Physician Views Preview: How will US rheumatologists react to potential Xeljanz labelling changes?

With the FDA potentially announcing updated safety guidance for Pfizer’s Xeljanz imminently, competing drug developers are keen to know if these recommendations will extend to other JAK inhibitors. To capture an essence of the potential impact, we are fielding a snap-poll to US-based rheumatologists asking the following questions…

  • Approximately what percentage of rheumatoid arthritis patients under your care do you currently treat with Xeljanz?
  • Has your use of Xeljanz declined this year as a result of ongoing regulatory safety reviews?
  • If your use of Xeljanz has declined, what alternative type of therapy have you most frequently switched patients to?
  • In response to findings from the ORAL Surveillance study, the European Medicine Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has issued initial guidance reminding healthcare professionals to carefully evaluate a patient's individual benefit-risk profile when deciding to prescribe or continue treatment with Xeljanz. The PRAC is advising healthcare professionals that Xeljanz should only be used in patients over 65 years of age, patients who are current or past smokers, patients with other cardiovascular risk factors, and patients with other malignancy risk factors, if no suitable treatment alternative is available. Assuming the FDA issued a similar recommendation, how would your current use of Xeljanz change?
  • If the FDA issued similar safety guidance to the EMA (which appears to be specific to Xeljanz) how comfortable would you be using other JAK inhibitor agents?

Results and analysis will be published later this week for FirstWord Pharma PLUS subscribers and can be purchased by non-FirstWord Pharma PLUS subscribers. To be notified when they become available, click here

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