Alemtuzumab (Campath) versus interferon beta-1a in early relapsing-remitting multiple sclerosis (RRMS)

There is a window of opportunity for immunotherapy for RRMS, where modulation of the immune response is able to alter the natural history of disability accumulation. The recent development of therapies for multiple sclerosis that seem to be more effective than interferons and glatiramer acetate (Copaxone) has led to a number of studies being carried out.

Now it seems that every day we inch nearer to improved management of MS and hopefully towards a cure.

This month a paper has been published which shows “a substantial advance in the treatment of multiple sclerosis”

The Lancet Neurology, Volume 10, Issue 4, Pages 338 – 348, April 2011

Alemtuzumab is a humanised monoclonal antibody that depletes lymphocytes, causing long-term immunomodulation.

Alemtuzumab (Campath)

In this study 334 treatment-naive patients with active, early RRMS were randomly assigned  to receive

• interferon beta-1a (44 μg subcutaneously three times per week), or
• 24 mg per day alemtuzumab intravenously for 2 or 3 annual cycles or
• 12 mg per day alemtuzumab intravenously for 2 or 3 annual cycles.

Then they analysed freedom from clinical disease activity (CDA; defined as no relapses and no sustained accumulation of disability) and occurrence of sustained reduction in disability  (sustained for 6 consecutive months )

They also analysed efficacy outcomes for subgroups based on

• age
• geographic region
• MRI-T1 brain volume
• MRI-T2 lesion volume
• disease duration,
• number of previous relapses within 2 years, and
• EDSS.

Results

322 patients were analysed. 161 of 215 patients (74.9%) treated with alemtuzumab were free of CDA at 36 months compared with 52 of 107 patients (48.5% treated with interferon beta-1a

Interpretation

Alemtuzumab reduced disease activity compared with interferon beta-1a in most of the analysed subgroups. Significantly greater numbers of patients experienced sustained improvement in disability after treatment with alemtuzumab than interferon beta-1a. The efficacy offered by alemtuzumab is a substantial advance in the treatment of multiple sclerosis.

In patients with established cerebral atrophy or a high lesion burden measured by MRI, there was a clear beneficial treatment effect of alemtuzumab over interferon beta-1a on relapse rate and risk of accumulating disability.

Ongoing phase 3 trials of alemtuzumab are exploring its efficacy on groups with wider inclusion criteria, including patients who have previously received disease-modifying therapies.