medwireNews: A 4-year follow-up study shows favorable and comparable efficacy and safety outcomes for patients with early rheumatoid arthritis (RA) who initiate treatment with the COBRA-light or COBRA regimen.
The original trial, in which 162 patients were randomly assigned to receive COBRA-light therapy, which combines initial low-dose prednisolone (30 mg/day) with methotrexate, or the COBRA regimen, comprising initial high-dose prednisolone (60 mg/day), methotrexate, and sulfasalazine, showed the noninferiority of the attenuated regimen.
“After 1 year, treatment was continued without protocol, and adjusted by the treating physician according to clinical judgement, preferably with a treat-to-target strategy,” the researchers explain, adding that 149 of the trial participants were included in the current analysis, conducted after a median follow-up of 49 months.
Over the 4-year period, patients had similar improvements in disease activity, physical functioning, and radiologic endpoints regardless of whether they had initiated treatment with the COBRA-light or COBRA regimens, and the prevalence of Boolean remission was also comparable.
The incidence of major comorbidities – such as cardiovascular events, hypertension, and type 2 diabetes – was similar in the initial COBRA-light and COBRA groups, as was survival, with three and two deaths reported, respectively.
Lead author Nicole Konijn (VU University Medical Center, Amsterdam, the Netherlands) and co-workers point out, however, that “the initial power calculation was based on the short- rather than the long-term outcome of the COBRA-light trial. Consequently, the power to detect subtle differences in comorbidity patterns is low.”
They continue: “A longer follow-up period (e.g. 10 or 15 years) is needed to study survival and long-term effects on major comorbidities.”
Other than the inevitable differences resulting from initiating treatment with different protocols, the use of other medications was similar in the treatment groups during the 4-year follow-up. For instance, 39% of 75 patients in the COBRA-light arm used glucocorticoid injections, as did 43% of the 79 patients in the COBRA arm.
The study authors conclude in Rheumatology that the “[p]ractical implications of our findings include a free choice for both physicians and patients to either start their treatment with COBRA-light or COBRA therapy; and assuming that barriers towards the use of COBRA therapy continue to exist, COBRA-light is an equally effective and safe therapy to use in early active RA.”
They add: “Our study confirms the importance and beneficial effects of early, treat-to-target combination therapy with traditional [disease-modifying anti-rheumatic drugs] and glucocorticoids in recent-onset RA patients over a 4-year period.”
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