Italy was the first European country to encounter the effects of the coronavirus disease 2019 (COVID-19) pandemic.1 For people with multiple sclerosis, the situation carries additional reasons for concern. Although emerging work suggests that some coexisting diseases, such as hypertension, might increase the severity of the COVID-19 infection, how less common conditions, such as multiple sclerosis, effect COVID-19 outcomes is still uncertain. Furthermore, immunosuppressive therapies, the mainstay of treatment for multiple sclerosis, might confer additional risks or, on the contrary, confer some protection. Therefore, collecting information to evaluate the relationship between multiple sclerosis and COVID-19 and implement immediate and appropriate protective strategies is crucial. Less crucial, but equally as important, are questions about the long-term effect of this pandemic on psychiatric comorbidities, such as depression and anxiety (common comorbidities in multiple sclerosis), the patient–physician relationship, the spread of scientific information, the development of new models of care, and the role of patients and patient organisations in the community.
The Italian Multiple Sclerosis Society (AISM), the Italian Multiple Sclerosis Foundation (FISM), and the Multiple Sclerosis Study Group of the Italian Neurological Society have set up a programme to help with these crucial elements in the response to COVID-19 in patients with multiple sclerosis. The programme was developed according to suggestions received from a group of neurologists, including health-care workers on the front-line and representatives of the AISM and the FISM. Further initiatives of the programme will also consider the results of an online survey made by the AISM and the FISM aimed at understanding the most pressing needs of people with multiple sclerosis during this pandemic.
Here we report the results of the pilot phase of an investigation of COVID-19 among people with multiple sclerosis, based on a core set of data collected from treatment providers through a specifically designed web-based case report form. The core data set includes clinical and demographic characteristics, and information on disease-modifying therapies. To be included, patients had to have symptoms and signs of COVID-19 infection, with or without a positive test (RT-PCR on nasal and pharyngeal swabs).
On March 14, 2020, we sent the case report form to more than 200 Italian neurologists from about 90 multiple sclerosis centres across Italy. As of April 7, 2020, we have collected data on 232 patients from 38 centres, 57 of whom tested positive for COVID-19 and 175 of whom had suspected COVID-19 symptoms but did not have a positive test (appendix p 1). Mean follow-up was 12·6 days (SD 7·4).
The severity of COVID-19 infection in 232 patients was classified as mild (no pneumonia or mild pneumonia) in 222 (96%), severe (shortness of breath, respiratory rates ≥30 breaths per min, blood oxygen saturation ≤93%, PaO2:FiO2 <300 mmHg/%, and an increase in lung infiltrates of >50% within 24–48 h) in four (2%), and critical (respiratory failure, septic shock, and multiple organ dysfunction or failure) in six (3%).2 Of the six critical patients, one recovered and five died; all had a positive swab (appendix p 2). 21 patients had undergone a 5-day course of methylprednisolone within 3 months before the onset of COVID-19.
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.3 These data must be considered only preliminary, however, and there is not enough information to speculate about any susceptibility to protection from COVID-19 afforded by disease-modifying therapies. The same is true for the effect of comorbidities, sex, and other medications (beyond just the disease-modifying therapies) that patients with multiple sclerosis might be taking.
We will continue to monitor these patients throughout the duration of the pandemic. When a system to record all patients with multiple sclerosis positive for COVID-19 is implemented, more data on the prevalence of these cases can be gathered.
Our web-based platform for data collection is available to all colleagues interested in collecting this type of data. Through procedures that are currently being defined, we also aim to make the raw consolidated data from this web-based case report form open access.
This online publication has been corrected. The corrected version first appeared at thelancet.com/neurology on May 28, 2020
Acknowledgments
MPS reports personal fees from Biogen, Merck, Teva, Novartis, Sanofi Genzyme, Roche, GeNeuro, and Medday, outside the submitted work. The Italian Study Group on COVID-19 infection in multiple sclerosis thanks Roche for donating the web-based platform for data collection. The study was approved by the Regional Ethics Committee of Liguria (n 130/2020 – DB id 10433). There is no prominent authorship and MPS is acting as the corresponding author on behalf of the Italian Study Group on COVID-19 infection in multiple sclerosis.
Supplementary Material
References
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