“At the moment, these results seem to be quite reassuring for most people with MS,” Marco Salvetti, MD, PhD, professor at Sapienza University and Sant’Andrea Hospital, in Rome, said in a press release.
Nevertheless, the early nature of these data must be taken into account. Evidence is also still lacking to determine how the use of disease-modifying therapies (DMTs), sex, or simultaneous conditions (comorbidities) affect this patient population, the researchers noted.
Their study, “An Italian programme for COVID-19 infection in multiple sclerosis,” was published in the journal The Lancet Neurology. It was written by Maria Pia Sormani, PhD, on behalf of the Italian Study Group on COVID-19 infection in MS.
Findings come from the pilot phase of an international web platform, called MuSC-19 (Multiple Sclerosis and COVID-19), that is collecting clinical and demographic data, as well as information on DMTs, on MS patients who have symptoms and signs of COVID-19 regardless of a confirmed infection via nasal and pharyngeal swabs.
The platform, donated by Roche, became active on March 14 in Italy, among the first European countries to experience severely the effects of COVID-19. Data are collected via an electronic case report form specifically developed for this pandemic, and provided to healthcare providers.
MuSC-19 is part of a program developed by The Italian Multiple Sclerosis Society (AISM), its Foundation (FISM), and the Multiple Sclerosis Study Group of the Italian Society of Neurology. The platform is also linked to the Italian MS Register, which currently collects data on more than 60,000 people with MS in Italy.
MuSC-19’s goal is to better understand the relationship between MS and COVID-19 and how a number of factors — namely age, sex, comorbidities, and treatments — affect infection outcomes in MS patients.
Particularly unclear is whether immunosuppressive therapies — the mainstay for MS treatment — increase a person’s susceptibility to severe COVID-19 infection, or if they might protect against the exacerbated immune and inflammatory responses associated with severe complications.
Such information can help to guide treatment decisions in MS patients with COVID-19 symptoms or a confirmed diagnosis, and “implement immediate and appropriate protective strategies,” Sormani wrote.
Sormani, a professor of biostatistics at the University of Genoa, is also responsible for the management of the MuSC-19 platform.
“The platform is accessible, upon registration, to the whole scientific community interested in collecting this type of data, regardless of their nationality and willingness to participate in this or other collateral initiatives aimed to collect clinical data and biological samples,” Sormani said in the release.
To date, 78 MS clinical centers in Italy and 28 centers from 15 other counties have contributed to the MuSC-19 platform, the AISM reported.
Study data covered 232 MS patients from 38 Italian centers who, as of April 7, had tested positive for COVID-19 (57 people) or were suspected of infection (175 people). Patients’ mean age was 44; most were women (69%), had relapsing-remitting MS (88%), and were being treated with a DMT (90.9%).
DMTs most frequently used by these people were Tecfidera (dimethyl fumarate, by Biogen), 24.6%; Gilenya (fingolimod, by Novartis), 13.4%; Ocrevus (ocrelizumab, by Genentech and Roche), 11.2%; Tysabri (natalizumab, by Biogen), 10.8%; and, glatiramer acetate (Copaxone, by Teva, and Glatopa, by Sandoz), 10.3%.
The vast majority — 223 patients, 96% of the total group — had a mild infection, defined as mild or no pneumonia. The infection was severe in four people, 2%, all of whom had shortness of breath, respiratory rates of at least 30 breaths per minute, and blood-oxygen saturation levels of 93% or less. Six patients, 3%, had critical infection, defined as respiratory failure, septic shock, and multiple organ dysfunction or failure, and were hospitalized in an intensive care unit.
Most MS patients, 209 or 90.1% of all with confirmed or suspected COVID-19 cases, were not hospitalized.
Of the six critical patients, all diagnosed with the virus, one recovered and five (2%) died. Patients who died tended to have comorbidities, higher disability, and/or were age 50 or older.
Although preliminary, these data suggest that most MS patients are likely to have a mild infection, in step with the general population, and that DMT use may not raise their risk of a severe infection.
“These results appear to be slightly reassuring and do not seem to contradict guidelines that we and others had already issued on the management of multiple sclerosis treatments in the time of the COVID-19 pandemic,” Sormani wrote.
Data also support that MS patients “with comorbidity and disability combined with older age are exposed to the risk of a worse evolution of the disease … [and] therefore require special care in preventing infection,” Salvetti added.
The researchers emphasized, however, the preliminary nature of these findings, and that MuSC-19’s data will continue to be updated throughout the pandemic.
“People with MS bring their experiences of the disease to research: for this reason, I invite all people who have faced home infection to tell their experience to researchers, also through their general practitioners,” said Francesco Vacca, AISM’s national president.
The program also includes an online survey created by AISM and FISM to understand the most pressing needs of people with MS during this emergency.
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