PMID- 36462399
OWN - NLM
STAT- MEDLINE
DCOM- 20230106
LR  - 20230203
IS  - 1532-3064 (Electronic)
IS  - 0954-6111 (Linking)
VI  - 206
DP  - 2023 Jan
TI  - Efficacy and safety of dupilumab as add-on therapy for patients with severe 
      asthma: A real-world Dutch cohort study.
PG  - 107058
LID - S0954-6111(22)00323-7 [pii]
LID - 10.1016/j.rmed.2022.107058 [doi]
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 (FEV(1)), 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 FEV(1) (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/muL) 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.
CI  - Copyright (c) 2022 Elsevier Ltd. All rights reserved.
FAU - Thelen, John C
AU  - Thelen JC
AD  - Department of Pulmonology, Franciscus Gasthuis & Vlietland, Rotterdam, the 
      Netherlands. Electronic address: john-thelen@hotmail.com.
FAU - van Zelst, Cathelijne M
AU  - van Zelst CM
AD  - Department of Pulmonology, Franciscus Gasthuis & Vlietland, Rotterdam, the 
      Netherlands; Department of Pulmonary Medicine, Erasmus MC, University Medical 
      Center, Rotterdam, the Netherlands.
FAU - van Brummelen, Sigrid E
AU  - van Brummelen SE
AD  - Department of Pulmonology, Franciscus Gasthuis & Vlietland, Rotterdam, the 
      Netherlands.
FAU - Rauh, Simone
AU  - Rauh S
AD  - Department of Science, Franciscus Gasthuis & Vlietland, Rotterdam, the 
      Netherlands.
FAU - In 't Veen, Johannes C C M
AU  - In 't Veen JCCM
AD  - Department of Pulmonology, Franciscus Gasthuis & Vlietland, Rotterdam, the 
      Netherlands.
FAU - Kappen, Jasper H
AU  - Kappen JH
AD  - Department of Pulmonology, Franciscus Gasthuis & Vlietland, Rotterdam, the 
      Netherlands.
FAU - Braunstahl, Gert-Jan
AU  - Braunstahl GJ
AD  - Department of Pulmonology, Franciscus Gasthuis & Vlietland, Rotterdam, the 
      Netherlands; Department of Pulmonary Medicine, Erasmus MC, University Medical 
      Center, Rotterdam, the Netherlands. Electronic address: 
      g.braunstahl@franciscus.nl.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20221126
PL  - England
TA  - Respir Med
JT  - Respiratory medicine
JID - 8908438
RN  - 0 (Adrenal Cortex Hormones)
RN  - 0 (Anti-Asthmatic Agents)
RN  - 420K487FSG (dupilumab)
SB  - IM
MH  - Humans
MH  - Adrenal Cortex Hormones/therapeutic use
MH  - *Anti-Asthmatic Agents/adverse effects
MH  - *Asthma/drug therapy
MH  - Cohort Studies
MH  - Quality of Life
MH  - Clinical Trials, Phase III as Topic
OTO - NOTNLM
OT  - Asthma exacerbation
OT  - Dupilumab
OT  - Real life
OT  - Severe asthma
OT  - T2-inflammation
EDAT- 2022/12/04 06:00
MHDA- 2023/01/04 06:00
CRDT- 2022/12/03 18:22
PHST- 2022/10/03 00:00 [received]
PHST- 2022/11/17 00:00 [revised]
PHST- 2022/11/19 00:00 [accepted]
PHST- 2022/12/04 06:00 [pubmed]
PHST- 2023/01/04 06:00 [medline]
PHST- 2022/12/03 18:22 [entrez]
AID - S0954-6111(22)00323-7 [pii]
AID - 10.1016/j.rmed.2022.107058 [doi]
PST - ppublish
SO  - Respir Med. 2023 Jan;206:107058. doi: 10.1016/j.rmed.2022.107058. Epub 2022 Nov 
      26.