Hung Yi-Teng, Lin Yu-Jr, Chiu Hsien-Yi, Huang Yu-Huei
Department of Dermatology, Chang Gung Memorial Hospital, Linkou Branch, Taoyuan City.
Research Services Center for Health Information, Chang Gung University, Taoyuan City.
Ther Adv Chronic Dis. 2021 Sep 29;12:20406223211046685. doi: 10.1177/20406223211046685. eCollection 2021.
Real-life data on patients with psoriasis treated with guselkumab are few and are needed to compare with trial-based data. We investigated the effect of clinical factors on real-world effectiveness of guselkumab.
This multicentre study retrospectively included 135 patients with psoriasis treated with guselkumab from June 2018 until November 2020. Effectiveness was assessed using the degree of improvement in the Psoriasis Area and Severity Index (PASI) scores at baseline and after 4, 12, 20, 28, and 36 weeks. Predictors of effectiveness were also evaluated.
At week 36, 67% of the patients achieved PASI 75. Multivariate logistic regression analysis revealed that heavier patients were less likely to achieve PASI 75 at week 4 than patients with lower body weights. Fewer patients exposed to only one biologic achieved PASI 75 at weeks 4, 20, 28, and 36 [odds ratio (OR) = 0.08 (95% CI, 0.01-0.48), 0.21 (95% CI, 0.05-0.74), 0.04 (95% CI, 0.00-0.35), and 0.07 (95% CI, 0.00-0.68), respectively] than biologic-naïve patients. Patients previously treated with more than one biologic were less likely to achieve PASI 75 at weeks 12, 20, 28, and 36 [OR = 0.05 (95% CI, 0.01-0.22), 0.03 (95% CI, 0.01-0.16), 0.00 (95% CI, 0.00-0.03), and 0.00 (95% CI, 0.00-0.044), respectively] than biologic-naïve patients. Patients with previous anti-interleukin (IL)-17 exposure, rather than tumour necrosis factor-α and IL-12/23 inhibitors, had lower PASI improvements to guselkumab than biologic-naïve patients at weeks 12, 20, and 28 [OR = 0.19 (95% CI, 0.03-0.90), 0.10 (95% CI, 0.02-0.55), and 0.03 (95% CI, 0.00-0.29), respectively].
The effectiveness of guselkumab was compromised in a real-world setting. Delayed onset of therapeutic response was noted in heavier patients. Biologic exposure, the number of previously used biologics, and previous exposure to IL-17 inhibitors were clinical predictors of a reduced response to guselkumab. Physicians may share this information with patients to make treatment decisions.
关于接受古塞库单抗治疗的银屑病患者的真实世界数据较少，需要与基于试验的数据进行比较。我们研究了临床因素对古塞库单抗在现实世界中的疗效的影响。
这项多中心研究回顾性纳入了2018年6月至2020年11月期间接受古塞库单抗治疗的135例银屑病患者。使用银屑病面积和严重程度指数（PASI）评分在基线时以及4、12、20、28和36周后的改善程度来评估疗效。还评估了疗效的预测因素。
在第36周时，67%的患者达到了PASI 75。多因素逻辑回归分析显示，体重较重的患者在第4周时达到PASI 75的可能性低于体重较轻的患者。在第4、20、28和36周时，仅接受过一种生物制剂治疗的患者达到PASI 75的人数少于未使用过生物制剂的患者[比值比（OR）分别为0.08（95%置信区间，0.01 - 0.48）、0.21（95%置信区间，0.05 - 0.74）、0.04（95%置信区间，0.00 - 0.35）和0.07（95%置信区间，0.00 - 0.68）]。既往接受过一种以上生物制剂治疗的患者在第12、20、28和36周时达到PASI 75的可能性低于未使用过生物制剂的患者[OR分别为0.05（95%置信区间，0.01 - 0.22）、0.03（95%置信区间，0.01 - 0.16）、0.00（95%置信区间，0.00 - 0.03）和0.00（95%置信区间，0.00 - 0.044）]。在第12、20和28周时，既往接触过抗白细胞介素（IL）-17的患者，而非肿瘤坏死因子-α和IL-12/23抑制剂的患者，与未使用过生物制剂的患者相比，对古塞库单抗的PASI改善较低[OR分别为0.19（95%置信区间，0.03 - 0.90）、0.10（95%置信区间，0.02 - 0.55）和0.03（95%置信区间，0.00 - 0.29）]。
在现实世界中，古塞库单抗的疗效受到影响。体重较重的患者治疗反应起效延迟。生物制剂暴露、既往使用生物制剂的次数以及既往接触IL-17抑制剂是对古塞库单抗反应降低的临床预测因素。医生可以与患者分享这些信息以做出治疗决策。
