替西罗莫司乳膏联合卤米松乳膏治疗中重度斑块状银屑病。

Tildrakizumab in Combination With Topical Halcinonide 0.1% Ointment for Treating Moderate to Severe Plaque Psoriasis.

出版信息

J Drugs Dermatol. 2023 Aug 1;22(8):766-772. doi: 10.36849/jdd.6830.

Abstract

BACKGROUND

This prospective, open-label study evaluated the effectiveness and safety of tildrakizumab plus topical halcinonide ointment in psoriasis patients.

METHODS

Adults (age greater than or equal to 18 years) with moderate to severe plaque psoriasis (body surface area [BSA] greater than or equal to 10%, physician's global assessment [PGA] greater than or equal to 3, psoriasis area severity index [PASI] greater than or equal to 12) received tildrakizumab (100 mg; s.c.) at weeks 0, 4, and 16. Patients with BSA >3% at week 16 received additional halcinonide 0.1% twice daily for 4 weeks (week 20) and were followed for another 4 weeks (week 24); those with BSA less than or equal to 3% were followed to week 24.

RESULTS

Twenty-five patients were enrolled (mean age 52.6 years; 68% male). The proportion of all patients achieving BSA less than or equal to 3% was 52.2% at week 16, 73.7% at week 20 (after 4 weeks of adjunctive halcinonide in patients with BSA >3% at week 16), and 84.2% at week 24 (4 weeks after halcinonide discontinuation). PASI 75 was attained in 60.9% of all patients at week 16, and 73.7% at weeks 20 and 24. In patients adding halcinonide, improvements from baseline in mean BSA, PGA, and PGA x BSA increased from week 16 (55%, 29%, and 64%, respectively) to week 20 (78%, 51%, and 88%, respectively), and were maintained through week 24. Quality of life improved with tildrakizumab monotherapy and further with adjunctive halcinonide. Adverse events (AEs) were infrequent. No serious AEs or discontinuations due to AEs were noted.

CONCLUSION

Tildrakizumab plus topical halcinonide ointment is safe and effective in controlling psoriasis for patients inadequately responding to tildrakizumab monotherapy.Bagel J, Novak K, Nelson E. Tildrakizumab in combination with topical halcinonide 0.1% ointment for treating moderate to severe plaque psoriasis. J Drugs Dermatol. 2023;22(8):766-772. doi:10.36849/JDD.6830.

摘要

背景

这项前瞻性、开放标签研究评估了替度鲁单抗联合外用哈西奈德软膏在银屑病患者中的疗效和安全性。

方法

年龄大于等于 18 岁的中重度斑块状银屑病患者（体表面积 [BSA]大于等于 10%，医生整体评估 [PGA]大于等于 3，银屑病面积严重指数 [PASI]大于等于 12）接受替度鲁单抗（100mg；皮下注射），在第 0、4 和 16 周。第 16 周 BSA 大于 3%的患者接受哈西奈德 0.1%软膏每日两次外用共 4 周（第 20 周），并在第 24 周继续随访；第 16 周 BSA 小于或等于 3%的患者在第 24 周继续随访。

结果

共纳入 25 例患者（平均年龄 52.6 岁；68%为男性）。第 16 周所有患者 BSA 小于或等于 3%的比例为 52.2%，第 20 周为 73.7%（第 16 周 BSA 大于 3%的患者在接受哈西奈德治疗 4 周后），第 24 周为 84.2%（哈西奈德停药后 4 周）。所有患者在第 16 周 PASI75 的比例为 60.9%，第 20 周和第 24 周为 73.7%。使用哈西奈德的患者，从第 16 周开始，BSA、PGA 和 PGA x BSA 的平均改善分别为 55%、29%和 64%，第 20 周分别为 78%、51%和 88%，并持续至第 24 周。替度鲁单抗单药治疗和联合哈西奈德可改善生活质量。不良事件（AE）少见。未观察到严重 AE 或因 AE 而停药。