TY - JOUR
T1 - Efficacy and safety of dupilumab as add-on therapy for patients with severe asthma
T2 - A real-world Dutch cohort study
AU - Thelen, John C.
AU - van Zelst, Cathelijne M.
AU - van Brummelen, Sigrid E.
AU - Rauh, Simone
AU - in ’t Veen, Johannes C.C.M.
AU - Kappen, Jasper H.
AU - Braunstahl, Gert Jan
N1 - Funding Information:
Financial support was provided by Sanofi as a research grant [Award number: SGZ-2021-13401]. The recipient was Gert-Jan Braunstahl, corresponding author.
Publisher Copyright:
© 2022 Elsevier Ltd
PY - 2023/1/1
Y1 - 2023/1/1
N2 - Background: Dupilumab as add-on treatment for severe uncontrolled asthma (SA) has shown to be effective and safe by phase-III-trials. Real-world data on clinical efficacy and safety is limited. Objective: We aim to investigate the efficacy and safety of dupilumab as add-on therapy for SA in a real-world cohort. Material and methods: The primary endpoint was annually exacerbation-rate (AER). Secondary outcomes were maintenance oral corticosteroid (mOCS) dependency, asthma control (ACQ-5), pulmonary function (FEV1), quality of life (AQLQ) and frequency of reported adverse events (AEs). Results: Overall, 148 patients were included. Median AER [IQR] reduced from 4.00 [2.00–5.00] at baseline to 1.00 [0.00–2.00] at 12 months (p < 0.001). mOCS-dependency reduced from 39.9% of the patients at baseline, to 20.3% at 6 months and to 14.9% at 12 months (p < 0.001). Median ACQ improved from 3.00 [2.00–3.80] at baseline to 1.80 [0.60–2.95] after 6 months and to 1.40 [0.20–2.60] after 12 months (p < 0.001). Median FEV1 (L) improved from 2.21 [1.58–2.85] to 2.50 [2.00–3.06] at 6 months and to 2.51 [1.88–3.04] after 12 months (p < 0.001). The outcomes improved most in subgroups with high eosinophils (≥300/μL) or FeNO (≥50 ppb) at baseline. AEs were reported by 45.3% (67/148), of which headache was most frequent. Conclusions: This study indicates that dupilumab as add-on therapy for SA is associated with significant improvements in exacerbation-rate, mOCS-dependency, asthma control, pulmonary function, and quality of life. These results are in line with those of previous phase-III-trials.
AB - Background: Dupilumab as add-on treatment for severe uncontrolled asthma (SA) has shown to be effective and safe by phase-III-trials. Real-world data on clinical efficacy and safety is limited. Objective: We aim to investigate the efficacy and safety of dupilumab as add-on therapy for SA in a real-world cohort. Material and methods: The primary endpoint was annually exacerbation-rate (AER). Secondary outcomes were maintenance oral corticosteroid (mOCS) dependency, asthma control (ACQ-5), pulmonary function (FEV1), quality of life (AQLQ) and frequency of reported adverse events (AEs). Results: Overall, 148 patients were included. Median AER [IQR] reduced from 4.00 [2.00–5.00] at baseline to 1.00 [0.00–2.00] at 12 months (p < 0.001). mOCS-dependency reduced from 39.9% of the patients at baseline, to 20.3% at 6 months and to 14.9% at 12 months (p < 0.001). Median ACQ improved from 3.00 [2.00–3.80] at baseline to 1.80 [0.60–2.95] after 6 months and to 1.40 [0.20–2.60] after 12 months (p < 0.001). Median FEV1 (L) improved from 2.21 [1.58–2.85] to 2.50 [2.00–3.06] at 6 months and to 2.51 [1.88–3.04] after 12 months (p < 0.001). The outcomes improved most in subgroups with high eosinophils (≥300/μL) or FeNO (≥50 ppb) at baseline. AEs were reported by 45.3% (67/148), of which headache was most frequent. Conclusions: This study indicates that dupilumab as add-on therapy for SA is associated with significant improvements in exacerbation-rate, mOCS-dependency, asthma control, pulmonary function, and quality of life. These results are in line with those of previous phase-III-trials.
UR - http://www.scopus.com/inward/record.url?scp=85142778850&partnerID=8YFLogxK
U2 - 10.1016/j.rmed.2022.107058
DO - 10.1016/j.rmed.2022.107058
M3 - Article
C2 - 36462399
AN - SCOPUS:85142778850
SN - 0954-6111
VL - 206
JO - Respiratory Medicine
JF - Respiratory Medicine
M1 - 107058
ER -