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Plasma exchange combined with azathioprine in multiple sclerosis using serial gadolinium-enhanced MRI to monitor disease activity

A randomized single-masked cross-over pilot study

From The National University Hospital, Rigshospitalet, The Neuroscience Center, Copenhagen MS Clinic (Drs. Sorensen, Wanscher, Schreiber, and Nordenbo), Department of Neurophysiology (Dr. Ravnborg), Department of Medicine P (Dr. Szpirt), and Hvidovre Hospital, The Danish Magnetic Resonance Center (Drs. Jensen and Christiansen), Copenhagen, Denmark.
Supported by Sigurd Abrahamsen and wife Addie Abrahamsen Foundation; Stockbroker Henry Hansen and wife Carla Hansen, born Westergaard Foundation; and Lions Club, Denmark. Azathioprine was kindly provided by The Welcome Foundation Ltd., Denmark.
Received June 14, 1995. Accepted in final form October 23, 1995.
Address correspondence and reprint requests to Dr Sorensen, Copenhagen MS Clinic, The Neuroscience Center, The National University Hospital, Rigshospitalet, DK-2100 Copenhagen, Denmark.

We enrolled 11 patients with secondary progressive MS in a randomized single-masked cross-over study of plasma exchange (PE) in combination with azathioprine 2 mg/kg. PE was performed once a week for 4 weeks and thereafter every second week for 20 weeks (14 treatments). Eight patients completed the whole trial, and three patients discontinued the trial, two during the run-in period of azathioprine treatment and one at the introduction of PE. The primary efficacy variables were the number of gadolinium-enhancing lesions and the occurrence of new enhancing lesions on serial MRI performed every 3 weeks during the PE and the control period. Secondary efficacy variables were the total MS lesion load on T₂-weighted MRI, multimodal evoked potentials, and clinical neurologic ratings. No significant differences were found regarding the number of enhancing lesions or occurrence of new enhancing lesions in the two periods. Although the total MS lesion load on MRI was significantly lower (p < 0.02) and central motor conduction times decreased significantly (p < 0.05) during PE, this small study did not provide sufficient evidence for a significant beneficial effect of PE or encourage a subsequent large randomized parallel group study.

NEUROLOGY 1996;46: 1620-1625

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