Real-world outcomes in patients with chronic spontaneous urticaria receiving omalizumab: insights from a clinical practice survey

References

• Zuberbier T, Abdul Latiff AH, Abuzakouk M, et al. The international EAACI/GA(2)LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2022;77(3):734–766. doi: 10.1111/all.15090.
   PubMed Web of Science ®Google Scholar
• Maurer M, Abuzakouk M, Bérard F, et al. The burden of chronic spontaneous urticaria is substantial: real-world evidence from ASSURE-CSU. Allergy. 2017;72(12):2005–2016. doi: 10.1111/all.13209.
   PubMed Web of Science ®Google Scholar
• Sánchez-Borges M, Ansotegui IJ, Baiardini I, et al. The challenges of chronic urticaria part 1: epidemiology, immunopathogenesis, comorbidities, quality of life, and management. World Allergy Organ J. 2021;14(6):100533. doi: 10.1016/j.waojou.2021.100533.
   PubMed Web of Science ®Google Scholar
• Staubach P, Eckhardt-Henn A, Dechene M, et al. Quality of life in patients with chronic urticaria is differentially impaired and determined by psychiatric comorbidity. Br J Dermatol. 2006;154(2):294–298. doi: 10.1111/j.1365-2133.2005.06976.x.
   PubMed Web of Science ®Google Scholar
• Porter E, Tierney E, Byrne B, et al. ‘It has given me my life back’: a qualitative study exploring the lived experience of patients with chronic spontaneous urticaria on omalizumab. Clin Exp Dermatol. 2022;47(11):2032–2034. doi: 10.1111/ced.15321.
   PubMed Web of Science ®Google Scholar
• Hoskin B, Ortiz B, Paknis B, et al. Humanistic burden of refractory and nonrefractory chronic idiopathic urticaria: a real-world study in the United States. Clin Ther. 2019;41(2):205–220. doi: 10.1016/j.clinthera.2018.12.004.
   PubMed Web of Science ®Google Scholar
• Hoskin B, Ortiz B, Paknis B, et al. Exploring the real-world profile of refractory and non-refractory chronic idiopathic urticaria in the USA: clinical burden and healthcare resource use. Curr Med Res Opin. 2019;35(8):1387–1395. doi: 10.1080/03007995.2019.1586222.
   PubMed Web of Science ®Google Scholar
• Engin B, Uguz F, Yilmaz E, et al. The levels of depression, anxiety and quality of life in patients with chronic idiopathic urticaria. J Eur Acad Dermatol Venereol. 2008;22(1):36–40. doi: 10.1111/j.1468-3083.2007.02324.x.
   PubMed Web of Science ®Google Scholar
• Staubach P, Dechene M, Metz M, et al. High prevalence of mental disorders and emotional distress in patients with chronic spontaneous urticaria. Acta Derm Venereol. 2011;91(5):557–561. doi: 10.2340/00015555-1109.
   PubMed Web of Science ®Google Scholar
• Wagner N, Zink A, Hell K, et al. Patients with chronic urticaria remain largely undertreated: results from the DERMLINE online survey. Dermatol Ther (Heidelb). 2021;11(3):1027–1039. doi: 10.1007/s13555-021-00537-5.
   PubMed Web of Science ®Google Scholar
• Maurer M, Staubach P, Raap U, 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(5):684–692. doi: 10.1111/cea.12900.
   PubMed Web of Science ®Google Scholar
• Kaplan A, Ledford D, Ashby M, et al. Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy. J Allergy Clin Immunol. 2013;132(1):101–109. doi: 10.1016/j.jaci.2013.05.013.
   PubMed Web of Science ®Google Scholar
• Maurer M, Rosén K, Hsieh H-J, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med. 2013;368(10):924–935. doi: 10.1056/NEJMoa1215372.
   PubMed Web of Science ®Google Scholar
• Staubach P, Metz M, Chapman-Rothe N, et al. Omalizumab rapidly improves angioedema-related quality of life in adult patients with chronic spontaneous urticaria: X-ACT study data. Allergy. 2018;73(3):576–584. doi: 10.1111/all.13339.
   PubMed Web of Science ®Google Scholar
• Salman A, Demir G, Bekiroglu N. The impact of omalizumab on quality of life and its predictors in patients with chronic spontaneous urticaria: real-life data. Dermatol Ther. 2019;32(4):e12975. doi: 10.1111/dth.12975.
   PubMed Web of Science ®Google Scholar
• Diluvio L, Piccolo A, Marasco F, et al. Improving of psychological status and inflammatory biomarkers during omalizumab for chronic spontaneous urticaria. Future Sci OA. 2020;6(9):FSO618. doi: 10.2144/fsoa-2020-0087.
   PubMed Web of Science ®Google Scholar
• Patella V, Zunno R, Florio G, et al. Omalizumab improves perceived stress, anxiety, and depression in chronic spontaneous urticaria. J Allergy Clin Immunol Pract. 2021;9(3):1402–1404. doi: 10.1016/j.jaip.2020.11.026.
   PubMed Web of Science ®Google Scholar
• Casale TB, Murphy TR, Holden M, et al. Impact of omalizumab on patient-reported outcomes in chronic idiopathic urticaria: results from a randomized study (XTEND-CIU). J Allergy Clin Immunol Pract. 2019;7(7):2487–2490.e1. doi: 10.1016/j.jaip.2019.04.020.
   PubMed Web of Science ®Google Scholar
• Kolkhir P, Pogorelov D, Darlenski R, et al. Management of chronic spontaneous urticaria: a worldwide perspective. World Allergy Organ J. 2018;11(1):14. doi: 10.1186/s40413-018-0193-4.
   PubMedGoogle Scholar
• Maurer M, Costa C, Gimenez Arnau A, et al. Antihistamine-resistant chronic spontaneous urticaria remains undertreated: 2-year data from the AWARE study. Clin Exp Allergy. 2020;50(10):1166–1175. doi: 10.1111/cea.13716.
   PubMed Web of Science ®Google Scholar
• Anderson P, Benford M, Harris N, et al. Real-world physician and patient behaviour across countries: disease-specific programmes - a means to understand. Curr Med Res Opin. 2008;24(11):3063–3072. doi: 10.1185/03007990802457040.
   PubMed Web of Science ®Google Scholar
• Babineaux SM, Curtis B, Holbrook T, et al. Evidence for validity of a national physician and patient-reported, cross-sectional survey in China and UK: the Disease Specific Programme. BMJ Open. 2016;6(8):e010352. doi: 10.1136/bmjopen-2015-010352.
   PubMed Web of Science ®Google Scholar
• Higgins V, Piercy J, Roughley A, et al. Trends in medication use in patients with type 2 diabetes mellitus: a long-term view of real-world treatment between 2000 and 2015. Diabetes Metab Syndr Obes. 2016;9:371–380. doi: 10.2147/DMSO.S120101.
   PubMed Web of Science ®Google Scholar
• Anderson P, Higgins V, Courcy J, et al. Real-world evidence generation from patients, their caregivers and physicians supporting clinical, regulatory and guideline decisions: an update on Disease Specific Programmes. Curr Med Res Opin. 2023;39(12):1707–1715. doi: 10.1080/03007995.2023.2279679.
   PubMed Web of Science ®Google Scholar
• United States Department of Health and Human Services. Summary of the HIPAA Privacy Rule. [internet]. 2003 May [cited 2023 July]. Available from: https://www.hhs.gov/hipaa/for-professionals/index.html.
   Google Scholar
• United States Department of Health and Human Services. Health Information Technology for Economic and Clinical Health (HITECH) Act 2009 [internet]. 2009. 2017 Jun [cited 2023 Jul]. Available from: https://www.hhs.gov/hipaa/for-professionals/special-topics/hitech-act-enforcement-interim-final-rule/index.html.
   Google Scholar
• European Pharmaceutical Market Research Association. Code of Conduct. 2023 Sept [cited 2023 Dec]. Available from: https://www.ephmra.org/code-conduct-aer
   Google Scholar
• Giménez-Arnau AM. Omalizumab for treating chronic spontaneous urticaria: an expert review on efficacy and safety. Expert Opin Biol Ther. 2017;17(3):375–385. doi: 10.1080/14712598.2017.1285903.
   PubMed Web of Science ®Google Scholar
• Devlin N, Parkin D, Janssen B. Methods for analysing and reporting EQ-5D data. Cham (Switzerland): Springer Nature; 2020.
   Google Scholar
• Pickard AS, Law EH, Jiang R, et al. United States valuation of EQ-5D-5L health states using an international protocol. Value Health. 2019;22(8):931–941. doi: 10.1016/j.jval.2019.02.009.
   PubMed Web of Science ®Google Scholar
• Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)–a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19(3):210–216. doi: 10.1111/j.1365-2230.1994.tb01167.x.
   PubMed Web of Science ®Google Scholar
• Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993;4(5):353–365. doi: 10.2165/00019053-199304050-00006.
   PubMed Web of Science ®Google Scholar
• Jenkins CD, Stanton BA, Niemcryk SJ, et al. A scale for the estimation of sleep problems in clinical research. J Clin Epidemiol. 1988;41(4):313–321. doi: 10.1016/0895-4356(88)90138-2.
   PubMed Web of Science ®Google Scholar
• Akdas E, Adisen E, Oztas MO, et al. Real-life clinical practice with omalizumab in 134 patients with refractory chronic spontaneous urticaria: a single-center experience. An Bras Dermatol. 2023;98:240–242. doi: 10.1016/j.abd.2022.06.003.
   PubMed Web of Science ®Google Scholar
• Saunders C, Byrne CD, Guthrie B, et al. External validity of randomized controlled trials of glycaemic control and vascular disease: how representative are participants? Diabet Med. 2013;30(3):300–308. doi: 10.1111/dme.12047.
   PubMed Web of Science ®Google Scholar