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A randomized controlled trial of recombinant interferon beta-1a in ALS

From the Istituto di Ricerche Farmacologiche "Mario Negri," Milan, and Ospedale "San Gerardo," Neurological Clinic, Monza (Drs. Beghi and Riva); Ospedale "Casa Sollievo," San Giovanni Rotondo (Drs. Beghi and Tonali); Ospedale "Le Molinette" (Dr. Chiò), Neurological Clinic, Turin; Università "La Sapienza" (Dr. Inghilleri), Neurological Clinic, Rome; Neurological and Physical Therapy Departments (Drs. Mazzini and Mora), Fondazione Clinica del Lavoro, Veruno; Neurological Department (Dr. Micheli), Fondazione Clinica del Lavoro, Gussago; Ospedale "San Paolo" (Dr. Poloni), Neurological Clinic, Milan; Università degli Studi di Bari (Dr. Serlenga), Neurological Clinic, Bari; Istituto Neurologico "C. Besta" (Dr. Testa), Milan; and Università Cattolica (Dr. Tonali), Neurological Clinic, Rome, Italy.

Address correspondence and reprint requests to Dr. Ettore Beghi, Istituto "Mario Negri," Via Eritrea 62, 20157 Milan, Italy.

OBJECTIVE: To evaluate the efficacy of recombinant interferon beta (IFNß)-1a in the treatment of ALS.

BACKGROUND: It has been proposed that IFNs affect the progression of ALS by interfering with putative immune mechanisms involved in the pathogenesis of the disease.

METHODS: Patients (n = 61) 40 to 70 years of age with a 6- to 24-month history of confirmed ALS with mild to moderate disability received IFNß-1a, 12 mIU (n = 31), or placebo (n = 30) subcutaneously three times a week for 6 months and were followed up for an additional 6 months. Patients were assessed after 4, 12, 24, 36, and 48 weeks. Medical Research Council scale, Norris scale, and bulbar scores as well as forced vital capacity were used to assess disability. Selected electrophysiologic measures (latency, amplitude, and duration of the compound muscle action potential) were also used.

RESULTS: Twenty patients randomized to IFNß-1a and 17 patients given placebo completed the study. A total of 16 patients receiving IFNß-1a became non–self-supporting compared with 16 on placebo (52% versus 53%). There were no significant differences between the two treatment groups for any of the measures of disease progression and disability. Deaths were reported in six patients treated with IFNß-1a and four patients on placebo. Adverse events were reported more frequently with IFNß-1a (77% of patients) compared with placebo (57%), with flu-like symptoms and local erythema being the commonest complaints.

CONCLUSIONS: This pilot study suggests that IFNß-1a is not effective in the treatment of ALS.

Key words: Interferon—ALS—Motor neuron disease—Randomized clinical trial

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