Author Of 2 Presentations
P0100 - Italian prospective multicentric observational real-life study of aggressive Relapsing Remitting Multiple Sclerosis treated with alemtuzumab (ID 1730)
- L. Moiola
- M. Di Cristinzi
- A. Sultana
- C. Zanetta
- F. Rinaldi
- L. Brambilla
- J. Frau
- S. Malucchi
- P. Annovazzi
- G. Puorro
- A. Bianco
- G. Lus
- P. Cavalla
- F. Sangalli
- M. Romeo
- G. Marfia
- A. Gallo
- V. Barcella
- S. Bucello
- M. Ferrò
- C. Lapucci
- L. Chiveri
- C. Chisari
- E. Baldi
- R. Clerici
- P. Banfi
- C. Tortorella
- R. Totaro
- R. Cerqua
- S. Tonietti
- V. Mantero
- G. Santuccio
- M. Filippi
Abstract
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.
P0421 - SARS-CoV-2 infection in multiple sclerosis patients: a single center experience in the province of Bergamo, Italy (ID 1461)
Abstract
Background
In Europe, the first case of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was reported in Lombardy region; the highest number of cases identified was in Eastern Lombardy , in particular in Bergamo’s province with 11,313 confirmed COVID19 patients up to April 30th 2020. The pandemic represents a challenge for neurologists treating Multiple Sclerosis (MS) because of the higher risk of infections of this population and for disease modifyng treatment (DMT) used. We report the experience of the MS center of Papa Giovanni XXIII Hospital in Bergamo, Italy.
Objectives
To evaluate the risk of SARS-CoV-2 infection and the outcome of the disease in MS patients treated with first and second line DMT.
Methods
We retrospectively and prospectively collected all MS patients who reported symptoms suggestive of SARS-CoV-2 infection since the beginning of February 2020. We considered for the analysis patients with a diagnosis confirmed by real-time reverse-trascriptase polymerase-chain-reaction (RT-PCR) on nasopharyngeal specimens as well as patients with suggestive symptoms and signs of SARS-CoV-2 infection who did not performed swab test and/or serological test. Since the begnning of pandemic , according to Italian reccomandation, we postponed the majority of treatment with depleting therapies whereas all the other drugs were usually continued.
Results
Between February 1st and and June 30, 153 patients with suspected SARS-CoV-2 infection were identified, which represent the 18% of the whole population regoularly followed at our MS center. The mean age was 45 years (range 20-71) and the mean EDSS was 2,5 ( range 1-8,5). The 81% of patients were female. A first line DMT was used in 92 patients (60%) while 51 patients (33%) were treated with second line DMT. Overall only 11 patients performed a nasopharyngeal swab during the symptomatic phase and a positivity was found in 7 patients. In an additional patient the diagnosis was confirmed on bronchoalveolar lavage fluid obtained by bronchoscopy. Only 3 patients (2%) presented a severe distress respiratory syndrome and were hospitalized in Intensive Care Unit. Two of these patients were female of 43 and 46 years old treated with Natalizumab and Ocrelizumab respectively both with mild disability (EDSS 2,5). The third patient was a disabled male of 56 years with a progressive form of MS (EDSS of 6.5). None of these patients had additional comorbidities and they all showed a complete recovery without sequaele.
Conclusions
In our experience the course of infection was mild in the large majority of patients independently of the ongoing DMT and no deaths were reported . The good outcome observed in our cohort might support a possible protective role of immunomodulation during SARS-CoV-2 infection. However, the diagnosis was confirmed only in a minority of our patients, therefore we cannot draw definitive conclusion and more data are needed to confirm our results.