To COVID-19 vaccinatate and be dammed or to wait to optimise vaccine response is a question being posed. This in part depends on what gets rid of the SARS-CoV-2 and what’s the risks from COVID-19. The boffs have put their eggs in the antibodies get rid of virus basket and made vaccines to the Spike protein that contains the infectious contact. However the biology looks like the Innate Immune and T cells are important. This is in part supported by the findings that people treated with anti-CD20 depleting antibodies generally recover. The vaccines also generate virus specific T cells
The manufactures of ocrelizumab are to be congratulated for being transparent about the cases with ocrelizumab. Here they argue that the risks of ocrelizumab-treatment is no greater than the MS population. Therefore the co-morbidities are more important than the disease modifying treatments. This is in part supported by the global registry data, although the anti-CD20 antibodies have given some concern compared to other DMT in terms of hosptilizations. However remember anti-CD20 is the only licenced treatment for progressive MS and people may have more disability which appears to be a risk factor for COVID-19.
Here is more data to allay fears and says that my original assessment of DMT risks were very good and the ABN (Association of British Neurologists) did not need to soil their pants:-)…No wonder they revoked my membership when I joined for free:-(….OK it was not because I had a go at the men and women in Grey Suits…I didn’t have GMC registration.
Background: There are limited data on the impact of coronavirus disease (COVID-19) caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) on people with multiple sclerosis (MS).
Objective: To better understand SARS-CoV-2 infection in ocrelizumab-treated people with MS.
Methods: Internal Roche/Genentech data sources: Cases of COVID-19 from ongoing Roche/Genentech clinical trials and from post-marketing use of ocrelizumab until July 31, 2020 were identified and assessed using descriptive statistics.External real-world data (RWD) source: An MS COVID-19 cohort and an ocrelizumab-treated MS COVID-19 cohort were identified and assessed from the OPTUM® de-identified COVID-19 Electronic Health Record (EHR) database.
Results: Roche/Genentech clinical trial data: There were 51 (1.3%) suspected or confirmed cases of COVID-19 identified from 4,000 patients ongoing in nine Roche/Genentech clinical trials. Of these, 26 (51%) were confirmed COVID-19 and 25 (49%) were suspected COVID-19. Sixteen (31.4%) patients were hospitalized. COVID-19 severity was mild-to-moderate in most patients (35, 68.6%). Ten (19.6%) patients had severe disease and there were three (5.9%) fatal cases. Most patients (43, 84.3%) recovered or were recovering.
There was no association apparent between duration of exposure to ocrelizumab and COVID-19. Among COVID-19 patients with previous serum immunoglobulin status (27/51, 52.9%), all (27/27, 100%) had IgG levels within the normal range. With regards to IgA and IgM, 7.4% (2/27) and 48.1% (13/27), respectively, had levels below lower limit of normal, compared with 6.4% (120/1,883) and 35.7% (671/1,880) in the reference clinical trial population. Roche/Genentech post-marketing safety database data: There were 307 post-marketing cases of COVID-19 in the Roche/Genentech global safety database. Of these, 263 (85.7%) were confirmed and 44 (14.3%) were suspected COVID-19. 100 (32.6%) patients were hospitalized. COVID-19 was asymptomatic, mild or moderate in 143 (46.6%) patients, severe in 52 (16.9%) patients, and critical in 15 (4.9%) patients. There were 17 (5.5%) fatal cases. Information on severity was not reported in 80 (26.1%) cases. Most patients (211, 68.7%) recovered or were recovering at the time of the report.External RWD data source: As of July 13, 2020, the OPTUM® database included EHRs for almost 1.2 million patients with suspected COVID-19, 130,500 of whom met the criteria for confirmed/clinically diagnosed COVID-19. A total of 357 patients with MS with confirmed COVID-19 were identified. Forty-eight (13.4%) were treated with ocrelizumab, of whom 12 (25.0%) were hospitalized and one died (2.1%). Similar rates of hospitalization, invasive ventilation, and death were observed in the ocrelizumab-treated and non-ocrelizumab-treated MS cohorts.Across the Roche/Genentech and RWD sources assessed, age, male sex, and the presence of comorbidities such as hypertension were associated with a more severe disease course of COVID-19. There was a higher number of comorbidities present in hospitalized versus non-hospitalized patients.
Conclusions: This assessment provides evidence that COVID-19 in ocrelizumab-treated people with MS is predominantly mild to moderate in severity with most patients not requiring hospitalization; in line with data reported from the general population and MS datasets. Risk factors known to be associated with severe COVID-19 outcomes in the general population also appear to influence COVID-19 severity in ocrelizumab-treated people with MS. Case fatality rates for ocrelizumab-treated people with MS were within published ranges for the general population and other MS cohorts.
We know that ocrelizumab is likely to blunt the antibody response but what does it do to the T cell response will be good to know. We can only find out if people volunteer to be vaccinated.