Safety of alemtuzumab in a nationwide cohort of Finnish multiple sclerosis patients

Abstract

Background Alemtuzumab is an effective disease-modifying therapy (DMT) for highly active multiple sclerosis (MS). However, safety concerns limit its use in clinical practice. Objectives To evaluate the safety of alemtuzumab in a nationwide cohort of Finnish MS patients. Methods In this retrospective case series study, we analyzed the data of all but two MS patients who had received alemtuzumab in Finland until 2019. Data were systematically collected from patient files. Results Altogether 121 patients were identified, most of whom had received previous DMTs (82.6%). Median follow-up time after treatment initiation was 30.3 months and exceeded 24 months in 78 patients. Infusion-associated reactions (IARs) were observed in 84.3%, 57.3%, and 57.1% of patients during alemtuzumab courses 1–3, respectively. Serious adverse events (SAEs) were observed in 32.2% of patients, serious IARs in 12.4% of patients, and SAEs other than IARs in 23.1% of patients. Autoimmune adverse events were observed in 30.6% of patients. One patient died of hemophagocytic lymphohistiocytosis, and one patient died of pneumonia. A previously unreported case of thrombotic thrombocytopenic purpura was documented. Conclusions SAEs were more frequent in the present cohort than in previous studies. Even though alemtuzumab is a highly effective therapy for MS, vigorous monitoring with a long enough follow-up time is advised.

Etiology, effects and management of comorbidities in multiple sclerosis: recent advances

“…The relationship between comorbidities and the DMTs can be bidirectional ( Table 3 ); by triggering onset of new comorbidities, the DMTs could augment the comorbidity burden for persons with MS. Examples include alemtuzumab, whereby autoimmune disease can occur in approximately 30% of treated persons with MS, the most common being thyroid-related ( 88 , 89 ). Even among the platform DMTs considered to have better safety profiles, exposure to interferon-beta has been associated with 1.8-fold increased odds of stroke and 1.6-fold increased odds of migraine ( 92 ).…”

Real-world treatment outcomes and safety of natalizumab in Finnish multiple sclerosis patients

“…[6][7][8] Also, recent studies and meta-analysis have demonstrated that NTZ is still highly effective and viable immunotherapy for RRMS in comparison to other high-efficacy DMTs. [21][22][23] Previous registry-based studies, including one Finnish study, have indicated that initiating treatment with a high-efficacy DMT in RRMS may reduce long-term disability progression and relapses compared to moderate-efficacy DMTs. [24][25][26][27] In the restricted cohort of our study, we did not identify a statistically significant difference in disability progression as measured with EDSS change between 22 treatment-naive patients and 82 patients who had previously used another DMT.…”

Alemtuzumab‐induced immune‐mediated thrombotic thrombocytopenic purpura: A newly described drug‐related autoimmune disease

“…2 The first case of TTP in alemtuzumab-treated patients, requiring ICU and plasmapheresis, was identified in a Finnish nationwide cohort of 121 RR-MS and secondaryprogressive MS patients. 14 No data on clinical manifestations, ADAMTS13 status, time between the administration and the occurrence of the TTP or evolution were available.…”