PMID- 38163585
OWN - NLM
STAT- MEDLINE
DCOM- 20240409
LR  - 20240409
IS  - 2213-2201 (Electronic)
VI  - 12
IP  - 4
DP  - 2024 Apr
TI  - Long-Term Safety of Dupilumab in Patients With Moderate-to-Severe Asthma: 
      TRAVERSE Continuation Study.
PG  - 991-997.e6
LID - S2213-2198(23)01406-X [pii]
LID - 10.1016/j.jaip.2023.12.043 [doi]
AB  - BACKGROUND: Previous clinical trials have demonstrated dupilumab efficacy and 
      safety in adults and adolescents with moderate to severe asthma for up to 3 
      years. OBJECTIVE: The TRAVERSE continuation study (NCT03620747), a single-arm, 
      open-label study, assessed safety and tolerability of dupilumab 300 mg every 2 
      weeks up to an additional 144 weeks ( approximately 3 years) in patients with moderate to 
      severe asthma who previously completed TRAVERSE (NCT02134028). METHODS: Primary 
      end points were incidence and event rates per 100 patient-years of 
      treatment-emergent adverse events (TEAEs). Secondary end points included adverse 
      events (AEs) of special interest, serious AEs, and AEs leading to study 
      discontinuation. RESULTS: A total of 393 patients participated in the TRAVERSE 
      continuation study (cumulative dupilumab exposure, 431.7 patient-years; median 
      treatment duration, 309 days). A total of 29 patients (7.4%) received more than 
      958 days of treatment. A total of 214 (54.5%) patients reported at least 1 TEAE 
      (event rate: 171.4); 37 (9.4%) experienced at least 1 treatment-related TEAE, 
      none of which were considered severe; 2 patients reported 6 TEAEs of moderate 
      intensity. A total of 22 (5.6%) patients reported serious AEs (event rate: 6.9). 
      AEs of special interest were reported in 24 patients (6.1%; event rate: 6.0). 
      Five (1.3%) deaths occurred (event rate: 1.2) following serious AEs of 
      coronavirus disease 2019 (COVID-19)-related pneumonia (3 patients), pancreatitis 
      (1 patient), and pulmonary embolism (1 patient). None of the TEAEs leading to 
      death were considered treatment-related. CONCLUSIONS: Dupilumab treatment was 
      well tolerated for up to an additional 3 years. Safety findings were consistent 
      with the known safety profile of dupilumab. These findings further support the 
      long-term use of dupilumab in patients with moderate to severe asthma.
CI  - Copyright (c) 2024 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Maspero, Jorge F
AU  - Maspero JF
AD  - Fundacion CIDEA, Buenos Aires, Argentina. Electronic address: 
      jorge.maspero@fundacioncidea.org.ar.
FAU - Peters, Anju T
AU  - Peters AT
AD  - Northwestern University Feinberg School of Medicine, Chicago, Ill.
FAU - Chapman, Kenneth R
AU  - Chapman KR
AD  - University of Toronto, Toronto, ON, Canada.
FAU - Domingo, Christian
AU  - Domingo C
AD  - Corporacio Sanitaria Parc Tauli, Sabadell, Autonomous University of Barcelona, 
      Barcelona, Spain.
FAU - Stewart, John
AU  - Stewart J
AD  - Sanofi, Montreal, QC, Canada.
FAU - Hardin, Megan
AU  - Hardin M
AD  - Sanofi, Cambridge, Mass.
FAU - Maroni, Jaman
AU  - Maroni J
AD  - Regeneron Pharmaceuticals, Inc., Tarrytown, NY.
FAU - Tawo, Kelsey
AU  - Tawo K
AD  - Sanofi, Bridgewater, NJ.
FAU - Khokhar, Faisal A
AU  - Khokhar FA
AD  - Regeneron Pharmaceuticals, Inc., Tarrytown, NY.
FAU - Mortensen, Eric
AU  - Mortensen E
AD  - Regeneron Pharmaceuticals, Inc., Tarrytown, NY.
FAU - Laws, Elizabeth
AU  - Laws E
AD  - Sanofi, Bridgewater, NJ.
FAU - Radwan, Amr
AU  - Radwan A
AD  - Regeneron Pharmaceuticals, Inc., Tarrytown, NY.
FAU - Jacob-Nara, Juby A
AU  - Jacob-Nara JA
AD  - Sanofi, Bridgewater, NJ.
FAU - Deniz, Yamo
AU  - Deniz Y
AD  - Regeneron Pharmaceuticals, Inc., Tarrytown, NY.
FAU - Rowe, Paul J
AU  - Rowe PJ
AD  - Sanofi, Bridgewater, NJ.
LA  - eng
SI  - ClinicalTrials.gov/NCT02134028
PT  - Journal Article
DEP - 20231230
PL  - United States
TA  - J Allergy Clin Immunol Pract
JT  - The journal of allergy and clinical immunology. In practice
JID - 101597220
RN  - 420K487FSG (dupilumab)
RN  - 0 (Antibodies, Monoclonal, Humanized)
SB  - IM
MH  - Adult
MH  - Adolescent
MH  - Humans
MH  - *Antibodies, Monoclonal, Humanized/adverse effects
MH  - *Asthma/drug therapy/epidemiology/chemically induced
MH  - Treatment Outcome
MH  - Double-Blind Method
OTO - NOTNLM
OT  - Adverse events
OT  - Asthma
OT  - Dupilumab
OT  - Long-term
OT  - Moderate to severe
OT  - Safety
EDAT- 2024/01/02 11:44
MHDA- 2024/04/09 06:45
CRDT- 2024/01/01 19:14
PHST- 2023/05/31 00:00 [received]
PHST- 2023/11/22 00:00 [revised]
PHST- 2023/12/24 00:00 [accepted]
PHST- 2024/04/09 06:45 [medline]
PHST- 2024/01/02 11:44 [pubmed]
PHST- 2024/01/01 19:14 [entrez]
AID - S2213-2198(23)01406-X [pii]
AID - 10.1016/j.jaip.2023.12.043 [doi]
PST - ppublish
SO  - J Allergy Clin Immunol Pract. 2024 Apr;12(4):991-997.e6. doi: 
      10.1016/j.jaip.2023.12.043. Epub 2023 Dec 30.