J Drugs Dermatol. 2023 Jul 1;22(7):668-672. doi: 10.36849/JDD.7497.
Psoriasis affects diverse racial and ethnic groups. In July 2021, the US Food and Drug Administration approved calcipotriene/betamethasone dipropionate (CAL/BDP) 0.005%/0.065% cream to treat plaque psoriasis in adults. The efficacy and safety of CAL/BDP in patients with skin of color (SOC) who have psoriasis is not well characterized.
A post hoc analysis of phase 3 clinical trial data (NCT03308799) was conducted to assess the efficacy, convenience, and safety of CAL/BDP cream versus CAL/BDP topical solution and vehicle cream in people with Fitzpatrick skin types IV to VI. Results: This study included 784 participants, 280 (35.7%) of whom had Fitzpatrick skin types IV to VI. Patients treated with CAL/BDP cream had greater disease improvement, treatment convenience scores, and overall satisfaction than those treated with CAL/BDP topical solution in the subgroup with skin types IV to VI and the total study population. Adverse event rates were similar between the subgroup with skin types IV to VI and the total study population for all treatment arms. Conclusion: Psoriasis is associated with a greater physical and psychosocial impact in patients with SOC. While many effective topical therapies exist, it may be helpful to conduct separate analyses of patients with SOC to assess the efficacy and safety of treatment in this population. This sub-analysis of phase 3 clinical trial data supports the efficacy and safety of CAL/BDP cream in the treatment of plaque psoriasis in patients with SOC. CAL/BDP cream also had greater convenience, formula acceptability, and overall satisfaction in both the subgroup with SOC and the total trial population, which may improve adherence to topical therapy and treatment outcomes for people with SOC who have psoriasis. Kontzias CL, Curcio A, Gorodokin B, et al. Efficacy, convenience, and safety of calcipotriene-betamethasone dipropionate cream in skin of color patients with plaque psoriasis. J Drugs Dermatol. 2023;22(7):668-672. doi:10.36849/JDD.7497.
银屑病影响着不同种族和民族的人群。2021 年 7 月,美国食品和药物管理局批准卡泊三醇/倍他米松双丙酸酯(CAL/BDP)0.005%/0.065%乳膏用于治疗成人斑块状银屑病。CAL/BDP 在有色人种(SOC)银屑病患者中的疗效和安全性尚未得到充分描述。
对 3 期临床试验数据(NCT03308799)进行了一项事后分析,以评估 CAL/BDP 乳膏与 CAL/BDP 局部溶液和载体乳膏在 Fitzpatrick 皮肤类型 IV 至 VI 的人群中的疗效、便利性和安全性。
这项研究纳入了 784 名参与者,其中 280 名(35.7%)为 Fitzpatrick 皮肤类型 IV 至 VI。在皮肤类型 IV 至 VI 的亚组和总研究人群中,与 CAL/BDP 局部溶液治疗相比,CAL/BDP 乳膏治疗的患者疾病改善程度更大、治疗便利性评分和总体满意度更高。在皮肤类型 IV 至 VI 的亚组和总研究人群中,所有治疗组的不良反应发生率相似。
银屑病会给 SOC 患者带来更大的身体和心理社会影响。虽然有许多有效的局部治疗方法,但对 SOC 患者进行单独分析以评估治疗的疗效和安全性可能会有所帮助。这项 3 期临床试验数据的亚组分析支持 CAL/BDP 乳膏在 SOC 患者斑块状银屑病治疗中的疗效和安全性。在 SOC 亚组和总试验人群中,CAL/BDP 乳膏的便利性、配方接受度和总体满意度也更高,这可能会提高 SOC 患者对局部治疗的依从性和治疗结果。Kontzias CL、Curcio A、Gorodokin B 等人。卡泊三醇/倍他米松双丙酸酯乳膏在斑块状银屑病 SOC 患者中的疗效、便利性和安全性。J 皮肤病学杂志。2023;22(7):668-672。doi:10.36849/JDD.7497。