Efficacy

Xolair provides proven efficacy for symptom relief of CSU.^1–3

Think proven efficacy

Disease control and a symptom-free life is a possibility with Xolair^1,3

At 12 weeks

• 82% of patients responded to Xolair treatment (exploratory endpoint)^†
• 34% of patients were itch- and hive-free (UAS7 = 0; secondary endpoint)³

Adapted from Novartis data on file and Kaplan A et al. 2013.^1,3

Data from a randomised, double-blind, placebo-controlled, parallel group study of 336 patients aged 12–75 years with CSU for ≥6 months, itch and hives for >6 consecutive weeks before enrolment despite therapy with H1-AH ± H2-AH ± LTRAs, and a UAS7 ≥16. Mean UAS7 at baseline was 31.2 for Xolair and 30.2 for placebo.

^†Proportion of patients achieving MID in UAS7 (reduction in UAS7 from baseline of ≥11 points).
^‡Background treatment with H1-AH at up to 4x the approved dose^§ ± H2-AH ± LTRAs.
^§Not licensed for CSU.

Think rapid and sustained itch reduction^3–5

During the treatment period

• Itch reduction in as little as 2 weeks in over 50% of patients^3,4   
  • Median time to achieve MID in ISS in Xolair-treated patients^¥
• Effect on itch sustained at Week 24³

Adapted from Novartis data on file and Kaplan A et al. 2013.^3–5

Data from a randomised, double-blind, placebo-controlled, parallel group study of 336 patients aged 12–75 years with CSU for ≥6 months, itch and hives for >6 consecutive weeks before enrolment despite therapy with H1-AH ± H2-AH ± LTRAs, and a UAS7 ≥16.  

^¥Reduction in ISS from baseline of ≥5 points.
**Change from baseline to Week 12 in weekly ISS (secondary endpoint). Exploratory endpoints were also evaluated at Week 24.
^#Background treatment with H1-AH at up to 4x the approved dose^¶ ± H2-AH ± LTRAs.
^¶Not licensed for CSU.

Think reduced angioedema burden

Reduced occurrence of angioedema vs placebo⁶

Over 28 weeks of Xolair treatment, and during follow-up, the mean number of angioedema-burdened days per week was lower than that in the placebo group (secondary endpoint).⁶

Adapted from Staubach P et al. 2016.⁶

Data from a randomised, double-blind, placebo-controlled study of 91 patients with CSU aged 18–75 years with wheals and ≥4 occurrences of angioedema in the last 6 months who were symptomatic despite therapy with high-dose H1-AH (2–4x the approved dose), and a UAS7 ≥14. Xolair was significantly superior to placebo in CU-Q2oL total score from Week 4 onwards over 28 weeks (p<0.001, primary endpoint).

^††Imputation: If for 5 or 6 days angioedema was assessed – no angioedema was assumed for the days without assessment. Full analysis set.

Think an improved quality of life
 

Significant improvement in quality of life for highly symptomatic CSU patients^3,7

73% reduction (−9.7) in mean DLQI (observed data) with Xolair 300 mg at Week 12 vs baseline (p<0.001, additional efficacy endpoint)^3,8

Adapted from Kaplan A et al. 2013 and Casale et al. 2015.^3,7

Data from a randomised, double-blind, placebo-controlled, parallel group study of 336 patients aged 12–75 years with CSU for ≥6 months, itch and hives for >6 consecutive weeks before enrolment despite therapy with H1-AH ± H2-AH ± LTRAs, and a UAS7 ≥16. Data represent the modified intention-to-treat (mITT) population.

^‡‡Background treatment with H1-AH at up to 4x the approved dose*** ± H2-AH ± LTRAs.
***Not licensed for CSU.
^¶¶Mean of patients’ percentage improvement in DLQI.