Study suggests roflumilast may be effective as a treatment for plaque psoriasis

Roflumilast cream has been shown to be effective in patients with plaque psoriasis after 8 weeks of use, according to research.

Although known for its use in the treatment of chronic obstructive pulmonary disease, roflumilast has been evaluated in 2 clinical trials as a topical treatment for plaque psoriasis. It is a phosphodiesterase 4 (PDE4) inhibitor that is both potent and selective.

The efficacy and safety of roflumilast topical cream as a treatment for plaque psoriasis was examined in two phase 3 trials. The research team for both trials was led by Mark G. Lebwohl, MD, and Leon H. Kircik, MD, of the Icahn School of Medicine at Mount Sinai in New York.

“Treating psoriasis in the intertriginous areas can be difficult because the skin in the intertriginous areas is thinner and more sensitive, allows for better drug absorption, and is prone to adverse effects associated with topical therapies,” Lebwohl and colleagues wrote. “The results reported here indicate that roflumilast may be an effective therapy for these difficult-to-treat areas.”

Research and methods

The 2 clinical trials – DERMIS-1 and DERMIS-2 – were parallel-group, double-blind, vehicle-controlled studies, with a combined total of 881 participants recruited. People recruited for the studies had to be 2 years of age or older and have been clinically diagnosed with plaque psoriasis for 6 months. The children needed a diagnosis only 3 months before.

Investigators required that patients with psoriasis of the extremities, trunk, face and/or intertriginous areas have plaque psoriasis affecting between 2 and 20% of the body surface area excluding the palms, scalp and of the soles of the feet, in order to be included. At a minimum, the Investigator’s Overall Assessment (IGA) score had to be low for participation to be permitted.

The research team randomized eligible participants 2-to-1 to receive 0.3% roflumilast cream or carrier cream once daily. Everyone involved, including patients, clinical staff, investigators and sponsors were unaware of the individual treatments.

Investigators defined the primary efficacy endpoint as patients receiving a clear or almost clear score on the IGA scale, as well as a 2-grade improvement from baseline at the end of 8 weeks of the test. They had 9 secondary endpoints, including intertriginous IGA assessment success, Worst Itch Numerical Rating Scale (WI-NRS) score, and a reduction in Psoriasis Area and Severity (PASI) score. Index).

Study results

At week 8 of the DERMIS-1 study, investigators found that 108 participants (42.4%) treated with roflumilast achieved the primary endpoint, compared to 8 participants (6.1%) treated with with vehicle (difference, 39.6%; 95% CI, 32.3 – 46.9%; P = 0.001). At 8 weeks in DERMIS-2, they found that 99 participants (37.5%) treated with roflumilast achieved the primary endpoint, compared to 9 participants (6.9%) in the vehicle arm (difference 28. 8%, 95% CI, 20.8 – 36.9%; P = 0.001).

Overall, the investigators observed statistically significant percentages of IGA success at 8 weeks in the treatment arms of both trials compared to the control groups. They found that of the 9 secondary endpoints, statistically significant differences in favor of roflumilast over vehicle treatment were reported in both trials, including intertriginous IGA success, PASI score, and success of the WI-NRS.

Additionally, they found that topically administered roflumilast had lower rates of adverse effects than oral PDE4 inhibitors. Investigators found that 17 of 18 participants in the treatment group from both trials, who reported diarrhea as an AE, reported mild cases. The majority of AEs were reported at the start of the 2-week treatment period and resolved after continued dosing.

The researchers added that these results indicate that roflumilast may be more effective for the treatment of intertriginous skin, since topical therapies generally have a harder time treating psoriasis in these areas due to the thinner and more sensitive.

“In current randomized clinical trials, few stinging, burning, or application site reactions have been reported with roflumilast or vehicle, including among the subpopulation that used roflumilast in the intertriginous areas, consistent with previous studies of topical roflumilast in psoriasis and atopic dermatitis,” they wrote.

Although the researchers state that further research will be needed to examine the long-term safety and effectiveness compared to alternative treatments, the results of both trials indicate positive results for the potential use of the treatment for plaque psoriasis. .

The study, “Effect of Roflumilast Cream vs Vehicle Cream on Chronic Plaque Psoriasis – The DERMIS-1 and DERMIS-2 Randomized Clinical Trials,” was published online by JAMA.