Objective: 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 (TNF) 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 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 (5.5/100PYs, including active tuberculosis, 0.5/100PYs). 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, 0.49-1.01). The standardised mortality ratio was 1.07 (95% CI, 0.75-1.49). At Week 12, 69% of patients achieved an ACR20 response, 87% a moderate, and 37% 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 a clinical practice setting.
- antirheumatic agents
- monoclonal antibody
- rheumatoid arthritis
- tumour necrosis factor