Almost all patients who completed 1 year reported they were well-controlled through 1 year1

Disease control was self-reported using the Angioedema Control Test (AECT).2*†

Proportion of patients well-controlled on DAWNZERA (AECT)

A graph showing proportion of patients well-controlled on DAWNZERA (AECT) from the pivotal study and OLE cohort. A graph showing proportion of patients well-controlled on DAWNZERA (AECT) from the pivotal study and OLE cohort.

In the OLE, 97% of patients across both dosing groups reported well-controlled disease based on the AECT1

*Disease control was self-reported using the AECT, which 55 of 57 patients completed at 1 year. Well-controlled was defined as ≥10 out of 16 possible points on the AECT.1,5

†The AECT was validated in 81 patients with recurrent angioedema, including 25 with HAE or acquired angioedema due to C1-INH deficiency. It was not specifically validated for HAE.5

AECT: Patient-reported disease control with DAWNZERA Q8W

74% of patients reported being well-controlled* at Week 24 (pivotal study, n=17/23)7

100% of patients reported being well-controlled* at Week 52 (OLE, n=13/13)1

AECT=Angioedema Control Test; HAE=hereditary angioedema; OLE=open-label extension; Q8W=every 8 weeks.

*Well-controlled was defined as ≥10 out of 16 possible points on the AECT.5

The Angioedema Control Test (AECT) is a 4-question test completed by patients to evaluate and monitor disease control. The questions asked are5,10:

one one

How often have you had angioedema?

two two

How much has your quality of life been affected by angioedema?

three three

How much has the unpredictability of your angioedema bothered you?

four four

How well has your angioedema been controlled by your therapy?

The AECT was validated in 81 patients with recurrent angioedema, including 25 with HAE or acquired angioedema due to C1-INH deficiency.5

It was not specifically validated for HAE; however, the AECT is included among the validated instruments recommended by the 2025 WAO Guidelines for routine assessment of disease control in patients with HAE.11

C1-INH=C1-inhibitor; HAE=hereditary angioedema; WAO=World Allergy Organization.

Patients reported improved AE-QoL with DAWNZERA1,3

Improvements in AE-QoL score with DAWNZERA
A graph showing improvements in AE-QoL score with DAWNZERA. A graph showing improvements in AE-QoL score with DAWNZERA.

At Week 52, DAWNZERA improved patient AE-QoL scores more than 4x the minimum clinically important difference (≥6 points)1,3

Overview of the AE-QoL6

  • Validated, angioedema-specific questionnaire in adults
  • Administered monthly
  • Consists of 4 domains (functioning, fatigue/mood, fears/shame, nutrition) and total scores

AE-QoL=angioedema quality of life; C1-INH=C1-inhibitor; HAE=hereditary angioedema; LSM=least squares mean; LTP=long-term prophylactic treatment; NR=not reported; OLE=open-label extension; Q4W=every 4 weeks; Q8W=every 8 weeks.

Study design: Pivotal study (OASIS-HAE) and open-label extension study (OASISplus)

Study design diagram showing the OASIS-HAE placebo-controlled trial and OASISplus open-label extension rollover and switch cohorts. Study design diagram showing the OASIS-HAE placebo-controlled trial and OASISplus open-label extension rollover and switch cohorts.

OASIS-HAE: Phase 3, randomized, double-blind, placebo-controlled 24-week trial of patients aged ≥12 years with HAE type 1 or 2 (N=90)3,8

  • At baseline, 69% of patients had >2 monthly attacks8
  • Enrolled patients had to have at least 2 investigator-confirmed attacks during the 8-week run-in period8

OASISplus: Ongoing, open-label, long-term safety (primary endpoint) and efficacy (secondary endpoint) study of patients with HAE type 1 or 2 (N=147)1,4

  • Open-label extension cohort: After 24 weeks, patients in OASIS-HAE were able to continue into the OASISplus open-label extension study†
  • Open-label switch cohort: An independent cohort of patients enrolled and had to be on a stable dose of prophylactic therapy for ≥12 weeks. Patients on a stable dose of HAE prophylactic prior to study entry started taking DAWNZERA every 4 weeks on study Day 1, following the 14-day switch protocol

92% of eligible patients opted to continue in the open-label extension study1†

C1-INH=C1-inhibitor; HAE=hereditary angioedema; Q4W=every 4 weeks; Q8W=every 8 weeks.

*Pooled placebo every 4 and 8 weeks.8

†83 of 90 eligible patients rolled over into the open-label extension study.1

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IMPORTANT SAFETY INFORMATION & INDICATION

CONTRAINDICATIONS

DAWNZERA is contraindicated in patients with a history of serious hypersensitivity reactions, including anaphylaxis, to donidalorsen or any of the excipients in DAWNZERA.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, have been reported in patients treated with DAWNZERA. If signs and symptoms of serious hypersensitivity reactions occur, discontinue DAWNZERA and institute appropriate therapy.

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥ 5%) are injection site reactions, upper respiratory tract infection, urinary tract infection, and abdominal discomfort.

INDICATION

DAWNZERA (donidalorsen) is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older.

Please see full Prescribing Information for DAWNZERA.

References: 1. Lumry WR, Tachdjian R, Craig T, et al. Donidalorsen for long-term prophylaxis of hereditary angioedema attacks: results from the OASISplus open-label extension cohort at year 1. J Asthma Allergy. 2026;19:592079. doi:10.2147/JAA.S592079 2. Riedl MA, Yarlas A, Bordone L, et al. Patient-reported outcomes in the phase III OASIS-HAE Study of donidalorsen for hereditary angioedema. Allergy. 2025;80(8):2361-2368. doi:10.1111/all.1656 3. Riedl MA, Tachdjian R, Lumry WR, et al. Efficacy and safety of donidalorsen for hereditary angioedema. N Engl J Med. 2024;391(1):21-31. doi:10.1056/NEJMoa2402478 4. Riedl MA, Bernstein JA, Jacobs JS, et al. Switching long-term prophylaxis to donidalorsen for hereditary angioedema: 1-year OASISplus results. Allergy. 2026;1-10. doi:10.1111/all.70294 5. 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):2050-2057.e4. doi:10.1016/j.jaip.2020.02.038 6. 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):1203-1209. doi:10.1111/all.12900 7. Data on file. Ionis Pharmaceuticals. 8. DAWNZERA. Prescribing information. Ionis Pharmaceuticals. 9. Riedl MA, Bernstein JA, Jacobs JS, et al. Donidalorsen treatment of hereditary angioedema in patients previously on long-term prophylaxis. J Allergy Clin Immunol Pract. 2025;13(9):2381-2389.e3. doi:10.1016/j.jaip.2025.06.018 10. 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):1165-1177. doi:10.1111/all.14144 11. Vázquez DO, Giavina-Bianchi P, Josviack D, et al. The 2025 WAO Guidelines for the classification, diagnosis, and treatment of hereditary angioedema, with consideration of worldwide disparities. World Allergy Organ J. 2026;19(5):101335. doi:10.1016/j.waojou.2026.101335