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Linomide in the treatment of multiple sclerosis: MRI results from prematurely terminated phase-III trials

Department of Radiology, University Hospital Vrije Universteit, Amsterdam, The Netherlands

G J Lycklmaà Nijeholt

Department of Radiology, University Hospital Vrije Universteit, Amsterdam, The Netherlands

C H Polman

Depautment of Neurology, University Hospital Vrije Universteit, Amsterdam, The Netherlands

H J Adér

Department of Epidemiology and Biostatistics, Vrije Universteit, Amsterdam, The Netherlands

F Barkhof

Department of Radiology, University Hospital Vrije Universteit, Amsterdam, The Netherlands

the 95 Line 146/147 Study Group

Due to an unexpected increase in serious cardiovascular event in MS patient treated with Linomide, a synthetic immunomodulator, two phase-III multinational relapsing remitting (RR) and secondary progressive (SP) MS trials had to be discontinued. MRI result of 413 patient who participated for at least 3 months were analysed. Patient received placebo, 2.5 or 5 mg Linomide. Scans were performed at pre-enrolment, month 3 and termination. The number and volume of enhancing lesions (ELV), and the number of active scans were evaluated At month 3, the decrease in the number of enhancing lesions in the placebo group was I I1%, compared with 15% in the 2.5 mg group (P=0.027) and 23% in the 5 mg group (P=0.057). Using the percentage of active scans as outcome parameter, the odds ratio for improvement between placebo and 2.5 mg group was 1.62 (P=0.14); between placebo and 5 mg Linomide group 3.58 (P=0.003). At termination, a rebound effect was noted in the 2.5 mg group (P=0.0 1). Analysis of the ELV showed no significant difference between placebo and treatment groups. Although Linomide has unacceptable side effect, it seems to have a modest effect on MS disease activity, as measured by MRI.

Key Words: magnetic resonance imaging • multiple sclerosis • Linomide

Multiple Sclerosis, Vol. 6, No. 2, 99-104 (2000)
DOI: 10.1177/135245850000600208


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