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

Mette Gyldenløve; Jennifer Astrup Sørensen; Simon Fage; Howraman Meteran; Lone Skov; Claus Zachariae; Filip Krag Knop; Mia-Louise Nielsen; Alexander Egeberg

doi:10.1016/j.jaad.2024.02.036

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

J Am Acad Dermatol. 2024 Mar 1:S0190-9622(24)00426-2. doi: 10.1016/j.jaad.2024.02.036. Online ahead of print.

Authors

Mette Gyldenløve¹, Jennifer Astrup Sørensen², Simon Fage³, Howraman Meteran⁴, Lone Skov⁵, Claus Zachariae⁵, Filip Krag Knop⁶, Mia-Louise Nielsen², Alexander Egeberg⁷

Affiliations

¹ 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.
² Department of Dermatology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.
³ Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark.
⁴ Department of Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Public Health, University of Aarhus Aarhus, Denmark.
⁵ 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.
⁶ 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.
⁷ 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.

PMID: 38431099
DOI: 10.1016/j.jaad.2024.02.036

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.

Keywords: COPD; PDE4-inhibitor; PSORRO; RCT; appetite; cardiometabolic; chronic obstructive pulmonary disease; metabolism; phosphodiesterase-4; psoriasis; randomized controlled trial; roflumilast; weight loss.