P158 Long-Term Safety of Lanadelumab in Hereditary Angioedema (Hae): Interim Results From the Help Ole Study

Johnston, D.; Banerji, Aleena; Nurse, Christina; Lü, Peng; Aygören‐Pürsün, Emel; Kiani‐Alikhan, Sorena; Soteres, D.; Lugar, Patricia L.; Zuraw, Bruce L.; Lockey, R.F.; Schwartz, Lora

doi:10.1016/j.anai.2019.08.262

Cited by 3 publications

(3 citation statements)

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“…As previously shown in the HELP [ 12 ] and HELP OLE studies [ 24 ], lanadelumab was generally well tolerated; no new safety signals were found. Most patients were satisfied with the ease of self-administering lanadelumab injections, reflected by high overall satisfaction ratings at months 1 and 6.…”

Section: Discussionsupporting

confidence: 65%

Long-term prophylaxis with lanadelumab for HAE: authorization for temporary use in France

Fain

Du-Thanh

Gobert

et al. 2022

Allergy Asthma Clin Immunol

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Background Hereditary angioedema (HAE) is associated with a heavy burden of illness. Objective To evaluate use of lanadelumab in a French Authorization for Temporary Use (ATU) program. Methods ATU requests were made between October 12, 2018, and March 13, 2019; patients were followed through September 23, 2019. At entry, patients received lanadelumab 300 mg every 2 weeks. HAE attack characteristics were evaluated at day (D) 0 and months (M) 3 and 6. Patients completed the Angioedema Quality of Life (AE-QoL) questionnaire at initiation and monthly and the Angioedema Activity Score questionnaire daily in 28 day cycles (AAS28). Results In total, 77 patients received ≥ 1 lanadelumab dose; 69 had ≥ 1 quarterly follow-up visit (analyzed population). Mean (standard deviation [SD]) lanadelumab exposure was 240.4 (53.7) days. Lanadelumab dose was modified in 12 patients (mostly to every 4 weeks). For the analyzed population, compared with attacks/month (mean [SD]) within 6 months before ATU (2.68 [2.54]), fewer attacks occurred between initiation and first visit (0.16 [0.42]; P < 0.001) or last visit (0.16 [0.42]; P < 0.001); D15 and last visit (0.15 [0.41]); and D70 and last visit (0.17 [0.70]). AE-QoL total and domain scores were significantly higher at initiation versus M3 and M6; 55% and 65% of patients, respectively, achieved a minimal clinically important difference from D0 to M3 and D0 to M6. Proportion of patients with AAS28 of 0 was higher during M3 (90%) and M6 (83%) than initiation (59%). The most frequently reported adverse events included headache (7.3%) and injection site pain (6.3%). Conclusions Lanadelumab reduced attack rates, improved quality of life, and was generally well tolerated.

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Section: Discussionsupporting

confidence: 65%

Long-term prophylaxis with lanadelumab for HAE: authorization for temporary use in France

Fain

Du-Thanh

Gobert

et al. 2022

Allergy Asthma Clin Immunol

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“…The long-term safety of lanadelumab was studied in the HELP study and in an open-label phase [93,94].…”

Section: Lanadelumabmentioning

confidence: 99%

Treatment of Hereditary Angioedema

Caballero

2021

J Investig Allergol Clin Immunol

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Hereditary angioedema due to C1-esterase inhibitor deficiency (C1-INH-HAE) is a rare autosomal dominant disease. In the last decade, new drugs and new indications for old drugs have played a role in the management of C1-INH-HAE. This review examines current therapy for C1-INH-HAE and provides a brief summary of drugs that are under development. Increased knowledge of the pathophysiology of C1-INH-HAE has been crucial for advances in the field, with inhibition of the kallikrein-kinin system (plasma kallikrein, activated factor XII) as a key area in the discovery of new drugs, some of which are already marketed for treatment of C1-INH-HAE. Pharmacological treatment is based on 3 pillars: treatment of acute angioedema attacks (on-demand treatment), short-term (preprocedure) prophylaxis, and long-term prophylaxis. The 4 drugs that are currently available for the treatment of acute angioedema attacks (purified plasma-derived human C1 esterase inhibitor concentrate, icatibant acetate, ecallantide, recombinant human C1 esterase inhibitor) are all authorized for self-administration, except ecallantide. Purified plasma-derived human C1 esterase inhibitor concentrate is the treatment of choice for short-term prophylaxis. Tranexamic acid, danazol, intravenous and subcutaneous nanofiltered purified plasma-derived human C1 esterase inhibitor concentrate, and lanadelumab can be used for long-term prophylaxis. New drugs are being investigated, mainly as long-term prophylaxis, and are aimed at blocking the kallikrein-kinin system by means of antiprekallikrein, antikallikrein, and anti–activated FXII action.

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“…The study showed that compared to placebo, lanadelumab significantly reduced attack frequency/ severity and improved QoL over a 26 week treatment period [12]. The HELP study open-label extension (OLE) has since shown sustained reduction in attack frequency and a good drug safety profile [13]. Lanadelumab is now approved in Canada for use as LTP for HAE 1/2 in patients ≥ 12 years of age.…”

Section: Open Accessmentioning

confidence: 99%

Impact of lanadelumab in hereditary angioedema: a case series of 12 patients in Canada

Iaboni

Kanani

Lacuesta

et al. 2021

Allergy Asthma Clin Immunol

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Background Hereditary angioedema (HAE) is a rare autosomal dominant disease resulting in recurring episodes of swelling, leading to considerable patient morbidity and mortality. Lanadelumab is a plasma kallikrein inhibitor that is approved as 1st line therapy in Canada for long term prophylaxis of HAE attacks. Objective To describe our clinical findings from a case series of adult patients with HAE type 1/2 who have been initiated on lanadelumab. Methods A chart review of HAE type 1/2 patients at three academic centers in Canada was undertaken with demographic and clinical data extracted. Patients were included if they had been receiving lanadelumab for at least 6 months. Patients with other causes of angioedema were excluded. Results 12 patients meeting enrollment criteria were identified. Compared to pre-lanadelumab, patients had mean reductions of 72% and 62% in attack rate and treated attack rate respectively. 3 patients reported complete remission from attacks after starting lanadelumab. Most patients had significant improvements in HAE impact on social outings. Conclusion Our case series findings support the 2019 International/Canadian HAE guideline that lanadelumab is an effective therapy for long term prophylaxis. In our patient population, initiation of lanadelumab improved disease control, minimized the burden of treatment and improved HAE impact on social outings.

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P158 Long-Term Safety of Lanadelumab in Hereditary Angioedema (Hae): Interim Results From the Help Ole Study

Cited by 3 publications

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Long-term prophylaxis with lanadelumab for HAE: authorization for temporary use in France

Long-term prophylaxis with lanadelumab for HAE: authorization for temporary use in France

Treatment of Hereditary Angioedema

Impact of lanadelumab in hereditary angioedema: a case series of 12 patients in Canada

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