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

Complete disease control and a symptom-free life is a possibility with Xolair2,3

The 2021 international EAACI/GA²LEN/EuroGuiDerm/APAAACI guidelines4 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 normalization 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.

At 12 weeks:

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  • 82% of patients responded to Xolair treatment (exploratory endpoint)‡2
  • 34% of patients on Xolair were itch- and hive-free (UAS7 =0; secondary endpoint)3
 

 

uas7-response-graph

Adapted from Novartis data on file and Kaplan A et al. 2013.2,3

Click for GLACIAL study design

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. The primary objective was to assess the safety of Xolair compared to placebo; the overall incidence and severity of adverse events and severe adverse events were similar in both the treatment groups.

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 licenced for CSU. Novartis does not condone the off-label use of any medicines. Please refer to individual products’ Summary of Product Characteristics before prescribing.

During the treatment period:

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  • RAPID: Itch reduction in as little as 2 weeks in over 50% of patients3,4
  • Minimal important difference (MID) in itch severity score (ISS) achieved in 69.8% of Xolair-treated patients
  • SUSTAINED: Effect on itch sustained at Week 24§3
 

 

itch-reduction-graph

 

Click for GLACIAL study design

 

Adapted from Novartis data on file and Kaplan A et al. 20133–5

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.

69.8% (N=176/252) of Xolair-treated patients achieved a reduction in ISS from baseline of ≥5 points vs 39.8% (N=33/83) of patients receiving placebo (p<0.001).
§The significant efficacy benefit with omalizumab (Xolair) was sustained to Week 24 vs placebo (-8.6 vs -4:0; Least squares mean treatment difference, -4.5 [95% CI, -6.1 to -3.0]; p<0.001).
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 licenced for CSU. Novartis does not condone the off-label use of any medicines. Please refer to individual products’ Summary of Product Characteristics before prescribing.

Reduced occurrence of angioedema vs placebo6

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  • 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
 

 

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Click for X-ACT study design

 

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). Novartis does not condone the off-label use of any medicines. Please refer to individual products’ Summary of Product Characteristics before prescribing.

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

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. Novartis does not condone the off-label use of any medicines. Please refer to individual products’ Summary of Product Characteristics before prescribing.

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

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  • 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

 

Not licenced for CSU. Novartis does not condone the off-label use of any medicines. Please refer to individual products’ Summary of Product Characteristics before prescribing.

*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
33.7% (n=252) of patients on omalizumab achieved UAS7=0 vs 4.8% (n=83) patients on placebo at week 12 in the GLACIAL study which evaluated efficacy as a secondary objective; p<0.001.3

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; GA2LEN, Global Allergy and Asthma European Network; H1-AH, H1-antihistamine; H2-AH, H2-antihistamine; IgE, immunoglobulin E; ISS, itch severity score; LTRA, leukotriene receptor antagonist; MID, minimal important difference; OMA, omalizumab; PBO, placebo; UAS7, urticaria activity score (seven days).

References

  1. Xolair® (omalizumab) 150 mg Summary of Product Characteristics.
  2. Novartis data on file XSU15-R002. Proportion of UAS7 MID responders at Week 12 – GLACIAL study.
  3. Kaplan A, et al. J Allergy Clin Immunol 2013;132(1):101–109.
  4. Zuberbier T, et al. Allergy 2021;00:1–33.
  5. Novartis, data on file XSU15-R003. Median time to MID response in weekly ISS – GLACIAL study.
  6. Novartis, data on file XSU15-R005. Percent reduction from baseline in weekly itch severity s core at week 12 (BOCF ) – GLACIAL study.
  7. Staubach P, et al. Allergy 2016;71(8):1135–1144.
  8. Finlay AY, et al. J Eur Acad Dermatol Venereol 2017;31(10):1715–1721.
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UK | March 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
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]