An open-label pilot study of the effectiveness of adalimumab in patients with rheumatoid arthritis and previous infliximab treatment: relationship to reasons for failure and anti-infliximab antibody status
| Autor: | Gerd R Burmester, Arie E. van der Bijl, C Antoni, Hartmut Kupper, Joachim R. Kalden, Kristina Unnebrink, Sonja Kary, Christina Beckmann, Ferdinand C. Breedveld |
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| Rok vydání: | 2007 |
| Předmět: |
musculoskeletal diseases
Male medicine.medical_specialty Pilot Projects Antibodies Monoclonal Humanized Antibodies Arthritis Rheumatoid Rheumatology Maintenance therapy Internal medicine medicine Adalimumab Humans Prospective Studies Rheumatoid arthritis Adverse effect skin and connective tissue diseases business.industry Tumor Necrosis Factor-alpha Antibodies Monoclonal General Medicine Middle Aged medicine.disease Tumor necrosis factor antagonist Infliximab Surgery Discontinuation Treatment failure Female Original Article business Rheumatism medicine.drug |
| Zdroj: | Clinical Rheumatology |
| ISSN: | 0770-3198 |
| Popis: | This prospective open-label pilot study evaluated the effectiveness and safety of adalimumab and the relationship to antibodies against infliximab (IFX) in adult patients with active rheumatoid arthritis (RA) who had been treated previously with IFX and experienced treatment failure owing to lack or loss of response or intolerance. Patients self-administered adalimumab 40 mg subcutaneously every other week for 16 weeks, followed by maintenance therapy for up to Week 56. Measures of effectiveness included American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) response criteria, 28-joint Disease Activity Score, and the Health Assessment Questionnaire Disability Index. Serum IFX concentrations, human antichimeric antibody against IFX (HACA), adalimumab serum concentrations, antiadalimumab antibody, and safety also were assessed. Of the 41 enrolled patients, 37 completed 16 weeks and 30 completed 56 weeks of treatment. Patients experienced clinically meaningful improvements in all measures of RA activity, with greater response rates observed for patients who had experienced loss of initial response to or intolerance of IFX. At Week 16, 46% of patients achieved an ACR20 and 28% achieved an ACR50; 61% achieved an at least moderate and 17% achieved a good EULAR response. Clinical benefit was maintained through Week 56 in all effectiveness parameters. Baseline HACA status did not significantly impact effectiveness. No new safety signals were observed; neither former IFX intolerance status nor baseline HACA status had a clinically relevant impact on adverse event frequency or severity. Adalimumab was effective and well-tolerated in patients with RA who previously failed IFX therapy, irrespective of reason for discontinuation and of HACA status. |
| Databáze: | OpenAIRE |
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