Table 1.

Clinical trial incidence, post-marketing frequency, and signs and symptoms of key autoimmune events after treatment with alemtuzumab.

Key autoimmune AEa	Incidence in clinical development program (alemtuzumab 12-mg treatment arm) (13)	Estimated frequency in post-marketing settingsb (22)	Signs and symptoms
Thyroid events	42c	Not available	Overactive thyroid: diaphoresis, unexplained weight loss, eye swelling, nervousness, tachycardia Underactive thyroid: unexplained weight gain, feeling cold, increased fatigue, newly occurring constipation
Immune thrombocytopenia	2.0d	0.72	Bruising, petechiae, purpura, mucosal bleeding, increased menses, hematuria, melena
Nephropathy	0.27	0.17	Blood in the urine (urine may be red or tea-colored), swelling in legs and feet, hemoptysis

^aDoes not include other rare autoimmune AEs (e.g., alopecia, acquired hemophilia A) that have been reported in alemtuzumab-treated patients (23, 24).

^bCalculated as number of cases/total number of patients (n = 18,561) treated through December 31, 2017.

^cOver 6 years in the pooled CARE-MS patients who received alemtuzumab 12 mg (n = 811).

^dOver 5 years of total follow-up for CARE-MS studies and 8 years for CAMMS223 study in patients who received alemtuzumab 12 mg (n = 1,217).

AE, adverse event; CARE-MS, Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis.