The combination of etanercept and methotrexate provides long-term remission and protects against radiographic progression in patients with rheumatoid arthritis (RA), according to a report in the December issue of Arthritis & Rheumatism.
"The combination of methotrexate and etanercept is safe and effective during at least 3 years of follow-up," Dr. Desiree van der Heijde from Leiden University Medical Center, The Netherlands told Reuters Health.
Dr. van der Heijde and colleagues in the TEMPO study evaluated the efficacy and safety of etanercept, methotrexate, and the combination of the two drugs in 682 patients with active RA in a 3-year double-blind, multicenter study.
Patients in the combination therapy group improved significantly more than patients in the methotrexate or etanercept group at all time points during the 3 years, the authors report. Patients treated with both drugs were also 2.3 to 2.6 times more likely to be in remission at any time point during the 3.
The improvement in physical disability at 3 years was highest with combination therapy (55%) and lower with either etanercept (37.0%) or methotrexate (33.3%) monotherapy.
The mean changes in total joint damage, erosion scores, and joint space narrowing were all significantly better for combination therapy than for etanercept therapy, which was, in turn, better than methotrexate therapy, the investigators say.
Significantly more patients in the combination group (76%) and etanercept group (61%) had radiographic remission of their disease at 3 years than patients in the methotrexate group (51%).
There were no new or unexpected safety findings reported during year 3, the researchers note, and the proportions of patients reporting at least 1 treatment-emergent adverse event or infection were similar across treatment groups.
"Conventional time point analyses as well as longitudinal analyses have clearly shown that the response to combination treatment was durable and maintained for at least 3 years of continuous therapy, with no unexpected safety findings," the authors conclude.
"Even patients with moderate to long disease duration can still reach remission if treated with effective treatment, and radiographic progression can be completely halted by the combination of methotrexate and etanercept," Dr. van der Heijde said.
"A trial with a high dose of methotrexate could be given first," Dr. van der Heijde suggested, "but patients should be monitored closely and if they do not reach remission, they should receive other treatment, e.g., combination with a TNF blocker."
Arthritis Rheum 2007;56:3925-3939.
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