Interferon beta-1b treatment in patients with relapsing±remitting multiple sclerosis under a standardized protocol in Spain Arbizu T, A  lvarez-Cermen Äo JC, Decap G, Ferna Ândez O, Urõ Âa DF, Garcõ Âa Merino A, Izquierdo G, Montalba Ân X. Interferon beta-1b treatment in patients with relapsing±remitting multiple sclerosis under a standardized protocol in Spain. Acta Neurol Scand 2000: 102: 209±217. # Munksgaard 2000. Objective ± A protocol system is being used in Spain for the prescription of innovative drugs including interferon beta-1b (IFNb-1b). Petitions for dispensing and reimbursement are based on the inclusion and exclusion criteria of pivotal trials, and are reviewed individually for approval by specialist committees. To estimate the performance of IFNb-1b in the clinical setting, data collected by the INSALUD and regional health services of Andalusia and Catalonia, together responsible for the healthcare of nearly 30 million individuals, were compiled in a common database for analysis. Methods ± Data comprise demographic and disease characteristics at the time of petition and at follow-up 3 months after treatment initiation and every 6 months thereafter. Ef®cacy was estimated by mean number of relapses per year, proportion of relapse-free patients, and disease progression as measured by the Expanded Disability Status Scale (EDSS). Safety parameters included adverse events and laboratory analyses. Results ± Between September 1995 and database cutoff in mid- 1998, petitions of 1419 patients were approved for IFNb-1b treatment. Patients were homogenous across the three databases and in the subgroups of patients completing 1 year (n=940) and 2 years (n=302) of treatment. There was a marked decrease in the mean number of relapses in the ®rst 12 months of IFNb-1b treatment for the 938 patients documented for 12 months, with a mean of 0.4 (t0.7 SD) relapses per patient and year, and a 2-year mean of 0.9 (t1.20 SD) in the 302 patients documented for 24 months. Of the 938 patients followed for i12 months, 505 (53.8%) were documented as being relapse-free during 12 months of treatment, and 146 (48.3%) of the 302 patients followed for i24 months, were relapse-free during 24 months of treatment. There were no differences in mean or median EDSS scores between baseline and months 12 and 24. Skin disorders were the most frequent adverse events, reported in over one-third of all patients; there were 159 injection site events, most frequently erythema (115 events). Systemic AEs pointing towards ¯u-like symptoms were reported in 288 of 1419 patients (20.3%). Leukopenia was the most frequently reported laboratory event. Elevations in liver transaminases were noted for 12 patients (0.8%) with SGOT increase and 7 (0.5%) with SGPT increase. Conclusion ± The protocol system has helped make IFNb treatment available to 8±10% of the estimated 15,000± 18,000 MS patients in the regions studied. In terms of ef®cacy, IFNb-1b performed in line with the pivotal study results. The safety pro®le of IFNb-1b was consistent with the published ®ndings and the drug labelling, and no new side effects or increased incidence of known side effects was observed. T. Arbizu 1 , J. C. A  lvarez-Cermen Äo 2 , G. Decap 3 , O. Ferna  ndez 4 , D. F. UrõÂa 5 , A. Garcõ Âa Merino 6 , G. Izquierdo 7 , X. Montalba Ân 8 1 Unidad de Esclerosis Multiple, Hospital de Belivitge, Barcelona; 2 Servicio de Neurologõ Âa, Hospital Ramo Ân y Cajal, Madrid; 3 Schering Espan Äa S.A., Madrid; 4 Servicio de Neurologõ Âa, Hospital Carlos Haya, Avda. Malaga; 5 Servicio de Neurologõ Âa, Hospital San Agustin, Avile Âs; 6 Servicio de Neurologia, Hospital Puerta de Hierro, Madrid; 7 Servicio de Neurologõ Âa, Hospital Universitario Virgen de la Macarena, Sevilla; 8 Unidad de Neuroimmunologia Clõ Ânica, Hospital Vall d'Hebron, Barcelona Key words: multiple sclerosis; Spain; interferon beta 1b T. Arbizu, Unidad de Esclerosis Multiple, Hospital de Belivitge, c/Feixa Llarga, E-08907 Hospitalet, Barcelona, Spain Accepted for publication May 16, 2000 Acta Neurol Scand 2000: 102: 209±217 Printed in UK. All rights reserved Copyright # Munksgaard 2000 ACTA NEUROLOGICA SCANDINAVICA ISSN 0001-6314 209