The OPTimization of Interferon for MS study : 375 mug interferon beta-1b in suboptimal responders
Articolo
Data di Pubblicazione:
2008
Citazione:
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.
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.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
Immunomodulatory drugs; Interferon beta (IFNβ); MRI activity; Multiple sclerosis; Suboptimal treatment response
Elenco autori:
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
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