Updated Results of the COVID-19 in MS Global Data Sharing Initiative: Anti-CD20 and Other Risk Factors Associated With COVID-19 Severity.

BACKGROUND AND OBJECTIVES: Certain demographic and clinical characteristics, including the use of some disease-modifying therapies (DMTs), are associated with severe acute respiratory syndrome coronavirus 2 infection severity in people with multiple sclerosis (MS). Comprehensive exploration of these relationships in large international samples is needed. METHODS: Clinician-reported demographic/clinical data from 27 countries were aggregated into a data set of 5,648 patients with suspected/confirmed coronavirus disease 2019 (COVID-19). COVID-19 severity outcomes (hospitalization, admission to intensive care unit [ICU], requiring artificial ventilation, and death) were assessed using multilevel mixed-effects ordered probit and logistic regression, adjusted for age, sex, disability, and MS phenotype. DMTs were individually compared with glatiramer acetate, and anti-CD20 DMTs with pooled other DMTs and with natalizumab. RESULTS: Of 5,648 patients, 922 (16.6%) with suspected and 4,646 (83.4%) with confirmed COVID-19 were included. Male sex, older age, progressive MS, and higher disability were associated with more severe COVID-19. Compared with glatiramer acetate, ocrelizumab and rituximab were associated with higher probabilities of hospitalization (4% [95% CI 1-7] and 7% [95% CI 4-11]), ICU/artificial ventilation (2% [95% CI 0-4] and 4% [95% CI 2-6]), and death (1% [95% CI 0-2] and 2% [95% CI 1-4]) (predicted marginal effects). Untreated patients had 5% (95% CI 2-8), 3% (95% CI 1-5), and 1% (95% CI 0-3) higher probabilities of the 3 respective levels of COVID-19 severity than glatiramer acetate. Compared with pooled other DMTs and with natalizumab, the associations of ocrelizumab and rituximab with COVID-19 severity were also more pronounced. All associations persisted/enhanced on restriction to confirmed COVID-19. DISCUSSION: Analyzing the largest international real-world data set of people with MS with suspected/confirmed COVID-19 confirms that the use of anti-CD20 medication (both ocrelizumab and rituximab), as well as male sex, older age, progressive MS, and higher disability are associated with more severe course of COVID-19.

Response to COVID-19 booster vaccinations in seronegative people with multiple sclerosis.

BACKGROUND: People with MS treated with anti-CD20 therapies and fingolimod often have attenuated responses to initial COVID-19 vaccination. However, uncertainties remain about the benefit of a 3rd (booster) COVID-19 vaccine in this group. METHODS: PwMS without a detectable IgG response following COVID-19 vaccines 1&2 were invited to participate. Participants provided a dried blood spot +/- venous blood sample 2-12 weeks following COVID-19 vaccine 3. Humoral and T cell responses to SARS-CoV-2 spike protein and nucleocapsid antigen were measured. RESULTS: Of 81 participants, 79 provided a dried blood spot sample, of whom 38 also provided a whole blood sample; 2 provided only whole blood. Anti-SARS-CoV-2-spike IgG seroconversion post-COVID-19 vaccine 3 occurred in 26/79 (33%) participants; 26/40 (65%) had positive T-cell responses. Overall, 31/40 (78%) demonstrated either humoral or cellular immune response post-COVID-19 vaccine 3. There was no association between laboratory evidence of prior COVID-19 and seroconversion following vaccine 3. CONCLUSIONS: Approximately one third of pwMS who were seronegative after initial COVID-19 vaccination seroconverted after booster (third) vaccination, supporting the use of boosters in this group. Almost 8 out of 10 had a measurable immune response following 3rd COVID-19 vaccine.

Lessons From the COVID-19 Pandemic to Improve the Health, Social Care, and Well-being of Minoritized Ethnic Groups With Chronic Conditions or Impairments: Protocol for a Mixed Methods Study.

BACKGROUND: The COVID-19 pandemic has inequitably impacted the experiences of people living with ill health/impairments or from minoritized ethnic groups across all areas of life. Given possible parallels in inequities for disabled people and people from minoritized ethnic backgrounds, their existence before the pandemic and increase since, and the discriminations that each group faces, our interest is in understanding the interplay between being disabled AND being from a minoritized ethnic group. OBJECTIVE: The overarching aim of the Coronavirus Chronic Conditions and Disabilities Awareness (CICADA) project, building on this understanding, is to improve pandemic and longer-term support networks, and access to and experiences of care, services, and resources for these underserved groups, both during the pandemic and longer term, thereby reducing inequities and enhancing social, health, and well-being outcomes. METHODS: This mixed methods study involves three "sweeps" of a new UK survey; secondary analyses of existing cohort and panel surveys; a rapid scoping review; a more granular review; and qualitative insights from over 200 semistructured interviews, including social network/map/photo elicitation methods and two subsequent sets of remote participatory research workshops. Separate stakeholder cocreation meetings, running throughout the study, will develop analyses and outputs. Our longitudinal study design enables the exploration of significant relationships between variables in the survey data collected and to the assessment of changes in variables over time, including consideration of varying pandemic contexts. The qualitative data will provide more granular detail. We will take a strengths and assets-based approach, underpinned by the social model of disability and by intersectional considerations to challenge discrimination. Our exploration of the social determinants of health and well-being is framed by the social ecological model. RESULTS: The CICADA project was funded by the Health and Social Care Delivery Research (HSDR) Programme of the United Kingdom (UK) National Institute for Health and Care Research (NIHR) in March 2021 and began in May 2021. Further work within the project (84 interviews) was commissioned in March 2022, a substudy focusing on mental health, specifically in Northeast England, Greater Manchester, and the Northwest Coast of the United Kingdom. Data collection began in August 2021, with the last participants due to be recruited in September 2022. As of January 2022, 5792 survey respondents and 227 interviewees had provided data. From April 2022, the time of article submission, we will recruit participants for the substudy and wave 2 of the surveys and qualitative work. We expect results to be published by winter 2022. CONCLUSIONS: In studying the experiences of disabled people with impairments and those living with chronic conditions who come from certain minoritized ethnic groups, we are aiming for transformative research to improve their health and well-being. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38361.

Lessons From the COVID-19 Pandemic to Improve the Health, Social Care, and Well-being of Minoritized Ethnic Groups With Chronic Conditions or Impairments: Protocol for a Mixed Methods Study.

BACKGROUND: The COVID-19 pandemic has inequitably impacted the experiences of people living with ill health/impairments or from minoritized ethnic groups across all areas of life. Given possible parallels in inequities for disabled people and people from minoritized ethnic backgrounds, their existence before the pandemic and increase since, and the discriminations that each group faces, our interest is in understanding the interplay between being disabled AND being from a minoritized ethnic group. OBJECTIVE: The overarching aim of the Coronavirus Chronic Conditions and Disabilities Awareness (CICADA) project, building on this understanding, is to improve pandemic and longer-term support networks, and access to and experiences of care, services, and resources for these underserved groups, both during the pandemic and longer term, thereby reducing inequities and enhancing social, health, and well-being outcomes. METHODS: This mixed methods study involves three "sweeps" of a new UK survey; secondary analyses of existing cohort and panel surveys; a rapid scoping review; a more granular review; and qualitative insights from over 200 semistructured interviews, including social network/map/photo elicitation methods and two subsequent sets of remote participatory research workshops. Separate stakeholder cocreation meetings, running throughout the study, will develop analyses and outputs. Our longitudinal study design enables the exploration of significant relationships between variables in the survey data collected and to the assessment of changes in variables over time, including consideration of varying pandemic contexts. The qualitative data will provide more granular detail. We will take a strengths and assets-based approach, underpinned by the social model of disability and by intersectional considerations to challenge discrimination. Our exploration of the social determinants of health and well-being is framed by the social ecological model. RESULTS: The CICADA project was funded by the Health and Social Care Delivery Research (HSDR) Programme of the United Kingdom (UK) National Institute for Health and Care Research (NIHR) in March 2021 and began in May 2021. Further work within the project (84 interviews) was commissioned in March 2022, a substudy focusing on mental health, specifically in Northeast England, Greater Manchester, and the Northwest Coast of the United Kingdom. Data collection began in August 2021, with the last participants due to be recruited in September 2022. As of January 2022, 5792 survey respondents and 227 interviewees had provided data. From April 2022, the time of article submission, we will recruit participants for the substudy and wave 2 of the surveys and qualitative work. We expect results to be published by winter 2022. CONCLUSIONS: In studying the experiences of disabled people with impairments and those living with chronic conditions who come from certain minoritized ethnic groups, we are aiming for transformative research to improve their health and well-being. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38361.

COVID-19 in people with multiple sclerosis: A global data sharing initiative.

BACKGROUND: We need high-quality data to assess the determinants for COVID-19 severity in people with MS (PwMS). Several studies have recently emerged but there is great benefit in aligning data collection efforts at a global scale. OBJECTIVES: Our mission is to scale-up COVID-19 data collection efforts and provide the MS community with data-driven insights as soon as possible. METHODS: Numerous stakeholders were brought together. Small dedicated interdisciplinary task forces were created to speed-up the formulation of the study design and work plan. First step was to agree upon a COVID-19 MS core data set. Second, we worked on providing a user-friendly and rapid pipeline to share COVID-19 data at a global scale. RESULTS: The COVID-19 MS core data set was agreed within 48 hours. To date, 23 data collection partners are involved and the first data imports have been performed successfully. Data processing and analysis is an on-going process. CONCLUSIONS: We reached a consensus on a core data set and established data sharing processes with multiple partners to address an urgent need for information to guide clinical practice. First results show that partners are motivated to share data to attain the ultimate joint goal: better understand the effect of COVID-19 in PwMS.