1. Medicines
  2. Dermatology
  3. XOLAIR® (omalizumab)
  4. Efficacy

Prescribing information

 

Efficacy

Key efficacy data for Xolair in CSU.

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 Xolair1,3

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 reduction3–5

During the treatment period

  • Itch reduction in as little as 2 weeks in over 50% of patients3,4   
    • 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 patients3,7

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.

Global, multicentre, randomised, double-blind, placebo-controlled study investigating Xolair in CSU patients whose signs and symptoms persisted despite treatment with H1-AH at up to 4 times the approved dose††† ± H2-AH ± LTRAs†††

  • Patients received 6 injections of either Xolair 300 mg (n=252) or placebo (n=83) at intervals of 4 weeks for a total of 24 weeks   
  • The study objective was to evaluate the safety and efficacy of 24 weeks’ treatment with Xolair    
  • Patients continued stable doses of pre-randomisation combination therapy (H1-AH ± H2-AH ± LTRAs) throughout the treatment period   
  • Patients were permitted rescue diphenhydramine 25 mg up to 3x/day at any point during the study

†††Unlicensed for treatment of CSU.

Randomised, double-blind, placebo-controlled, multicentre, 28-week treatment study with an 8-week follow-up period 

  • Patients aged 18–75 years with a diagnosis of CSU with angioedema and a history of insufficient treatment response to 2–4x the approved dose of non-sedating H1-AH‡‡‡ were randomised 1:1 to receive Xolair 300 mg (n=44), or placebo (n=47) subcutaneously every 4 weeks    
  • The study objective was to evaluate the efficacy of Xolair vs placebo at Week 28 using the CU-Q2oL questionnaire. Secondary objectives included: number of angioedema-burdened days, time interval between successive angioedema episodes, disease activity, angioedema-specific and overall quality of life impairment   
  • Patients continued stable doses of pre-randomisation H1-AH treatment    
  • Patients were permitted rescue betamethasone and clemastine in case of life-threatening angioedema

‡‡‡Unlicensed for treatment of CSU.

 

*Post hoc analysis of phase 3 studies (ASTERIA I & II, and GLACIAL), demonstrated clinically meaningful improvements in quality of life (measured using DLQI) in patients with CSU.8

Indication: Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1-antihistamine treatment.9

CSU, chronic spontaneous urticaria; CU-Q2oL, Chronic Urticaria Quality of Life; DLQI, Dermatology Life Quality Index; H1-AH, H1-antihistamine; H2-AH, H2-antihistamine; IgE, immunoglobulin E; ISS, itch severity score; LTRA, leukotriene receptor antagonist; MID, minimal important difference; UAS7, urticaria activity score (seven days).

References     

  1. Novartis data on file XSU15-R002. Proportion of UAS7 MID responders at week 12 – GLACIAL study.
  2. Novartis, data on file XSU15-R004. Proportion of UAS7<16 responders at week 12 (BOCF) – GLACIAL study.
  3. Kaplan A et al. J Allergy Clin Immunol 2013;132(1):101–109.
  4. Novartis, data on file XSU15-R003. Median time to MID response in weekly ISS – GLACIAL study.
  5. Novartis, data on file XSU15-R005. Percent reduction from baseline in weekly itch severity score at week 12 (BOCF) – GLACIAL study.
  6. Staubach P et al. Allergy 2016;71(8):1135–1144.\
  7. Casale TB et al. J Allergy Clin Immunol Pract 2015;3(5):743–750.e1.
  8. Finlay AY et al. J Eur Acad Dermatol Venereol 2017;31(10):1715–1721.
  9. Xolair® (omalizumab) 150 mg Summary of Product Characteristics
XSU20-C011 July 2020.
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