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

Author(s): Durelli L, Barbero P, Bergui M, Versino E, Bassano MA, Verdun E, Ferrero B, Rivoiro C, Ferrero C, Picco E, Ripellino P, Viglietti D, Giuliani G, Montanari E, Clerico M, for the OPTIMS Study Group*

Affiliation(s): Dipartimento di Scienze Cliniche, e Biologiche, Universita' di Torino, Divisione di Neurologia, Ospedale Universitario S. Luigi Gonzaga, Regione Gonzole, 10, 10043, Orbassano (Torino), Italy, luca.durelli@unito.it.

Publication date & source: 2008-09, J Neurol., 255(9):1315-1323. Epub 2008 Sep 25.

We aimed to evaluate the safety and MRI efficacy of interferon beta-1b (IFNbeta-1b) 375 mug (subcutaneously [sc] every other day [eod]) in relapsing-remitting multiple sclerosis (RRMS) patients with a suboptimal response to IFNbeta-1b 250 mug, 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 IFNbeta-1b 250 mug sc eod; during the study phase suboptimal treatment responders were randomized either to IFNbeta-1b 250 or 375 mug 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 mug 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 mug group. Increasing the dose of IFNbeta-1b from 250 mug to 375 mug 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.

Page last updated: 2008-11-03

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