We aimed to evaluate the safety and MRI efficacy of interferon beta-1b (IFNβ-1b) 375 μg (subcutaneously [sc] every other day [eod]) in relapsingremitting 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.

The OPTimization of Interferon for MS study : 375 mug interferon beta-1b in suboptimal responders / L. Durelli, P. Barbero, M. Bergui, E. Versino, M.A. Bassano, E. Verdun, B. Ferrero, C. Rivoiro, C. Ferrero, E. Picco, P. Ripellino, D. Viglietti, G. Giuliani, E. Montanari, M. Clerico, G. Meola, E.A. Scarpini, OPTIMS study Group. - In: JOURNAL OF NEUROLOGY. - ISSN 0340-5354. - 255:9(2008 Sep 25), pp. 1315-1323.

The OPTimization of Interferon for MS study : 375 mug interferon beta-1b in suboptimal responders

G. Meola;E.A. Scarpini;
2008-09-25

Abstract

We aimed to evaluate the safety and MRI efficacy of interferon beta-1b (IFNβ-1b) 375 μg (subcutaneously [sc] every other day [eod]) in relapsingremitting 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.
Immunomodulatory drugs; Interferon beta (IFNβ); MRI activity; Multiple sclerosis; Suboptimal treatment response
Settore MED/26 - Neurologia
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/60373
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