Optimization of the treatment of patients with severe chronic urticaria
DOI:
https://doi.org/10.26641/2307-0404.2023.3.288930Ключові слова:
urticaria, chronic forms of dermatosis, quality of life, rash, itching, immunoglobulin E, monoclonal antibodies, antihistamines, serum tryptaseАнотація
Severe chronic urticaria (SCU) is a common disease that burdens the lives of millions of people, reduces their quality of life, and imposes a significant economic burden not only on the health care system, but also directly on the patient. To date, a single approach regarding the optimal dosing of omalizumab in this cohort of patients has not been determined. The purpose of the work: based on the assessment of the quality of life of patients with SCU and dynamic clinical and laboratory observation, to study the effectiveness and prove the feasibility of using the minimum dose of 150 mg for omalizumab according to the scheme every 21 days intramuscularly three times, which will allow to optimize the treatment tactics of these patients and reduce the economic burden of the cost of their treatment. In a prospective single-center study lasting 33 weeks, 104 patients with a diagnosis of SCU were included. All patients underwent a general clinical examination, quality of life indicators using the SKINDEX-29 questionnaire were studied; blood tryptase level once before the start of treatment using ImmunoCAP was determined, the level of total IgE in blood serum using an immunochemical method with electrochemiluminescence detection before and after the end of treatment was determined. The patients were divided into two groups: Group 1 (54 people) had a relapse of urticaria within 3 to 6 months after completing a course of second-generation histamine H1-receptor blockers and received a course of omalizumab at a dose of 150 mg intramuscularly every three weeks three times. Group 2 (50 people) had a relapse of urticaria no earlier than 6 months after the previous course of second-generation histamine H1-receptor blockers and received desloratadine, 5 mg during the first four weeks and 20 mg during the next four weeks. Indicators of urticaria activity (UAS7) and quality of life (SKINDEX-29) in patients were determined before the start of treatment and at each of the visits (on the 10th, 31st and 52nd days of therapy when treated with omalizumab and five and nine weeks after initiation of desloratadine therapy), and UAS7 was assessed six months after the end of treatment. Methods of descriptive and analytical statistics were used to process the obtained data. According to our data, patients with SCU are mostly people of working age, more than half of whom have a history of the disease for five years or more, in 70% of cases of a valid study, they are characterized by an increased content of total IgE and have a low level of indicators according to the questionnaire SKINDEX-29 at the level of physical symptoms, emotional sphere and functioning. We found that in patients of observation Groups 1 and 2, after the treatment, the level of total IgE in blood serum decreased statistically significantly. In patients of Group 1, the appointment of omalizumab in the minimum dose made it possible to ensure the control of urticaria symptoms already after the first injection in 15% of cases, and after the third injection there was a stable remission with the absence of urticaria symptoms during six months of follow-up in 92.3% of patients, against the existing 24% of subjects of Group 2, who after therapy according to UAS7 had very severe and severe symptoms. After the completion of treatment in patients of Group 2, nine weeks after the initiation of desloratadine therapy according to the SKINDEX-29 questionnaire, 44% of cases and 46% of very severe negative effects of urticaria on the emotional sphere and functioning remained, respectively; and in 46% of cases there was a low quality of life according to the generalized assessment of the impact of the disease at the level of "severe". At the same time, among the patients of Group 1, after completion of omalizumab therapy on the 52nd day of observation, no case of severe or very severe negative impact of urticaria on the quality of life was registered in any of the domains. Thus, the effectiveness and justified expediency of prescribing omalizumab treatment of 150 mg with an interval of 21 days three times in patients with SCU, who have a recurrence of chronic dermatosis within 3 to 6 months after the second-generation histamine H1-receptor blocker therapy has been confirmed.
Посилання
Zuberbier T, Abdul Latiff AH, Abuzakouk M, Aquilina S, Asero R, Baker D, et al. The international EAACI/GA2LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2022;77(3):734-66. doi: https://doi.org/10.1111/all.15090
Denysenko OI. [Modern approaches to the treat-ment of chronic spontaneous urticaria in adult patients]. Ukrainskyi zhurnal dermatolohii, venerolohii, kosmeto-lohii. 2020;2:34-40. Ukrainian. doi: https://doi.org/10.30978/UJDVK2020-2-34
Kolkhir P, Giménez-Arnau AM, Kulthanan K, Peter J, Metz M, Maurer M. Urticaria. Nat Rev Dis Primers. 2022;8(1):1-22. doi: https://doi.org/10.1038/s41572-022-00389-z
Schoepke N, Asero R, Ellrich A, et al. Biomarkers and clinical characteristics of autoimmune chronic spon-taneous urticaria: Results of the PURIST Study. Allergy. 2019;74:2427-36. doi: https://doi.org/10.1111/all.13949
Gonçalo M, Gimenéz-Arnau A, Al-Ahmad M, Ben-Shoshan M, Bernstein JA, Ensina LF, et al. The global burden of chronic urticaria for the patient and society. Br J Dermatol. 2021;184(2):226-36. doi: https://doi.org/10.1111/bjd.19561
Maurer M, Staubach P, Raap U, Richter-Huhn G, Bauer A, Ruëff F, et al. H1-antihistamine-refractory chro-nic spontaneous urticaria: it's worse than we thought – first results of the multicenter real-life AWARE study. Clin Exp Allergy. 2017;47(5):684-92. doi: https://doi.org/10.1111/cea.12900
Tharp MD, Bernstein JA, Kavati A, Ortiz B, MacDonald K, Denhaerynck K, et al. Benefits and Harms of Omalizumab Treatment in Adolescent and Adult Patients With Chronic Idiopathic (Spontaneous) Urticaria: A Meta-analysis of "Real-world" Evidence. JAMA Dermatol. 2019;155(1):29-38. doi: https://doi.org/10.1001/jamadermatol.2018.3447
Curto-Barredo L, Spertino J, Figueras-Nart I, Ex-pósito-Serrano V, Guilabert A, Melé-Ninot G, et al. Oma-lizumab updosing allows disease activity control in patients with refractory chronic spontaneous urticaria. Br J Dermatol. 2018;179(1):210-2. doi: https://doi.org/10.1111/bjd.16379
Metz M, Vadasz Z, Kocatürk E, Giménez-Arnau AM. Omalizumab Updosing in Chronic Spontaneous Urticaria: an Overview of Real-World Evidence. Clin Rev Allergy Immunol. 2020;59(1):38-45. doi: https://doi.org/10.1007/s12016-020-08794-6
Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report. Allergy. 2011;66(3):317-30. doi: https://doi.org/10.1111/j.1398-9995.2010.02496.x
Lacour JP, Khemis A, Giordano-Labadie F, et al. The burden of chronic spontaneous urticaria: unsatis-factory treatment and healthcare resource utilization in France (the ASSURE-CSU study). Eur J Dermatol. 2018;28(6):795-802. doi: https://doi.org/10.1684/ejd.2018.3446
Hawro T, Ohanyan T, Schoepke N, et al. The Urticaria Activity Score-Validity, Reliability, and Respon-siveness. J Allergy Clin Immunol Pract. 2018;6(4):1185-90.e1. doi: https://doi.org/10.1016/j.jaip.2017.10.001
Botto N, Raffi J, Trivedi M, Ramirez F, Allen IE, Chren MM. Validating a Quality-of-Life Instrument for Allergic Contact Dermatitis. Dermatitis. 2019;30(5):300-5. doi: https://doi.org/10.1097/DER.0000000000000515
Immunoglobulin E (IgE), Individual Quant [Internet]. [cited 2023 Apr 02]. Available from: https://www.healthcare.uiowa.edu/path_handbook/rhandbook/test1094.html
Pagano M, Gauvreau K, Mattie H. Principles of Biostatistics. CRC Press; 2022. 735 p.
Agache I, Rocha C, Pereira A, et al. Efficacy and safety of treatment with omalizumab for chronic spontaneous urticaria: A systematic review for the EAACI Biologicals Guidelines. Allergy. 2021;76:59-70. doi: https://doi.org/10.1111/all.14547
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