Efficacy of Roflumilast in the Treatment of Psoriasis

Summary

Roflumilast (Daxas®), a selective, long-acting inhibitor of the enzyme phosphodiesterase-4 (PDE4), is used for severe chronic obstructive pulmonary disease. Recent research suggest roflumilast is effective in treating psoriasis. The aim of this investigator-initiated trial is to study the efficacy of oral roflumilast in patients with plaque psoriasis. This has not previously been done.

Timeline

Start

2021-01-01

Primary completion

2022-12-12

Completion

2022-12-12

Publications

• Baez E, Gyldenlove M, Ben Abdallah H, Emmanuel T, Sorensen JA, Thomsen SF, Zachariae C, Egeberg A, Skov L, Iversen L, Johansen C. Oral Roflumilast Suppresses Proinflammatory Cytokine Signaling and Reduces CD4+ T-Cell and Neutrophil Infiltration in Psoriasis. J Invest Dermatol. 2025 Dec;145(12):3079-3088.e3. doi: 10.1016/j.jid.2025.04.034. Epub 2025 May 20.
• Gyldenlove M, Meteran H, Sorensen JA, Fage S, Yao Y, Lindhardsen J, Nissen CV, Todberg T, Thomsen SF, Skov L, Zachariae C, Iversen L, Nielsen ML, Egeberg A. Efficacy and safety of oral roflumilast for moderate-to-severe psoriasis-a randomized controlled trial (PSORRO). Lancet Reg Health Eur. 2023 Apr 21;30:100639. doi: 10.1016/j.lanepe.2023.100639. eCollection 2023 Jul.

Drugs

Indications