Sorensen Eric P, Fanucci Kristina A, Saraiya Ami, Volf Eva, Au Shiu-chung, Argobi Yahya, Mansfield Ryan, Gottlieb Alice B
J Drugs Dermatol. 2015 Aug;14(8):893-8.
Additional studies are needed to examine the efficacy of ustekinumab in psoriasis patients who have previously been exposed to tumor necrosis factor inhibitors (TNFi).
To examine the predictive effect of TNFi primary failure and the number of TNFi exposures on the efficacy of ustekinumab in psoriasis treatment.
This retrospective study examined 44 psoriasis patients treated at the Tufts Medical Center Department of Dermatology between January 2008 and July 2014. Patients were selected if they were treated with ustekinumab and had ≥ 1 previous TNFi exposure. The following subgroups were compared: patients with vs without a previous TNFi primary failure, and patients with one vs multiple previous TNFi exposures. The efficacy measure used was the previously validated Simple Measure for Assessing Psoriasis Activity (S-MAPA), which is calculated by the product of the body surface area and physician global assessment. The primary outcome was the percentage improvement S-MAPA from course baseline at week 12 of ustekinumab treatment. Secondary outcomes were the psoriasis clearance, primary failure, and secondary failure rates with ustekinumab treatment.
Patients with a previous TNFi primary failure had a significantly lower percentage improvement in S-MAPA score at week 12 of ustekinumab treatment compared with patients without TNFi primary failure (36.2% vs 61.1%, P=.027). Multivariate analysis demonstrated that this relationship was independent of patient demographics and medical comorbidities. Patients with multiple TNFi exposures had a non-statistically significant lower percentage S-MAPA improvement at week 12 (40.5% vs 52.9%, P=.294) of ustekinumab treatment compared with patients with a single TNFi exposure.
Among psoriasis patients previously exposed to TNFi, a history of a previous TNFi primary failure predicts a decreased response to ustekinumab independent of patient demographics and medical comorbidities.
需要进行更多研究以检验乌司奴单抗在既往曾接触过肿瘤坏死因子抑制剂(TNFi)的银屑病患者中的疗效。
探讨TNFi原发性失败和TNFi暴露次数对乌司奴单抗治疗银屑病疗效的预测作用。
这项回顾性研究纳入了2008年1月至2014年7月在塔夫茨医疗中心皮肤科接受治疗的44例银屑病患者。入选患者需接受过乌司奴单抗治疗且既往至少有1次TNFi暴露。比较以下亚组:有或无既往TNFi原发性失败的患者,以及有1次或多次既往TNFi暴露的患者。疗效评估采用先前验证的评估银屑病活动度简易量表(S-MAPA),其计算方法为体表面积与医生整体评估的乘积。主要结局是乌司奴单抗治疗第12周时S-MAPA较疗程基线的改善百分比。次要结局是乌司奴单抗治疗的银屑病清除率、原发性失败率和继发性失败率。
与无TNFi原发性失败的患者相比,既往有TNFi原发性失败的患者在乌司奴单抗治疗第12周时S-MAPA评分的改善百分比显著更低(36.2%对61.1%,P = 0.027)。多因素分析表明,这种关系独立于患者人口统计学特征和合并疾病。与有单次TNFi暴露的患者相比,有多次TNFi暴露的患者在乌司奴单抗治疗第12周时S-MAPA改善百分比略低,但无统计学意义(40.5%对52.9%,P = 0.294)。
在既往接触过TNFi的银屑病患者中,既往TNFi原发性失败史预示着独立于患者人口统计学特征和合并疾病的情况下对乌司奴单抗的反应降低。