RESEARCH - Humira plus MTX is more effective than Humira alone in patients with established RA

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

Adalimumab plus methotrexate is more effective than adalimumab alone in

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

longitudinal, observational, multicenter study.

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 (p<0.001) and remission (p=0.07). At 6 months 80.8% of

the patients in the combination therapy group and 59.5% in the monotherapy

group remained on therapy (p=0.002). 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

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=1\

6679432

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