Adalimumab plus MTX is more effective than adalimumab alone in patients w/established RA

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Adalimumab plus methotrexate is more effective than adalimumab alone in

patients with established rheumatoid arthritis: Results from a 6-month

longitudinal, observational, multicenter study.

Ann Rheum Dis. 2006 May 5; [Epub ahead of print]

Heiberg MS, Rodevand E, Mikkelsen K, Kaufmann C, Didriksen A, Mowinckel P,

Kvien TK. Diakonhjemmet Hospital, Norway.

OBJECTIVES: To compare the effectiveness of adalimumab monotherapy and

adalimumab plus methotrexate in patients with established RA.

METHODS: Data from an ongoing longitudinal, observational study in Norway

were used to compare response to treatment with two different adalimumab

regimens (monotherapy n=84, combination with MTX n=99). Patients were

assessed with measures of disease activity, health status and utility

scores. We analyzed within-group changes from baseline to follow-up at 3 and

6 months, and the changes were compared between groups after adjustment for

the propensity score. The groups were also compared for the proportions of

patients achieving EULAR good response, DAS-28 remission and treatment

terminations.

RESULTS: The improvement from baseline was statistically significant for all

measures in the adalimumab + MTX group, but only for DAS-28, joint counts, 2

SF-36 dimensions and patient's and investigator's global assessment in the

monotherapy group. All between-group differences were numerically in favor

of combination therapy and statistically significant for CRP, joint counts,

DAS-28, M-HAQ, investigator's global assessment, 4 SF-36 dimensions and

SF-6D at 6 months. More patients in the combination therapy group reached

EULAR good response and remission. At 6 months 80.8% of the patients in the

combination therapy group and 59.5% in the monotherapy group remained on

therapy. More withdrawals were due to adverse events in the monotherapy

therapy group.

CONCLUSIONS: Our consistent results across several categories of endpoints

suggest that adalimumab combined with methotrexate is effective in RA

patients treated in daily clinical practice and superior to adalimumab

monotherapy.

PMID: 16679432 [PubMed - as supplied by publisher]