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

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Published Online First: 5 May 2006. doi:10.1136/ard.2006.051540

ls of the Rheumatic Diseases 2006;65:1379-1383

© 2006 by BMJ Publishing Group Ltd & European League Against Rheumatism

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EXTENDED REPORT

Adalimumab and methotrexate is more effective than adalimumab alone in

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

longitudinal, observational, multicentre study

M S Heiberg1, E Rødevand2, K Mikkelsen3, C Kaufmann4, A Didriksen5, P

Mowinckel1 and T K Kvien1

1 Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway

2 Department of Rheumatology, St Olav Hospital, Trondheim, Norway

3 Department of Rheumatology, Lillehammer Hospital for Rheumatic Diseases,

Lillehammer, Norway

4 Department of Rheumatology, Buskerud Central Hospital, Drammen, Norway

5 Department of Rheumatology, University Hospital Northern Norway, Tromsø,

Norway

Objectives: To compare the effectiveness of adalimumab monotherapy and

adalimumab and methotrexate (MTX) combination therapy in patients with

established rheumatoid arthritis.

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. Within-group changes were analysed 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 European League Against Rheumatism (EULAR) good

response, Disease Activity Score (DAS)28 remission and treatment

terminations.

Results: The improvement from baseline was significant for all measures in

the adalimumab and MTX group, but only for DAS28, joint counts, two

Short-form Health Survey with 36 questions (SF-36) dimensions and patient's

and investigator's global assessment in the monotherapy group. All

between-group differences were numerically in favour of combination therapy

and significant for C reactive protein, joint counts, DAS28, Modified Health

Assessment Questionnaire, investigator's global assessment, four SF-36

dimensions and Short Form 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 treatment (p = 0.002). More

withdrawals in the monotherapy group were due to adverse events.

Conclusions: Our results were consistent across several categories of end

points and suggest that adalimumab combined with MTX is effective in

patients with rheumatoid arthritis treated in daily clinical practice and is

superior to adalimumab monotherapy.

http://ard.bmjjournals.com/cgi/content/abstract/65/10/1379

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