Prescribing information

 

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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.1

Xolair provides significant improvement in quality of life for highly symptomatic CSU patients vs placebo (p<0.001)2–7

The 2021 international EAACI/GA2LEN/EuroGuiDerm/APAAACI guidelines state that the “goal of treatment is to treat the disease until it is gone and as efficiently and safely as possible, aiming at a continuous UAS7 =0, complete control and a normalisation of quality of life.”

It is imperative that patients are monitored regularly from diagnosis, to establish their level of disease control, so that treatment can be optimised accordingly Find out more and download monitoring tools here.

See the difference that Xolair could make for your CSU patients by expanding the ‘THINK’ sections below.

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  • 73% reduction (-9.7) in mean DLQI (observed data) with Xolair 300 mg at Week 12 vs baseline (p<0.001, additional efficacy endpoint)2,7

 

What is DLQI?
A gold standard in monitoring the impact of skin disease on QoL
Click here

 

 

improved-qol-diagram

Click for GLACIAL study design

Adapted from Kaplan A et al. 2013 and Casale et al. 2015.2,6

Background treatment with H1-AH at up to 4x the approved dose ± H2-AH ± LTRAs. Novartis does not condone the off-label use of any medicines. Please refer to individual products’ Summary of Product Characteristics before prescribing.
Mean of patients’ percentage improvement in DLQI

Xolair improved quality of life related to angioedema measured using CU-Q2oL (LOCF, FAS), p<0.001 vs. placebo8

 

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  • Significantly superior reduction in the CU-Q2oL total score from Week 4 onwards over the 28 weeks of treatment versus placebo (p<0.001, primary endpoint)†5

What is CU-Q2oL?
CU-Q2oL measures various aspects of quality of life (QoL) that are specific to patients with chronic urticaria. The scale ranges from 0 to 100, where high scores indicate low QoL.5

 

 

cu-q2ol_change_diagram

 

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. CU-Q2oL measures various aspects of QoL (scale: 0–100; high scores indicate low QoL) that are specific to chronic urticaria. CU-Q2oL. Novartis does not condone the off-label use of any medicines. Please refer to individual products’ Summary of Product Characteristics before prescribing.

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

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  • 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
 

 

 

Not licenced for CSU.

*Post hoc analysis of Phase III studies,2 omalizumab 300 mg significantly improved total DLQI scores vs placebo: ‒ ASTERIA I (OMA: n=161, PBO: n=80): mean decrease from baseline to Week 12 of -10.3 vs -6.1 (p<0.0001). ‒ ASTERIA II (OMA: n=161, PBO: n=79): -10.2 vs -6.1 (p=0.0004). ‒ GLACIAL (OMA: n=252, PBO: n=83): -9.7 vs -5.1 (p<0.0001).7

APAAACI, Asia Pacific Association of Allergy, Asthma, and Clinical Immunology; CSU, chronic spontaneous urticaria; CU-Q2oL, Chronic Urticaria Quality of Life; DLQI, Dermatology Life Quality Index; EAACI, European Academy of Allergy and Clinical Immunology; FAS, full analysis set; GA2LEN, Global Allergy and Asthma European Network; H1-AH, H1-antihistamine; H2-AH, H2-antihistamine; IgE, immunoglobulin E; ISS, itch severity score; LOCF, last observation carried forward; LTRA, leukotriene receptor antagonist; MID, minimal important difference; QoL, quality of life; UAS7, urticaria activity score (seven days).

References

  1. Xolair® (omalizumab) 150 mg Summary of Product Characteristics.
  2. Kaplan A, et al. J Allergy Clin Immunol 2013;132(1):101–109.
  3. Novartis, data on file XSU15-R003. Median time to MID response in weekly ISS – GLACIAL study.
  4. Novartis, data on file XSU15-R005. Percent reduction from baseline in weekly itch severity score at week 12 (BOCF ) – GLACIAL study.
  5. Staubach P, et al. Allergy 2016;71(8):1135–1144.
  6. Casale TB, et al. J Allergy Clin Immunol Pract 2015;3(5):743–750.e1.
  7. Finlay AY, et al. J Eur Acad Dermatol Venereol 2017;31(10):1715–1721.
  8. Novartis data on file XSU16-R016.
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UK | April 2022 | 164032
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
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