PMID- 38096105
OWN - NLM
STAT- Publisher
LR  - 20240104
IS  - 2325-6621 (Electronic)
IS  - 2325-6621 (Linking)
DP  - 2023 Dec 14
TI  - Adjunctive Systemic Corticosteroids for Pulmonary Exacerbations of Cystic 
      Fibrosis.
LID - 10.1513/AnnalsATS.202308-673OC [doi]
AB  - RATIONALE: Pulmonary exacerbations (PEx) remain the most common cause of 
      morbidity, recurrent hospitalization and diminished survival in people with CF 
      (PWCF), and are characterized by excess inflammation. Corticosteroids are potent, 
      widely available anti-inflammatory drugs. However, corticosteroid efficacy data 
      from randomized controlled trials (RCTs) in PWCF are limited. OBJECTIVES: To 
      determine whether adjunctive systemic corticosteroid therapy is associated with 
      improved outcomes in acute CF PEx. METHODS: We performed a secondary analysis of 
      STOP2, a large multicenter RCT of antimicrobial treatment durations for adult 
      PWCF presenting with PEx, that included the use of corticosteroids as a 
      stratification criterion in its randomization protocol. Corticosteroid treatment 
      effects were determined after propensity score-matching for covariates including 
      age, sex, baseline FEV1, genotype and randomization arm. The primary outcome 
      measure was the change in percent predicted FEV1 (ppFEV1). Symptoms, time to next 
      PEx and the incidence of adverse events (AEs) and serious adverse events (SAEs) 
      were assessed as secondary endpoints. Phenotypic factors associated with the 
      clinical decision to prescribe steroids were also investigated. RESULTS: 
      Corticosteroids were prescribed for 168 of 982 PEx events in STOP2 (17%). Steroid 
      prescription was associated with decreased baseline ppFEV1, increased age, and 
      female sex. Co-treatment with corticosteroids was independent of treatment arm 
      allocation, and did not result in greater mean ppFEV1 response, longer median 
      time to next PEx or more substantial symptomatic improvement compared to 
      propensity-matched PWCF receiving antibiotics alone. AEs were not increased in 
      corticosteroid-treated PWCF. The total number of SAEs - but not the number of 
      corticosteroid-related or PEx-ralated SAEs - was higher among patients receiving 
      corticosteroids. CONCLUSION: Empiric, physician-directed treatment with systemic 
      corticosteroids, while common, is not associated with improved clinical outcomes 
      in PWCF receiving antibiotics for PEx.
FAU - McElvaney, Oliver J
AU  - McElvaney OJ
AD  - University of Washington, 7284, Medicine, Seattle, Washington, United States.
AD  - Seattle Children's Research Institute, 145793, Cystic Fibrosis Therapeutics 
      Development Network Coordinating Center, Seattle, Washington, United States; 
      omcelv@uw.edu.
FAU - Heltshe, Sonya L
AU  - Heltshe SL
AD  - Seattle Children's Research Institute, 145793, Cystic Fibrosis Therapeutics 
      Development Network Coordinating Center, Seattle, Washington, United States.
AD  - University of Washington School of Medicine, 12353, Seattle, Washington, United 
      States.
FAU - Odem-Davis, Katherine
AU  - Odem-Davis K
AD  - Seattle Children's Research Institute, 145793, Seattle, Washington, United 
      States.
FAU - West, Natalie E
AU  - West NE
AD  - Johns Hopkins University, 1466, Medicine, Baltimore, Maryland, United States.
FAU - Sanders, Don B
AU  - Sanders DB
AD  - Indiana University, 1772, Pediatrics, Bloomington, Indiana, United States.
FAU - Fogarty, Barbra
AU  - Fogarty B
AD  - Seattle Children's Research Institute, 145793, Seattle, Washington, United 
      States.
FAU - VanDevanter, Donald R
AU  - VanDevanter DR
AD  - Case Western Reserve University School of Medicine, 12304, Pediatrics, Cleveland, 
      Ohio, United States.
FAU - Flume, Patrick A
AU  - Flume PA
AD  - Medical University of South Carolina, 2345, Medicine, Charleston, South Carolina, 
      United States.
AD  - Medical University of South Carolina, 2345, Pediatrics, Charleston, South 
      Carolina, United States.
FAU - Goss, Christopher H
AU  - Goss CH
AD  - University of Washington, 7284, Medicine, Seattle, Washington, United States.
AD  - University of Washington, 7284, Pediatrics, Seattle, Washington, United States.
AD  - Seattle Children's Research Institute, 145793, Cystic Fibrosis Therapeutics 
      Development Network Coordinating Center, Seattle, Washington, United States.
LA  - eng
GR  - P30 DK089507/DK/NIDDK NIH HHS/United States
PT  - Journal Article
DEP - 20231214
PL  - United States
TA  - Ann Am Thorac Soc
JT  - Annals of the American Thoracic Society
JID - 101600811
SB  - IM
EDAT- 2023/12/14 18:43
MHDA- 2023/12/14 18:43
CRDT- 2023/12/14 12:53
PHST- 2023/12/14 18:43 [medline]
PHST- 2023/12/14 18:43 [pubmed]
PHST- 2023/12/14 12:53 [entrez]
AID - 10.1513/AnnalsATS.202308-673OC [doi]
PST - aheadofprint
SO  - Ann Am Thorac Soc. 2023 Dec 14. doi: 10.1513/AnnalsATS.202308-673OC.