Abstract
This paper deals with thyroid disease that can occur after treatment with alemtuzumab (humanized monoclonal anti-CD52) for relapsing–remitting multiple sclerosis (MS). The 5-year incidence of thyroid adverse events in phase 3 clinical trials is up to 40.7%. In most cases, the thyroid dysfunction is mild and easily manageable and only few serious thyroid adverse events have been reported. The need for patient education on the risk of thyroid dysfunction, as well as regular clinical and biochemical thyroid function screening is well described. However, practical clinical guidance in case of abnormal thyroid-related findings prior to or after alemtuzumab treatment is currently lacking. Therefore, a Belgian taskforce consisting of MS and thyroid experts was created in 2016, with the objective of issuing a clinical thyroid management algorithm based on available scientific evidence and personal experience with regard to alemtuzumab treatment-related thyroid adverse events.
Highlights
Alemtuzumab is a humanized monoclonal antibody approved for the treatment of adult patients with active multiple sclerosis (MS) in more than 65 countries [1, 2]
In mothers with Graves’ disease (GD), maternal thyrotropin receptor antibodies (TRAbs) can be transferred to the fetus, which can potentially result in transient fetal and neonatal hyperthyroidism
Available evidence suggests that in case of active MS, potential thyroid-related adverse events usually do not represent a contra-indication for treatment with alemtuzumab, as Autoimmune thyroid disease (AITD) most often has a mild clinical course
Summary
Alemtuzumab is a humanized monoclonal antibody approved for the treatment of adult patients with active multiple sclerosis (MS) in more than 65 countries [1, 2]. Research suggests immunomodulatory effects through the depletion of mature and circulating B- and T lymphocytes, followed by a repopulation and long-lasting shift in immunological balance, including alterations in the number, proportions, and properties of some lymphocyte subsets, increased representation of regulatory T-lymphocyte subsets, and increased representation of memory T- and B lymphocytes This mechanism may be relevant to the durable efficacy of this drug [6,7,8]. A risk management plan (RMP) has been implemented to mitigate the risk of autoimmune conditions in MS patients treated with alemtuzumab Thyroid function tests, such as serum thyroid stimulating hormone (TSH) levels, should be obtained prior to initiation of treatment and every 3 months thereafter until 48 months following the last infusion. Due to the current lack of practical clinical guidance with regard to managing thyroid-related autoimmunity after alemtuzumab treatment, a Belgian taskforce was created in 2016 consisting of experts in MS and in thyroid disease, with the objective of issuing practical recommendations to guide the treating physician
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