Two-year clinical and radiographic results with combination
etanercept-methotrexate therapy versus monotherapy in early rheumatoid arthritis:
a two-year, double-blind, randomized study.
Author(s): Emery P, Breedveld F, van der Heijde D, Ferraccioli G, Dougados M, Robertson D,
Pedersen R, Koenig AS, Freundlich B; Combination of Methotrexate and Etanercept
in Early Rheumatoid Arthritis Trial Group.
Affiliation(s): University of Leeds, NIHR Leeds Musculoskeletal Biomedical Research Unit,
[corrected] Leeds, UK. p.emery@leeds.ac.uk
Publication date & source: 2010, Arthritis Rheum. , 62(3):674-82
OBJECTIVE: To evaluate how continuation of and alterations to initial year 1
combination etanercept-methotrexate (MTX) therapy and MTX monotherapy regimens
affect long-term remission and radiographic progression in early, active
rheumatoid arthritis.
METHODS: Subjects were randomized at baseline for the entire 2-year period; those
who completed 1 year of treatment with combination or MTX monotherapy entered
year 2. The original combination group either continued combination therapy (the
EM/EM group; n = 111) or received etanercept monotherapy (the EM/E group; n =
111) in year 2; the original MTX monotherapy group either received combination
therapy (the M/EM group; n = 90) or continued monotherapy (the M/M group; n = 99)
in year 2. Efficacy end points included remission (a Disease Activity Score in 28
joints [DAS28] <2.6) and radiographic nonprogression (change in the modified
Sharp/van der Heijde score < or = 0.5) at year 2. A last observation carried
forward analysis from the modified intention-to-treat population (n = 398) and a
post hoc nonresponder imputation (NRI) analysis (n = 528) were performed for
remission.
RESULTS: At year 2, DAS28 remission was achieved by 62/108, 54/108, 51/88, and
33/94 subjects in the EM/EM, EM/E, M/EM, and M/M groups, respectively (P < 0.01
for the EM/EM and M/EM groups versus the M/M group). This effect was corroborated
by a more conservative post hoc 2-year NRI analysis, with remission observed in
59/131, 50/134, 48/133, and 29/130 of the same respective groups (P < 0.05 for
each of the EM/EM, EM/E, and M/EM groups versus the M/M group). The proportions
of subjects achieving radiographic nonprogression (n = 360) were 89/99, 74/99,
59/79, and 56/83 in the EM/EM (P < 0.01 versus each of the other groups), EM/E,
M/EM, and M/M groups, respectively. No new safety signals or between-group
differences in serious adverse events were seen.
CONCLUSION: Early sustained combination etanercept-MTX therapy was consistently
superior to MTX monotherapy. Combination therapy resulted in important clinical
and radiographic benefits over 2 study years, without significant additional
safety risk.
Erratum in
Arthritis Rheum. 2010 Oct;62(10):3005.
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