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: Many patients treated with Natalizumab experience end of dose interval (EDI) symptoms towards the end of the administration cycle. Objectives and aims: During the pandemic, to minimize patients accesses to the hospital and reduce exposure to Sars-CoV-2, we advised and asked patients undergoing treatment with Natalizumab if they wanted to be shifted from a Standard Interval Dosing (SID of 4 weeks) to and Extended Interval Dosing (EID of 5-6 weeks), regardless of their JCV index. Our main objective was to study prevalence and incidence of End of Dosing Interval (EDI) symptoms when Extended Interval Dosing (EID) was adopted, considering the variable prevalence of the wearing off effect. Method(s): We enrolled 87 patients, from May 2020 to January 2021, evaluated at baseline and during a 6 months follow-up with a survey focused on End of Dosing Interval Symptoms(EDIs), Fatigue Severity Scale (FSS), Expanded Disability Status Scale (EDSS) and Magnetic Resonance Imaging. Result(s): Among the 87 patients, 32(36.8%) reported End of Dose Interval (EDI) symptoms. Most common EDI symptom was fatigue (93.7%). Of note, among the patients with an EID (71), 16.9% patients reported a new onset of fatigue, where none was present before adopting the EID. Mean EDSS was higher in the group reporting EDI symptoms (3.6 EDI vs 2.2 non-EDI, p<0.05).Sphincterial functions were the ones that differed the most between the EDIsymptoms group and the non-EDI-symptoms group (1.4 EDIs vs 0.62 non-EDIs, p<0.05), among EDSS different components. Conclusion(s): The present study confirms that fatigue is the most common Natalizumab wearing-off symptom and 16.9% of patients develop a new onset of fatigue adopting an EID. Interestingly, there is a strong correlation between higher EDSS and fatigue in an EID setting. An increase of people suffering from fatigue is to be expected after adopting an EID, especially in the people with a higher EDSS and impairment of sphincterial functions. EID in our study does not compromise safety and efficacy of Natalizumab.
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
Introduction: The vaccination against SARS-CoV-2 is the main strategy to contain the pandemic and minimize hospitalizations principally in people with chronic diseases such multiple sclerosis (MS). Disease-modifyng therapies (DMTs) may impact on vaccine responses in MS people. Objective and Aims: To evaluate humoral and T-cell response after SARS-CoV-2 mRNA vaccine in MS people treated with different DMTs. Method(s): 130 MS patients treated with different DMTs were recruited, blood samples for detection of SARS-CoV-2 antibodies were collected at T0, before the first dose of vaccine, at T1, before the second dose, and T2 one month after. In a subgroup of 51 patients and 20 controls, samples were collected at T0 and T2 to test T-cell immune response to Spike antigen of SARS-CoV-2 by ELISPOT-IFNgamma. Result(s): All 130 patients had negative SARS-CoV-2 antibodies before vaccination, 66% showed IgG response to the first dose of vaccine (mean [SD],757[852] AU/mL), and 88,5% after the second dose (7259,06[7251]).The IgG response rate to vaccine was 100% (20/20) in healthy controls and MS patients treated with teriflunomide (5/5), dimethyl-fumarate (5/5) and natalizumab (9/9), while it was significantly lower in patients treated with fingolimod (76.2%, 16/21) and ocrelizumab (36.4%, 4/11). The IgG levels in fingolimod (552.3 [957.9]) and ocrelizumab (159.1 [301.2]) were also significantly lower than healthy controls (P<0.0001). We detected positive Spike-specific T-cell responses in 100% of vaccinated healthy controls and patients treated with teriflunomide, dimethyl-fumarate and natalizumab, in 90.5% (19/21) of patients treated with fingolimod, and 63.8% (7/11) of patients treated with ocrelizumab. Conclusion(s): The study confirm that the mRNA vaccine induce humoral specific responses in the majority of DMT-treated SM patients. It is noticeable the development of a T- cell-specific response to SARS-CoV-2 in patients treated with fingolimod and ocrelizumab, even with lower rates of humoral response. These findings encourage SARS-CoV-2 vaccination in all MS patients treated with DMTs.
ABSTRACT
Background and aims: Neurological manifestations of COVID-19 have been described. We report a case of seropositive NMOSD and acute myositis following SARS-CoV-2 infection. Methods: A previous healthy 35-years old man was admitted for NORB, a month after paucisymptomatic SARS-CoV-2 infection. Nasopharyngeal tests for SARS-CoV-2 was negative and serological IgG and IgM were positive. The neurological examination showed left eye blindness and myalgia. Blood examination showed elevated CK (>1000 UI/l), positive ANA (1:640) and anti-TPO (>1300 U/ml). Brain MRI showed T2/FLAIR left optic nerve hyperintensity with contrast enhancement. The EMG revealed signs of acute myogenic damage. He received intravenous methylprednisolone with poor recovery on vison but full recovery on muscle symptoms. Four months later he present NORB in contralateral eye;MRI showed optic chiasm hyperintensity, serum anti-AQP-4-antibodies were positive, EMG and CK were normalized. The patient received intravenous steroids and Immunoglobulins and started rituximab. Nevertheless, three months later he developed the area postrema syndrome, he was retreated with intravenous steroids and immunoglobulins and achieved a complete recovery. In March 2021, he underwent the second course of rituximab with clinical and radiological stability. Results: The patient was diagnosed with seropositive NMOSD, presented with recurrent NORB and area postrema syndrome, associated to acute myositis and autoimmune tiroiditis after SARS-CoV-2 infection. Conclusions: We supposed that SARS-CoV-2 may cause a post-infectious autoimmune response directed against AQP4 and other target (the muscle, the tiroid gland). Post-infectious autoimmunity is a potential mechanism in a subset of patients with COVID-19-related neurologic disease. Further research is needed to clarify this association.
ABSTRACT
Background and aims: Many patients treated with Natalizumab experience End of Dose Interval (EDI) symptoms towards the end of the administration cycle. During the pandemic, due to the unknown effects of SARS-CoV-2 infection on patients undergoing treatment with Natalizumab (NTZ), we decided to shift patients on NTZ from a Standard Interval Dosing (SID of 4 weeks) to an Extended Interval Dosing (EID of 5–6 weeks). Our main objective was to study the prevalence and incidence of EDI symptoms in our MS center, along with its efficacy and safety. Methods We reviewed 102 patients in our MS center treated with natalizumab for at least 12 months using EID. When tolerated/possible, patients were shifted from a SID of 4 weeks to an EID of 5–6 weeks. Patients were asked to report any worsening of their symptoms during the administration cycle, fatigue was assessed right before the administration of NTZ, with surveys and Fatigue Severity Scale (FSS). Results: Among the 102 patients, 41 (40.19%) reported end of dose interval (EDI) symptoms, and the most common one was fatigue. Among those 41 patients: 26 (63%) had a Relapsing Remitting (RR) course while 15 (37%) had a Secondary Progressive (SP) course. Of note, 15 (36.58%) patients reported a new onset of fatigue where none was present before the EID. Our data suggest that with EID efficacy is still preserved since only 6 patients showed new lesions on follow-up-MRI and with little clinical significance. Conclusions: Our study shows that when EID was adopted, fatigue was higher in the RR course group, with efficacy still preserved.