Abstract

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.

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