Feldman Steven R, Koo John Y M, Johnson Lori A, Preston Norman J
Center for Dermatology Research, Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
Cutis. 2009 Oct;84(4 Suppl):25-32.
Moderate to severe psoriasis often requires systemic treatment, but even biologic medications do not always induce complete clearing in patients. In many instances, physicians supplement biologic treatment with topical agents as adjunctive therapy to obtain additional clearing of plaques. To evaluate the effectiveness of the addition of a superpotent corticosteroid--clobetasol propionate spray 0.05%--to various psoriasis treatments, a phase 4, multicenter, open-label, community-based trial was conducted. In this study, clobetasol propionate spray 0.05% applied twice daily was added on to a variety of existing stable treatments including systemic biologic agents in participants with moderate, severe, or very severe plaque psoriasis. The decision to add clobetasol propionate spray 0.05% to stable psoriasis therapy was determined by each investigator based on his/her evaluation of a participant's needs. A total of 159 participants from the trial adhered to stable (> or = 3 months' duration) therapeutic regimens that included a biologic treatment. In this population, at the end of the study period, 81.0% of participants with moderate disease at baseline, 79.5% of participants with severe disease at baseline, and 58.8% of participants with very severe disease at baseline were rated as clear or almost clear (target plaque severity [TPS]). Worst skin tolerability response was assessed postbaseline and included erythema (20.3% mild, 8.9% moderate, 1.9% severe), peeling (26.6% mild, 7.0% moderate, 1.3% severe), dryness (34.8% mild, 8.9% moderate, 1.3% severe), and stinging (25.3% mild, 3.8% moderate, 0.6% severe). Telangiectasia and skin atrophy were reported in 1.3% of participants each at some point during the study (postbaseline). Pruritus was reported in 7.6% of participants and folliculitis was reported in 1.9% of participants. Eight participants experienced adverse events (AEs) that were regarded as probably related to the study medication (clobetasol propionate spray 0.05%). Because those participants who entered the study already were receiving one medication (the biologic agent), it is believed that most of the reported AEs were due to the addition of clobetasol propionate spray 0.05%, and those AEs associated with the biologic agent and/or the combination of the two may be underreported. Although the results of this study are intriguing, further research is needed to evaluate if the addition of topical therapies, such as superpotent corticosteroids, are effective and safe options for treating psoriasis plaques when control with biologic therapy is not fully effective on its own.
中度至重度银屑病通常需要进行全身治疗，但即使是生物药物也并非总能使患者完全清除症状。在许多情况下，医生会使用局部用药作为辅助疗法来补充生物治疗，以进一步清除斑块。为了评估添加超强效皮质类固醇——0.05%丙酸氯倍他索喷雾剂——到各种银屑病治疗方案中的有效性，开展了一项4期、多中心、开放标签、基于社区的试验。在本研究中，对于中度、重度或极重度斑块状银屑病患者，将每日两次应用的0.05%丙酸氯倍他索喷雾剂添加到包括全身生物制剂在内的多种现有稳定治疗方案中。是否添加0.05%丙酸氯倍他索喷雾剂到稳定的银屑病治疗方案中，由每位研究者根据其对参与者需求的评估来决定。该试验共有159名参与者坚持采用稳定（持续时间≥3个月）的治疗方案，这些方案包括生物治疗。在这个群体中，在研究期结束时，基线为中度疾病的参与者中有81.0%、基线为重度疾病的参与者中有79.5%、基线为极重度疾病的参与者中有58.8%被评定为清除或几乎清除（目标斑块严重程度 [TPS]）。在基线后评估了最差皮肤耐受性反应，包括红斑（轻度20.3%，中度8.9%，重度1.9%）、脱皮（轻度26.6%，中度7.0%，重度1.3%）、干燥（轻度34.8%，中度8.9%，重度1.3%）和刺痛（轻度25.3%，中度3.8%，重度0.6%）。在研究期间（基线后）的某个时间点，分别有1.3%的参与者报告了毛细血管扩张和皮肤萎缩。7.6%的参与者报告有瘙痒，1.9%的参与者报告有毛囊炎。8名参与者经历了被认为可能与研究药物（0.05%丙酸氯倍他索喷雾剂）相关的不良事件（AE）。由于那些进入研究的参与者已经在接受一种药物（生物制剂）治疗，所以据信大多数报告的不良事件是由于添加了0.05%丙酸氯倍他索喷雾剂所致，而那些与生物制剂和/或两者联合相关的不良事件可能未被充分报告。尽管本研究的结果很有趣，但仍需要进一步研究来评估添加局部治疗，如超强效皮质类固醇，在生物治疗单独控制不完全有效时，是否是治疗银屑病斑块的有效且安全的选择。
