We aimed to evaluate the safety and MRI efficacy of interferon beta-1b (IFN beta-1b) 375 mu g (subcutaneously [sc] every other day [eod]) in relapsing-remitting multiple sclerosis (RRMS) patients with a suboptimal response to IFN beta-1b 250 mu g, 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 IFN beta-1b 250 mu g sc eod; during the study phase suboptimal treatment responders were randomized either to IFN mu-1b 250 or 375 mu g sc eod. Primary outcome was the proportion of patients without MRI activity during study Months 9-12 according to the intention-to-treat 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 mu g 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 mu g group. Increasing the dose of IFN beta-1b from 250 mu g to 375 mu g 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.

MRI activity and neutralising antibody as predictors of response to interferon beta treatment in multiple sclerosis

CAROLEI, ANTONIO
2008-01-01

Abstract

We aimed to evaluate the safety and MRI efficacy of interferon beta-1b (IFN beta-1b) 375 mu g (subcutaneously [sc] every other day [eod]) in relapsing-remitting multiple sclerosis (RRMS) patients with a suboptimal response to IFN beta-1b 250 mu g, 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 IFN beta-1b 250 mu g sc eod; during the study phase suboptimal treatment responders were randomized either to IFN mu-1b 250 or 375 mu g sc eod. Primary outcome was the proportion of patients without MRI activity during study Months 9-12 according to the intention-to-treat 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 mu g 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 mu g group. Increasing the dose of IFN beta-1b from 250 mu g to 375 mu g 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.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11697/7689
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