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Fingolimod and COVID-19

Guidance to HCPs

  • Novartis is committed to patients' health and safety. In these unprecedented times, we are striving to keep patients, care partners, and healthcare providers up to date and provide the latest information to help inform decisions related to the use of our products. Novartis continues to collect data to address concerns related to the impact of COVID-19 on patients treated with fingolimod
  • In general, patients and prescribers should act in accordance with local government and health authority guidance concerning the COVID-19 pandemic (including guidance on social distancing and self-isolation, as applicable). HCPs may also consult advice specific to patients with multiple sclerosis provided by international or local healthcare professional and patient organizations1-3
  • HCPs should be aware that the immune system effects of fingolimod, integral to the mechanism of action in multiple sclerosis, may increase the risk of infections (including viral infections), as disclosed in the product label. Novartis believes that treatment decisions should be made between a patient and their treating health care professional based on a benefit-risk assessment specific to the individual patient

SARS-CoV-2 vaccination considerations

  • To date all of the SARS-CoV-2 vaccines currently approved and available or in development belong to three main categories: (1) mRNA based; (2) viral-vector vaccines: (3) inactivated vaccines
  • There is currently no report on efficacy or safety of SARS-CoV-2 vaccines in immunocompromised persons or in patients receiving immunomodulatory drugs
  • As with inactivated vaccines, the use of viral-vector-, or mRNA based SARS-CoV-2 vaccines in patients receiving immunomodulant/immunosuppressant therapies such as fingolimod may have a diminished immune response
  • Vaccination against SARS-CoV-2 should be considered on a case-by-case basis at the discretion of the physician and according to the guidelines in the local vaccine product prescribing information4
  • The physician should take into account the individual benefit-risk assessment of either interrupting or continuing fingolimod5
    • When stopping fingolimod for vaccination, the possible return of disease activity should be considered
    • Vaccinations may be less effective if administered during fingolimod treatment and for up to 2 months after discontinuation of treatment with fingolimod6,7,8
  • For patients getting started on fingolimod, it is recommended to initiate treatment at least 1 month following the second dose of SARS-CoV-2 vaccine5,6,7

Based on the totality of the data available from the COVID-19 case reports in the post-marketing setting and comprehensive data analysis by the MS Data Alliance Global Data sharing initiative9

  • A final conclusion cannot be drawn if a higher risk of COVID-19 exists in patients treated with fingolimod compared with the general population​
  • Available data indicates a similar COVID-19 disease course in MS patients treated with fingolimod compared to the general population​

Postmarketing

COVID-19_post marketing_v5
*Patient exposure during 28-Feb-2020 to 27-Dec-2020
  • As of 27-December-2020, Novartis have received 342 confirmed or suspected COVID-19 cases in fingolimod-treated patients in the post-marketing setting10
  • 59 were suspected cases of COVID-19
  • 283 were confirmed cases (SARS-CoV-2 test positive, or noted to be diagnosed with COVID-19) and includes registry and published cases
    • Age mean (range): 44 years (11–69) – based on 224 cases where information provided; Female/male cases: 190/71
    • Four patients had fatal outcome
    • At the time of most recent follow up, 140 cases were reported as recovered or recovering, while information was not available for 114 cases

COVID-19 infection confirmed cases​5

COVID-19 infection confirmed cases
*Ascertained based on the most serious criteria
**One patient (aged 66 years) had multiple risk factors (details not reported); one patient (aged 39 years) had active secondary progressive MS; one patient (aged 45 years) had unspecified mixed connective tissue disorder; one patient was 64 years of age with no details provided regarding medical history. Two patients with fatal outcome were noted to also be hospitalized
^12 of 13 cases (where information was reported) with one or more COVID-19 risk factors
#Reported by non-HCPs; one patient with no further details provided; one patient had mild disease
§Important medical event that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the other serious outcomes
23 cases received from non-HCPs; all cases, where sufficient information was provided for severity assessment,  were asymptomatic, mild, or moderate

COVID-19 severity and outcome5

COVID-19 severity and outcome
Note: Numbers in parenthesis indicate – (patients hospitalized; patients requiring ventilation, CPAP or ICU admission)
*Not all moderate cases were hospitalized
**One patient had multiple unspecified risk factors; the other patient had active secondary progressive MS
This section provides a summary of cases of fingolimod treated patients either suspected as having or reported to have COVID-19 as reported in the Novartis safety database, including spontaneous reports submitted voluntarily and cases identified in the scientific literature. There is typically underreporting in this setting, therefore the true numerator is unknown. The denominator is also unknown, as the actual number of patients on therapy with fingolimod is not readily available. Many of the cases contain very limited information and includes cases that are lost to follow up. Therefore, due to these limitations, it is not possible to draw any meaningful conclusions concerning the incidence of COVID-19 or course of illness in patients receiving fingolimod

Impact of COVID-19 in MS in a real world setting​

  • MS is an autoimmune, chronic inflammatory, neurodegenerative disorder of CNS where patients are generally treated with immunosuppressants or immunomodulators.11 The current COVID-19 pandemic has raised concerns regarding the immune response to viral infections in MS patients treated with disease modifying therapies12
  • Comprehensive data sharing and analyses regarding the effect of COVID-19 in people with MS have been conducted by the COVID-19 in MS - GDSI.9 The GDSI initiative is a joint initiative of the MS International Federation and the MS Data Alliance, acting under the umbrella of the European Charcot Foundation and in collaboration with many (data) partners across the globe​
  • According to the MS International Federation, the evidence available suggests that people with MS taking fingolimod do not have an increased risk of more severe COVID-19 symptoms13,14,15
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Abbreviations
CNS, central nervous system; COVID-19, corona virus disease-19; CPAP, continuous positive airway pressure; GDSI, Global Data Sharing Initiative; HCP, healthcare professional; ICU, intensive care unit; mRNA, messenger ribonucleic acid; MS, multiple sclerosis; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2
References
1. World Health Organization. Coronavirus disease (COVID-19) outbreak. Accessed 4-Dec-2020. https://www.who.int/emergencies/diseases/novel-coronavirus-2019 
2. European Centre for Disease Prevention and Control. COVID-19. Accessed 4-Dec-2020. https://www.ecdc.europa.eu/en/novel-coronavirus-china
3. US Centers for Disease Control and Prevention. Coronavirus Disease 2019 (COVID-19). Accessed 4-Dec-2020. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html#clinical-management-treatment%3C 
4 Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States. Accessed 10-Feb-2021. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html#underlying-conditions
5. National Multiple Sclerosis Society. Timing MS medications with COVID-19 mRNA vaccines. Accessed February 18, 2021. https://www.nationalmssociety.org/coronavirus-covid-19-information/multiple-sclerosis-and-coronavirus/covid-19-vaccine-guidance/Timing-MS-Medications-with-COVID-19-mRNA-Vaccines
6. Gilenya US Prescribing Information. Accessed 10-Feb-2021. https://www.novartis.us/sites/www.novartis.us/files/gilenya.pdf
7. Gilenya Summary of Product Characteristics. Accessed 10-Feb-2021. https://www.ema.europa.eu/en/medicines/human/EPAR/gilenya
8. Kappos L, et al. Neurology. 2015; 84 (9) 872-879.
9. Simpson-Yap S, et al. First results of the COVID-19 in MS Global Data Sharing Initiative suggest anti-CD20 DMTs are associated with worse COVID-19 outcomes. Abstract submitted at MSVIRTUAL 2020. https://cslide.ctimeetingtech.com/msdc2020/attendee/confcal/session/calendar/2020-09-26?q=COVID
10. Data on File, cutoff date 27-Dec-2020, Novartis Pharma AG. 
11. Oh J, et al. Curr Opin Neurol. 2018;31(6):752-759. 
12. Rostami Mansoor S, et al. J Med Virol. 2020;12:10.1002/jmv.26593. doi: 10.1002/jmv.26593. 
13. Sormani MP, et al. Lancet Neurol. 2020;19(6):481-482. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3631244 
14. Louapre C, et al. JAMA Neurol. 2020;e202581. 
15. MS International Federation. COVID-19. Last updated on January 13, 2021. Accessed February 15, 2021. http://www.msif.org/wp-content/uploads/2021/01/Jan-2021-MSIF-Global-advice-on-COVID-19-for-people-with-MS-FINAL.pdf
* Indication wording varies in different countries. The current website is a global information resource. Local Prescribing Information/ Summary of Product Characteristics approved by individual country’s regulatory authority is the primary source of information for the indication of fingolimod in the individual country.