Medical College of Wisconsin, Milwaukee, WI, USA.
University of Southern California, Los Angeles, CA, USA.
J Eur Acad Dermatol Venereol. 2018 Nov;32(11):1940-1949. doi: 10.1111/jdv.15012. Epub 2018 Jul 18.
Anxiety and depression are clinically significant comorbidities associated with psoriasis. Improvements in psoriasis are known to decrease anxiety and depression. Guselkumab, an anti-interleukin-23 monoclonal antibody, has demonstrated efficacy and safety for the treatment of moderate-to-severe psoriasis.
Assess improvements in anxiety and depression with guselkumab vs. placebo and adalimumab using the Hospital Anxiety and Depression Scale (HADS).
In VOYAGE 2, a Phase 3, randomized, double-blind, placebo- and adalimumab-controlled study, patients received placebo (through week 16 followed by crossover to guselkumab), guselkumab, or adalimumab through week 24. HADS consists of two subscales measuring anxiety (HADS-A) and depression (HADS-D), with scores ranging from 0 to 21 and higher scores indicating more severe symptoms. Scores ≥8 indicate instrument-defined anxiety or depression. Severity of psoriasis was assessed using the Psoriasis Area and Severity Index (PASI).
Among 989 patients randomized (with baseline HADS measurements), mean HADS-A and HADS-D scores were 6.8 ± 4.2 and 5.3 ± 4.2, respectively; 38.6% of patients reported HADS-A ≥8 and 27.7% HADS-D ≥8 at baseline. At week 16, a significantly greater proportion of guselkumab patients with baseline HADS-A or HADS-D ≥8 reported HADS-A <8 (51.4% vs. 25.9%; P < 0.001) or HADS-D <8 (59.2% vs. 27.0%; P < 0.001) vs. placebo patients. At week 24, a greater proportion of guselkumab patients with baseline HADS-A or HADS-D ≥8 reported HADS-A <8 (58.4% vs. 42.9%; P = 0.028) or HADS-D <8 (59.8% vs. 46.4%; P = 0.079) vs. adalimumab patients. PASI improvements correlated with improvement in anxiety (r = 0.27; P < 0.0001) and depression (r = 0.25; P < 0.0001) scores in patients with baseline HADS-A or HADS-D ≥8. Greater improvements in HADS were also observed at week 16 in guselkumab-treated patients vs. placebo using a more stringent cut-off of HADS ≥11.
Guselkumab treatment was associated with greater improvements in symptoms of anxiety and depression scores in patients with psoriasis compared with placebo and adalimumab.
焦虑和抑郁是与银屑病相关的具有临床意义的共病。改善银屑病可降低焦虑和抑郁。抗白细胞介素-23 单克隆抗体古塞单抗已被证明对中重度银屑病的治疗有效且安全。
使用医院焦虑和抑郁量表（HADS）评估古塞单抗与安慰剂和阿达木单抗相比治疗焦虑和抑郁的改善情况。
在一项 3 期、随机、双盲、安慰剂对照和阿达木单抗对照的 VOYAGE 2 研究中，患者接受安慰剂（第 16 周后交叉至古塞单抗）、古塞单抗或阿达木单抗，直至第 24 周。HADS 由两个子量表组成，分别评估焦虑（HADS-A）和抑郁（HADS-D），评分范围为 0 到 21，分数越高表示症状越严重。得分≥8 表示仪器定义的焦虑或抑郁。银屑病严重程度采用银屑病面积和严重程度指数（PASI）评估。
在 989 名随机分组的患者（有基线 HADS 测量值）中，平均 HADS-A 和 HADS-D 评分分别为 6.8±4.2 和 5.3±4.2；基线时，38.6%的患者报告 HADS-A≥8，27.7%的患者报告 HADS-D≥8。在第 16 周时，与安慰剂患者相比，基线 HADS-A 或 HADS-D≥8 的古塞单抗患者报告 HADS-A<8（51.4%比 25.9%；P<0.001）或 HADS-D<8（59.2%比 27.0%；P<0.001）的比例显著更高。在第 24 周时，与阿达木单抗患者相比，基线 HADS-A 或 HADS-D≥8 的古塞单抗患者报告 HADS-A<8（58.4%比 42.9%；P=0.028）或 HADS-D<8（59.8%比 46.4%；P=0.079）的比例更高。在基线 HADS-A 或 HADS-D≥8 的患者中，银屑病的改善与焦虑（r=0.27；P<0.0001）和抑郁（r=0.25；P<0.0001）评分的改善相关。与安慰剂相比，在第 16 周时，古塞单抗治疗组患者的 HADS 评分也有更大的改善，且使用更严格的 HADS≥11 的标准。
与安慰剂和阿达木单抗相比，古塞单抗治疗可改善银屑病患者焦虑和抑郁症状评分。
