Highlights
- •Safety profile of alemtuzumab may differ in real-world populations compared to subject investigated in clinical trials.
- •The switch to alemtuzumab must take into account previous therapeutic regimens.
- •The implementation of a monitoring program is crucial to recognize and promptly manage adverse events.
- •The efficacy of alemtuzumab is maintained after other second line therapies.
Abstract
Background
Alemtuzumab, is a compound approved for highly active MS, and, in Europe, employed
after the use of other disease-modifying treatments (DMTs) with an escalation approach
or used as a first therapeutic option. The occurrence of secondary autoimmune adverse
events and or infections can differ depending on the employed approach.
Objective
To evaluate the efficacy and safety of alemtuzumab in real-world MS population that
encompassed patients previously treated with other DMTs.
Methods
35 patients, treated with alemtuzumab in a single MS Center, were followed for at
least 36 months. The study investigated the prevalence of patients reaching the phase
of the non-active disease (NEDA-3). All the adverse events were also reported, and
correlations assessed.
Results
At the 36-month follow-up, 66,7% of patients achieved the NEDA-3 status, 90,5% of
the patients were relapse-free, 85,7% showed no signs of disability progression, nor
signs of MRI activity. Adverse events were observed in 45,7% of the patients and ranked
as severe in 23% of them. Cases of autoimmune hemolytic anemia (AIHA), pancytopenia,
viral hepatitis E, and noninfectious meningo-encephalomyelitis were found and reported.
For these complications, the post hoc analysis showed possible interactive factors
and causality related to previous DMT treatments.
Conclusions
In a real-world MS population like the one investigated in our study, alemtuzumab
was found to be an effective treatment when employed as an escalation or rescue therapy.
The compound exhibits a variable safety profile and frequent adverse events that are
likely depending on previous treatments and their impact on the immune system.
Keywords
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Article info
Publication history
Published online: November 05, 2019
Accepted:
November 4,
2019
Received in revised form:
October 31,
2019
Received:
April 2,
2019
Identification
Copyright
© 2019 Elsevier B.V. All rights reserved.
