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. 2026 Mar 14.
doi: 10.1111/all.70294. Online ahead of print.

Switching Long-Term Prophylaxis to Donidalorsen for Hereditary Angioedema: 1-Year OASISplus Results

Marc A Riedl  1 , Jonathan A Bernstein  2 , Joshua S Jacobs  3 , Timothy Craig  4   5   6 , William R Lumry  7 , H James Wedner  8 , Aleena Banerji  9 , Selina Gierer  10 , Andrew Smith  11 , Michael E Manning  12 , Francesca Perego  13 , Laura Bordone  14 , Sabrina Treadwell  14 , Tao Lin  14 , Kenneth B Newman  14 , Aaron Yarlas  14 , Danny M Cohn  15
Affiliations

Switching Long-Term Prophylaxis to Donidalorsen for Hereditary Angioedema: 1-Year OASISplus Results

Marc A Riedl et al. Allergy. .

Abstract

Background: Donidalorsen is an antisense oligonucleotide designed to reduce plasma prekallikrein in patients with hereditary angioedema (HAE). The Switch cohort of the OASISplus study (NCT05392114) evaluated the long-term safety and efficacy of donidalorsen in patients who switched from a long-term prophylactic treatment (LTP) to donidalorsen with 1-year outcomes.

Methods: This study enrolled patients with HAE aged ≥ 12 years previously on stable doses of an LTP (lanadelumab, berotralstat, C1 inhibitor). Patients directly switched from an LTP to donidalorsen 80 mg administered subcutaneously once every 4 weeks. Endpoints included incidence and severity of treatment-emergent adverse events (TEAEs; primary endpoint), monthly HAE attack rate, Angioedema Quality of Life (AE-QoL), and Angioedema Control Test (AECT) measured at baseline and Week 52.

Results: Sixty-five patients enrolled, and 54 (83.1%) completed 1 year. Eleven (16.9%) patients discontinued treatment during the first year, and one discontinued treatment after 1 year. Donidalorsen reduced HAE attack rates from baseline on the prior LTP by 67.6% over 52 weeks. Fifty-six of 64 (87.5%) dosed patients experienced a TEAE; most reported mild to moderate events. The most common treatment-related TEAEs were injection-site erythema (10.9%) and injection-site pruritus (10.9%). One patient had a serious adverse event that was not treatment-related. AE-QoL total score improved by 12.2 points (clinically meaningful ≥ 6 points) from baseline to Week 52, and 90.4% of patients had well-controlled disease (AECT ≥ 10) at Week 52.

Conclusion: In patients who switched from another LTP, donidalorsen was well tolerated and improved long-term HAE attack rates, quality of life, and disease control.

Keywords: angioedema; clinical immunology; inflammation; quality‐of‐life.

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References

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