Bissonnette Robert, Papp Kim, Poulin Yves, Lauzon Gilles, Aspeslet Launa, Huizinga Robert, Mayo Patrick, Foster Robert T, Yatscoff Randall W, Maksymowych Walter P
Innovaderm Research, Montreal, Canada.
J Am Acad Dermatol. 2006 Mar;54(3):472-8. doi: 10.1016/j.jaad.2005.10.061. Epub 2006 Jan 23.
Use of current oral calcineurin inhibitors for the treatment of psoriasis is limited by toxicity.
Evaluate the safety and efficacy of ISA247, a new oral calcineurin inhibitor, in plaque psoriasis patients.
This 12-week, randomized, double-blind, placebo-controlled, parallel-group study included 201 plaque psoriasis patients with > or = 10% body surface area involvement. Patients were randomized to placebo, ISA247 0.5 mg/kg/d, and ISA247 1.5 mg/kg/d groups. End points included a 2-point reduction in the Static Global Assessment score and a 75% reduction in the Psoriasis Area and Severity Index.
A 2-point SGA reduction was achieved in 0% (placebo), 15.6% (0.5 mg/kg/d), and 45.1% (1.5 mg/kg/d) (P < .0001). A 75% reduction in the Psoriasis Area and Severity Index was achieved in 0% (placebo), 18.2% (0.5 mg/kg/d), and 66.7% (1.5 mg/kg/day) (P < .0001). While serum creatinine increased in patients treated with ISA247 1.5 mg/kg/d, it remained within the normal range.
Longer-term studies are needed to evaluate the effect of ISA247 on renal function.
ISA247 appears safe and effective for treating moderate to severe psoriasis.
目前口服钙调神经磷酸酶抑制剂用于治疗银屑病时受到毒性的限制。
评估新型口服钙调神经磷酸酶抑制剂ISA247治疗斑块状银屑病患者的安全性和有效性。
这项为期12周的随机、双盲、安慰剂对照、平行组研究纳入了201例体表面积受累≥10%的斑块状银屑病患者。患者被随机分为安慰剂组、ISA247 0.5 mg/kg/d组和ISA247 1.5 mg/kg/d组。终点包括静态整体评估评分降低2分以及银屑病面积和严重程度指数降低75%。
安慰剂组（0%）、0.5 mg/kg/d组（15.6%）和1.5 mg/kg/d组（45.1%）实现静态整体评估评分降低2分（P <.0001）。安慰剂组（0%）、0.5 mg/kg/d组（18.2%）和1.5 mg/kg/d组（66.7%）实现银屑病面积和严重程度指数降低75%（P <.0001）。虽然接受1.5 mg/kg/d ISA247治疗的患者血清肌酐升高，但仍在正常范围内。
需要进行长期研究以评估ISA247对肾功能的影响。
ISA247治疗中度至重度银屑病似乎安全有效。
