|
A multicenter, randomized, double-blind clinical trial of combination
therapy with adalimumab plus methotrexate versus methotrexate alone or
adalimumab alone in patients with early, aggressive rheumatoid arthritis who
had not had previous methotrexate treatment.
OBJECTIVE:
To compare the efficacy and safety of adalimumab plus methotrexate (MTX)
versus MTX monotherapy or adalimumab monotherapy in patients with early,
aggressive rheumatoid arthritis (RA) who had not previously received MTX
treatment.
METHODS:
This was a 2-year, multicenter, double-blind, active comparator-controlled
study of 799 RA patients with active disease of <3 years' duration who had
never been treated with MTX. Treatments included adalimumab 40 mg
subcutaneously every other week plus oral MTX, adalimumab 40 mg
subcutaneously every other week, or weekly oral MTX. Co-primary end points
at year 1 were American College of Rheumatology 50% improvement (ACR50) and
mean change from baseline in the modified total Sharp score.
RESULTS:
Combination therapy was superior to both MTX and adalimumab monotherapy in
all outcomes measured. At year 1, more patients receiving combination
therapy exhibited an ACR50 response (62%) than did patients who received MTX
or adalimumab monotherapy (46% and 41%, respectively; both (P < 0.001).
Similar superiority of combination therapy was seen in ACR20, ACR70, and
ACR90 response rates at 1 and 2 years. There was significantly less
radiographic progression (P < or = 0.002) among patients in the combination
treatment arm at both year 1 and year 2 (1.3 and 1.9 Sharp units,
respectively) than in patients in the MTX arm (5.7 and 10.4 Sharp units) or
the adalimumab arm (3.0 and 5.5 Sharp units). After 2 years of treatment,
49% of patients receiving combination therapy exhibited disease remission
(28-joint Disease Activity Score <2.6), and 49% exhibited a major clinical
response (ACR70 response for at least 6 continuous months), rates
approximately twice those found among patients receiving either monotherapy.
The adverse event profiles were comparable in all 3 groups.
CONCLUSION:
In this population of patients with early, aggressive RA, combination
therapy with adalimumab plus MTX was significantly superior to either MTX
alone or adalimumab alone in improving signs and symptoms of disease,
inhibiting radiographic progression, and effecting clinical remission.
Reference:
Arthritis Rheum. 2006 Jan;54(1):26-37 |