Health-related quality of life with hereditary angioedema following prophylaxis with subcutaneous C1-inhibitor with recombinant hyaluronidase

Weller, Karsten; Maurer, Marcus; Fridman, Moshe; Supina, Dylan; Schranz, Jennifer; Magerl, Markus

doi:10.2500/aap.2017.38.4025

Cited by 29 publications

(21 citation statements)

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“…A significant improvement in patient-reported healthrelated quality of life was demonstrated in the study. The extent of improvement in quality of life total scores with lanadelumab compared with placebo was similar to that seen with omalizumab compared with placebo for the treatment of chronic spontaneous urticaria in patients with recurrent angioedema 21 and was greater than that seen with subcutaneous C1 inhibitor with recombinant hyaluronidase for prophylaxis, 22 although treatment duration differed in these trials.…”

Section: Discussionmentioning

confidence: 57%

Effect of Lanadelumab Compared With Placebo on Prevention of Hereditary Angioedema Attacks

Banerji

Riedl

Bernstein

et al. 2018

JAMA

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200

188

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IMPORTANCE Current treatments for long-term prophylaxis in hereditary angioedema have limitations. OBJECTIVE To assess the efficacy of lanadelumab, a fully human monoclonal antibody that selectively inhibits active plasma kallikrein, in preventing hereditary angioedema attacks. DESIGN, SETTING, AND PARTICIPANTS Phase 3, randomized, double-blind, parallel-group, placebo-controlled trial conducted at 41 sites in Canada, Europe, Jordan, and the United States. Patients were randomized between March 3, 2016, and September 9, 2016; last day of follow-up was April 13, 2017. Randomization was 2:1 lanadelumab to placebo; patients assigned to lanadelumab were further randomized 1:1:1 to 1 of the 3 dose regimens. Patients 12 years or older with hereditary angioedema type I or II underwent a 4-week run-in period and those with 1 or more hereditary angioedema attacks during run-in were randomized. INTERVENTIONS Twenty-six-week treatment with subcutaneous lanadelumab 150 mg every 4 weeks (n = 28), 300 mg every 4 weeks (n = 29), 300 mg every 2 weeks (n = 27), or placebo (n = 41). All patients received injections every 2 weeks, with those in the every-4-week group receiving placebo in between active treatments. MAIN OUTCOME AND MEASURES Primary efficacy end point was the number of investigator-confirmed attacks of hereditary angioedema over the treatment period. RESULTS Among 125 patients randomized (mean age, 40.7 years [SD, 14.7 years]; 88 females [70.4%]; 113 white [90.4%]), 113 (90.4%) completed the study. During the run-in period, the mean number of hereditary angioedema attacks per month in the placebo group was 4.0; for the lanadelumab groups, 3.2 for the every-4-week 150-mg group; 3.7 for the every-4-week 300-mg group; and 3.5 for the every-2-week 300-mg group. During the treatment period, the mean number of attacks per month for the placebo group was 1.97; for the lanadelumab groups, 0.48 for the every-4-week 150-mg group; 0.53 for the every-4-week 300-mg group; and 0.26 for the every-2week 300-mg group. Compared with placebo, the mean differences in the attack rate per month were −1.

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Section: Discussionmentioning

confidence: 57%

Effect of Lanadelumab Compared With Placebo on Prevention of Hereditary Angioedema Attacks

Banerji

Riedl

Bernstein

et al. 2018

JAMA

Self Cite

200

188

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“…Частота умеренно выраженных аллергических реакций может быть выше, потому что они, вероятно, не всегда описываются в исследованиях [37]. Крапивница и ангионевротический отёк были зарегистрированы менее чем в 0,1 % случаев [38]. При введении высоких доз гиалуронидазы (200 000 ЕД), частота аллергических осложнений возрастала до 31,3 % [39].…”

Section: Reviews обзорыunclassified

“…Немедленные и отсроченные аллергические реакции на гиалуронидазы были описаны как гиперчувствительность типа I (опосредуемая IgE) и типа IV (опосредуемая Т-клетками) [40]. Кроме того, эти ферменты продемонстрировали повышение капиллярной проницаемости, потенциально ухудшающей течение вышеупомянутых реакций [38].…”

Section: Reviews обзорыunclassified

Hyaluronidase in cosmetology: evidence-based medicine review

Elena¹,

Murakov²,

Elena³

et al. 2020

Medical news of the North Caucasus

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Академия постдипломного образования федерального медико-биологического агентства России, москва, Российская Федерация 2 Российский университет дружбы народов, москва, Российская Федерация hYaluronidase in cosmeTologY: eVidence-Based medicine reVieW Vladimirova e. V. 1 , murakov s. V. 1 , sanches e. a. 1 , markova Yu. a. 1 , Bagramova g. e. 2 1 academy of postgraduate education of fmBa russia, moscow, russian federation 2 peoples' friendship university of russia, moscow, russian federation Целью настоящего обзора является анализ современных данных об использовании гиалуронидазы в косметологии с позиции доказательной медицины. Клинические данные свидетельствуют о высокой эффективности применения гиалуронидазы для лечения асимметрии, гиперкоррекции, миграции, визуализации филлера, эффекта Тиндаля, сосудистых осложнений, нарушений зрительной функции и отсроченных нежелательных реакций. Разведение и объём вводимого препарата варьируют в зависимости от конкретного показания, объёма введенного внутридермального имплантата и рекомендаций производителя. Наиболее значимым противопоказанием к использованию препаратов гиалуронидазы в косметологии является наличие гиперчувствительности, поэтому перед первым применением следует проводить тест на чувствительность к препарату. Ключевые слова: гиалуронидаза, косметология, гиалуроновая кислота, филлеры, осложнения, лечение The purpose of the present review was to analyze current data on hyaluronidase application in cosmetology from the standpoint of evidence-based medicine. Clinical evidence suggests a high efficacy of hyaluronidase for the treatment of asymmetry, hypercorrection, migration, filler visualization, Tyndall effect, vascular complications, impaired visual function and delayed reactions. The dilution and volume of the hyaluronidase to be injected varies depending on the specific indication, the volume of the intradermal implant and the manufacturer's recommendations. The most significant contraindication for hyaluronidase preparations in cosmetology is the hypersensitivity, therefore, a drug sensitivity test should be performed before the first use.

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“…Promising data are emerging from trials of additional novel prophylactic therapies, which could help achieve the goal of patients with HAE to lead normal lives and improving quality of life. 8,16,17 With various levels of confidence of patients administering on-demand medication, 18 physicians must continue to manage patients with individualized treatment plans and encourage patients with HAE to treat all attacks, to treat the attack as soon as it is clearly recognized, and to always carry two doses of on-demand treatment. 16 It is reassuring that patients with HAE who receive long-term prophylaxis are largely treated at home and are relatively satisfied with this approach, likely due to the reduced burden of treatment associated with home therapy.…”

mentioning

confidence: 99%

Hereditary angioedema from the patient's perspective: A follow-up patient survey

Banerji

Liu

Busse

et al. 2018

allergy asthma proc

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Health-related quality of life with hereditary angioedema following prophylaxis with subcutaneous C1-inhibitor with recombinant hyaluronidase

Abstract: Despite early termination and prestudy prophylactic intravenous C1-INH use by 43% of the patients, improved AE-QoL scores were observed after ≤16 weeks of subcutaneous C1-INH-rHuPH20 prophylaxis.

Cited by 29 publications

References 0 publications

Effect of Lanadelumab Compared With Placebo on Prevention of Hereditary Angioedema Attacks

Effect of Lanadelumab Compared With Placebo on Prevention of Hereditary Angioedema Attacks

Hyaluronidase in cosmetology: evidence-based medicine review

Hereditary angioedema from the patient's perspective: A follow-up patient survey

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