TY - JOUR

T1 - Effects of oral roflumilast therapy on body weight and cardiometabolic parameters in patients with psoriasis – results from a randomized controlled trial (PSORRO)

AU - Gyldenløve, Mette

AU - Sørensen, Jennifer Astrup

AU - Fage, Simon

AU - Meteran, Howraman

AU - Skov, Lone

AU - Zachariae, Claus

AU - Knop, Filip Krag

AU - Nielsen, Mia Louise

AU - Egeberg, Alexander

N1 - Publisher Copyright: © 2024 American Academy of Dermatology, Inc.

PY - 2024

Y1 - 2024

N2 - 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.

AB - 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.

KW - appetite

KW - cardiometabolic

KW - chronic obstructive pulmonary disease

KW - COPD

KW - metabolism

KW - PDE4-inhibitor

KW - phosphodiesterase-4

KW - psoriasis

KW - PSORRO

KW - randomized controlled trial

KW - RCT

KW - roflumilast

KW - weight loss

U2 - 10.1016/j.jaad.2024.02.036

DO - 10.1016/j.jaad.2024.02.036

M3 - Journal article

C2 - 38431099

AN - SCOPUS:85189094417

JO - American Academy of Dermatology. Journal

JF - American Academy of Dermatology. Journal

SN - 0190-9622

ER -