Check Out the Clinical Trial Results
Patient Portrayal
Patient Portrayal
Check Out the Clinical Trial Results
Studied for over 10 years
AYVAKIT has been extensively studied in clinical trials for over 10 years and across 3 different disease states, including over 4 years for ISM. Since 2020, over 1,700* patients have been treated with AYVAKIT.
AYVAKIT is clinically proven to help reduce the symptoms of ISM
- The efficacy and safety of AYVAKIT was studied in a randomized, placebo controlled clinical trial with 212 adults over 24 weeks.
- Each patient had moderate to severe ISM symptoms, despite taking at least 2 symptom-directed therapies. 141 received AYVAKIT and 71 received placebo. Both AYVAKIT- and placebo-treated patients continued their best supportive care*
- After 24 weeks, patients on placebo had the option to take AYVAKIT. This part of the trial is currently ongoing; however, results presented here are up to week 48.
- In the clinical trial, patients were asked to report the severity of 11 symptoms on a scale from 0 (none) to 10 (worst). These numbers were then combined to produce a total symptom score, a tool to help measure the efficacy of AYVAKIT.
AYVAKIT plus best supportive care significantly reduced overall symptoms of ISM from baseline*
ON PLACEBO + BEST SUPPORTIVE CARE (N=71) -9.6 average point reduction in total symptom score
ON AYVAKIT + BEST SUPPORTIVE CARE (N=141) -15.3 average point reduction in total symptom score
ON AYVAKIT + BEST SUPPORTIVE CARE (N=60) -20.2 average point improvement in total symptom score
AT 24 WEEKS
-9.6
-15.3
AT 48 WEEKS†
-20.2
At 24 weeks, AYVAKIT plus best supportive care significantly reduced symptoms of ISM,* including:
- Brain fog
- Dizziness
- Headache
- Fatigue
- Flushing
- Bone pain
- Itching
- Spots on the skin
- Abdominal pain
- Diarrhea
- Nausea
*Reduction of total symptom score does not imply impact on each symptom
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