Trial of Roflumilast Cream for Chronic Plaque Psoriasis

The New England Journal of Medicine
Mark G LebwohlARQ-151 201 Study Investigators

Abstract

Systemic oral phosphodiesterase type 4 (PDE-4) inhibitors have been effective in the treatment of psoriasis. Roflumilast cream contains a PDE-4 inhibitor that is being investigated for the topical treatment of psoriasis. In this phase 2b, double-blind trial, we randomly assigned adults with plaque psoriasis in a 1:1:1 ratio to use roflumilast 0.3% cream, roflumilast 0.15% cream, or vehicle (placebo) cream once daily for 12 weeks. The primary efficacy outcome was the investigator's global assessment (IGA) of a status of clear or almost clear at week 6 (assessed on a 5-point scale of plaque thickening, scaling, and erythema; a score of 0 indicates clear, 1 almost clear, and 4 severe). Secondary outcomes included an IGA score indicating clear or almost clear plus a 2-grade improvement in the IGA score for the intertriginous area and the change in the Psoriasis Area and Severity Index (PASI) score (range, 0 to 72, with higher scores indicating worse disease). Safety was also assessed. Among 331 patients who underwent randomization, 109 were assigned to roflumilast 0.3% cream, 113 to roflumilast 0.15% cream, and 109 to vehicle cream. An IGA score indicating clear or almost clear at week 6 was observed in 28% of the patients in the r...Continue Reading

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Citations

Oct 2, 2020·Journal of Cutaneous Medicine and Surgery·Zainab RidhaMelinda J Gooderham
Jan 7, 2021·The Journal of Dermatology·Masaru Honma, Kei Hayashi
Mar 26, 2021·Psoriasis : Targets and Therapy·Milica Milakovic, Melinda J Gooderham
Jan 29, 2021·Journal of the American Academy of Dermatology·Joy AssafRoland Tomb
Jun 2, 2021·The Medical Clinics of North America·Justin W MarsonMark G Lebwohl
May 21, 2021·Journal of Experimental Pharmacology·Kam Lun Ellis HonAlexander K C Leung
Jul 9, 2021·Psoriasis : Targets and Therapy·Hakim Ben AbdallahLars Iversen

Dec 4, 2020·Annales de dermatologie et de vénéréologie·E Sbidian
Oct 28, 2021·American Journal of Clinical Dermatology·Ana Maria Lé, Tiago Torres

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