Enstilar喷剂治疗银屑病的试验数据是怎样的?

Trial of Enstilar spray to treat psoriasis

Clinical trials have proven that fixed-dose calcipotriol/betamethasone aerosol foam (Cal/BD, Enstilar) is effective in treating patients with scalp psoriasis. However, data on the actual efficacy of calcipotriol/betamethasone aerosol foam in this patient subpopulation are lacking. Therefore, this study investigated the efficacy and tolerability of Cal/BD aerosol foam treatment for 4 weeks in daily clinical practice in patients with scalp psoriasis.

research methods

This prospective, non-interventional, multicenter study involved 217 adult patients with scalp psoriasis who received 4 weeks of Cal/BD (Enstilar) aerosol foam treatment. Primary endpoints include the proportion of patients with <10% scalp area affected (Scalp-BSA) and "mild" scalp PGA after 4 weeks, and the proportion of patients with an absolute PSSI score of ≤2 points after 4 weeks. Secondary endpoints included patient-reported erythema, pruritus, scaling, and thickness changes at baseline, 3 days, 1 week, 2 weeks, and 4 weeks.

Test results

After 4 weeks, 53.4% of patients treated with Cal/BD aerosol foam had scalp-BSA <10% and scalp-PGA mild. Additionally, 47.6% of patients had PSSI ≤2. Itching and other symptoms (induration, erythema, and scaling) improved within 3 days. The proportion of patients who reported that scalp psoriasis had no impact on their quality of life (Dermatology Quality of Life Index 0/1 point) increased from 3.2% at baseline to 47.9% at the end of the study. Patient satisfaction with treatment was high.

Overall, 97.4% of primary care providers rated the tolerability of Cal/BD(R) aerosol foam as "good"/"very good" with no new safety concerns.

Test conclusion

This study demonstrates that Cal/BD (Enstilar) aerosol foam has the characteristics of good efficacy, rapid onset of action, good tolerability and safety in the actual treatment of patients with scalp psoriasis.

How Enstilar works

Enstilar is a combination product of calcipotriol (a vitamin D analog) and betamethasone dipropionate (a corticosteroid). Enstilar is the first spray foam psoriasis drug. It is a once-daily, alcohol-free foam preparation that can be used on most skins all over the body and is easy for patients to carry and use. Enstilar was approved by the U.S. Food and Drug Administration (FDA) in October 2020 for the topical treatment of plaque psoriasis in patients ≥12 years old.

Enstilar usage and dosage

Shake can before using Enstilar Styrofoam. Apply Enstilar Foam to the affected area once daily for 4 weeks. The maximum should not exceed 60 grams every 4 days. Gently rub into Enstilar foam. Please wash your hands after using this product. When control is reached, stop the Enstilar foam.

Enstilar Foam should not be used on the face, groin or armpits, or if skin atrophy is present in the treatment area.

Enstilar Foam is not intended for oral, ophthalmic, or intravaginal use.

Enstilar is effective in treating psoriasis and can improve patients' quality of life. It is recommended that patients follow the doctor's instructions and not use it blindly to avoid adverse effects.

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References

Pinter A, Green LJ, Selmer J, Praestegaard M, Gold LS, Augustin M; trial investigator group. A pooled analysis of randomized, controlled, phase 3 trials investigating the efficacy and safety of a novel, fixed dose calcipotriene and betamethasone dipropionate cream for the topical treatment of plaque psoriasis. J Eur Acad Dermatol Venereol. 2022 Feb;36(2):228-236. doi: 10.1111/jdv.17734. Epub 2021 Nov 5. PMID: 34628687.