Cut to fast relief
Results measured at week 12 for chronic spontaneous urticaria (CSU) and symptomatic dermographism (SD)
CSU patient portrayal.
Fast relief from hives and itch measured at week 12
In one clinical study:
Weekly hives severity score (HSS7) dropped 10.47 points with RHAPSIDO vs 6.00 with placebo on average from the start of the study.
Weekly itch severity score (ISS7) dropped 8.95 points with RHAPSIDO vs 5.72 with placebo on average from the start of the study.
†These results were calculated from observed data. No statistical analyses were done and conclusions should not be drawn.
Weekly urticaria activity score (UAS7=0) with RHAPSIDO (27.9% vs 6.5% with placebo) at week 12.
Results seen as early as week 2
Weekly urticaria activity score (UAS7 ≤6) with RHAPSIDO (30% vs 5.9% with placebo) at week 2.
How results were tested in clinical trials
RHAPSIDO was studied in 2 identical clinical trials in adults (≥18 years of age) with CSU who continued to have symptoms while taking antihistamines. All participants stayed on antihistamines while also taking either RHAPSIDO or placebo (in the trial presented: RHAPSIDO, n=297; placebo, n=153). Placebo does not contain any active medicine. Results were similar between both trials.
Measuring hives and itch relief
Hives and itch were measured using 3 established scales. Participants rated their hives and itch twice a day from 0 to 3, with higher scores indicating more severe symptoms. The average daily ratings were added up each week and compared to their starting scores.
Fast and complete response from hives based on TFS measured at week 12
In the clinical study:
Results seen as early as week 2
TFS, Total Fric Score.
Reduction in most bothersome symptom (MBS) at week 12
At the start of the study, people identified their most bothersome SD symptom by selecting between itch, burning, or pain. Their individually chosen symptom was then tracked throughout the study.
Weekly MBS score was reduced an average of 1.96 points with RHAPSIDO vs 0.33 points with placebo compared to the start of the study.
How results were tested in clinical research
RHAPSIDO was studied in adults (≥18 years of age) with SD who continued to have symptoms while taking antihistamines. All participants stayed on antihistamines while also taking either RHAPSIDO or placebo (RHAPSIDO, n=58; placebo, n=57). Placebo does not contain any active medicine.
Explanation of how data were evaluated
Total Fric Score (TFS): Measures how the skin responds in number of hives seen after it has been scratched or rubbed with the FricTest® (score ranging from 0 to 4). A Fric test uses a 4-prong tool that applies pressure to the skin, to induce hives in patients with SD.
Weekly most bothersome symptom (MBS) score: Measures the MBS for a week (score ranging between 0 and 10).
CSU and SD can last for a while. Your doctor will determine how long you should take RHAPSIDO. For RHAPSIDO to work the way it’s meant to, it’s important to continue taking it exactly as your doctor prescribed.
