| Autor: |
Durelli, L., Barbero, P., Bergui, M., Versino, E., Bassano, M., Verdun, E., Ferrero, B., Rivoiro, C., Ferrero, C., Picco, E., Ripellino, P., Viglietti, D., Giuliani, G., Montanari, E., Clerico, M. |
| Předmět: |
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| Zdroj: |
Journal of Neurology; Sep2008, Vol. 255 Issue 9, p1315-1323, 9p, 2 Diagrams, 3 Charts, 1 Graph |
| Abstrakt: |
We aimed to evaluate the safety and MRI efficacy of interferon beta-1b (IFNβ-1b) 375 μg (subcutaneously [sc] every other day [eod]) in relapsing-remitting multiple sclerosis (RRMS) patients with a suboptimal response to IFNβ-1b 250 μg, i.e., with MRI activity or relapses. The OPTimization of Interferon for MS (OPTIMS) study was a prospective multicenter randomized phase 2 trial comprising a 6-month run-in phase (to identify suboptimal responders) and a 6-month randomized phase of open-label clinical and blinded MRI follow-up. During run-in all patients were treated with IFNβ-1b 250 μg sc eod; during the study phase suboptimal treatment responders were randomized either to IFNβ-1b 250 or 375 μg sc eod. Primary outcome was the proportion of patients without MRI activity during study Months 9–12 according to the intention-totreat principle. 216 RRMS patients entered the study: 83 suboptimal responders were identified and randomized, 7 refused to continue treatment, 76 were included in the analysis. More patients treated with 375 μg had no MRI activity at Months 9–12 (30/36 vs.16/40; relative risk, 0.28; 95 % confidence interval, 0.08–0.47; p = 0.0001). Sensitivity analysis (“worst case scenario”) confirmed the results. No new or unexpected adverse events were observed, but there was a trend towards more withdrawals in the 375 μg group. Increasing the dose of IFNβ-1b from 250 μg to 375 μg is a successful strategy for reducing subclinical signs of disease activity in RRMS patients. Further studies are needed to show whether this dose may also improve clinical efficacy. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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