Update on infective complications in patients treated with alemtuzumab for multiple sclerosis: review and meta-analysis of real-world and randomized studies.
OBJECTIVE
We aimed to systematically assess the pooled prevalence of infective complications in randomized controlled trials (RCTs) and real-world studies (RWSs) investigating alemtuzumab treatment in multiple sclerosis (MS), also looking at selected infections and their severity.


METHODS
We included in the analysis RCTs and RWSs investigating the use of alemtuzumab in MS in which infective complications were reported, as well as case reports of rare infections. We conducted a meta-analysis of proportions and a random effect model meta-regression to investigate heterogeneity.


RESULTS
The pooled prevalence of infective complications in alemtuzumab treated MS patients is 24%. The most common reported infections are respiratory tract infections (47%) and the most part of the infections are mild-to-moderate (85%). Severe infections account for 6% of the total estimate. We found first-time-reported cases of invasive aspergillosis, hepatitis E virus infection, EBV hepatitis, and cerebral toxoplasmosis. The prevalence of infections is higher in studies conducted before 2009, and in studies with higher proportion of male participants.


CONCLUSIONS
Clinicians should be aware that the prevalence of serious infections during alemtuzumab can be higher than expected from RCTs. Peculiar opportunistic infections should be considered when evaluating a patient treated with alemtuzumab who develops signs of infection.
['Buonomo|Antonio Riccardo|AR|', 'Viceconte|Giulio|G|', 'Zappulo|Emanuela|E|', 'Maraolo|Alberto Enrico|AE|', 'Russo|Cinzia Valeria|CV|', 'Carotenuto|Antonio|A|', 'Moccia|Marcello|M|', 'Gentile|Ivan|I|']
D000074323:Alemtuzumab D006801:Humans D007155:Immunologic Factors D009103:Multiple Sclerosis D009894:Opportunistic Infections D015995:Prevalence D016032:Randomized Controlled Trials as Topic D012720:Severity of Illness Index
Alemtuzumab multiple sclerosis opportunistic infections monoclonal antibodies