Effects of oral roflumilast therapy on body weight and cardiometabolic parameters in patients with psoriasis - results from a randomized controlled trial (PSORRO).

COPD PDE4-inhibitor PSORRO Patient consent Psoriasis RCT appetite cardiometabolic chronic obstructive pulmonary disease metabolism phosphodiesterase-4 randomized controlled trial roflumilast weight loss

Journal

Journal of the American Academy of Dermatology
ISSN: 1097-6787
Titre abrégé: J Am Acad Dermatol
Pays: United States
ID NLM: 7907132

Informations de publication

Date de publication:
29 Feb 2024
Historique:
received: 13 10 2023
revised: 15 02 2024
accepted: 19 02 2024
medline: 3 3 2024
pubmed: 3 3 2024
entrez: 2 3 2024
Statut: aheadofprint

Résumé

Weight loss is reported with oral roflumilast, which is approved for chronic obstructive pulmonary disease. Recently, the drug has shown efficacy in psoriasis, a disease strongly linked to overweight/obesity. To describe the effects of oral roflumilast on body weight and cardio-metabolic parameters in patients with psoriasis. Post-hoc analyses from the PSORRO study, where patients with moderate-to-severe plaque psoriasis were randomized 1:1 to oral roflumilast 500 μg once-daily or placebo for 12 weeks, followed by active, open-label treatment through week 24 in both groups. Changes in body weight, blood pressure, gastrointestinal symptoms, and laboratory tests were registered. No lifestyle or dietary interventions were applied. Forty-six patients were randomized. Baseline characteristics across groups were comparable; mean weight was 103.6kg. In patients receiving roflumilast, median weight change was -2.6% and -4% at week 12 and 24, respectively. Corresponding numbers were 0.0% and -1.3% in patients initially allocated to placebo. Reduced appetite was more frequent with active therapy. No changes in blood pressure or laboratory tests were observed. Post-hoc analyses and low numbers. Oral roflumilast induced weight loss and reduced appetite, which support the growing evidence of roflumilast as an attractive treatment alternative for patients with psoriasis.

Sections du résumé

BACKGROUND BACKGROUND
Weight loss is reported with oral roflumilast, which is approved for chronic obstructive pulmonary disease. Recently, the drug has shown efficacy in psoriasis, a disease strongly linked to overweight/obesity.
OBJECTIVE OBJECTIVE
To describe the effects of oral roflumilast on body weight and cardio-metabolic parameters in patients with psoriasis.
METHODS METHODS
Post-hoc analyses from the PSORRO study, where patients with moderate-to-severe plaque psoriasis were randomized 1:1 to oral roflumilast 500 μg once-daily or placebo for 12 weeks, followed by active, open-label treatment through week 24 in both groups. Changes in body weight, blood pressure, gastrointestinal symptoms, and laboratory tests were registered. No lifestyle or dietary interventions were applied.
RESULTS RESULTS
Forty-six patients were randomized. Baseline characteristics across groups were comparable; mean weight was 103.6kg. In patients receiving roflumilast, median weight change was -2.6% and -4% at week 12 and 24, respectively. Corresponding numbers were 0.0% and -1.3% in patients initially allocated to placebo. Reduced appetite was more frequent with active therapy. No changes in blood pressure or laboratory tests were observed.
LIMITATIONS CONCLUSIONS
Post-hoc analyses and low numbers.
CONCLUSION CONCLUSIONS
Oral roflumilast induced weight loss and reduced appetite, which support the growing evidence of roflumilast as an attractive treatment alternative for patients with psoriasis.

Identifiants

DOI: 10.1016/j.jaad.2024.02.036 PMID: 38431099
pubmed: 38431099
pii: S0190-9622(24)00426-2
doi: 10.1016/j.jaad.2024.02.036
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2024. Published by Elsevier Inc.

Auteurs

Mette Gyldenløve (M)

Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. Electronic address: mette.gyldenloeve@regionh.dk.

Jennifer Astrup Sørensen (JA)

Department of Dermatology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.

Simon Fage (S)

Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark.

Howraman Meteran (H)

Department of Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Public Health, University of Aarhus; Aarhus, Denmark.

Lone Skov (L)

Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.

Claus Zachariae (C)

Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.

Filip Krag Knop (FK)

Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Center for Clinical Metabolic Research, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Steno Diabetes Center Copenhagen, Herlev, Denmark.

Mia-Louise Nielsen (ML)

Department of Dermatology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.

Alexander Egeberg (A)

Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Dermatology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.

Classifications MeSH