When the cycle of chronic idiopathic urticaria (CIU) symptoms persists despite H1 antihistamine treatment, consider XOLAIR earlier. XOLAIR was studied in patients who experienced itch and hives for ≥8 consecutive weeks prior to enrollment despite the use of H1 antihistamines. 23,24
XOLAIR has been shown to reduce mean weekly itch severity and mean weekly hive count scores in appropriate CIU patients 12 years and older uncontrolled on H1 antihistamines. 10 Use the links below to learn more:
Mean
Weekly Itch Data
Mean
Weekly Hive Data
Complete
Relief Data
See additional information for patient baseline characteristics. Please see full safety information.
Mean Weekly Itch Data
XOLAIR Delivered Effective Itch Relief
In Studies 1 & 2:
Study Designs
The safety and efficacy of XOLAIR for the treatment of CIU was assessed in 2 placebo-controlled, multiple-dose clinical studies of 24 weeks’ duration (CIU Study 1; N=319) and 12 weeks’ duration (CIU Study 2; N=322). Patients received XOLAIR 300 mg, 150 mg, 75 mg, or placebo in addition to their baseline level of H1 antihistamine therapy. The 75-mg dose is not approved for use. 1 Concomitant CIU treatments other than H1 antihistamines were not allowed during the study. 23,24
Demonstrated Reductions in Mean Weekly Itch Severity Score Throughout Treatment
Study 1: Change From Baseline and Percentage Reduction
in
Mean Weekly Itch Severity Score at Week 12 (N=241) 10,24*†
Similar Results Were Seen in Study 2
71% and 56% reductions in mean weekly itch severity score from baseline at week 12 were demonstrated for XOLAIR 300 mg and 150 mg, respectively, vs 36% for the active control group. 10*†
XOLAIR reduced mean weekly itch severity score at week 12 from baseline, which was the primary endpoint (XOLAIR 300 mg [n=79], -9.8 from 13.7; XOLAIR 150 mg [n=82], -8.1 from 14.2; active control [n=79], -5.1 from 14.0). 24
- The difference in LS mean vs active control was -4.8 for XOLAIR 300 mg (P<.001; 95% CI: -6.5, -3.1) and -3.0 for XOLAIR 150 mg (P<.01; 95% CI: -4.9, -1.2). 24
During Studies 1 and 2, the itch severity score was measured twice a day (AM and PM) on a scale of 0 (none) to 3 (severe). The daily itch severity score was the average of the morning and evening scores, and the weekly itch severity score (0-21) was the sum of the daily itch severity scores over 7 days. 10
*All patients received their dose of study drug or placebo in addition to stable doses of their prerandomization H1 antihistamine. 10
†The weekly itch severity score was calculated for each patient at each week. The mean change from baseline (the primary efficacy analysis) and the mean percentage change in weekly itch severity score were calculated for each treatment group for comparison vs active control at week 12 (the primary efficacy analysis time point). 24
LS, least squares; q4w, every 4 weeks.
Mean Weekly Hive Data
XOLAIR Delivered Effective Hive Relief
In Studies 1 & 2:
Study Designs
The safety and efficacy of XOLAIR for the treatment of CIU was assessed in 2 placebo-controlled, multiple-dose clinical studies of 24 weeks’ duration (CIU Study 1; N=319) and 12 weeks’ duration (CIU Study 2; N=322). Patients received XOLAIR 300 mg, 150 mg, 75 mg, or placebo in addition to their baseline level of H1 antihistamine therapy. The 75-mg dose is not approved for use. 1 Concomitant CIU treatments other than H1 antihistamines were not allowed during the study. 23,24
Demonstrated Reductions in Mean Weekly Hive Count Score From Baseline at Week 12 10
Study 1: Change From Baseline and Percentage Reduction in Mean Weekly Hive Count Score at Week 12 (N=241) 1,10,23*†
Similar Results Were Seen in Study 2
74% and 57% reductions in mean weekly hive count score from baseline at week 12 were demonstrated for XOLAIR 300 mg and 150 mg, respectively, vs 31% for the active control group. 10‡
XOLAIR reduced mean weekly hive count score at week 12 from baseline (XOLAIR 300 mg [n=79], -12.0 from 15.8; XOLAIR 150 mg [n=82], -9.8 from 17.1; active control [n=79], -5.2 from 17.0). 24
- The difference in LS mean vs active control was -7.1 for XOLAIR 300 mg (P<.001; 95% CI: -9.3, -4.9) and -4.5 for XOLAIR 150 mg (P<.001; 95% CI: -6.7, -2.4). 24
During Studies 1 and 2, the hive count score was measured twice a day (AM and PM) on a scale of 0 (no hives) to 3 (>12 hives). The daily hive count score was the average of the morning and evening scores, and the weekly hive count score (0-21) was the sum of the daily hive count scores over 7 days. 10
‡All patients received their dose of study drug or placebo in addition to stable doses of their prerandomization H1 antihistamine. 10
§Secondary efficacy endpoints across all studies were change from baseline in UAS7 at week 12, change from baseline in weekly hive count score at week 12, and the proportion of patients with UAS7=0 at week 12. 10
UAS7, urticaria activity score over 7 days.
Complete Relief Data
Study Designs
The safety and efficacy of XOLAIR for the treatment of CIU was assessed in 2 placebo-controlled, multiple-dose clinical studies of 24 weeks’ duration (CIU Study 1; N=319) and 12 weeks’ duration (CIU Study 2; N=322). Patients received XOLAIR 300 mg, 150 mg, 75 mg, or placebo in addition to their baseline level of H1 antihistamine therapy. The 75-mg dose is not approved for use. 1 Concomitant CIU treatments other than H1 antihistamines were not allowed during the study. 23,24
Based on Decreases in Mean Weekly Itch Severity and Hive Count Scores
More Than One-Third (36%) of Patients Achieved Complete Relief With XOLAIR 300 mg 23,24†
Study 1: Percentage of Patients Achieving Complete Relief
(No
Itch and No Hives, UAS7=0) at Week 12 (N=241) 23
†XOLAIR for CIU is dosed at 300 mg or 150 mg every 4 weeks. See full dosing information.
Similar Results Were Seen in Study 2
44% and 22% of patients achieved complete relief at week 12 with XOLAIR 300 mg and 150 mg, respectively, vs 5% with the active control group. 24
UAS7, urticaria activity score over 7 days.
Complete Relief May Be Possible for Your Patients
UAS7: Understanding the Urticaria Activity Score (UAS)
The UAS Is a Composite Score of Itch Severity and Hive Count 1,10
- To assess disease severity in patients with CIU, patients record the severity of their itch and the number of hives twice daily (morning and evening). Their daily itch severity/hive count scores are an average of their morning and evening scores.
- Each component of the UAS is scored on a scale of 0 to 3 (0=none to 3=intense/severe); the 2 scores are added together for a daily total of 0 to 6.
Urticaria Activity Score
The UAS7 Is the Sum of the Average Daily UAS Over 7 Days 1,10
- After 7 days, average daily scores from the morning and
evening assessments are added together.
- Values can range between 0 and 21 for weekly itch severity, and 0 to 21 for weekly hive count.
- The UAS7 ranges from 0 to 42.
In XOLAIR CIU clinical trials, disease severity was measured by the UAS7—which helped determine the primary efficacy endpoint. 1,24
- Disease severity was measured by the UAS7 (range, 0-42)—a composite of the weekly itch severity score (range, 0-21) and the weekly hive count score (range, 0-21). 1
- All patients were required to have a UAS7 of ≥16 and a weekly itch severity score of ≥8 for the 7 days prior to randomization, despite having used an H1 antihistamine for at least 2 weeks. 1
Patient Baseline Characteristics
Select Baseline Characteristics 23,24
