A randomised trial of prednisolone
Journal
The European respiratory journal
ISSN: 1399-3003
Titre abrégé: Eur Respir J
Pays: England
ID NLM: 8803460
Informations de publication
Date de publication:
04 2022
04 2022
Historique:
received:
24
06
2021
accepted:
29
08
2021
pubmed:
11
9
2021
medline:
3
5
2022
entrez:
10
9
2021
Statut:
epublish
Résumé
Whether a combination of glucocorticoid and antifungal triazole is superior to glucocorticoid alone in reducing exacerbations in patients with allergic bronchopulmonary aspergillosis (ABPA) remains unknown. We aimed to compare the efficacy and safety of prednisolone-itraconazole combination We randomised subjects with treatment-naïve acute-stage ABPA complicating asthma to receive either prednisolone alone (4 months) or a combination of prednisolone and itraconazole (4 and 6 months, respectively). The primary outcomes were exacerbation rates at 12 months and glucocorticoid-dependent ABPA within 24 months of initiating treatment. The key secondary outcomes were response rates, percentage decline in serum total IgE at 6 weeks, time to first ABPA exacerbation and treatment-emergent adverse events (TEAEs). We randomised 191 subjects to receive either prednisolone (n=94) or prednisolone-itraconazole combination (n=97). The 1-year exacerbation rate was 33% and 20.6% in the prednisolone monotherapy and prednisolone-itraconazole combination arms, respectively (p=0.054). None of the participants progressed to glucocorticoid-dependent ABPA. All of the subjects experienced a composite response at 6 weeks, along with a decline in serum total IgE (mean decline 47.6% There was a trend towards a decline in ABPA exacerbations at 1 year with the prednisolone-itraconazole combination
Sections du résumé
BACKGROUND
Whether a combination of glucocorticoid and antifungal triazole is superior to glucocorticoid alone in reducing exacerbations in patients with allergic bronchopulmonary aspergillosis (ABPA) remains unknown. We aimed to compare the efficacy and safety of prednisolone-itraconazole combination
METHODS
We randomised subjects with treatment-naïve acute-stage ABPA complicating asthma to receive either prednisolone alone (4 months) or a combination of prednisolone and itraconazole (4 and 6 months, respectively). The primary outcomes were exacerbation rates at 12 months and glucocorticoid-dependent ABPA within 24 months of initiating treatment. The key secondary outcomes were response rates, percentage decline in serum total IgE at 6 weeks, time to first ABPA exacerbation and treatment-emergent adverse events (TEAEs).
RESULTS
We randomised 191 subjects to receive either prednisolone (n=94) or prednisolone-itraconazole combination (n=97). The 1-year exacerbation rate was 33% and 20.6% in the prednisolone monotherapy and prednisolone-itraconazole combination arms, respectively (p=0.054). None of the participants progressed to glucocorticoid-dependent ABPA. All of the subjects experienced a composite response at 6 weeks, along with a decline in serum total IgE (mean decline 47.6%
CONCLUSIONS
There was a trend towards a decline in ABPA exacerbations at 1 year with the prednisolone-itraconazole combination
Identifiants
pubmed: 34503983
pii: 13993003.01787-2021
doi: 10.1183/13993003.01787-2021
pii:
doi:
Substances chimiques
Antifungal Agents
0
Glucocorticoids
0
Itraconazole
304NUG5GF4
Immunoglobulin E
37341-29-0
Prednisolone
9PHQ9Y1OLM
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright ©The authors 2022. For reproduction rights and permissions contact permissions@ersnet.org.
Déclaration de conflit d'intérêts
Conflict of interest: R. Agarwal has received grant support for conducting research in ABPA from Cipla Pharmaceuticals, Mumbai, India, outside the submitted work. Conflict of interest: V. Muthu has nothing to disclose. Conflict of interest: I.S. Sehgal has nothing to disclose. Conflict of interest: S. Dhooria has nothing to disclose. Conflict of interest: K.T. Prasad has nothing to disclose. Conflict of interest: M. Garg has nothing to disclose. Conflict of interest: A.N. Aggarwal has nothing to disclose. Conflict of interest: A. Chakrabarti has nothing to disclose.