Место шкал и опросников в оценке тяжести течения и подборе долгосрочной профилактики у пациентов с наследственным ангиоотеком

Манто И.А., Латышева Е.А., Сорокина Л.Е., Латышева Т.В. Место шкал и опросников в оценке тяжести течения и подборе долгосрочной профилактики у пациентов с наследственным ангиоотеком. Терапевтический архив. 2021;93(12):1498–1509. DOI: 10.26442/00403660.2021.12.201294

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Manto IA, Latysheva EA, Sorokina LE, Latysheva TV. The place of scales and questionnaires in assessing the disease’s severity and the long-term prophylaxis’s prescribing in patients with hereditary angioedema. Terapevticheskii Arkhiv (Ter. Arkh.). 2021;93(12):1498–1509. DOI: 10.26442/00403660.2021.12.201294

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Аннотация

Наследственный ангиоотек (АО) – наследственное жизнеугрожающее заболевание, которое проявляется рецидивирующими АО различной силы и локализации. На сегодняшний день не разработаны единые критерии оценки тяжести течения заболевания. Необходимо учитывать много разных факторов: не только частоту рецидивов, но и их продолжительность, силу, влияние на внешний вид пациента, выраженность болевого синдрома; не менее важны влияние заболевания на качество жизни пациента, количество дней нетрудоспособности, удовлетворенность пациента уже назначенным лечением. Кроме того, отсутствуют критерии назначения долгосрочной профилактики и параметров выбора конкретного препарата. Наилучшим решением обоих вопросов представляется внедрение в клиническую практику шкал и опросников, специально разработанных для определения таких показателей, как активность заболевания, контроль заболевания, качество жизни у пациентов с рецидивирующими АО. Получить исчерпывающее представление о тяжести течения заболевания у конкретного пациента возможно при комбинированном применении оценочных инструментов.

Ключевые слова: наследственный ангиоотек, ангиоотек, брадикинин

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Hereditary angioedema is a hereditary life-threatening disease characterized by recurrent angioedema of various strength and localization. To date, definite disease’s severity criteria have not been developed. There are many different factors to consider not only the frequency of episodes, but also their duration, strength, influence on the patient's appearance, the severity of the pain syndrome. Disease related quality of life, the number of work disability days, and the patient's satisfaction with the prescribed treatment are important. In addition, there are no criteria for prescribing long-term prophylaxis, and no parameters for choosing a specific drug. The introduction of specific scales and questionnaires developed to assess such characteristics as disease activity, disease control, quality of life in patients with recurrent angioedema into clinical practice seems to be the best solution for both questions. The comprehensive understanding of the disease’s severity in a particular patient can be carried out with the combined use of assessment tools.

Keywords: hereditary angioedema, angioedema, bradykinin

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Список литературы

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3. Bouillet L, Launay D, Fain O, et al. Hereditary angioedema with C1 inhibitor deficiency: clinical presentation and quality of life of 193 French patients. Ann Allergy Asthma Immunol. 2013;111(4):290-4. DOI:10.1016/j.anai.2013.07.012
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8. Syed YY. Lanadelumab: First Global Approval. Drugs. 2018;78(15):1633-7. DOI:10.1007/s40265-018-0987-2
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DOI:10.1186/s13601-017-0172-9
10. Nicola S, Rolla G, Brussino L. Breakthroughs in hereditary angioedema management: a systematic review of approved drugs and those under research Database and key words (MeSH). Drugs Context. 2019;8:212605. DOI:10.7573/dic.212605
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13. Weller K, Magerl M, Peveling-Oberhag A, et al. The Angioedema Quality of Life Questionnaire (AE-QoL) – assessment of sensitivity to change and minimal clinically important difference. Allergy. 2016;71(8):1203-9. DOI:10.1111/all.12900
14. Weller K, Groffik A, Magerl M, et al. Development, validation, and initial results of the Angioedema Activity Score. Allergy. 2013;68(9):1185-92. DOI:10.1111/all.12209
15. Forjaz MJ, Ayala A, Caminoa M, et al. HAE-AS, a specific disease activity scale for hereditary angioedema with C1-inhibitor deficiency. J Investig Allergol Clin Immunol. 2021;31(3):246-52. DOI:10.18176/jiaci.0479
16. Weller K, Donoso T, Magerl M, et al. Validation of the Angioedema Control Test (AECT) – A Patient-Reported Outcome Instrument for Assessing Angioedema Control. J Allergy Clin Immunol Pract. 2020;8(6):2050-7.e4. DOI:10.1016/j.jaip.2020.02.038
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19. Buttgereit T, Vera C, Weller K, et al. Lanadelumab Efficacy, Safety, and Injection Interval Extension in HAE: A Real-Life Study. J Allergy Clin Immunol Pract. 2021;9(10):3744-51. DOI:10.1016/j.jaip.2021.04.072
20. McMillan CV, Speight J, Relan A, et al. Content Validity of Visual Analog Scales to Assess Symptom Severity of Acute Angioedema Attacks in Adults with Hereditary Angioedema. Patient. 2012;5(2):113-26. DOI:10.2165/11597490-000000000-00000
21. Lumry WR, Castaldo AJ, Vernon MK, et al. The humanistic burden of hereditary angioedema: Impact on health-related quality of life, productivity, and depression. Allergy Asthma Proc. 2010;31(5):407-14. DOI:10.2500/aap.2010.31.3394
22. Aabom A, Andersen K, Perez-Fernández E, et al. Health-related Quality of Life in Danish Patients with Hereditary Angioedema. Acta Derm Venereol. 2015;95(2):225-6. DOI:10.2340/00015555-1835
23. Lumry WR, Miller DP, Newcomer S, et al. Quality of life in patients with hereditary angioedema receiving therapy for routine prevention of attacks. Allergy Asthma Proc. 2014;35(5):371-6. DOI:10.2500/aap.2014.35.3783
24. Sánchez MD, Cuervo J, Rave D, et al. Hereditary angioedema in Medellín (Colombia): Clinical evaluation and quality of life appraisal. Biomedica. 2015;35(3):419-28. DOI:10.7705/biomedica.v35i3.2417
25. Weller K, Groffik A, Magerl M, et al. Development and construct validation of the angioedema quality of life questionnaire. Allergy. 2012;67(10):1289-98. DOI:10.1111/all.12007
26. Kulthanan K, Chularojanamontri L, Rujitharanawong C, et al. Angioedema quality of life questionnaire (AE-QoL) – interpretability and sensitivity to change. Health Qual Life Outcomes. 2019;17(1):160. DOI:10.1186/s12955-019-1229-3
27. Morioke S, Takahagi S, Kawano R, et al. A validation study of the Japanese version of the Angioedema Activity Score (AAS) and the Angioedema Quality of Life Questionnaire (AE-QoL). Allergol Int. 2021;70(4):471-9. DOI:10.1016/j.alit.2021.04.006
28. Kulthanan K, Chularojanamontri L, Rujitharanawong C, et al. Angioedema Activity Score (AAS): A Valid and Reliable Tool to Use in Asian Patients. BioMed Research Int. 2019;2019:9157895. DOI:10.1155/2019/9157895
29. Weller K, Donoso T, Magerl M, et al. Development of the Angioedema Control Test – A patient‐reported outcome measure that assesses disease control in patients with recurrent angioedema. Allergy. 2020;75(5):1165-77. DOI:10.1111/all.14144
30. Agostoni A, Aygoren-Pursun E, Binkley KE, et al. Hereditary and acquired angioedema: problems and progress: proceedings of the third C1 esterase inhibitor deficiency workshop and beyond. J Allergy Clin Immunol. 2004;114(3 Suppl.):S51-131. DOI:10.1016/j.jaci.2004.06.047
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32. Bafunno V, Bova M, Loffredo S, et al. Mutational spectrum of the C1 inhibitor gene in a cohort of italian patients with hereditary angioedema: Description of nine novel mutations. Ann Hum Genet. 2014;78(2):73-82. DOI:10.1111/ahg.12052
33. Andrejević SS, Korošec P, Šilar M, et al. Hereditary Angioedema Due to C1 Inhibitor Deficiency in Serbia: Two Novel Mutations and Evidence of Genotype-Phenotype Association. PLoS One. 2015;10(11):e0142174. DOI:10.1371/journal.pone.0142174
34. Кузьменко Н.В., Викторова Е.А., Павлова А.В., и др. Характеристика молекулярно-генетических дефектов и клинических особенностей в группе пациентов с наследственным ангионевротическим отеком 1-го и 2-го типов. Вопросы гематологии/онкологии и иммунопатологии в педиатрии. 2017;16(4):35-42 [Kuzmenko NB, Viktorova EA, Pavlova AV, et al. Genetic and clinical characteristics of a group of patients with hereditary angioedema type 1 and 2. Pediatric Hematology/Oncology and Immunopathology. 2017;16(4):35-42 (in Russian)]. DOI:10.24287/1726-1708-2017-16-4-35-42
35. Maia LSM, Moreno AS, Ferriani MPL, et al. Genotype-phenotype correlations in Brazilian patients with hereditary angioedema due to C1 inhibitor deficiency. Allergy. 2019;74(5):1013-6. DOI:10.1111/all.13699
36. Prior N, Remor E, Gómez-Traseira C, et al. Development of a disease-specific quality of life questionnaire for adult patients with hereditary angioedema due to C1 inhibitor deficiency (HAE-QoL): Spanish multi-centre research project. Health Qual Life Outcomes. 2012;10:82. DOI:10.1186/1477-7525-10-82
37. Zuberbier T, Abdul Latiff AH, Abuzakouk M, et al. The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2021. DOI:10.1111/all.15090
38. Moxie GmbH. Our products. Commercial use. Accessed November 5, 2021. Available at: https://moxie-gmbh.de/our-products/commercial-use. Accessed: 25.10.2021

________________________________________________

1. Bliznec EA, Viktorova EA, Vishneva EA, et al. Hereditary angioedema. Clinical guidelines (D84.1). Russian Journal of Allergy. 2021;18(2):77-114 (in Russian). DOI:10.36691/RJA1447
2. Maurer M, Magerl M, Ansotegui I, et al. The international WAO/EAACI guideline for the management of hereditary angioedema-The 2017 revision and update. Allergy. 2018;73(8):1575-96. DOI:10.1111/all.13384
3. Bouillet L, Launay D, Fain O, et al. Hereditary angioedema with C1 inhibitor deficiency: clinical presentation and quality of life of 193 French patients. Ann Allergy Asthma Immunol. 2013;111(4):290-4. DOI:10.1016/j.anai.2013.07.012
4. Bowen T, Cicardi M, Farkas H, et al. Canadian 2003 International Consensus Algorithm For the Diagnosis, Therapy, and Management of Hereditary Angioedema. J Allergy Clin Immunol. 2004;114(3):629-37. DOI:10.1016/j.jaci.2004.06.043
5. Busse PJ, Christiansen SC, Riedl MA, et al. US HAEA Medical Advisory Board 2020 Guidelines for the Management of Hereditary Angioedema. J Allergy Clin Immunol Pract. 2021;9(1):132-150.e3. DOI:10.1016/j.jaip.2020.08.046
6. Aygören-Pürsün E, Magerl M, Maetzel A, Maurer M. Epidemiology of Bradykinin-mediated angioedema : a systematic investigation of epidemiological studies. Orphanet J Rare Dis. 2018;13:73. DOI:10.1186/s13023-018-0815-5
7. Craig T, Busse P, Gower RG, et al. Long-term prophylaxis therapy in patients with hereditary angioedema with C1 inhibitor deficiency. Ann Allergy Asthma Immunol. 2018;121(6):673-9. DOI:10.1016/j.anai.2018.07.025
8. Syed YY. Lanadelumab: First Global Approval. Drugs. 2018;78(15):1633-7. DOI:10.1007/s40265-018-0987-2
9. Riedl MA, Bernstein JA, Craig T, et al. An open-label study to evaluate the long-term safety and efficacy of lanadelumab for prevention of attacks in hereditary angioedema: design of the HELP study extension. Clin Transl Allergy. 2017;7:36.
DOI:10.1186/s13601-017-0172-9
10. Nicola S, Rolla G, Brussino L. Breakthroughs in hereditary angioedema management: a systematic review of approved drugs and those under research Database and key words (MeSH). Drugs Context. 2019;8:212605. DOI:10.7573/dic.212605
11. Riedl MA, Banerji A, Gower R. Current medical management of hereditary angioedema. Ann Allergy Asthma Immunol. 2021;126(3):264-72.
DOI:10.1016/j.anai.2020.10.009
12. Bodnja OS, Demina DV, Kuz'menko NB, et al. Long-term prophylaxis therapy in patients with hereditary angioedema in Russia: resolution of the expert Council. Russian Journal of Allergy. 2021;18(3):126-30 (in Russian). DOI:10.36691/RJA1485
13. Weller K, Magerl M, Peveling-Oberhag A, et al. The Angioedema Quality of Life Questionnaire (AE-QoL) – assessment of sensitivity to change and minimal clinically important difference. Allergy. 2016;71(8):1203-9. DOI:10.1111/all.12900
14. Weller K, Groffik A, Magerl M, et al. Development, validation, and initial results of the Angioedema Activity Score. Allergy. 2013;68(9):1185-92. DOI:10.1111/all.12209
15. Forjaz MJ, Ayala A, Caminoa M, et al. HAE-AS, a specific disease activity scale for hereditary angioedema with C1-inhibitor deficiency. J Investig Allergol Clin Immunol. 2021;31(3):246-52. DOI:10.18176/jiaci.0479
16. Weller K, Donoso T, Magerl M, et al. Validation of the Angioedema Control Test (AECT) – A Patient-Reported Outcome Instrument for Assessing Angioedema Control. J Allergy Clin Immunol Pract. 2020;8(6):2050-7.e4. DOI:10.1016/j.jaip.2020.02.038
17. Bork K, Anderson JT, Caballero T, et al. Assessment and management of disease burden and quality of life in patients with hereditary angioedema: a consensus report. Allergy Asthma Clin Immunol. 2021;17(1):40. Published 2021 Apr 19. DOI: 10.1186/s13223-021-00537-2
18. Bygum A, Busse P, Caballero T, Maurer M. Disease severity, activity, impact, and control and how to assess them in patients with hereditary angioedema. Front Med (Lausanne). 2017;4:212. DOI:10.3389/fmed.2017.00212
19. Buttgereit T, Vera C, Weller K, et al. Lanadelumab Efficacy, Safety, and Injection Interval Extension in HAE: A Real-Life Study. J Allergy Clin Immunol Pract. 2021;9(10):3744-51. DOI:10.1016/j.jaip.2021.04.072
20. McMillan CV, Speight J, Relan A, et al. Content Validity of Visual Analog Scales to Assess Symptom Severity of Acute Angioedema Attacks in Adults with Hereditary Angioedema. Patient. 2012;5(2):113-26. DOI:10.2165/11597490-000000000-00000
21. Lumry WR, Castaldo AJ, Vernon MK, et al. The humanistic burden of hereditary angioedema: Impact on health-related quality of life, productivity, and depression. Allergy Asthma Proc. 2010;31(5):407-14. DOI:10.2500/aap.2010.31.3394
22. Aabom A, Andersen K, Perez-Fernández E, et al. Health-related Quality of Life in Danish Patients with Hereditary Angioedema. Acta Derm Venereol. 2015;95(2):225-6. DOI:10.2340/00015555-1835
23. Lumry WR, Miller DP, Newcomer S, et al. Quality of life in patients with hereditary angioedema receiving therapy for routine prevention of attacks. Allergy Asthma Proc. 2014;35(5):371-6. DOI:10.2500/aap.2014.35.3783
24. Sánchez MD, Cuervo J, Rave D, et al. Hereditary angioedema in Medellín (Colombia): Clinical evaluation and quality of life appraisal. Biomedica. 2015;35(3):419-28. DOI:10.7705/biomedica.v35i3.2417
25. Weller K, Groffik A, Magerl M, et al. Development and construct validation of the angioedema quality of life questionnaire. Allergy. 2012;67(10):1289-98. DOI:10.1111/all.12007
26. Kulthanan K, Chularojanamontri L, Rujitharanawong C, et al. Angioedema quality of life questionnaire (AE-QoL) – interpretability and sensitivity to change. Health Qual Life Outcomes. 2019;17(1):160. DOI:10.1186/s12955-019-1229-3
27. Morioke S, Takahagi S, Kawano R, et al. A validation study of the Japanese version of the Angioedema Activity Score (AAS) and the Angioedema Quality of Life Questionnaire (AE-QoL). Allergol Int. 2021;70(4):471-9. DOI:10.1016/j.alit.2021.04.006
28. Kulthanan K, Chularojanamontri L, Rujitharanawong C, et al. Angioedema Activity Score (AAS): A Valid and Reliable Tool to Use in Asian Patients. BioMed Research Int. 2019;2019:9157895. DOI:10.1155/2019/9157895
29. Weller K, Donoso T, Magerl M, et al. Development of the Angioedema Control Test – A patient‐reported outcome measure that assesses disease control in patients with recurrent angioedema. Allergy. 2020;75(5):1165-77. DOI:10.1111/all.14144
30. Agostoni A, Aygoren-Pursun E, Binkley KE, et al. Hereditary and acquired angioedema: problems and progress: proceedings of the third C1 esterase inhibitor deficiency workshop and beyond. J Allergy Clin Immunol. 2004;114(3 Suppl.):S51-131. DOI:10.1016/j.jaci.2004.06.047
31. Bygum A, Fagerberg CR, Ponard D, et al. Mutational spectrum and phenotypes in Danish families with hereditary angioedema because of C1 inhibitor deficiency. Allergy. 2011;66(1):76-84. DOI:10.1111/j.1398-9995.2010.02456.x
32. Bafunno V, Bova M, Loffredo S, et al. Mutational spectrum of the C1 inhibitor gene in a cohort of italian patients with hereditary angioedema: Description of nine novel mutations. Ann Hum Genet. 2014;78(2):73-82. DOI:10.1111/ahg.12052
33. Andrejević SS, Korošec P, Šilar M, et al. Hereditary Angioedema Due to C1 Inhibitor Deficiency in Serbia: Two Novel Mutations and Evidence of Genotype-Phenotype Association. PLoS One. 2015;10(11):e0142174. DOI:10.1371/journal.pone.0142174
34. Kuzmenko NB, Viktorova EA, Pavlova AV, et al. Genetic and clinical characteristics of a group of patients with hereditary angioedema type 1 and 2. Pediatric Hematology/Oncology and Immunopathology. 2017;16(4):35-42 (in Russian). DOI:10.24287/1726-1708-2017-16-4-35-42
35. Maia LSM, Moreno AS, Ferriani MPL, et al. Genotype-phenotype correlations in Brazilian patients with hereditary angioedema due to C1 inhibitor deficiency. Allergy. 2019;74(5):1013-6. DOI:10.1111/all.13699
36. Prior N, Remor E, Gómez-Traseira C, et al. Development of a disease-specific quality of life questionnaire for adult patients with hereditary angioedema due to C1 inhibitor deficiency (HAE-QoL): Spanish multi-centre research project. Health Qual Life Outcomes. 2012;10:82. DOI:10.1186/1477-7525-10-82
37. Zuberbier T, Abdul Latiff AH, Abuzakouk M, et al. The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2021. DOI:10.1111/all.15090
38. Moxie GmbH. Our products. Commercial use. Accessed November 5, 2021. Available at: https://moxie-gmbh.de/our-products/commercial-use. Accessed: 25.10.2021

Авторы

И.А. Манто*1, Е.А. Латышева1,2, Л.Е. Сорокина1,3, Т.В. Латышева1,4

1 ФГБУ «Государственный научный центр “Институт иммунологии”» ФМБА России, Москва, Россия;
2 ФГАОУ ВО «Российский национальный исследовательский медицинский университет им. Н.И. Пирогова» Минздрава России, Москва, Россия;
3 ФГАОУ ВО «Крымский федеральный университет им. В.И. Вернадского», Симферополь, Россия;
4 ФГБОУ ВО «Московский государственный медико-стоматологический университет им. А.И. Евдокимова» Минздрава России, Москва, Россия
*irina.manto@yandex.ru

________________________________________________

Irina A. Manto*1, Elena A. Latysheva1,2, Leya E. Sorokina1,3, Tatiana V. Latysheva1,4

1 State Research Center – Institute of Immunology, Moscow, Russia;
2 Pirogov Russian National Research Medical University, Moscow, Russia;
3 Vernadsky Crimean Federal University, Simferopol, Russia;
4 Yevdokimov Moscow State University of Medicine and Dentistry, Moscow, Russia
*irina.manto@yandex.ru

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