دورية
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. |
| المصدر: | Rheumatology; April 2002, Vol. 41 Issue: 4 p430-430, 1p |
| مستخلص: | <it>Objectives</it>. To compare the 48‐week drug survival, efficacy and toxicity of monotherapy with a fully human anti‐tumour necrosis factor‐<it>α</it> (TNF‐<it>α</it>) 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. <it>Methods</it>. Patients with RA, enrolled in phase I trials with a human anti‐TNF‐<it>α</it> 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 <it>vs</it> MTX with folate supplementation, which was co‐ordinated by our department. The studies with anti‐TNF‐<it>α</it> and MTX were performed in the same period and had very similar inclusion, exclusion, response and stop criteria. <it>Results</it>. Sixty‐one patients treated with anti‐TNF‐<it>α</it> moAb were compared with 137 receiving MTX monotherapy. At baseline, patients in the anti‐TNF‐<it>α</it> group had a longer disease duration (median 108 <it>vs</it> 50 months, <it>P</it>=0.0001) and a more protracted history of second‐line anti‐rheumatic drugs than those treated with MTX (median 4 <it>vs</it> 1, <it>P=</it>0.0001). The 48‐week dropout rate was lower among patients treated with anti‐TNF (23 <it>vs</it> 45% in the MTX group, <it>P</it><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‐<it>α</it> group than in the MTX group (<it>P</it>=0.005). The percentage of responders was higher in the anti‐TNF‐<it>α</it> 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‐<it>α</it> group <it>vs</it> 40% in the MTX group (<it>P</it>=0.0001). Clinical and demographic characteristics were, in general, poor predictors for response to therapy at week 48. The clinical response after the first anti‐TNF‐<it>α</it> dose tended to increase the chance of prolonged efficacy of this approach [relative risk (95% confidence interval): 2 (0.75–6.0)]. The previous number of second‐line drugs was the only predictive variable for response to MTX to which it was inversely related [relative risk (95% confidence interval): −0.71 (−0.57 to −0.88)]. <it>Conclusions</it>. In patients with active, long‐standing RA, blocking TNF‐<it>α</it> is more effective and better tolerated than MTX monotherapy. An early response increases the chance of a sustained effect of anti‐TNF‐<it>α</it>. In contrast to MTX, the response to anti‐TNF‐<it>α</it> is not affected by previous disease‐modifying anti‐rheumatic drug history. |
| قاعدة البيانات: | Supplemental Index |
Full Text Finder | تدمد: | 14620324 14620332 |
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| DOI: | 10.1093/rheumatology/41.4.430 |