THE OPTIMIZATION OF INTERFERON FOR MS STUDY: 375 MICROG INTERFERON BETA-1B IN SUBOPTIMAL RESPONDERS
| Autor: | Durelli L, Barbero P, Verdun E, Ferrero B, Clerico M, Ricci A, Cucci A, Contessa G, Rivoiro C, Ferrero C, Picco E, Ripellino P, Viglietti D, Bergui M, Zhong JJ, Versino E, Rottoli M, Moroni S, Teatini F, Schoenhuber R, Spissu A, Reggio A, Lo Fermo S, Liberto A, Perla F, Grasso E, Montanari E, Pesci I, Manneschi L, Ghezzi A, Zaffaroni M, Carolei A, Totaro R, Giuliani G, Pucci E, Cartechini E, Scarpini E, Clerici R, Protti A, Erminio C, Cotrufo R, Lus G, Bergamaschi R, Romani A, Bassano MA, Policreti A, Iudice A, Frittelli C, Motti L, Marcello N, Meola G, Robotti M, Cavallo R, Ravetti C, Deotto K., SAVETTIERI, Giovanni, SALEMI, Giuseppe |
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| Přispěvatelé: | Durelli L, Barbero P, Verdun E, Ferrero B, Clerico M, Ricci A, Cucci A, Contessa G, Rivoiro C, Ferrero C, Picco E, Ripellino P, Viglietti D, Bergui M, Zhong JJ, Versino E, Rottoli M, Moroni S, Teatini F, Schoenhuber R, Spissu A, Reggio A, Lo Fermo S, Liberto A, Perla F, Grasso E, Montanari E, Pesci I, Manneschi L, Ghezzi A, Zaffaroni M, Carolei A, Totaro R, Giuliani G, Pucci E, Cartechini E, Scarpini E, Clerici R, Protti A, Erminio C, Cotrufo R, Lus G, Savettieri G, Salemi G, Bergamaschi R, Romani A, Bassano MA, Policreti A, Iudice A, Frittelli C, Motti L, Marcello N, Meola G, Robotti M, Cavallo R, Ravetti C, Deotto K |
| Jazyk: | angličtina |
| Rok vydání: | 2008 |
| Předmět: |
Adult
medicine.medical_specialty Time Factors Adolescent Injections Subcutaneous suboptimal treatment response Gastroenterology Drug Administration Schedule law.invention Young Adult Multiple Sclerosis Relapsing-Remitting Adjuvants Immunologic Randomized controlled trial law Internal medicine medicine Humans Single-Blind Method Prospective Studies Adverse effect Prospective cohort study interferon beta (IFNβ) immunomodulatory drug Subclinical infection Dose-Response Relationship Drug business.industry Interferon beta-1b Interferon-beta Middle Aged Magnetic Resonance Imaging Confidence interval Surgery Clinical trial Treatment Outcome Neurology Relative risk multiple sclerosi MRI activity Settore MED/26 - Neurologia Neurology (clinical) business Follow-Up Studies |
| Popis: | We aimed to evaluate the safety and MRI efficacy of interferon beta-1b (IFNbeta-1b) 375 microg (subcutaneously [sc] every other day [eod]) in relapsing-remitting multiple sclerosis (RRMS) patients with a suboptimal response to IFNbeta-1b 250 microg, 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 microg sc eod; during the study phase suboptimal treatment responders were randomized either to IFNbeta-1b 250 or 375 microg 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 microg 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 microg group. Increasing the dose of IFNbeta-1b from 250 microg to 375 microg 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. |
| Databáze: | OpenAIRE |
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