Pharmacovigilance Data on Ocrelizumab

In view of a number of inquiries, I assume that a work recently published in the journal Multiple Sclerosis and Related Disorders (MSARD) has caused some confusion. The work deals with the occurrence of COVID-19 in MS patients who have been treated with ocrelizumab (Hughes R, Pedotti R, Koendgen H. COVID-19 in persons with multiple sclerosis treated with ocrelizumab – A pharmacovigilance case series. Mult Scler Relat Disord. 2020 May 16;42:102192).

The basic tenor of my patients’ critical questions is how experts and self-help groups can claim that there is currently no cause for concern if patients are treated with ocrelizumab (Ocrevus) during the corona pandemic, even though the aforementioned work presents data from over 100 patients treated with ocrelizumab who have contracted COVID-19 – 26 patients even so seriously that hospitalization was necessary. This is not only per se a very high number of infected patients, but above all a high number of seriously ill MS patients. Shouldn’t we worry about these numbers if we are currently being treated with ocrelizumab?

Therefore, a brief explanation below as to why this article does not particularly “shake” the professional world and also does not have the potential to change our current recommendations.

The authors of the paper are employees of Roche (pharmaceutical manufacturer of ocrelizumab), who have analyzed the pharmacovigilance data of ocrelizumab with regard to COVID-19. Pharmacovigilance refers to the continuous and systematic monitoring of the safety of a finished medicinal product after market approval. Since knowledge about adverse effects is not yet complete at the time of approval (because the drug has been clinically tested on a comparatively small number of patients in the approval studies), pharmacovigilance is crucial for the detection of rare or very rare adverse effects and interactions and thus for the overall assessment of a new drug. In the EU, pharmaceutical companies are obliged to report adverse drug reactions to the respective national drug regulatory authority.

At the time of the pharmacovigilance analysis, about 3.5 million people worldwide had been confirmed to have contracted COVID-19, about 160,000 people with MS are treated worldwide with Ocrevus. Against this background, the number of 100 patients whose COVID-19 disease was reported within the framework of pharmacovigilance should be viewed – with the additional limitation that only 74 cases had a positive test, the remaining reports were suspected cases.

The severity of the COVID-19 symptoms was stated in 77 reports. Accordingly, 49 people suffered from asymptomatic/mild/moderate symptoms (64%), 23 people suffered from severe disease (30%, diagnosis of pneumonia) and five people were critically ill (6%). The further course is known from a total of 64 cases – fortunately, all patients have recovered or are improving. When evaluating the data, the time from the last ocrelizumab administration/the total exposure until the onset of COVID-19 disease could also be calculated in 40/46 cases (40/46%). The time from the last infusion was on average 12.5 weeks, the total exposure up to the time of the disease was on average 84.2 weeks.

Now, pharmacovigilance data – and the authors admit this – are subject to a number of limitations. Reporting is voluntary, the reported information is often incomplete, the collection of follow-up data is difficult and often delayed – limitations that probably became more pronounced during the pandemic. In addition, incomplete reporting of COVID-19 cases may be due to differences in national testing capacity and strategy. This means that probably mainly manifest, or more severe COVID-19 diseases with ocrelizumab were reported. It can be assumed that milder infections of MS patients were not reported at all. This is also suggested by the fact that only 100 cases with COVID-19 were reported from over 160,000 treated patients. If you only look at these 100 cases, the impression is given by the numbers that patients with ocrelizumab would have to expect a clinically manifest or more severe disease in a high percentage.

This is certainly not the case – the authors also conclude that the presented data largely correspond to larger COVID-19 case series, which are also shifted towards clinically symptomatic patients. Even in Germany, we assume that the number of infected people is about 10 times higher than the reported cases, as many COVID infections simply have a very mild course. Accordingly, the authors also draw the conclusion that there is currently no evidence of a more severe course of COVID-19 in people with MS treated with ocrelizumab.

This view thus corresponds exactly to what MS experts and self-help organizations communicate in their recommendations: There is no evidence that MS patients, treated with any immunotherapy, have a higher risk of severe COVID-19 courses than the general population – therefore, despite Corona, the focus should continue to be on adequate therapy for multiple sclerosis.

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