罗氟司特乳膏治疗银屑病的试验数据?

Roflumilast cream contains a PDE-4 inhibitor and is currently being studied for topical treatment of psoriasis.

research methods

In this Phase 2b double-blind trial (NCT03638258), adult patients with plaque psoriasis were randomly assigned in a 1:1:1 ratio to receive 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 recovery or nearly recovery status at week 6

Test results

Of the 331 patients who underwent random assignment, 109 were assigned to roflumilast 0.3% cream, 113 to roflumilast 0.15% cream, and 109 to vehicle cream. Twenty-eight percent of patients in the roflumilast 0.3% group had a clear or mostly clear IGA score at week 6, 23% of patients in the roflumilast 0.15% group had a clear or mostly clear IGA score at week 6, and 8% of patients in the vehicle group had a clear or mostly clear IGA score at week 6.

Among the approximately 15% of patients who had at least mild intertrigeminal psoriasis at baseline, 73% of patients in the roflumilast 0.3% group had an IGA score of "none" or "basically none" at week 6 and improved their intertrigeminal area IGA score by 2 grades, compared with 44% of the roflumilast 0.15% group and 29% of the drug group.

Mean baseline PASI scores were 7.7 in the roflumilast 0.3% group, 8.0 in the roflumilast 0.15% group, and 7.6 in the drug group; mean changes from baseline at week 6 were -50.0%, -49.0%, and -17.8%, respectively. Application site reactions occurred with similar frequency in the roflumilast and drug groups.

Test conclusion

Applying once daily to psoriasis affected areas is more effective than applying a carrier cream in achieving clear or mostly resolved psoriasis after 6 weeks.

Roflumilast cream benefits

The U.S. Food and Drug Administration (FDA) approved ZORYVE (roflumilast) 0.3% cream in July 2022 for the treatment of plaque psoriasis in patients 12 years of age or older. Roflumilast has been shown to be safe and effective in multiple clinical trials, improving disease clearance in hard-to-treat areas such as knees and elbows, as well as sensitive areas such as the face. Roflumilast is a selective phosphodiesterase 4 (PDE4) inhibitor that blocks the enzyme activity of PDE4 that cleaves cyclic adenosine monophosphate (cAMP) and is the best alternative to effective topical corticosteroids.

Roflumilast cream price

At present, we know that in overseas markets, the price of roflumilast cream is about $12,420 per box, which is not fixed due to various factors such as exchange rates.

As of October 2023, roflumilast cream has not yet been launched in mainland China. Patients in need can purchase it in areas where it is already on the market, but they need to pay attention to purchasing it from regular and qualified hospital pharmacies to avoid being deceived.

You can also obtain it through domestic professional overseas medical service organizations (such as Medical Companion Travel) with a doctor's prescription. The medicine can be mailed to your home. It is guaranteed to be authentic and more cost-effective. It is recommended to consult the customer service staff for specific costs and acquisition procedures.

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References

Lebwohl MG, Papp KA, Stein Gold L, Gooderham MJ, Kircik LH, Draelos ZD, Kempers SE, Zirwas M, Smith K, Osborne DW, Trotman ML, Navale L, Merritt C, Berk DR, Welgus H; ARQ-151 201 Study Investigators. Trial of Roflumilast Cream for Chronic Plaque Psoriasis. N Engl J Med. 2020 Jul 16;383(3):229-239. doi: 10.1056/NEJMoa2000073. PMID: 32668113.