Learn how CSU is diagnosed.
In clinical studies, **XOLAIR was shown to help reduce the severity of itch* and the number of hives† in patients who continued to have symptoms that were not controlled by H1 antihistamine treatment. Individual results may vary.
Watch real patient stories of people like you, who understand what it's like living with CSU.
*To measure itch severity, patients were asked to write down how itchy they felt every morning and night on a scale of 0-3. The average daily score was then added together over 7 days for the weekly itch severity score.
**Based on results from CSU Studies 1 and 2.
†To measure the hive score, patients were asked to count the number of hives on their bodies twice daily. (0= no hives, 1= 1 to 6 hives, 2= 7 to 12 hives, 3= more than 12 hives) The average daily score was then added together over 7 days for the weekly hive count score.
Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after treatment is initiated. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction.
Results of a CSU Study in Adults and Adolescents
XOLAIR was studied for 24 weeks to measure the severity of itch* and number of hives† (on a weekly basis) of CSU patients who continued to have hives while on antihistamine therapy. Open the tab below to see the results of the study and how it was done. Individual results may vary.
How the study was done§:
‡Based on results from CSU Study 1, a 24-week clinical study.
§78 patients were given 75 mg of XOLAIR. The 75 mg dose did not demonstrate consistent evidence of efficacy and is not approved for use.
Results reflective of 300 mg dose in one study with CSU patients. Two doses studied. Similar results observed in second study. People who used XOLAIR 150 mg saw a 47% decrease in itch severity and 50% fewer hives, with more than one in six itch and hive free, at 12 weeks. Severity in both studies was measured by weekly itch severity score (range 0-20) and weekly hive count score (range 0-21). A total of 641 CSU patients already taking an antihistamine participated in the two studies.
Individual results may vary.
Do not receive and use XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Results of Another CSU Study in Adults and Adolescents
XOLAIR was studied for 12 weeks to measure the severity of itch* and number of hives† (on a weekly basis) of CSU patients who continued to have hives while on antihistamine therapy. Open the tab below to see the results of the study and how it was done. Your results may vary.
How the study was done:||
‖82 patients were given 75 mg of XOLAIR. The 75 mg dose did not demonstrate consistent evidence of efficacy and is not approved for use.
These are not all the possible side effects of XOLAIR. Call your doctor for medical advice about side effects.
To learn how XOLAIR might help patients with CSU, medical teams did research—this is known as clinical studies. Experts wanted to know how much XOLAIR could reduce 1) the severity of itch and 2) the number of hives.
Not all clinical studies are the same. However, many factors, such as the number of people who participate, types of people, the location of the participants, and other external or internal matters, can play a role in the outcome of a clinical study. This is why they are so important to do—and why more than one study may be done. Also remember that all people are unique—even if they do share a common condition such as CSU.
Two studies were conducted looking at the effect of XOLAIR in patients with CSU. In the studies, all the patients remained on an H1 antihistamine. Patients were then split into 3 different groups. Two groups (the XOLAIR groups) received different doses of XOLAIR, and the third (the Control group) received a placebo.
What is a "Control Group"?
In this group, patients received H1 antihistamine treatment and a placebo. A placebo is a look-alike treatment with no active medicine that can affect an illness. Placebos can take many forms, such as a pill, an injection, or even a procedure. In this case, it was an injection.
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