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of people treated with TAVNEOS® in combination
of people taking
In the study, remission was defined as achieving a Birmingham Vasculitis Activity Score (BVAS) of 0 and not taking glucocorticoids for treatment of GPA or MPA within 4 weeks prior to Week 26.
of people treated with
TAVNEOS® in combination
stayed in remission†
of people taking Standard Therapy
In the study, sustained remission was defined as remission at Weeks 26 and 52 without relapse between Week 26 and Week 52. Remission at Week 52 was defined as BVAS of 0 and not taking glucocorticoids for treatment of GPA or MPA within 4 weeks of Week 52.
Lower risk of relapse for people treated with TAVNEOS® in combination with additional immunosuppressive therapy compared to people treated with Standard Therapy
In the study, relapse was defined as a return of GPA or MPA activity on the basis of at least 1 major item, at least 3 non-major items, or 1 or 2 non-major items for at least 2 consecutive visits on the BVAS after remission (BVAS of 0) had been achieved.
Immunosuppressive therapy: rituximab or cyclophosphamide followed by azathioprine or mycophenolate mofetil (if azathioprine was not tolerated).
Standard Therapy: immunosuppressive therapy and a gradual reduction of prednisone over time.
In the study, patients were allowed glucocorticoids not supplied as part of the study medication.
According to a quality-of-life survey,§ people treated with TAVNEOS® and additional immunosuppressive therapy had scores that showed greater improvement than those treated with Standard Therapy. From the start of the study to Week 52, people in the TAVNEOS® group had an improvement in their overall:
Based on responses to the Short Form-36 version 2 (SF-36 V2) survey. The SF-36 V2 survey was not developed specifically for patients with severe active GPA or MPA. Additionally, there is a possibility that the difference between treatments may have been due to chance alone and not due to TAVNEOS®, so these results were not considered significant. Results should be interpreted with caution.
Everyone in the study was allowed to use glucocorticoids as needed regardless of what treatment they used. However, those treated with TAVNEOS® in combination with additional immunosuppressive therapy compared to those treated with Standard Therapy had a lower median total dose of glucocorticoids of 81% (TAVNEOS® = 600 mg; Standard Therapy = 3097.5 mg), and a lower mean total dose of glucocorticoids of 56% (TAVNEOS® = 1675.5 mg; Standard Therapy = 3846.9 mg).
To see how well your kidneys are working, your doctor may check the estimated glomerular filtration rate (eGFR). Generally, the higher the eGFR the better the kidney function.
TAVNEOS can cause serious side effects, including:
Your healthcare provider will do blood tests to check how well your liver is working before starting and during your treatment with TAVNEOS.
The most common side effects of TAVNEOS include:
TAVNEOS is a prescription medicine that is used with other medicines (such as glucocorticoids) to treat adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener’s granulomatosis, and microscopic polyangiitis [MPA]).
TAVNEOS is available as a 10 mg capsule.
You are encouraged to report negative side effects to Amgen at 1-833-828-6367 or to the FDA by
visiting www.fda.gov/medwatch or calling 1-800-332-1088.