| This is a promotional email for UK Healthcare Professionals, sent on behalf of Takeda UK Limited.
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Prescribing Information and Adverse Event reporting can be found at the bottom of this email.
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| TAKHZYRO®▼ (lanadelumab) is indicated for routine prevention of recurrent attacks of hereditary angioedema in patients aged 12 years and older.1 |
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| Meet Jesse, a 39-year-old office administrator struggling with hereditary angioedema (HAE). |
| The following patient case is fictitious and designed to represent the types of patients who may benefit from TAKHZYRO. |
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Jesse has been using androgen derivatives as long-term prophylaxis for 15 years,*
but still has breakthrough attacks that significantly impact his life and lead to
frequent A&E visits. Jesse’s treatment regime means multiple prescriptions of
different medications, including icatibant and C1-INH for treating acute attacks.
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| *Androgens are not licensed for use in treating hereditary angioedema.
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| Jesse feels burdened by the number of different medications he is on, and the number of injections he needs every month.
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“I’m fed up of taking all these different medications for my hereditary angioedema and still getting attacks.
I just want one medication that could control my condition without the daily reminders and numerous different pills and injections*”
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| *Individual responses to treatment may vary. Patients are advised to carry treatment for acute HAE attacks at all times.
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HOW ARE YOU MANAGING PATIENTS LIKE
JESSE IN YOUR HAE CLINIC?
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| You can find out more by speaking with a TAKEDA UK Ltd representative
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| Please select YES if you would like a Takeda UK Ltd representative to get in touch. |
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| (by selecting YES you are confirming that you are happy for your contact details to be shared by Data4NHS with Takeda UK Limited solely to fulfil this request and to be retained for no longer than necessary for this purpose).
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| AIM FOR ZERO ATTACKS WITH TAKHZYRO
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| TAKHZYRO is a single effective medication clinically proven to significantly reduce attacks, with many patients achieving prolonged periods of ZERO attacks.1-3
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Aim for ZERO attacks
In a Phase 3, double-blind study of 125 patients with HAE (HELP-03*), TAKHZYRO demonstrated an 87% reduction in attacks [0.26 attacks/4 weeks 300 mg Q2W (n=27) vs 1.97 attacks/4 weeks with placebo (n=41†); p<0.001) primary endpoint].‡2
The HELP OLE study was a Phase 3 open-label extension to the HELP-03 study, consisting of patients who completed the randomised, double-blind study (rollovers) and additional patients who were not part of the HELP-03 study (non-rollovers).§‖3
Attacks requiring acute treatment were equivalent to 1 every ~20 weeks¶ with TAKHZYRO in rollover patientsII** vs 1 every 9.2 days at baseline (calculated from mean 4-weekly attack rates of 0.20 and 3.04, respectively; n=106) (secondary endpoint).3
High-morbidity attacks†† equivalent to 1 every ~2.6 years‡‡ with TAKHZYRO in rollover patientsII** vs 1 every 8.3 weeks at baseline (calculated from mean 4-weekly attack rates of 0.03 and 0.48, respectively; n=106) (secondary endpoint).3
81.8% (n=212) of patients were attack free for ≥6 months, with 97.7% mean percentage of attack-free days during treatment (exploratory endpoint).‖‖3
68.9% of patients experienced ZERO attacks during 12 months of treatment (n=144/209 [exploratory analysis]).‖3
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Improved patient QoL
TAKHZYRO can improve patient QoL, with a clinically meaningful improvement in AE-QoL in both HELP-03 and HELP OLE.1-3
- HELP-03: The mean change in AE-QoL total score from baseline for TAKHZYRO 300 mg Q2W was -20 vs -5 with placebo.¶¶1,2
- HELP OLE: The mean change in AE-QoL total score from baseline was -10.2 and -19.5 for rollovers and nonrollovers, respectively.3
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Dosing and administration
TAKHZYRO is a subcutaneous injection which can be self-administered using a pre-filled syringe (recommended starting dose 300 mg Q2W).1 A dosing interval of 300 mg Q4W is also effective and may be considered if the patient is stably attack free with Q2W, especially in patients with a low weight.1
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Generally acceptable tolerability profile
The most common ARs with TAKHZYRO were injection-site reactions, of which 90% resolved within 1 day, with a median duration of 6 minutes.1 Other common adverse reactions were hypersensitivity, dizziness, rash maculo-palpular, myalgia, Alanine aminotransferase increased and Aspartate aminotransferase increased.1
In the HELP OLE study, the tolerability profile was consistent with HELP-03. Injection site reactions were the most frequently reported TEAE, the majority of which were mild and resolved within one day (primary endpoint).3
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| HEAR FROM OTHER HEALTHCARE PROFESSIONALS CARING FOR PATIENTS LIKE JESSE, AIMING FOR ZERO
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| Organised and funded by Takeda, HAE Exchange brings together Immunologists, Nurse Specialists and other experts to share best practice and discuss the latest research in HAE.
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| On the HAE Exchange website you’ll find useful resources such as:
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Expert-led videos discussing real patients with HAE
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Congress videos from the 2021 UKPIN conference. (UKPIN is now part of BSI‑CIPN)
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2021 UKPIN speaker talking heads
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Click the button below to access patient case studies, panel discussions and other
HAE-relevant topics, including the dialogue on the use of TAKHZYRO. |
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(Clicking this button will take you to theHAEexchange.com, a Takeda-owned website which
contains promotional content. The videos are initiated and funded by Takeda UK Ltd) |
*The HELP-03 study was an international, randomised, double-blind, Phase 3 study of 125 patients with HAE over 26 weeks. Patients were randomised to receive TAKHZYRO 300 mg Q2W (n=27), TAKHZYRO 300 mg Q4W (n=29), TAKHZYRO 150 mg Q4W (n=28) or placebo (n=41).3
†A dosing interval of 300 mg every 4 weeks may be considered if the patient is stably attack free with Q2W, especially in patients with low weight.1
‡Mean monthly attack rate: investigator-confirmed attacks/4 weeks.2
§All patients received open-label TAKHZYRO 300 mg Q2W over a mean treatment period of 29.6 months (range 1.4–34.2 months), followed by a 4-week safety follow-up before discharge from the study. The primary endpoint of HELP OLE was to evaluate long-term safety of repeated TAKHZYRO dosing.3
‖Rollover patients received dose of TAKHZYRO 300 mg until their first attack (dose-and-wait-period), then 300 mg Q2W (regular dosing stage); non-rollovers received TAKHZYRO 300 mg Q2W.3
¶Calculated by: 1 ÷ 0.2 = 5; 4 (4-weekly rate) x 5 = 20. Therefore, 1 attack every 20 weeks.
**Baseline data were not available for nonrollover patients’ HAE attacks requiring acute treatment or for their high-morbidity attacks.3
††High-morbidity attacks were defined as any attack that had ≥1 of the following characteristics: severe, resulted in hospitalisation (except hospitalisation for observation <24 hours), haemodynamically significant (systolic blood pressure <90 mmHg, required intravenous hydration, or associated with syncope/near-syncope), or laryngeal involvement.3
‡‡Calculated by: 1 ÷ 0.03 = 33.3; (4-weekly rate); 4 (4-weekly rate) x 33.3 = 133.33. Therefore, 1 attack every 133.33 weeks. 133.33 ÷ 52 = 2.56. Therefore, 1 attack every 2.56 years.
‖‖Starting from the first dose of lanadelumab on day 0 of the HELP OLE (regular dosing period for rollover patients). An attack-free day was defined as a calendar day with no investigator-confirmed hereditary angioedema attack. One month is considered to be 4 weeks (28 days).3
¶¶All data are least squares (LS) mean change from baseline to Week 26 across TAKHZYRO treatment arms vs placebo.1 These findings are tertiary endpoint analyses and therefore require further investigation to corroborate the findings.
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Abbreviations
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| AE-QOL, angioedema quality of life; AR, adverse reaction; C1-INH, C1 esterase inhibitor; OLE, open-label extension; Q2W, every 2 weeks; Q4W, every 4 weeks; QoL, quality of life; UKPIN, UK Primary Immunodeficiency Network. |
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References
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1. |
TAKHZYRO® Summary of Product Characteristics [GB & NI]. |
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Banerji A, et al. JAMA. 2018;320:2108–2121. |
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Banerji A, et al. Allergy. 2022;77:979–990. |
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▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Adverse events should be reported. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Takeda at: AE.GBR-IRL@takeda.com
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| Click here for TAKHZYRO Prescribing Information
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| Click here for FIRAZYR (icatibant) Prescribing Information
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| Click here for CINRYZE (C1-esterase inhibitor [human]) Prescribing Information
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Job code: C-APROM/GB/TAKH/0119
Date of preparation: February 2023 |
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| ©2023 Takeda UK Limited. All rights reserved. TAKHZYRO® is a registered trademark of Dyax Corp. CINRYZE® and the CINRYZE Logo® are registered trademarks of ViroPharma Biologics LLC. FIRAZYR® is a registered trademark of Shire Orphan Therapies GmbH. Takeda® and the Takeda Logo® are registered trademarks of Takeda Pharmaceutical Company Limited. Takeda UK Limited, 1 Kingdom Street, London, W2 6BD, United Kingdom. |
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