Title: Alemtuzumab vs. Interferon
1Alemtuzumab vs. Interferon ß-1a in Early Multiple
Sclerosis1
- 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. - 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. - 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 1
Addenbrookes Clinical Research Centre
- Introduction
- 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. - 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. - 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-ß. 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.
Figure 2
Conclusions 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
Figure 3
University of Cambridge Neuroscience
1. The CAMMS223 Trial Investigators Alemtuzumab
vs. Interferon Beta-1a in Early Multiple
Sclerosis The New England Journal of Medicine
Vol. 3591786-1801 (October 23, 2008)
Poster prepared by T Button on behalf of CAMMS223
Trial Investigators PI AJ Coles, PI DAS
Compston