دورية أكاديمية
Drug survival, efficacy and toxicity of monotherapy with a fully human anti-tumour necrosis factor-{alpha} antibody compared with methotrexate in long-standing rheumatoid arthritis
| العنوان: | Drug survival, efficacy and toxicity of monotherapy with a fully human anti-tumour necrosis factor-{alpha} antibody compared with methotrexate in long-standing rheumatoid arthritis |
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| المؤلفون: | Barrera, P., van der Maas, A., van Ede, A. E., Kiemeney, B. A. L. M., Laan, R. F. J. M., van de Putte, L. B. A., van Riel, P. L. C. M. |
| بيانات النشر: | Oxford University Press |
| سنة النشر: | 2002 |
| المجموعة: | HighWire Press (Stanford University) |
| مصطلحات موضوعية: | Original Papers |
| الوصف: | Objectives . To compare the 48‐week drug survival, efficacy and toxicity of monotherapy with a fully human anti‐tumour necrosis factor‐ α (TNF‐ α ) monoclonal antibody (moAb) and methotrexate (MTX) in patients with active long‐standing rheumatoid arthritis (RA). Secondary aims were to identify potential predictors for clinical response. Methods . Patients with RA, enrolled in phase I trials with a human anti‐TNF‐ α moAb and followed for at least 48 weeks at our centre, were compared with patients receiving MTX monotherapy without folate supplementation. The first 6 weeks of anti‐TNF therapy were placebo‐controlled and followed by an open‐label study. Patients treated with MTX participated in a 48‐week, double‐blind, phase III study of MTX alone vs MTX with folate supplementation, which was co‐ordinated by our department. The studies with anti‐TNF‐ α and MTX were performed in the same period and had very similar inclusion, exclusion, response and stop criteria. Results . Sixty‐one patients treated with anti‐TNF‐ α moAb were compared with 137 receiving MTX monotherapy. At baseline, patients in the anti‐TNF‐ α group had a longer disease duration (median 108 vs 50 months, P =0.0001) and a more protracted history of second‐line anti‐rheumatic drugs than those treated with MTX (median 4 vs 1, P= 0.0001). The 48‐week dropout rate was lower among patients treated with anti‐TNF (23 vs 45% in the MTX group, P <0.005). Proportional hazard analysis showed a significantly lower dropout risk among anti‐TNF‐treated patients [relative risk (95% confidence interval): 0.28 (0.12–0.6) uncorrected and 0.17 (0.06–0.45) corrected for confounders). The 48‐week area under the curve for the disease activity score (DAS) was smaller in the anti‐TNF‐ α group than in the MTX group ( P =0.005). The percentage of responders was higher in the anti‐TNF‐ α group over the whole study period. The median percentage of visits in which a patient fulfilled the European League Against Rheumatism (EULAR) response criteria was 83% in the anti‐TNF‐ α ... |
| نوع الوثيقة: | text |
| وصف الملف: | text/html |
| اللغة: | English |
| العلاقة: | http://rheumatology.oxfordjournals.org/cgi/content/short/41/4/430Test; http://dx.doi.org/10.1093/rheumatology/41.4.430Test |
| DOI: | 10.1093/rheumatology/41.4.430 |
| الإتاحة: | https://doi.org/10.1093/rheumatology/41.4.430Test http://rheumatology.oxfordjournals.org/cgi/content/short/41/4/430Test |
| حقوق: | Copyright (C) 2002, British Society for Rheumatology |
| رقم الانضمام: | edsbas.C1747DD9 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1093/rheumatology/41.4.430 |
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