COVID-19

Patient safety is Roche/Genentech’s highest priority and we are closely monitoring the evolving coronavirus disease (COVID-19) situation. We believe that treatment decisions should be made between a patient and their treating neurologist/healthcare professional based on a benefit/risk assessment specific to the individual patient.

COVID-19 is caused by a new strain of coronavirus called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), so knowledge about how it may affect people with multiple sclerosis (MS) and those treated with ocrelizumab is currently unavailable.

Like many other disease-modifying therapies for MS, ocrelizumab works by making changes to the immune system.

Per the ocrelizumab European Summary of Product Characteristics (SmPC; Section 4.8):

In the active-controlled studies in RMS, infections occurred in 58.5% of patients receiving Ocrevus vs 52.5% of patients receiving interferon beta 1a. Serious infections occurred in 1.3% of patients receiving Ocrevus vs 2.9% of patients receiving interferon beta 1a. In the placebo-controlled study in PPMS, infections occurred in 72.2% of patients receiving Ocrevus vs 69.9% of patients receiving placebo. Serious infections occurred in 6.2% of patients receiving Ocrevus vs 6.7% of patients receiving placebo. An increase in the rate of serious infections was observed in RMS between Years 2 and 3, but not in subsequent years. No increase was observed in PPMS.

Ocrelizumab administration must be delayed in patients with an active infection until the infection is resolved.

Indications vary in different countries. The local prescribing information from your country is the primary source of information on the known and potential risks associated with ocrelizumab.

Frequently asked questions

  • COVID-19 is caused by a new strain of coronavirus called SARS-CoV-2, so knowledge about how it may affect people with multiple sclerosis (MS) and those treated with ocrelizumab is currently unavailable. Additionally, there are no data currently available to inform specific recommendations or changes to treatment protocols for people treated with ocrelizumab. 
  • We are actively discussing with the neurology community insights and perspectives relating to MS and COVID-19; however, we believe that treatment decisions should be made between a patient and their treating neurologist or other medical professional based on a benefit/risk assessment specific to the individual patient 
  • Physicians and patients should consult their local ocrelizumab prescribing information for relevant information regarding the safety of ocrelizumab. For additional information and context surrounding the risk of infections with ocrelizumab, please consult the website section on infections.

  • We are actively discussing with the neurology community insights and perspectives relating to MS and COVID-19 as we do not yet know how it will affect people with MS. Additionally, there are no data currently available to inform specific recommendations or changes to treatment protocols for people treated with ocrelizumab.
  • While we understand that some neurological and patient societies recommend the delay of treatment initiation or re-treatment, we believe patients should speak with their neurologist or other medical professional before discontinuing or delaying treatment, so that decisions can be made based on a benefit/risk assessment specific to the individual patient.  

The current clinical situation may necessitate to delay a scheduled dose of ocrelizumab due to logistical reasons or based on an individual benefit/ risk decision.
 
  • As per ocrelizumab label: If an infusion of ocrelizumab is missed, it should be administered as soon as possible; do not wait until the next planned dose. The treatment interval of 6 months (with a minimum of 5 months) for ocrelizumab should be maintained between doses.
  • Based on limited data1 available from the ORCHESTRA studies, there is no evidence that a delay in ocrelizumab dosing will increase the Infusion-Related Reaction (IRR) rate with the next 600mg dose administered as a single infusion.  

  • COVID-19 is caused by a new strain of coronavirus called SARS-CoV-2, so knowledge about how it may affect people with multiple sclerosis (MS) and those treated with ocrelizumab is currently unavailable. 
  • Like many other disease-modifying therapies for MS, ocrelizumab works by making changes to the immune system. 
  • Per the ocrelizumab European Summary of Product Characteristics (SmPC; Section 4.8):

    In the active-controlled studies in RMS, infections occurred in 58.5% of patients receiving Ocrevus vs 52.5% of patients receiving interferon beta 1a. Serious infections occurred in 1.3% of patients receiving Ocrevus vs 2.9% of patients receiving interferon beta 1a. In the placebo-controlled study in PPMS, infections occurred in 72.2% of patients receiving Ocrevus vs 69.9% of patients receiving placebo. Serious infections occurred in 6.2% of patients receiving Ocrevus vs 6.7% of patients receiving placebo. An increase in the rate of serious infections was observed in RMS between Years 2 and 3, but not in subsequent years. No increase was observed in PPMS.

  • Patient safety is Roche’s highest priority. As a company we are closely following developments regarding COVID-19 and we are committed to keeping the MS community updated with any new information to help inform health decisions related to ocrelizumab.

     

  • The upper and lower respiratory tract infections reported in patients treated with ocrelizumab were predominantly mild to moderate (80-90%).
  • The proportion of respiratory tract infections was higher in Ocrevus treated patients compared to interferon beta-1-a and placebo.
    • In the RMS clinical trials, 39.9% of Ocrevus treated patients and 33.2% interferon beta-1-a treated patients experienced an upper respiratory tract infection and 7.5% of Ocrevus treated patients and 5.2% of interferon beta-1-a treated patients experienced a lower respiratory tract infection.
    • In the PPMS clinical trial, 48.8% of Ocrevus treated patients and 42.7% of patients who received placebo experienced an upper respiratory tract infection, and 9.9% of Ocrevus treated patients and 9.2% of patients who received placebo experienced a lower respiratory tract infection.

  • Rates of serious infections in all patients exposed to ocrelizumab in clinical trials remain low and consistent with rates of infection-related hospitalizations in real-world MS cohorts.
    • Ocrelizumab was not associated with an increased risk of serious infections in MS patients, as shown in our Phase III clinical studies vs comparators (interferon beta-1a or placebo). Of those serious infections, which occurred, the vast majority were bacterial, and the patients responded to standard of care treatment. Longer-term data through continued observation in our open-label extension studies has revealed no new or particular pattern of serious infections in MS patients treated with ocrelizumab.
  • Ocrelizumab has been shown to have an increased risk of contracting certain infections, including upper respiratory tract infections that were predominantly mild to moderate (classified as non-serious).
    • A higher proportion of ocrelizumab-treated patients experienced non-serious infections compared with patients taking Rebif (interferon beta-1a) (58.5% vs. 52.5%) or placebo (72.2% vs. 69.9%). These infections were predominantly mild to moderate, were equally likely to be bacterial or viral, and resolved with standard of care treatment and in most cases patients remained on treatment with ocrelizumab.

  • Per the ocrelizumab European Summary of Product Characteristics (SmPC; Section 4.4):

    In a randomized open-label study [VELOCE], RMS patients were able to mount humoral responses, although decreased, to tetanus toxoid, 23-valent pneumococcal polysaccharide with or without a booster vaccine, keyhole limpet hemocyanin neoantigen, and seasonal influenza vaccines.

  • In the VELOCE study, humoral responses were attenuated at all time points in patients who were B-cell depleted and received ocrelizumab compared with those who did not, but patients were nonetheless able to mount humoral responses to the vaccines and neoantigen studied. For more information, please go to the most recent ocrelizumab safety data. 

  • We are aware of reports of multiple sclerosis (MS) patients, on ocrelizumab treatment, who have been diagnosed with COVID-19.
  • Patient safety is Roche’s highest priority, and consistent with our safety reporting processes we report to health authorities in accordance with standard pharmacovigilance processes.
  • With the worldwide situation in relation to COVID-19 evolving, it is anticipated that the number of COVID-19 cases will increase and as a result it is likely that the number of COVID-19 cases in people with MS, that are being treated with disease modifying treatments (DMTs), will also rise.
  • We are aware that physicians in Italy are evaluating setting up a registry to record cases of COVID-19 in relation to MS patients to gather any insights and data that could potentially inform future recommendations.

Prescribing information

Indications vary in different countries. The local prescribing information from your country is the primary source of information on the known and potential risks associated with ocrelizumab.
References
 
  1. Roche data on file, 2020