Prescribing information

 

            __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

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 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.”

As recommended by the latest CSU treatment guidelines, patient-reported outcome measures (PROMs) are crucial to evaluating and monitoring disease activity and severity, disease control and quality of life in patients with urticaria.4,5

 

Expand the sections below to learn more about each key PROM for CSU and either access editable PDF downloads or submit a contact form to order complementary hard copies from Novartis. Alternatively, you can use the following links to jump to the relevant measure.

Download editable UCT PDF now

The UCT is designed to assess urticaria control. It is simple to complete and is suited to tracking every 4 weeks, although a UCT-7 is also available which tracks urticaria control every 7 days.4,5

  • Validated and specifically designed for chronic urticaria
  • Self-administered, retrospective (past 4 weeks) 4-item questionnaire
  • Each answer is scored ranging from 0 to 4
  • The summed score ranges from 0 (no control) to 16 (complete control)

The UCT covers the following 4 domains5

 

utc-icon-1

 

Overall CSU control

utc-icon-2

 

Physical symptoms (itch, hives, swelling)

utc-icon-3

 

Quality of life impact

utc-icon-4

 

Frequency of treatment inadequacy

 

 

UCT score interpretation by the 2021 EAACI guidelines6

Minimal important clinical difference: 3 points5

clinical-difference-diagram

Adapted from 2021 EAACI guidelines, Zuberbier T, et al.4

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

Contact us for UCT hard copies

Download editable UAS7 PDF now

The UAS7 is designed to assess disease activity and severity. It is a comprehensive measure that requires the patient to record their symptoms daily for a week. The UAS7 should be used in routine clinical practice to determine disease activity and response to treatment of patients with CSU. Scores are summarised over one week (7 days) for a maximum of 42 weeks.6

  • Patient scores the intensity of their hives (number of and area covered by wheals [0 to 3] and itch [0 to 3]) each day for 7 days, where 0=none, 1=mild, 2=moderate and 3=intense6
  • Maximum weekly score is 42 – a higher score corresponds to more severe disease6
  • Severe CSU has a UAS7 score of 28–427
  • Included in the NICE guidance as an example of objective assessment of disease severity8
  • The UAS7 does not assess angioedema. Patients with angioedema should use the Angioedema Activity Score (AAS)6

Here is a figure to explain how UAS7 scoring can be interpreted:

uas7-score-chart

 

Contact us for UAS7 hard copies

Download editable DLQI PDF now

The DLQI is a simple, weekly, validated questionnaire used to evaluate health-related quality of life in patients with skin diseases – not only CSU.9 Where patients may experience comorbid conditions, it may also be useful to consider other specific QoL measures such as the Cu-Q2oL, which assesses itch, hives and angioedema, and AE-QoL, which assesses angioedema alone.10 (Both not available here due to copyright).

  • The DLQI consists of:

 

dlqi-icon-1

 

Symptoms and feelings

dlqi-icon-2

 

Daily activities

dlqi-icon-3

 

Personal relationships

dlqi-icon-4

 

Leisure

dlqi-icon-5

 

Work and school

dlqi-icon-6

 

Treatment

 

 

  • The effect of the disease on each domain is scored from 0 (not at all) to 3 (very much) for each question, giving a total score of between 0 and 309
  • How scores can be interpreted:11
    0–1 no effect at all on patient’s life
    2–5 small effect on patient’s life
    6–10 moderate effect on patient’s life
    11–20 large effect on patient’s life
    21–30 extremely large effect on patient’s life

 

Contact us for DLQI hard copies

Patient-reported outcomes resources

Click on the links below to view the patient-reported outcomes resources, and if you have any further requests, please contact a Novartis representative. 

 

Symptom control icon

Symptom control

UCT12

Four questions

Quick

Retrospective (4 weeks)

Use at first consultation and every follow-up consultation

Disease severity icon

Disease severity

UAS710

Two questions

Symptoms scored daily

Prospective (1 week)

Use at every follow-up consultation

Quality of life icon

Quality of life

DLQI5

10 questions

Not specific to CSU

Retrospective (1 week)

Use at first consultation and every 6 months thereafter

 

As part of our mission to be as environmentally friendly as possible, we provide our resources in electronic form.

These materials should not be printed by healthcare professionals.

BSACI, British Society for Allergy and Clinical Immunology; CSU, chronic spontaneous urticaria; DLQI, Dermatology Life Quality Index; EAACI, European Academy of Allergy and Clinical Immunology; EDF, European Dermatology Forum; GA2LEN, Global Allergy and Asthma European Network; IgE, immunoglobulin E; NICE, National Institute for Health and Care Excellence; UAS7, urticaria activity score at seven days; UCT, urticaria control test; WAO, World Allergy Organization.

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. Moestrup K, et al. Int J D ermatol 2017;56(12):1342–1348.
  6. Sabroe RA, et al. Br J Dermatol 2021. ePub ahead of print. Available at: https://doi.org/10.1111/bjd.20892 [Accessed March 2022].
  7. Stull D, et al. Br J Dermatol 2017;177:1093–1101.
  8. National Institute for Health and Care Excellence. How should I diagnose Urticaria? Available from: https://cks.nice.org.uk/topics/urticaria/diagnosis/diagnosis/ [Accessed March 2022].
  9. Finlay AY, et al. Clin Exp Dermatol 1994;19(3):210–216.
  10. Weller K , et at. JEADV 2015;29 (Suppl. 3);38–44.
  11. British Association of Dermatologists. Dermatology Life Quality Index (DLQI). Available at: https://www.bad.org.uk/shared/get-file.ashx?id=1653&itemtype=document [Accessed March 2022].
  12. Weller K, et al. J Allergy Clin Immunol 2014;133(5):1365–1372.
Rate this content: 
No votes yet
UK | April 2022 | 164032
×

Ask Speakers

×

Medical Information Request

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]