Aletuzumab(ALZ) is an approved drug for the treatment of active recurrent-remitting multiple sclerosis (RRMS), with proved efficacy and safety in clinical trials. Among its most frequent adverse effects are autoinmune disorders related to secondary autoinmunity (SA) phenomena.
We analyze and characterize secondary autoinmunity in our multiple sclerosis unit after more than five years of clinical experience.
Retrospective observational descriptive study of RRMS patients treated with ALZ in our center, characterizing SA phenomena after more than 5 years of experience
n=131(77% women), with a mean age of 40,2 years (SD±9,1) and a mean time of disease of 13.8 years (SD±7,1). The mean pre-treatment EDSS was 4,5 (DS±1,6) with an prior annualized relapse rate of 1.48 (SD±0,83). SA was found in 42 patients (32%), most of them with thyroid disease (81% with 73,5% hyperthyroidism, asymptomatic majority) with aggresive treatment (surgical, radiotherapy) in 20%. Hematological SA was found in 0.01% (autoinmune thrombopenia, with monophasic course and excellent response to pharmacological treatment) and cutaneous SA in 0.05% (most of them vitiligo and well-controlled alopecia areata and one patient with chronic urticaria). Currently one patient is under study for nephropathy (0.01%). Like the available evidence, we detected an increase in SA around third year.
In our experience ALZ is emerging as a drug with a safety profile similar to available evidence regarding SA, although some complications have been described in other body systems, and it requires an adequate patient selection and close clinical control.