BACKGROUND: Patients with primary progressive MS have atypical clinical and MRI characteristics and have been excluded from most therapeutic trials. The authors report a randomized, controlled trial restricted to primary progressive MS. METHODS: Fifty subjects were randomized to weekly IM interferon beta-1a 30 microg, 60 microg, or placebo for 2 years. The primary endpoint was time to sustained progression in disability. Secondary outcomes included the timed 10-meter walk, nine-hole peg test, and on MRI, T2 and T1 brain lesion loads and brain and spinal cord atrophy. RESULTS: The 30- microg dose of interferon beta-1a was well tolerated, but the 60- microg dose caused severe flulike reactions and raised liver enzymes. No treatment effect was seen on the primary endpoint. Subjects on interferon beta-1a 30 microg had a lower rate of accumulation of T2 lesion load than controls (p = 0.025); subjects on 60 microg had a greater rate of ventricular enlargement than controls (p = 0.025). CONCLUSIONS: This study has demonstrated that interferon beta-1a 30 microg was well tolerated, identified useful outcome measures, but showed no efficacy on the primary outcome measure or on most of the secondary outcome measures.
BACKGROUND: Patients with primary progressive MS have atypical clinical and MRI characteristics and have been excluded from most therapeutic trials. The authors report a randomized, controlled trial restricted to primary progressive MS. METHODS: Fifty subjects were randomized to weekly IM interferon beta-1a 30 microg, 60 microg, or placebo for 2 years. The primary endpoint was time to sustained progression in disability. Secondary outcomes included the timed 10-meter walk, nine-hole peg test, and on MRI, T2 and T1 brain lesion loads and brain and spinal cord atrophy. RESULTS: The 30- microg dose of interferon beta-1a was well tolerated, but the 60- microg dose caused severe flulike reactions and raised liver enzymes. No treatment effect was seen on the primary endpoint. Subjects on interferon beta-1a 30 microg had a lower rate of accumulation of T2 lesion load than controls (p = 0.025); subjects on 60 microg had a greater rate of ventricular enlargement than controls (p = 0.025). CONCLUSIONS: This study has demonstrated that interferon beta-1a 30 microg was well tolerated, identified useful outcome measures, but showed no efficacy on the primary outcome measure or on most of the secondary outcome measures.
Authors: M Mateo Paz Soldán; Martina Novotna; Nuhad Abou Zeid; Nilufer Kale; Melih Tutuncu; Daniel J Crusan; Elizabeth J Atkinson; Aksel Siva; B Mark Keegan; Istvan Pirko; Sean J Pittock; Claudia F Lucchinetti; Brian G Weinshenker; Moses Rodriguez; Orhun H Kantarci Journal: Neurology Date: 2014-11-14 Impact factor: 9.910
Authors: P Rieckmann; K V Toyka; C Bassetti; K Beer; S Beer; U Buettner; M Chofflon; M Götschi-Fuchs; K Hess; L Kappos; J Kesselring; N Goebels; H-P Ludin; H Mattle; M Schluep; C Vaney; U Baumhackl; T Berger; F Deisenhammer; F Fazekas; M Freimüller; H Kollegger; W Kristoferitsch; H Lassmann; H Markut; S Strasser-Fuchs; K Vass; H Altenkirch; S Bamborschke; K Baum; R Benecke; W Brück; D Dommasch; W G Elias; A Gass; W Gehlen; J Haas; G Haferkamp; F Hanefeld; H-P Hartung; C Heesen; F Heidenreich; R Heitmann; B Hemmer; T Hense; R Hohlfeld; R W C Janzen; G Japp; S Jung; E Jügelt; J Koehler; W Kölmel; N König; K Lowitzsch; U Manegold; A Melms; J Mertin; P Oschmann; H-F Petereit; M Pette; D Pöhlau; D Pohl; S Poser; M Sailer; S Schmidt; G Schock; M Schulz; S Schwarz; D Seidel; N Sommer; M Stangel; E Stark; A Steinbrecher; H Tumani; R Voltz; F Weber; W Weinrich; R Weissert; H Wiendl; H Wiethölter; U Wildemann; U K Zettl; F Zipp; R Zschenderlein; G Izquierdo; A Kirjazovas; L Packauskas; D Miller; B Koncan Vracko; A Millers; A Orologas; M Panellus; C J M Sindic; M Bratic; A Svraka; N R Vella; Z Stelmasiak; K Selmaj; H Bartosik-Psujik; K Mitosek-Szewczyk; E Belniak; A Mochecka; A Bayas; A Chan; P Flachenecker; R Gold; B Kallmann; V Leussink; M Mäurer; K Ruprecht; G Stoll; F X Weilbach Journal: J Neurol Date: 2004-11 Impact factor: 4.849
Authors: D R Booth; A T Arthur; S M Teutsch; C Bye; J Rubio; P J Armati; J D Pollard; R N S Heard; G J Stewart Journal: J Mol Med (Berl) Date: 2005-08-02 Impact factor: 4.599