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Alemtuzumab vs. Interferon β-1a in Early Multiple Sclerosis1
Figure 1
Addenbrooke’s Clinical Research Centre
Introduction
Safety and Side Effects
•Patients experienced slightly more adverse events on alemtuzumab
than interferon. This was almost entirely due to the mild or
moderate symptoms associated with the infusion of alemtuzumab,
typically headache and rash, which were controllable with simple
measures.
•Multiple sclerosis (MS) is thought to be an autoimmune disease in
which aberrant immune responses led by focal lymphocytic
infiltrations cause damage of myelin and axons. It is the
commonest potentially disabling disease of the central nervous
system in the Western World.
•Infections were more common in the alemtuzumab group, however
this was predominantly due to increased respiratory tract (upper and
lower) infections rather than more serious opportunistic infections.
Malignancy was balanced between the treatment arms; after the
study period in the alemtuzumab group there was a single case of
leukaemia.
•Alemtuzumab is a monoclonal antibody, humanised to reduce the
potential for patients to develop an immune response against it, that
targets CD52 on lymphocytes and monocytes. It is currently
licensed for the treatment of B-CLL and has been studied in patients
with multiple sclerosis at Cambridge since 1991.
•The significant (common and potentially severe) complication of
alemtuzumab treatment was autoimmunity.
This was most
frequently treatable hyper/hypo-thyroidism and less commonly
immune thrombocytopaenic purpura (ITP). For one patient the ITP
was fatal.
Figure 2
•This multicentre phase 2, randomised, rater blinded trial was of
previously untreated patients with early relapsing-remitting multiple
sclerosis. Disease activity was confirmed clinically (two or more
relapses in the preceding 2 years) and radiologically (one or more
enhancing lesions on cranial magnetic resonance imaging).
•The control group was actively treated with interferon-β. Two
dose regimens of alemtuzumab were tested; there was no difference
between the two doses in the safety or outcome measures, so the
alemtuzumab data are pooled.
Conclusions
Figure 3
In early, untreated, relapsing-remitting multiple sclerosis
compared to interferon:
Alemtuzumab suppresses relapse rate by 74% figure1
Alemtuzumab reduces the rate of fixed disability by 74% figure2
Alemtuzumab improves mean disability figure3
As previously described, adverse effects of alemtuzumab are
infusion reaction infections and autoimmunity
Phase 3 studies of alemtuzumab are currently enrolling
University of Cambridge
Neuroscience
Poster prepared by T Button on behalf of CAMMS223
Trial Investigators: PI AJ Coles, PI DAS Compston
1. The CAMMS223 Trial Investigators
Alemtuzumab vs. Interferon Beta-1a in Early
Multiple Sclerosis The New England Journal of
Medicine Vol. 359:1786-1801 (October 23,
2008)