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 - Copyright © 2024. Published by Elsevier Inc.
PY - 2024/7
Y1 - 2024/7
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 - Administration, Oral
KW - Adult
KW - Aged
KW - Aminopyridines/administration & dosage
KW - Benzamides/administration & dosage
KW - Blood Pressure/drug effects
KW - Body Weight/drug effects
KW - Cyclopropanes/administration & dosage
KW - Double-Blind Method
KW - Female
KW - Humans
KW - Male
KW - Middle Aged
KW - Phosphodiesterase 4 Inhibitors/administration & dosage
KW - Psoriasis/drug therapy
KW - Severity of Illness Index
KW - Treatment Outcome
KW - Weight Loss/drug effects
UR - http://www.scopus.com/inward/record.url?scp=85189094417&partnerID=8YFLogxK
U2 - 10.1016/j.jaad.2024.02.036
DO - 10.1016/j.jaad.2024.02.036
M3 - Journal article
C2 - 38431099
SN - 0190-9622
VL - 91
SP - 64
EP - 71
JO - Journal of the American Academy of Dermatology
JF - Journal of the American Academy of Dermatology
IS - 1
ER -