A complete benefit-risk assessment of TYSABRI starts by evaluating the 3 known PML risk factors1,a

  • PML is an opportunistic viral infection of the brain caused by the John Cunningham virus (JCV) that usually leads to death or severe disability. JCV infection is required for the development of PML
    • There are no known interventions that can reliably prevent PML or that can adequately treat PML if it occurs
    • PML is not the only factor to consider when assessing the safety profile of TYSABRI
  • Regular anti-JCV antibody testing may help mitigate risk of PML and help identify patients suitable for starting or continuing on TYSABRI
  • Based on postmarketing data, the estimated US incidence of PML is stratified out to 8 yearsb

aPML risk is inferred from the estimated US incidence. The risk estimates are based on postmarketing data in the United States from approximately 100,000 TYSABRI-exposed patients. The anti-JCV antibody status was determined using an anti-JCV antibody test (ELISA) that has been analytically and clinically validated and is configured with detection and inhibition steps to confirm the presence of JCV-specific antibodies with an analytical false-negative rate of 3%. 

bAs of June 2020. 

Your patients may benefit from the powerful efficacy of TYSABRI, which has a PML risk of 0.01% for JCV– patients and ≤0.7% for JCV+ patients out to 8 years

Regular anti-JCV antibody testing may help mitigate the risk of PML and help identify patients suitable for starting or continuing TYSABRI1

Free and frequent testing supports PML risk mitigation1

  • JCV infection is required for the development of PML
  • Patients taking TYSABRI should be tested regularly to assess whether their status has changed
  • The JCV seroconversion rate from negative to positive in patients with MS is 3–8% annually

Early detection of PML is important1

  • MRI findings may be apparent before clinical signs or symptoms suggestive of PML. Periodic monitoring for radiographic signs consistent with PML should be considered to allow for early diagnosis of PML
    • Consider monitoring patients at high risk of PML more frequently
  • Lower PML-related mortality and morbidity have been reported following TYSABRI discontinuation in patients with PML who were initially asymptomatic compared to patients with PML who had characteristic clinical signs and symptoms at diagnosis. It is not known whether these differences are due to early detection and discontinuation of TYSABRI or due to differences in disease in these patients
Continually evaluate treatment response and disease activity as measured by MRI activity, relapse rate, and EDSS progression2

Typical symptoms associated with PML are diverse, progress over days to weeks, and may include1:

  • Progressive weakness on one side of the body or clumsiness of limbs
  • Disturbances of speech or vision
  • Changes in thinking, memory, and orientation leading to confusion and personality changes

Upon initial suspicion of PML, follow these 4 steps1:

Call Biogen (1-866-633-4636) as soon as possible to report the adverse event.

To make the diagnosis of PML, various MRI evaluations, including gadolinium-enhanced and T2-weighted scans, as well as PCR analysis of CSF for JC viral DNA, are recommended1

There are no known interventions that can reliably prevent or that can adequately treat PML if it occurs.

  • Although PLEX has not been prospectively studied in TYSABRI-treated patients with PML, it has been used in such patients in the postmarketing setting to remove TYSABRI more quickly from the circulation. There is no evidence that PLEX has any benefit in the treatment of opportunistic infections such as PML
  • PML has been reported following discontinuation of TYSABRI in patients who did not have findings suggestive of PML at the time of discontinuation
  • Patients should continue to be monitored for any new signs or symptoms that may be suggestive of PML for approximately 6 months following discontinuation of TYSABRI

This information is provided as an educational resource for healthcare providers. It is not intended to be a substitute for consultation with your patients and review of reference material and medical literature. Healthcare providers should make all treatment decisions based on the context of the situation and their own clinical judgment.

Learn more about monitoring with TOUCH®

Because of the risk of PML, TYSABRI is available only under a restricted distribution program, the TOUCH Prescribing Program.

Only prescribers, pharmacies, and administration sites enrolled in the TOUCH Prescribing Program (REMS program) are able to prescribe, distribute, or infuse TYSABRI.

Learn More About TOUCH®