Abstract
BACKGROUND: Weight loss is reported with oral roflumilast, which is approved for chronic obstructive pulmonary disease (COPD). Recently, the drug has shown efficacy in psoriasis, a disease strongly linked to overweight/obesity.
OBJECTIVE: To describe the effects of oral roflumilast on body weight and cardio-metabolic parameters in patients with psoriasis.
METHODS: Posthoc 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: Forty-six patients were randomized. Baseline characteristics across groups were comparable; mean weight was 103.6 kg. 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: Posthoc analyses and low numbers.
CONCLUSION: Oral roflumilast induced weight loss and reduced appetite, which support the growing evidence of roflumilast as an attractive treatment alternative for patients with psoriasis.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Journal of the American Academy of Dermatology |
| Vol/bind | 91 |
| Udgave nummer | 1 |
| Sider (fra-til) | 64-71 |
| Antal sider | 8 |
| ISSN | 0190-9622 |
| DOI | |
| Status | Udgivet - 2024 |
Bibliografisk note
Funding Information:We wish to thank the participating patients, departments, and staff at Herlev and Gentofte Hospital, Bispebjerg and Frederiksberg Hospital, and Aarhus University Hospital. Research funding was provided from Herlev and Gentofte Hospital, University of Copenhagen, Kgl. Hofbuntmager Aage Bangs Fond, Psoriasis Forskningsfonden, Simon Spies fonden, C. C. Klestrup og hustru Henriette Klestrups mindelegat, and Fonden af familien Kjærsgaard, Sunds. Funding sources: The Danish market authorization holder of oral roflumilast did not provide any financial or in-kind support for the trial, and none of the involved hold any financial interest in the study drug. Independent grants were received from the Simon Spies Foundation, The Danish Psoriasis Research Foundation, the CC. Klestrup og hustru Henriette Klestrups Mindelegat, the Kgl. Hofbuntmager Aage Bangs Foundation, and Fonden af familien Kjærsgaard, Sunds. Dr Gyldenløve was supported by a 4-year postdoctoral fellowship from Herlev and Gentofte Hospital, University of Copenhagen.
Publisher Copyright:
© 2024 American Academy of Dermatology, Inc.