Author Of 3 Presentations
LB1169 - Psychological consequences of COVID-19 pandemic in Italian MS patients: a surprising resilience (ID 1668)
Abstract
Background
Italy was strongly hit by COVID-19 pandemic, therefore the Italian Government decreed urgent measures promoting social distancing in order to limit the spread of the virus. In fact, since March 11th, all not indispensable work, social, sporting, retail and recreational activities were suspended or, where possible, converted to the so-called smart-working. Fear of getting sick from COVID-19, government’s lockdown and the imposed social distancing might have an impact on anxiety, depression and quality of life (QoL) in people with Multiple Sclerosis (pwMS).
Objectives
The aim of our study was to investigate anxiety, depression and QoL changes in pwMS during SARS-CoV-2 outbreak and lockdown in Italy.
Methods
Sixty-seven pwMS with a previous (less than 6 months) neuropsychological evaluation before SARS-CoV-2 outbreak (T0) were re-evaluated at the time of the outbreak and lockdown in Italy (T1). They underwent a clinical and neurological evaluation (at T0) and completed the State-Trait Anxiety Inventory (STAI-Y1), the Beck Depression Inventory second edition (BDI-II), and Multiple Sclerosis Quality of Life-54 (MsQoL-54) at T0 and T1. Bonferroni correction for multiple comparisons was applied.
Results
BDI-II and STAI-Y1 scores did not change between T0 and T1, whereas the satisfaction on sexual function subscale of MsQoL-54 was significantly higher at T1 (p<0.001).
Conclusions
Despite the tight Italian lockdown due to the COVID-19 pandemic and the fear of getting sick, we did not observe a relevant negative impact on anxiety, depression and QoL of our sample of pwMS. Contrariwise, we were even able to detect some positive effects on specific aspects of QoL, such as sexual satisfaction.
P0273 - A multicentre, real-life study on the risk of lymphopenia and infections discloses a favourable safety profile of cladribine in MS patients. (ID 1086)
Abstract
Background
Background. Lymphopenia monitoring during treatment with disease modifying drugs for MS is relevant because of the potential increased risk of infections. Lymphopenia is an anticipated effect of cladribine (CLD) treatment, given its mechanism of action.
Objectives
Objectives. We aimed to i) characterize the absolute lymphocyte count (ALC) changes, and ii) evaluate the risk of infections in CLD-treated RRMS patients. ALCs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Methods
Materials and methods. In this observational multicentre study, demographic, clinical and MRI data of the patients included in the Free Of Charge CLD program were collected. ALC was also collected at baseline (before therapy initiation) and at month 3, 7, 12, 15, 19 and 24.
Results
Results. 236 patients were enrolled in 56 Italian MS Centres (71% F; mean age: 39+11.5 years; mean disease duration: 10+8.5 years). The median baseline EDSS was 3.0 (quartiles 1.5-3.5; range 0-6.5). 53 patients (22.5%) were treatment naïve, 107 (45.3%) switched to CLD from first line DMDs (for inefficacy), 76 (32.2%) switched to CLD after a second line therapy (33/76 for safety reason, 43/76 for inefficacy). Mean follow up was 12.2+5 months. At baseline, median ALC was 1615.0 cell/mm3 (quartiles, 1300.0-2200.0). At month 3, ALC was available in 190/236 and 101/190 had lymphopenia: 12 (6.3%) grade 3, 47 (24.7%) grade 2 and 42 (22.1%) grade 1. Among patients presenting grade 3 at month 3, only one had persistent ALC <500 cell/mm3 at month 7. At month 7, ALC was available in 180/236 and 77/180 had lymphopenia: 1 (0.6%) grade 4, 1 (0.6%) grade 3, 43 (23.9%) grade 2 and 32 (17.8%) grade 1. Up to date, 159/236 patients were re-treated. No retreatment was delayed because of grade 4 lymphopenia. No patient presented grade 4 lymphopenia at month 15, 6/89 (6.6%) experienced grade 3, 37/89 (40.7%) grade 2, 17/89 (18.7%) grade 1. At month 19, 1/38 (2.6%) presented grade 3 lymphopenia, 11/38 (29.0%) grade 2 and 9/38 (23.7%) grade 1. At month 24, 1/9 (11.1%) patient presented grade 3 and 1/9 (11.1%) presented grade 4 lymphopenia. During treatment course, 15 patients experienced infections (1 VZV, 3 HSV), none occurring in grade 3 or 4 lymphopenia.
Conclusions
Conclusions. In our study, the risk of grade 3 and 4 lymphopenia was lower compared to that observed in RCT. Moreover, grade 3 lymphopenia was transient in the majority of the patients. Compared to RTC, a more favourable CLD safety profile emerged in our study.
P0910 - Relapse-free and NEDA status with Cladribine in a real life population: a multicentre study (ID 1484)
Abstract
Background
Trials leading to Cladribine (CLD) approval for the treatment of Multiple Sclerosis (MS) were conducted over a decade ago: there is a need of proof of CLD efficacy and safety profile in the present MS therapeutic landscape.
Objectives
To evaluate CLD efficacy and safety profile in the current MS population, and to identify early predictors of response.
Methods
Before the drug was marketed under the national healthcare system, in Italy CLD was available through a Free Of Charge (FOC) program. We asked all participating MS centres to contribute to the present study, collecting demographic, clinical and MRI data of the patients who received CLD in the FOC program.
Results
56 MS centres participated to the study, for a total of 236 patients (71% F) (mean age: 39 + 11,5 years; mean disease duration: 10 + 8,5 years). Mean Annualized Relapse Rate (ARR) in the two years before CLD was 0,7 + 0,6; median baseline EDSS was 3 (quartiles 1,5-3,5; range 0-6,5). 53 patients (22,5%) were treatment naïve, 107 (45,3%) switched to CLD from first-line DMDs (for inefficacy), 76 (32,2%) switched to CLD from a second line therapy (33/76 for safety or loss of tolerability, 43/76 for inefficacy). Mean follow up was 12,2 + 5 months. 84,7% of the patients were relapse-free at follow-up. Mean ARR at follow-up was 0,2 + 0,6. Patients taking CLD as first therapy were less likely to experience a relapse (HR 0,6; 95% CI: 0,2-0,8; p = 0,04) while a higher baseline ARR was a predictor of clinical activity (HR 2,7, 95% CI: 1,4-5,6; p = 0,004). Median EDSS at follow up was 2 (quartiles 1-3,5). EDSS was stable in 73.7%, improved of at least 1 point in 21,6% and worsened of at least 1 point in 4,7% of the patients. 157/236 patients completed one year of follow up. Of these 92 (59,7%) reached No Evidence of Disease Activity (NEDA-3); NEDA-3 was achieved more frequently by naive patients (70%) than switchers from a first (57%) or a second line (50%) (HR 2,3; 95% CI: 1,01-5,3; p = 0,04). 33/236 patients reported at least one adverse event (AE), most frequently infections (15 cases); other AEs included gastrointestinal side effects, cutaneous rash, aphthous stomatitis and headache. Two severe AEs were reported (one pneumonia, one melanoma).
Conclusions
Even with the limitations of a retrospective study, our data confirm CLD safety and efficacy profile. Consistently with previous studies on patients with a first demyelinating event, CLD efficacy is maximized when used early in the course of MS.
Presenter Of 1 Presentation
P0650 - The contribution of cortical lesions to fatigue and depression in relapsing remitting multiple sclerosis. (ID 1163)
Abstract
Background
Despite the high prevalence and debilitating nature of fatigue and depression in Relapsing-Remitting Multiple Sclerosis (RRMS), the underlying pathophysiology is still far from being fully understood. While several findings highlighted the contribution of white matter lesion load (WMLL) and brain atrophy, the role of cortical lesions (CL) has been only marginally assessed.
Objectives
To investigate: i) the contribution of CL volume to fatigue and depression; ii) the relative role of total CL volume (tCLV), intracortical lesion volume (ICLV) and juxtacortical lesion volume (JCLV).
Methods
Sixty-five RRMS patients underwent: i) clinical evaluation including the Expanded Disability Status Scale (EDSS), ii) assessment of fatigue and depression trough the Modified Fatigue Impact Scale (MFIS) and the Beck Depression Inventory (BDI), iii) a 3T–MRI protocol including Double-Echo (DE) and 3D–Double Inversion Recovery (DIR) imaging to identify WMLL and CL. Correlation analyses were run between WMLL, CL and MFIS, and BDI. A multiple linear regression model was applied to evaluate the contribution of CL to MFIS and BDI, controlling for clinico-demographic data and WMLL.
Results
The correlation analysis showed that tCLV and JCLV correlated with MFIS (rho= 0.31, p=0.007; rho= 0.28, p=0.01 rispectively) and BDI (rho= 0.24, p=0.03 and rho= 0.23, p=0.04, rispectively), while ICLV or WMLL did not correlate with neither MFIS nor BDI. Regression analysis did not reveal any CL volume as a significant predictor of fatigue or depression.
Conclusions
Although CL volume is not a significant independent predictor of fatigue and depression, our study shows a significant role of CL volume in determining these symptoms in RRMS.