Optimization of the treatment of patients with severe chronic urticaria

IF 0.2 Q4 MEDICINE, GENERAL & INTERNAL
Ye.M. Dytiatkovska, N.O. Nedohybchenko
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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\". 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引用次数: 0

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.
重型慢性荨麻疹患者的优化治疗
严重慢性荨麻疹(SCU)是一种常见疾病,给数百万人的生活带来负担,降低了他们的生活质量,不仅给卫生保健系统带来了巨大的经济负担,而且直接给患者带来了负担。迄今为止,关于该队列患者中omalizumab的最佳剂量的单一方法尚未确定。工作目的:通过对SCU患者生活质量的评估,结合临床和实验室的动态观察,研究并证明按照方案使用最小剂量150mg的omalizumab每21天肌注3次的有效性和可行性,从而优化该类患者的治疗策略,减轻其治疗费用的经济负担。在一项持续33周的前瞻性单中心研究中,104名诊断为SCU的患者被纳入研究。所有患者均接受一般临床检查,使用SKINDEX-29问卷研究生活质量指标;采用免疫cap法测定治疗开始前1次血清胰蛋白酶水平,采用免疫化学法电化学发光检测治疗结束前后血清总IgE水平。患者被分为两组:1组(54人)在完成一个疗程的第二代组胺h1受体阻滞剂治疗后3 - 6个月内荨麻疹复发,并接受了一个疗程的omalizumab治疗,剂量为150mg,每三周肌肉注射三次。第二组(50人)在上一疗程的第二代组胺h1受体阻滞剂治疗后不早于6个月荨麻疹复发,并接受地氯雷他定治疗,前4周5mg,后4周20mg。在治疗开始前和每次就诊时(奥玛珠单抗治疗第10、31和52天,地氯雷他定开始治疗后5周和9周)测定患者的荨麻疹活性指标(UAS7)和生活质量指标(SKINDEX-29),并在治疗结束后6个月评估UAS7。采用描述性统计和分析性统计的方法对所得数据进行处理。根据我们的数据,SCU患者多为工作年龄人群,超过一半的患者有5年以上的病史,在有效研究的70%的病例中,他们的特征是总IgE含量升高,根据问卷SKINDEX-29在身体症状、情绪领域和功能水平上的指标水平较低。我们发现观察1、2组患者治疗后血清总IgE水平下降有统计学意义。在第1组患者中,指定最小剂量的omalizumab可以确保15%的病例在第一次注射后就已经控制了荨麻疹症状,在第三次注射后,92.3%的患者在6个月的随访中稳定缓解,没有荨麻疹症状,而第2组现有的24%的受试者在根据UAS7治疗后出现了非常严重和严重的症状。根据SKINDEX-29问卷,第2组患者治疗完成后,在开始地氯雷他定治疗9周后,分别有44%的病例和46%的非常严重的荨麻疹对情绪领域和功能的负面影响仍然存在;在46%的病例中,根据对疾病影响的“严重”水平的普遍评估,生活质量较低。同时,在第1组患者中,在观察第52天完成omalizumab治疗后,在任何领域均未记录到严重或非常严重的荨麻疹对生活质量的负面影响。因此,对于在第二代组胺h1受体阻滞剂治疗后3 - 6个月内慢性皮肤病复发的SCU患者,三次给予150 mg、间隔21天的omalizumab治疗的有效性和合理的方便性已经得到证实。
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来源期刊
Medical Perspectives-Medicni Perspektivi
Medical Perspectives-Medicni Perspektivi MEDICINE, GENERAL & INTERNAL-
CiteScore
0.40
自引率
0.00%
发文量
85
审稿时长
9 weeks
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