Effect of Alemtuzumab Infusions on Vital Signs: A Prospective Observational Study in Patients with Relapsing-Remitting Multiple Sclerosis.

BACKGROUND

Alemtuzumab efficacy and safety were established in phase 3 randomized trials. We characterize vital signs during and after the first alemtuzumab infusion course.

METHODS

Patients with relapsing-remitting multiple sclerosis commercially prescribed alemtuzumab 12 mg/day on 5 consecutive days (initial course) were enrolled in this prospective, observational study. Preinfusion medications included methylprednisolone, antihistamine, and antipyretics. Primary end point: change from precourse baseline in vital signs during and 2 hours after each alemtuzumab infusion. Secondary end points: infusion duration and serious adverse events (AEs) starting within 24 hours and within 7 days after infusion (AEs collected up to 15 days after treatment). Potentially clinically significant vital sign abnormalities were based on predefined thresholds from literature review.

RESULTS

In the 304 patients treated, minimal increases in mean systolic (≤8 mm Hg) and diastolic (≤3 mm Hg) blood pressures from precourse baseline were observed on infusion days 3 to 5. An increase in mean heart rate (20 beats per minute) during the first infusion day normalized by day 2, and smaller increases (5 beats per minute) occurred during subsequent infusions. Serious AEs occurred in two patients (0.7%) during or within 24 hours after infusion and in three patients (1.0%) within 7 days. Mean/median infusion duration was 4 hours. Vital sign abnormalities with potential clinical significance occurred in 62.5% of patients.

CONCLUSIONS

Although most patients had potentially clinically significant vital sign abnormalities, mean changes from baseline during and after infusion of the first alemtuzumab course were clinically insignificant. No new safety signals were detected.

Informations de copyright

© 2020 Consortium of Multiple Sclerosis Centers.

Déclaration de conflit d'intérêts

Dr Chinea has received speaking and/or consulting fees from Acorda, Allergan, Biogen, Genentech, Novartis, Sanofi, and Teva and research support from Biogen and Novartis. Dr Honeycutt has received consulting fees, speaker honoraria, and/or research support from Actelion, Alkermes, Biogen, Celgene, EMD Serono, Mallinckrodt, MedImmune, Novartis, Roche, Sanofi, and Teva. Dr Miller has received speaking and/or consulting fees from Acorda Therapeutics, Allergan, Amgen, Biogen, Genentech, Mallinckrodt, Novartis, Sanofi, and Teva and research support from Adamas Pharmaceuticals, Allergan, Biogen, Elan, EMD Serono, Genentech, Ipsen, Novartis, Ono Pharmaceuticals, Sanofi Genzyme, Sun Pharma, and Teva Neuroscience. Dr Graves has received consulting fees and speaker honoraria from Acorda Therapeutics, EMD Serono, and Sanofi. Drs Jacobs and Wu are employees of Sanofi. Dr LaGanke has received compensation for consulting from Acorda Therapeutics, Bayer, Biogen, Cephalon, EMD Serono, Novartis, Pfizer, Questcor, Sanofi Genzyme, Strativa, Teva, and UCB.