Alemtuzumab-Related Thyroid Dysfunction in a Phase 2 Trial of Patients With Relapsing-Remitting Multiple Sclerosis

Abstract

Thyroid dysfunction was more common with alemtuzumab than with SC IFNB-1a. There were few serious episodes. Regular monitoring facilitated early detection. Unique features of this population included high prevalence of Graves' hyperthyroidism, multiple episodes of thyroid dysfunction in individual patients, spontaneous hypothyroidism after overt Graves' hyperthyroidism, and a high prevalence of TBII-positive overt hypothyroidism.

Comorbid autoimmune pathology in patients treated with disease modifying drugs

“…[62] были включены 334 пациента с рецидивирующе-ремит-тирующим РС, которых разделили на три группы: получавшие ИФНβ, а также получавшие алемтузу-маб в дозировках 12 и 24 мг внутривенно соответ-ственно. Показатели функции ЩЖ и наличие тирео-тропин-связывающего ингибирующего иммуногло-булина оценивали через 1 мес от начала лечения, затем ежеквартально, наличие антител к тиреопе-роксидазе -каждые 6 мес.…”

Alemtuzumab Induced Thyroid Disease in Multiple Sclerosis: A Review and Approach to Management

“…This similar pattern of appearance of thyroid disease was seen previously in the CAMMS223 phase II trial. 17,18 The yearly incidence of hypothyroidism ranged from 5.7-20.9%, whereas that of all causes of thyrotoxicosis, including GD, ranged from 1.2 -11.9%; the yearly incidence of SPT ranged between 0.7 -1.9%. A summary of incidence of thyroid adverse events in CARE MS trials is presented in Table 3.…”

“…20 Further studies are required to assess the causal relationship between thyroid cancer and Alemtuzumab treatment. 18 did an extensive review of all thyroid dysfunction that occurred in the phase II study of Alemtuzumab in MS (CAMMS223). Thyroid adverse events were defined clearly and included overt and subclinical hyperthyroidism and overt and subclinical hypothyroidism.…”

“…Interestingly, spontaneous resolution of overt GD occurred in 36% of patients and some went on to develop spontaneous hypothyroidism. 18 A summary of incidence of thyroid adverse events in CAMMS223 trial is presented in Table 4.…”

“…In other words, 76.8% of the patients with GD due to AITD in CAMMS223 did not require RAI or thyroidectomy. 18,22 It is not described in detail when RAI or thyroidectomies were done, or whether it was due to failure of medical treatment or physician and patient preference.…”