Improvements in patient-reported outcomes with oral roflumilast for psoriasis: Results from a randomized controlled trial (PSORRO)
Corresponding Author
Mette Gyldenløve
Department of Dermatology and Allergy, Copenhagen University Hospital – Herlev and Gentofte, Hellerup, Denmark
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
Correspondence
Mette Gyldenløve, Department of Dermatology and Allergy, Copenhagen University Hospital – Herlev and Gentofte, Gentofte Hospitalsvej 15, DK-2900 Hellerup, Denmark.
Email: [email protected]
Search for more papers by this authorJennifer Astrup Sørensen
Department of Dermatology, Copenhagen University Hospital – Bispebjerg and Frederiksberg, Copenhagen, Denmark
Search for more papers by this authorSimon Francis Thomsen
Department of Dermatology, Copenhagen University Hospital – Bispebjerg and Frederiksberg, Copenhagen, Denmark
Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
Search for more papers by this authorSimon Fage
Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark
Search for more papers by this authorLars Iversen
Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark
Search for more papers by this authorLone Skov
Department of Dermatology and Allergy, Copenhagen University Hospital – Herlev and Gentofte, Hellerup, Denmark
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
Search for more papers by this authorClaus Zachariae
Department of Dermatology and Allergy, Copenhagen University Hospital – Herlev and Gentofte, Hellerup, Denmark
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
Search for more papers by this authorAlexander Egeberg
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
Department of Dermatology, Copenhagen University Hospital – Bispebjerg and Frederiksberg, Copenhagen, Denmark
Search for more papers by this authorMia-Louise Nielsen
Department of Dermatology, Copenhagen University Hospital – Bispebjerg and Frederiksberg, Copenhagen, Denmark
Search for more papers by this authorCorresponding Author
Mette Gyldenløve
Department of Dermatology and Allergy, Copenhagen University Hospital – Herlev and Gentofte, Hellerup, Denmark
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
Correspondence
Mette Gyldenløve, Department of Dermatology and Allergy, Copenhagen University Hospital – Herlev and Gentofte, Gentofte Hospitalsvej 15, DK-2900 Hellerup, Denmark.
Email: [email protected]
Search for more papers by this authorJennifer Astrup Sørensen
Department of Dermatology, Copenhagen University Hospital – Bispebjerg and Frederiksberg, Copenhagen, Denmark
Search for more papers by this authorSimon Francis Thomsen
Department of Dermatology, Copenhagen University Hospital – Bispebjerg and Frederiksberg, Copenhagen, Denmark
Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
Search for more papers by this authorSimon Fage
Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark
Search for more papers by this authorLars Iversen
Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark
Search for more papers by this authorLone Skov
Department of Dermatology and Allergy, Copenhagen University Hospital – Herlev and Gentofte, Hellerup, Denmark
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
Search for more papers by this authorClaus Zachariae
Department of Dermatology and Allergy, Copenhagen University Hospital – Herlev and Gentofte, Hellerup, Denmark
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
Search for more papers by this authorAlexander Egeberg
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
Department of Dermatology, Copenhagen University Hospital – Bispebjerg and Frederiksberg, Copenhagen, Denmark
Search for more papers by this authorMia-Louise Nielsen
Department of Dermatology, Copenhagen University Hospital – Bispebjerg and Frederiksberg, Copenhagen, Denmark
Search for more papers by this author
Open Research
DATA AVAILABILITY STATEMENT
The data that support the findings of this article are available from the corresponding author upon reasonable request.
REFERENCES
- 1Deshpande PR, Rajan S, Sudeepthi BL, Abdul Nazir CP. Patient-reported outcomes: a new era in clinical research. Perspect Clin Res. 2011; 2(4): 137–144.
- 2Gyldenløve M, Meteran H, Sorensen JA, Fage S, Yao Y, Lindhardsen J, et al. Efficacy and safety of oral roflumilast for moderate-to-severe psoriasis-a randomized controlled trial (PSORRO). Lancet Reg Health Eur. 2023; 30:100639.
- 3Saadi DG, El-Komy MHM, Khedr H, Shawky N, Hegazy AA, Azzazi Y, et al. A randomized, controlled pilot study of oral roflumilast compared with intramuscular methotrexate for plaque and scalp psoriasis. J Am Acad Dermatol. 2024; 90: 1063–1065.
- 4Lebwohl MG, Kircik LH, Moore AY, Stein Gold L, Draelos ZD, Gooderham MJ, et al. Effect of roflumilast cream vs vehicle cream on chronic plaque psoriasis: the DERMIS-1 and DERMIS-2 randomized clinical trials. JAMA. 2022; 328(11): 1073–1084.
- 5 EMA. Summary of product characteristics (SmPC), roflumilast. Accessed June 2, 2022. https://www.ema.europa.eu/en/documents/product-information/daxas-epar-product-information_en.pdf
- 6Janjua S, Fortescue R, Poole P. Phosphodiesterase-4 inhibitors for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2020; 5(5):Cd002309.
- 7Gyldenløve M, Sorensen JA, Fage S, Meteran H, Skov L, Zachariae C, et al. 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; 91: 64–71.
- 8Wu JJ, Penfold RB, Primatesta P, Fox TK, Stewart C, Reddy SP, et al. The risk of depression, suicidal ideation and suicide attempt in patients with psoriasis, psoriatic arthritis or ankylosing spondylitis. J Eur Acad Dermatol Venereol. 2017; 31(7): 1168–1175.