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Adalimumab and methotrexate is more effective than adalimumab alone in patients with established rheumatoid arthritis: results from a 6-month longitudinal, observational, multicentre study
  1. M S Heiberg1,
  2. E Rødevand2,
  3. K Mikkelsen3,
  4. C Kaufmann4,
  5. A Didriksen5,
  6. P Mowinckel1,
  7. T K Kvien1
  1. 1Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway
  2. 2Department of Rheumatology, St Olav Hospital, Trondheim, Norway
  3. 3Department of Rheumatology, Lillehammer Hospital for Rheumatic Diseases, Lillehammer, Norway
  4. 4Department of Rheumatology, Buskerud Central Hospital, Drammen, Norway
  5. 5Department of Rheumatology, University Hospital Northern Norway, Tromsø, Norway
  1. Correspondence to:
    M S Heiberg
    Department of Rheumatology, Diakonhjemmet Hospital, Box 23 Vinderen, N-0319 Oslo, Norway;marte.schrumpf{at}


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.

  • DAS, Disease Activity Score
  • DMARD, disease-modifying antirheumatic drug
  • EULAR, European League Against Rheumatism
  • LOS, longitudinal observation study
  • MTX, methotrexate
  • RCT, randomised controlled trial
  • SF-36, Short-form Health Survey with 36 questions
  • SF-6D, Short Form 36
  • SRM, standardised mean response
  • TNF, tumour necrosis factor
  • VAS, Visual Analogue Scale

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  • Published Online First 5 May 2006

  • Funding: Research grants for the NOR-DMARD study have been received from Abbott, Amgen, Wyeth, Aventis, MSD, Schering-Plough/Centocor and the Norwegian Directorate for Health and Social affairs. The work was supported by The Norwegian Women’s Public Health Association. No pharmaceutical company participated in study design, data collection, data handling or manuscript preparation.

  • Competing interests: MSH and TKK have received consultancies and invited speaker honoraria from different pharmaceutical companies that are marketing TNF-blocking agents. ER, KM, CK, AD and PM have no competing interests.

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