Explore the clinical trial designs

SWIFT-1 and SWIFT-2 were multicenter, randomized, double-blind, placebo-controlled exacerbation trials1

SWIFT-1 & SWIFT-2 clinical trial designs

SOC=Medium- to high-dose ICS plus ≥1 controller.

 

Primary endpoint: Annualized exacerbation* rate

All patients experiencing an exacerbation were treated with SCS.

Key inclusion criteria:

  • ≥12 years old with asthma
  • BEC: ≥150 cells/μL at screening or ≥300 cells/μL in the previous 12 months
  • Medium- to high-dose ICS + ≥1 additional controller
  • ≥2 exacerbations in previous 12 months

No minimum baseline ACQ-5 required.

  • *

    Defined as worsening of asthma requiring: systemic corticosteroids (IV or oral for ≥3 days or single IM dose) or hospitalization or ED visit; or at least double the existing maintenance systemic corticosteroid dose for ≥3 days.

ACQ-5=Asthma Control Questionnaire (5-item); BEC=blood eosinophil count; ED=emergency department; ICS=inhaled corticosteroid;

IM=intramuscular; IV=intravenous; SC=subcutaneous; SCS=systemic corticosteroids; SOC=standard of care.

Key patient characteristics in SWIFT-1 and SWIFT-2 (N=762)1,2:

Asthma control*†

  • ACQ-5 <1.5: 25% (n=185)​
  • ACQ-5 ≥1.5: 75% (n=559)

No minimum baseline ACQ-5 required

ICS dose‡

  • Medium-dose: 44% (n=333)​
  • High-dose: 56% (n=429)

History of exacerbations§

  • 2‖: 80% (n=606)​
  • ≥3: 20% (n=155)
  • * Scores on the Asthma Control Questionnaire-5 range from 0 to 6, with higher scores indicating worse asthma control (minimal clinically important difference, -0.5).3 Score of ≥1.5 indicates poor asthma control.4
  • † ACQ-5 outcomes are based on patients with available data (N=744).
  • ‡ Medium ICS dose=440 mcg fluticasone propionate (FP) daily metered dose or equivalent; high ICS dose >440 mcg FP daily metered dose or equivalent.
  • § Exacerbations that required systemic corticosteroids in past 12 months.
  • ‖ 1 patient in SWIFT-1 had a history of 0 exacerbations.

ACQ-5=Asthma Control Questionnaire (5-item); ICS=inhaled corticosteroid.

SWIFT-1 and SWIFT-2 demographics and baseline characteristics1,2

  SWIFT-1
(N=382)		 SWIFT-2
(N=380)
Age (y) of patients (SD) 54 (14.2) 53 (16.2)
Female, n (%) 223 (58) 241 (63)
Duration of asthma (SD) 22 (16.2) 25 (18.5)
Pre-bronchodilator FEV1, mL (SD) 1881 (695.5) 1801 (672.3)
Pre-bronchodilator % predicted FEV1 (SD) 62 (15.2) 62 (15.9)
% Reversibility (SD) 17 (15.3) 18 (17.4)
Eosinophil count, cells/mcL, median (min, max) 310 (20; 2,360) 340 (10; 4,440)
Number of exacerbations in previous year (SD) 2.2 (0.7) 2.7 (1.9)
Medium-dose ICS use (%)* 179 (47) 154 (41)
High-dose ICS use (%)* 203 (53) 226 (59)
ICS+LABA+LAMA use (%) 95 (25) 127 (33)
Score on ACQ-5†
  • EXDENSUR
  • Placebo
 2.22 ± 1.12
2.34 ± 1.10		 2.20 ± 1.07
2.13 ± 1.00
Maintenance OCS use (%) 21 (5) 19 (5)
Total IgE, U/mcL, median (min, max) 185 (2; 12,142) 180 (2; 16,199)

Data are presented in mean unless otherwise stated.

  • * Medium ICS dose=440 mcg fluticasone propionate (FP) daily metered dose or equivalent; high ICS dose >440 mcg FP daily metered dose or equivalent.
  • †

    Scores on the Asthma Control Questionnaire-5 range from 0 to 6, with higher scores indicating worse asthma control (minimal clinically important difference, -0.5).3 Score of ≥1.5 indicates poor asthma control.4

ACQ-5=Asthma Control Questionnaire (5-item); FEV1=forced expiratory volume in 1 second; ICS=inhaled corticosteroid; IgE=immunoglobulin E; IV=intravenous; LABA=long-acting beta2-agonist; LAMA=long-acting muscarinic antagonist; OCS=oral corticosteroids; SD=standard deviation.

AGILE: Open-label extension (OLE) study2

AGILE was a 52-week, multicenter, single-arm, open-label study to evaluate the long-term safety, immunogenicity, and efficacy of EXDENSUR in 629 patients aged 12+ with severe asthma with an eosinophilic phenotype, who completed SWIFT-1 or SWIFT-2 trials and met eligibility criteria. All patients in AGILE received EXDENSUR added to SOC regardless of their previous treatment allocation (EXDENSUR or placebo).*

AGILE open-label extension (OLE) study design

SOC=medium- to high-dose ICS plus ≥1 controller.

 

Primary endpoints: Incidence of AEs/SAEs, Immunogenicity§

 

  • Most frequent AEs (≥5%): nasopharyngitis (13%), upper respiratory tract infection (11%), COVID-19 (7%), and bronchitis (5%). SAEs in ≥1%: asthma‖

  • Anti-drug antibodies positive in 9% (55/622) of patients with 5 patients positive for neutralizing antibodies

 

Post hoc integrated analysis of SWIFT-1/2 and AGILE description: 104-week post hoc analysis of patients who completed AGILE OLE; the purpose was to assess long-term safety and efficacy of EXDENSUR over 2 years.

  • * Adjustments to background asthma treatment were allowed at physician discretion.
  • †EXDENSUR:placebo.
  • ‡ 641/762 patients entered AGILE from SWIFT-1/2; safety population, n=629.
  • § As measured by the presence of ADAs/NAbs to depemokimab.
  • ‖ Asthma reported as an AE means worsening or exacerbation of asthma.

ADAs=anti-drug antibodies; AE=adverse event; ICS=inhaled corticosteroid; NAbs=neutralizing antibodies; SAE=severe adverse event; SC=subcutaneous; SOC=standard of care.

More to explore:

Efficacy data

Explore results from two phase 3 clinical trials and an open-label extension study.

VIEW DATA

Safety

Learn more about the established safety profile of EXDENSUR up to 2 years.

SEE SAFETY PROFILE

Patient identification

Discover which patients in your practice are ready for treatment with EXDENSUR.

IDENTIFY PATIENTS

Indication & Safety Info

Indication

Important Safety Information

Indication

EXDENSUR is indicated for the add-on maintenance treatment of severe asthma, characterized by an eosinophilic phenotype, in adult and pediatric patients aged 12 years and older. EXDENSUR is not indicated for the relief of acute bronchospasm or status asthmaticus.

Important Safety Information

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis, can occur following administration of EXDENSUR. If a hypersensitivity reaction occurs, discontinue EXDENSUR and initiate appropriate therapy.

Acute Asthma Symptoms or Deteriorating Disease
EXDENSUR should not be used to treat acute asthma symptoms or acute exacerbations.

Risk Associated with Abrupt Reduction of Corticosteroid Dosage
Upon initiation of EXDENSUR therapy, do not abruptly discontinue systemic or inhaled corticosteroids. Reductions in corticosteroid dose, if appropriate, should be gradual and under the supervision of a healthcare provider. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection
Patients with pre-existing helminth infections should be treated for their infection prior to initiation of EXDENSUR therapy. If patients become infected while receiving EXDENSUR and do not respond to anti-helminth treatment, discontinue EXDENSUR until the infection resolves.

ADVERSE REACTIONS

In patients receiving EXDENSUR, the most common adverse reactions (≥4%) were upper respiratory tract infection, allergic rhinitis, influenza, arthralgia, and pharyngitis. Injection site reactions have also occurred. 

USE IN SPECIFIC POPULATIONS

The data in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Transport of endogenous IgG antibodies and monoclonal antibodies, such as depemokimab-ulaa, across the placenta increases as pregnancy progresses and peaks during the third trimester.

EXDENSUR can cross the placenta during pregnancy and the presence of the YTE modification may prolong and increase exposure to the infant exposed in utero. The impact of transmission to the fetus should be considered. Pregnant women exposed to EXDENSUR, or their healthcare providers, should report EXDENSUR exposure by calling 1-888-825-5249.

Please see full Prescribing Information for EXDENSUR.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or 1-888-825-5249, or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References

  1. Jackson DJ, Wechsler ME, Jackson DJ, et al. Twice-yearly depemokimab in severe asthma with an eosinophilic phenotype. N Engl J Med. 2024;391(24):2337-2349. doi:10.1056/NEJMoa2406673

  2. Data on file, GSK.

  3. Juniper EF, Svensson K, Mörk AC, Ståhl E. Measurement properties and interpretation of three shortened versions of the asthma control questionnaire. Respir Med. 2005;99(5):553-558.

  4. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention, 2026. Updated May 2026. Available at: https://ginasthma.org/wp-content/uploads/2026/05/GINA-2026-Strategy-Report-WMS.pdf. Accessed May 6, 2026.