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Adalimumab alone and in combination with disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis in clinical practice: the Research in Active Rheumatoid Arthritis (ReAct) trial.

AbstractOBJECTIVE:
To evaluate the safety and effectiveness of adalimumab alone or in combination with standard disease-modifying antirheumatic drugs (DMARDs) for the treatment of rheumatoid arthritis (RA).
METHODS:
Patients with active RA despite treatment with DMARDs or prior treatment with a tumour necrosis factor antagonist participated in a multicentre, open-label clinical study of adalimumab 40 mg every other week for 12 weeks with an optional extension phase. Patients were allowed to continue with pre-existing traditional DMARDs. Long-term safety results are reported for all patients (4210 patient-years (PYs) of adalimumab exposure). The observed effectiveness results at week 12 are reported using American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) response criteria.
RESULTS:
Among the 6610 treated patients, adalimumab was generally well tolerated. Serious infections occurred in 3.1% of patients (5.5/100 PYs, including active tuberculosis, 0.5/100 PYs). Demyelinating disease (0.06%) and systemic lupus erythematosus (0.03%) were rare serious adverse events. The standardised incidence ratio of malignancy was 0.71 (95% CI 0.49 to 1.01). The standardised mortality ratio was 1.07 (95% CI 0.75 to 1.49). At week 12, 69% of patients achieved an ACR20 response, 83% a moderate, and 33% a good EULAR response. Adalimumab was effective in combination with a variety of DMARDs. The addition of adalimumab to antimalarials was comparably effective to the combination of adalimumab and methotrexate.
CONCLUSIONS:
Considering the limitations of an open-label study, adalimumab alone or in combination with standard DMARDs appeared to be well tolerated and effective in 6610 difficult-to-treat patients with active RA treated in clinical practice.
AuthorsGerd R Burmester, Xavier Mariette, Carlomaurizio Montecucco, Indalecio Monteagudo-Sáez, Michel Malaise, Athanasios G Tzioufas, Johannes W J Bijlsma, Kristina Unnebrink, Sonja Kary, Hartmut Kupper
JournalAnnals of the rheumatic diseases (Ann Rheum Dis) Vol. 66 Issue 6 Pg. 732-9 (Jun 2007) ISSN: 0003-4967 [Print] England
PMID17329305 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)
Chemical References
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Antirheumatic Agents
  • Tumor Necrosis Factor-alpha
  • Adalimumab
Topics
  • Adalimumab
  • Adult
  • Aged
  • Antibodies, Monoclonal (adverse effects, therapeutic use)
  • Antibodies, Monoclonal, Humanized
  • Antirheumatic Agents (adverse effects, therapeutic use)
  • Arthritis, Rheumatoid (drug therapy)
  • Drug Therapy, Combination
  • Female
  • Humans
  • Male
  • Middle Aged
  • Opportunistic Infections (etiology)
  • Patient Dropouts
  • Severity of Illness Index
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha (antagonists & inhibitors)

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