
Emery P, et al. Ann Rheum Dis 2008; 67:1516–1523.
Figures and tables reproduced with permission from BMJ Publishing Group Ltd © 2008.
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