ABSTRACT
Introduction and aims: Multiple Sclerosis (MS) Centers experienced a significant disruption of their clinical activities during the first waves of COVID-19 pandemic. As part of a national multicenter survey (COVId Ms Patients SATisfaction survey - COVIMPSAT), we collected i) the opinion on quality of care (QoC) received by people with MS (pwMS) from MS Centers (MSC), and ii) data on therapeutic adherence and discontinuation, during the lockdown period (March-May 2020) in Italy. Method(s): In April-May 2021, 16 Italian MSC compiled and sent a digital (35-item) survey to their patients. Statistical analyses were performed with SPSS, version 25. Result(s): 1670 pwMS (67.3% women) completed the survey. Most of them (89.9%) were on disease-modifying therapies (DMTs). The most used DMTs were dimethyl fumarate (18.6%), ocrelizumab (14.4%) and natalizumab (13.9%). During the lockdown period, 88% did not modify their DMT regimen, while 11% reported a change in DMT intake, with a reduction in 7.8% and a drug discontinuation in only 4.2% cases. Almost 9 out of 10 pwMS (89.1%) were able to get in contact with their MSC without difficulties. Thirty-six percent of pwMS contacted their MSC for getting information about COVID-19, while 30% were directly contacted from the MSC personnel to provide information on MS and COVID-19 and preventive behaviours. More than half of the patients (63.5%) performed their check-up visits at the MSC with the same schedule as the pre-pandemic period, while 36.5% of pwMS voluntary skipped follow-up visits mainly because of fear of getting COVID-19 infection (46%) and the sensation of feeling well without an absolute/urgent need of a check-up visit (16.8%). Interestingly, although only 1.3% of pwMS underwent a teleneurology follow-up visit, 80% of patients suggested to invest more in telemedicine programs in order to expand contact channels with MSC. The overall opinion of pwMS on MSC during the pandemic period in Italy was more than positive, with 32% of pwMS declaring a significant increase in trust in their MSC. Conclusion(s): Italian pwMS judged globally well the activity, accessibility and information received by their MSC during the first wave of COVID-19 pandemic. Only 1 out of 10 pwMS underwent a change in their DMT regimen, showing a high drug adherence. Our data also demonstrate that implementing telemedicine programs would further improve the QoC of patients, particularly those with higher disability or living far from the MSC.
ABSTRACT
Introduction, objectives and aims: COVID-19 pandemic caused a significant disruption of clinical activities at Multiple Sclerosis (MS) Centers. As part of a national multicenter survey (COVId Ms Patients SATisfaction survey - COVIMPSAT) aimed at collecting patients' opinion regarding the quality of care and information received from MS Centers (MSC) during the pandemic, we report data about COVID-19 infections and vaccination cycle and how they were managed by the MSC. Material(s) and Method(s): In April-May 2021, 16 Italian MSC developed and sent a digital (35-item) survey by email to their patients. Statistical analyses were performed with SPSS, version 25. Result(s): 1670 people with MS (pwMS;67.3% women) completed the survey. 169 (10.1%) reported a diagnosis of COVID-19 infection: 63% were symptomatic, while 37% were not. As regards treatment for COVID-19, only 3% of the patients were hospitalized. The impact of COVID-19 infection on MS-related neurological symptoms was as follow: 69.3% of pwMS stated that the severity of their MS-related symptoms remained stable, 21.5% reported a worsening of pre-existing symptoms, 7.4% affirmed that new neurological symptoms emerged, while only 1.8% reported an improvement of MS-related symptomatology. At the time of the survey, 60.6% of pwMS were inoculated at least one dose of COVID-19 vaccine. Vaccination appointments were scheduled by: MSC staff alone (44.9%), MSC staff together with the general practitioner (17.5%), the general practitioner alone (16.1%), other Institutions (12.1%), and by the patients themselves (9.3%). At the moment of the survey 39.4% of pwMS were not vaccinated yet. The three major reasons for not being vaccinated yet were: being already on a vaccination list (40.8%), willing to be vaccinated but without an appointment (17.6%), still undecided or not willing to be vaccinated (19.3%). Conclusion(s): The results of this multicentre survey revealed a low hospitalization rate of pwMS, in line with previous studies (Moghadasi et al, 2021). In the majority of the sample, COVID-19 symptomatology did not have a significant impact on MS-related neurological symptoms. MSC promoted and facilitated vaccination procedures and scheduling, alone or in combination with the general practitioner, in more than half of pwMS.
ABSTRACT
Background: Dihydroorotate dehydrogenase (DHODH) inhibition is an established mode of action for disease-modifying treatment of relapsing-remitting multiple sclerosis (RRMS). Vidofludimus calcium (IMU-838) is a selective and potent second- generation DHODH oral immunomodulator being developed for the treatment of several immune-mediated diseases including MS and COVID-19. The inhibition of the DHODH enzyme leads to metabolic stress in stimulated lymphocytes with subsequent reduction of pro-inflammatory cytokines and induction of apoptosis. Due to IMU-838's pharmacological selectivity and lack of relevant off-target effects on kinases, increased rates of typical antiproliferative effects (neutropenia, alopecia and gastrointestinal disturbances) have not been observed in clinical trials. The serum half-life of approximately 30 hours allows quick on- and off-dosing. Objectives: To report topline efficacy, safety, and tolerability of IMU-838 in the relapsing MS EMPhASIS trial (NCT03846219), the first trial of IMU-838 in MS. Methods: EMPhASIS is a phase 2 multicenter, double-blind, placebo-controlled, randomized, parallel-group trial to assess the efficacy and safety of two once-daily oral doses of IMU-838 (30 and 45 mg/day) in patients with RRMS. Inclusion criteria are age 18-55 years, active RRMS defined by the evidence of clinical and radiological disease activity, and Expanded Disability Status Scale (EDSS) 0-4. The primary endpoint is the cumulative number of combined unique active MRI lesions over 24 weeks. Secondary endpoints include efficacy, safety and tolerability parameters. The study also includes a subsequent optional, open-label treatment period to evaluate long-term safety and tolerability. Results: 210 subjects (65% women) were enrolled in 36 centers across four European countries. The mean age at baseline was 36.8 years (SD 8.8). 198 subjects (94%) completed the 24-week main treatment period, with the last follow-up visit in April 2020. Database lock will be in July 2020 and top-line data will be available shortly thereafter. Primary outcome and several secondary outcomes (including safety data) will be presented. Conclusions: IMU-838 is an orally available, next-generation selective immunomodulator with a potentially more favorable profile than first-generation DHODH inhibitors. Top-line results of IMU-838 on primary and several secondary endpoints in patients with RRMS in the EMPhASIS trial will be presented.