罗氟司特乳膏(roflumilast)治疗银屑病的优势有哪些？

Author: Medicalhalo

Release time: 2025-10-19 11:44:20

Unlike other topical drugs, roflumilast cream is safer and can treat cartilage areas. It is not irritating to the skin and can be used continuously and for a long time without making the skin thinner. The effect is obvious.

High safety profile

Common reports include diarrhea, pain at the administration site, nausea, headache, insomnia, upper respiratory tract infection, and urinary tract infection. Most adverse events were mild or moderate in severity, with few application site reactions reported among participants.

The phosphodiesterase type 4 inhibitor roflumilast cream (roflumilast) was studied in Phase III and significantly improved lesions and itching, with no reported side effects.

Unique treatment area

In the Phase III study, 48% of patients treated with roflumilast had an investigator global assessment score of clear or almost clear at week 8.

The unique advantage of this cream is that it successfully treats the intercartilage area and reduces itching symptoms, the results of which can significantly improve the patient's quality of life. Roflumilast cream (roflumilast) was evaluated as an option for use in the interchondral area with favorable results in a small sample,

Therapeutic efficacy was significant

Roflumilast cream (roflumilast), a topical phosphodiesterase-4 (PDE-4) inhibitor recently approved for the treatment of plaque psoriasis, is also indicated for use in the interchondral area. The active ingredient roflumilast inhibits PDE-4, thereby suppressing the pro-inflammatory immune response in psoriatic lesions.

Two Phase 3 clinical trials demonstrated the efficacy of once-daily application of roflumilast cream to treat plaque psoriasis in patients 12 years of age and older. At Week 8, an Investigator's Global Assessment Score of 0 or 1, level 2 compared to baseline, the primary efficacy endpoint, was observed in 39.1% (225/576) of patients receiving roflumilast cream, compared with 6.6% (20/305) of patients receiving vehicle.

Background: Systemic oral phosphodiesterase type 4 (PDE-4) inhibitors are effective in the treatment of psoriasis. Roflumilast cream contains a PDE-4 inhibitor and is being studied as a topical treatment for psoriasis.

Methods: This study used a phase 2b double-blind clinical study, in which patients were treated with 0.3% roflumilast cream (roflumilast), 0.15% roflumilast cream (roflumilast), or vehicle (placebo) once daily in a 1:1:1 ratio for a total of 12 weeks. The primary effectiveness outcome was the researcher's overall assessment (IGA) of clean or nearly clean conditions in the sixth week (0=clear, 1=basically clear, 4=severe).

Results: Among 331 patients who underwent randomization, 109 were assigned to the roflumilast 0.3% cream group, 113 to the roflumilast 0.15% cream group, and 109 to the excipient cream group. At week six, 28% of the 0.3% roflumilast group, 23% of the 0.15% roflumilast group, and 8% of the vehicle group had clear IGA scores.

Of the approximately 15% of patients who had at least mild baseline interchondral psoriasis, 29% of patients in the vehicle group, 44% of patients in the roflumilast 0.15% group, and 73% of patients in the roflumilast 0.3% group showed a clear or almost clear IGA score plus a grade 2 improvement in the interchondral area IGA score at Week 6.

Mean baseline PASI scores were 7.7 in the 0.3% roflumilast group, 8.0 in the 0.15% roflumilast group, and 7.6 in the vehicle group. Compared with the baseline, the average change rates in week 6 were -50.0%, -49.0%, and -17.8%. The incidence of application site reactions was similar in the roflumilast and vehicle groups.

Conclusion: Roflumilast cream (roflumilast) applied once daily to psoriasis affected areas can achieve a clear or nearly transparent state after 6 weeks compared with vehicle cream.

Can be used for a long time

Roflumilast cream (roflumilast) contains 3 mg (0.3%) of roflumilast per gram. The main ingredient is roflumilast. It does not contain hormones, is not irritating to the skin, and does not produce the side effects of hormone drugs. It also has anti-inflammatory and immune-regulating effects, so patients can use it for a long time under the guidance of a doctor without causing skin thinning.

Easy to use

Roflumilast cream (roflumilast) is in the form of a cream, which is easy to apply and absorbed quickly, making it convenient for patients to use.

Summary

Roflumilast cream (roflumilast) has obvious effects in treating psoriasis, and has the advantages of being easy to use and non-irritating to the skin. Patients can use it correctly under the guidance of a doctor. Psoriasis patients should keep their skin clean at ordinary times, strengthen skin protection in winter and spring, and use sun therapy. Develop good sleeping habits and ensure adequate sleep to help recover from illness.