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Wednesday 19 December 2018
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Omalizumab recommended in new global chronic urticaria guideline

A new global guideline on chronic urticaria (CU) recommends Xolair® (omalizumab), indicated as add-on therapy for the treatment of chronic spontaneous urticaria (CSU), for patients who are not responding to antihistamines.1,2

 

Xolair is the only licensed treatment option for CSU, a type of CU, for patients unresponsive to antihistamines.1

 

CU, including CSU, is a severe disease that causes itchy, persistent hives and painful swelling. The guideline recommends Xolair as the only treatment qualified with very good efficacy and very good safety in CSU.2 The guideline was endorsed by key dermatologic and allergy professional medical societies around the world.

 

Marcus Maurer, MD, Professor of Dermatology and Allergy and Director of Research at the Department of Dermatology and Allergy, Allergie-Centrum-Charité of the Charité - Universitätsmedizin in Berlin, Germany said: "I highly welcome the new guideline, as it brings greater public awareness of the disease and treatment. Also, it provides clear directions for physicians on how to treat patients suffering from this undertreated, debilitating disease. The most important phrase is: Treat the disease until it is gone."

 

"This guideline is encouraging news for CSU patients who have difficult to control symptoms," said Shreeram Aradhye MD, Chief Medical Officer and Global Head Medical Affairs, Novartis Pharmaceuticals. "The recommendation reinforces the important role of Xolair to provide effective symptom control in CSU when antihistamines prove inadequate. Xolair is the only biologic shown to be effective in CSU." 

 

The new guideline aims to achieve complete symptom control of patients. Studies have shown that CSU, if not controlled, or only partially controlled, has a major impact on the quality of sleep and the social and working lives of patients.3,4 Patients treated with Xolair for 12 weeks experienced significant improvements in quality of life by 78% (vs placebo 44%, p<0.0001) as measured by the Dermatology Life Quality Index (DLQI).5 In addition, data show that almost 90% of CSU patients who responded well to initial Xolair treatment regained symptom control within 12 weeks of Xolair retreatment following a treatment interruption, based on Weekly Urticaria Activity Score (UAS7) criteria (UAS7<=6)[6]. Xolair is currently only licensed for CSU.1 Also, Xolair is approved for the treatment of moderate-to-severe or severe persistent allergic asthma.1

 

References

  1. Xolair Summary of Product Characteristics. Novartis Europharm Limited. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000606/WC500057298.pdf. Last accessed January 2018.
  2. Zuberbier at al. The EAACI/GA²LEN/EDF/WAO Guideline for the Definition, Classification, Diagnosis and Management of Urticaria. The 2017 Revision and Update. Allergy. 2018 Jan 15. doi: 10.1111/all.13397 [Epub ahead of print]
  3. Maurer M et al. The burden of chronic spontaneous urticaria is substantial: Real-world evidence from ASSURE-CSU. Allergy 2017. Advanced online publication. DOI:10.111
  4. Maurer et al. H1-antihistamine-refractory chronic spontaneous urticaria: it's worse than we thought - first results of the multicenter real-life AWARE study. Clin Exp Allergy. 2017;47:684-692.
  5. Rosén K et al. Chronic idiopathic/spontaneous urticaria (CIU/CSU) refractory to standard of care: omalizumab improves quality of life (QoL) as assessed by the dermatology life quality index. 23rd World Congress of Dermatology, Vancouver, Canada, 2015. Oral presentation (presentation number FC23-06).

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