Background Early, intensive treatment of rheumatoid arthritis (RA) with intensive combinaion therapy (COBRA therapy) considerably lowers disease activity and suppresses radiological progression. Although proven to be very effective, uptake of COBRA therapy among rheumatologists has been suboptimal, for reasons including fear of possible side-effects. A modified schedule of the COBRA therapy with a lower dose of prednisone (i.e. COBRA-light), might be equally effective, while lessening the physicians concerns about side-effects.
Objectives To investigate whether COBRA-light therapy is non-inferior to COBRA-therapy in patients with early, active RA.
Methods Patients with early, active RA were randomised to either COBRA therapy (MTX 7.5 mg/week, SSZ 2 g/day and prednisone 60 mg/d, tapered to 7.5 mg/day) (n=81) or COBRA-light therapy (MTX 25 mg/week and 30 mg prednisone, tapered to 7.5 mg/day) (n=83). Primary treatment goal was minimal disaese activity, defined as DAS44 <1.6. After 3 months treatment, methotrexate dose could be increased up to 25mg/week, when DAS44 remained above 1.6.A difference in delta DAS44>0.5 between the groups after 6 months was considered clinically relevant.
Results At baseline, patientshad active disease: mean (SD) DAS44 4.13 (0.81) for the COBRA arm and 3.95 (0.9) for the COBRA-light arm. Two patients (COBRA-light) did not initiate treatment and two patients dropped-out of the study due to an adverse events (myocardial infarction in COBRA and manic episode in COBRA-light). The preliminary results show that after six months, mean DAS44 significantly decreased in both groups (–2.50 (1.21) for COBRA and –2.18 (1.10) for COBRA-light). The difference in delta DAS44 between the groups, 0.32 (95% confidence limits: –0.03;0.68; p=0.08), was smaller than the clinically relevant difference. Minimal disease activity was reached in almost half of patients in both groups (49% and 41% in COBRA and COBRA-light respectively).
Conclusions Current results suggest that COBRA-light therapy is non-inferior to standard COBRA therapy: both strategies effectively lower disease activity after six months treatment in early, active RA patients. The clinical and radiological effects on longer follow up are still under study.
Disclosure of Interest None Declared
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