In patients with relapsing multiple sclerosis (MS), treatment with alemtuzumab (ATZ), a monoclonal antibody, induces slight, but significant increases in systolic blood pressure (SBP) that are independent of high-dose methylprednisolone (HDMP) use, according to a study findings published in the journal Multiple Sclerosis and Related Disorders.
The researchers sought to examine BP change in patients with MS who received previous HDMP treatment, compared with those who received HDMP only, for acute relapse of MS. The current study enrolled patients who were diagnosed with relapsing MS according to 2010 or 2017 McDonald criteria, were aged 18 years and older, and were treated with 1 or more cycle(s) of ATZ between January 1, 2015, and December 31, 2021 , at the Medical University of Innsbruck or the Medical University of Vienna, both in Austria. For each patient in the ATZ/HDMP group, 2 disability-, sex-, and age-matched patients who received treatment with HDMP for acute relapse of MS comprised the control group.
Disability was measured using the Expanded Disability Status Scale (EDSS). Differences in EDSS score of ±5 and age of ±5 years were acceptable measures for the matching of control individuals. The primary study endpoint was maximum change in SBP from prior to the ATZ treatment cycle to the maximum value measured during the treatment cycle. Secondary endpoints included change in diastolic BP (DBP) and change in heart rate (HR) from prior to the treatment cycle to the maximum value measured during the treatment cycle.
A total of 30 patients treated with ATZ/HDMP and 60 sex-, age- and EDSS-matched control individuals were enrolled in the study. ATZ was administered as a 12-mg/day intravenous (IV) infusion, with 2 treatment cycles scheduled in each patient. Each ATZ infusion was preceded by treatment with methylprednisolone.
Study findings revealed that change in SBP reported in the ATZ/HDMP treatment group was significantly higher than in the HDMP control group (mean maximum change, 12.8 mm Hg vs 8.1 mm HG; P =.33). An increase in SBP that exceeded 20% from baseline was observed in 16.7% (5 of 30) of patients treated with ATZ/HDMP vs 5.0% (3 of 60) of those treated with HDMP (P =.078). The day after the initial ATZ infusion, compared with the HDMP control group, mean HR was higher in the ATZ/HDMP group
bpm, respectively; 82.5 bpm vs 73.2 bpm, respectively; P=.005). No significant group difference in maximal change in DBP (HDMP: 6.7 mm Hg vs ATZ/HDMP: 5.8 mm Hg; P =.636) or maximal change in HR (3.6 beats per minute [bpm] vs 6.4 bpm, respectively; P =.299) was reported.
A limitation of the current study is its retrospective design. Moreover, although BP measurement was available once daily in the morning, no additional BP measurements were available throughout the course of the day.
“A strict cardiovascular monitoring during ATZ infusion, exclusion of cardiovascular comorbidities before treatment and clinical awareness is necessary to reduce possible risks of ATZ treatment,” the researchers concluded.
Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Di Pauli F, Riedl K, Hegen H, et al. Alemtuzumab induced hemodynamic change in relapsing multiple sclerosis occurs independent of corticosteroid premedication – a retrospective multicentre study. Mult Scler Relat Disord. Published online April 20, 2022. doi:10.1016/j.msard.2022.103810