Background

Alemtuzumab(ALEM) is an anti-CD52 monoclonal antibody approved for the treatment of active Multiple Sclerosis(MS) which showed an overall high efficacy in clinical trials, also in the highly active subgroup of patients.

Objectives

The aim of this multicenter obervational study is to evaluate efficacy and safety of ALEM-treatment in a population of aggressive MS naïve-patients at year 2 and 3 after a complete cycle of treatment.

Methods

We conducted a multicenter prospective observational study in a cohort of ALEM-naïve MS patients. Clinical and neuroradiological parameters were collected from patients’ clinical records in 26 Italian MS Centers from October 2015 to May 2020.

Results

133 naïve patients were treated with ALEM: 60,2% females, mean age 31,4(± 8,9) years, mean disease duration 18,5(± 22,7) months, mean follow-up(FU) 34,2(± 12,1) months, median EDSS 3(0-6,5), ARR in the year preceding treatment 1,8 (± 0,9), mean number of brain T2/FLAIR-hyperintense lesions 29,8 (± 20,8) and mean number of Gd-enhancing lesions 3,4(± 5,1). Regarding ALEM efficacy, we report data obtained after the first complete cycle of treatment (2 ALEM-courses) because the occurrence of disease activity between the first and second course is not indicative of a therapeutic failure. 99 and 61 over 133 patients have at least 24 and 36 months FU respectively: 97% and 82% were relapse-free, ARR was 0,02 and 0,1, 92.9% and 82% were MRI activity-free and 97,7% and 91,8% progression-free with median EDSS of 2,0 and 1,5 (IQR 1 – 2,5) at year 2 and 3. The mean time to first relapse was 27,6(± 6,4) months 89,2% and 69,4% of patients reached NEDA-3 at year 2 and year 3 respectively. 5,3% of patients needed a third cycle of therapy. Overall 74,4% of patients had adverse events. Infusion-reaction and infections occurred respectively in 70,1% and 9,8% of patients; regarding secondary autoimmune disease the most frequent was thyroid dysfunction (15,8%).

Conclusions

In our very active MS-population after ALEM-treatment a strong reduction of both relapse rate and MRI activity was achieved. These results strengthen the assumption that aggressive naïve patient is an ideal candidate for immune system resetting, likely due to young age, short disease duration and low disability. Furthermore, absence of previous immunomodulating/immunosuppressant drugs altering the immune system could play a key role in determining effectiveness of this powerful drug. However, longer FU is needed to confirm our data and evaluate whether an early induction therapy could be worthy in this specific population, balancing benefit-risk ratio.

Background

Telemedicine is a live communication between patients and physicians through different technological tools. It became fundamental during COVID-19 pandemic to keep on taking care of patients in more medical fields than before. Given the chance for telemedicine to become a pivotal part of neurological routine practice, we investigated patients and neurologists satisfaction about this tool.

Objectives

This survey aimed to understand satisfactionabout telemedicine during pandemic and its possible use in the future outside pandemic

Methods

We administered a brief survey to a cohort of Multiple Sclerosis (MS) patients and their neurologists at MS center of San Raffaele Hospital, Milan. Demographic and clinical data (EDSS, treatment) were collected.

Results

151 patients filled out the survey: 75% females; mean age 42.2yy (18-73); median EDSS 1.5 (0-7). Treatments were almost equally distributed across first and second-line drugs (10% interferon, 10% glatiramer acetate, 14% teriflunomide, 22% dimethylfumarate, 23% fingolimod, 3% cladribine, 8% alemtuzumab, 10% ocrelizumab).

87% of patients appreciated telemedicine during pandemic; 10% had a positive opinion but with a need for traditional evaluations, while 3% were not satisfied.

Considering the possible routine use of telemedicine outside the pandemic, 82% firmly stated the importance of traditional evaluations. In particular, 44% would alternate in person and remote visits, while 38% strongly preferred traditional ones. Among the latters, the main reasons were the need for human empathy with the neurologist and the feeling that traditional evaluations may lead to better clinical outcomes. The remaining 18% would always use telemedicine except in the case of acute events. Neurologists and residents (n=18) were inquired about telemedicine: no one would use it as the only tool, 33% would alternate it with traditional practice and 67% would use it only in special contexts.

Conclusions

In our survey, both patients and neurologists recognized the importance of telemedicine during a pandemic. Patients more than physicians seemed ready to use it in everyday clinical practice. These data may be biased by a still ongoing patients fear and physicians lack of confidence in this multifaceted tool. The pandemic spurred the development of institutional telematic platforms capable of providing legal protection and traceability of visits and communication between patients and physicians. So far, we can conclude that telemedicine is a useful tool to overcome space-time limits, giving the best care to all patients in any condition. However, it cannot replace but only integrate traditional medicine.