Abstract | OBJECTIVE: 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: 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.
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Authors | Gerd R Burmester, Xavier Mariette, Carlomaurizio Montecucco, Indalecio Monteagudo-Sáez, Michel Malaise, Athanasios G Tzioufas, Johannes W J Bijlsma, Kristina Unnebrink, Sonja Kary, Hartmut Kupper |
Journal | Annals of the rheumatic diseases
(Ann Rheum Dis)
Vol. 66
Issue 6
Pg. 732-9
(Jun 2007)
ISSN: 0003-4967 [Print] England |
PMID | 17329305
(Publication Type: Clinical Trial, Journal Article, Multicenter Study)
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Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Antirheumatic Agents
- Tumor Necrosis Factor-alpha
- Adalimumab
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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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