Gerdes Sascha, Weisenseel Peter, Groß Durdana, Ostendorf Rolf, Zimmer Sebastian, Otto Adriana, Taut Friedemann J H, Makuc Judita, Jacobsen Simmy, Trenkler Nina, Behrens Juliane, Mortazawi Dariusch
Psoriasis Center Kiel, Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Dermatologikum Hamburg, Hamburg, Germany.
J Dermatol. 2025 Sep;52(9):1368-1381. doi: 10.1111/1346-8138.17866. Epub 2025 Aug 9.
G-EPOSS is a prospective, non-interventional, German multicenter study evaluating the effects of guselkumab, an interleukin-23 inhibitor, in patients with moderate-to-severe plaque psoriasis in real-world clinical practice.
To evaluate the effectiveness of guselkumab in psoriasis and its impact on quality of life (QoL), sexual impairment, and perceived stigmatization.
Adult patients received guselkumab according to routine clinical practice. Primary endpoint (Psoriasis Area and Severity Index [PASI] ≤ 3 at week [W]28) data are published. Secondary endpoints over 76 weeks include PASI, Nail Psoriasis Severity Index (NAPSI), anogenital Physician's Global Assessment (aPGA), Dermatology Life Quality Index (DLQI), Relationship and Sexuality Scale (RSS), Perceived Stigmatization Questionnaire (PSQ), Patient Benefit Index (PBI), and drug survival assessments. Outcomes were evaluated in the overall population and subgroups defined by body mass index (BMI), age, disease duration, sex, anogenital psoriasis, depression, and super-response to guselkumab (PASI = 0 at W20 and W28).
A total of 295 patients were included in these analyses. Baseline mean disease duration, PASI, and aPGA scores were 17.4 years, 15.3, and 2.7, respectively. In total, 26.4% of patients had received prior biologic therapy. At W76, 87.5% of patients achieved PASI ≤ 3, and 47.3% achieved PASI = 0; response rates were higher with shorter disease duration. Overall, 18.3% of patients were super-responders. Among patients with NAPSI ≥ 1 or aPGA ≥ 1 at baseline, NAPSI = 0 and aPGA = 0 were achieved by 52.2% and 75.8% of patients at W76, respectively. A high aPGA = 0 response rate was observed in all BMI subgroups. Improvements were observed through W76 across individual items of the DLQI, RSS, and PSQ and across all subgroups evaluated. A shorter disease duration was associated with additional benefit for some outcomes. At W76, PBI > 3 was documented for 88.1% of patients, and the probability of drug survival was 88.7%. No new safety signals were detected.
Guselkumab treatment provided sustained improvements over 76 weeks in psoriasis, sexual impairment, QoL, and perceived stigmatization, irrespective of BMI, age, disease duration, sex, presence of anogenital psoriasis, or depression.
G-EPOSS是一项前瞻性、非干预性的德国多中心研究，旨在评估白细胞介素-23抑制剂古塞库单抗在中度至重度斑块状银屑病患者的真实临床实践中的效果。
评估古塞库单抗治疗银屑病的有效性及其对生活质量（QoL）、性功能障碍和感知污名化的影响。
成年患者按照常规临床实践接受古塞库单抗治疗。主要终点（第28周时银屑病面积和严重程度指数[PASI]≤3）数据已发表。76周的次要终点包括PASI、指甲银屑病严重程度指数（NAPSI）、肛门生殖器医师整体评估（aPGA）、皮肤病生活质量指数（DLQI）、关系与性量表（RSS）、感知污名化问卷（PSQ）、患者获益指数（PBI）和药物生存评估。在总体人群以及根据体重指数（BMI）、年龄、病程、性别、肛门生殖器银屑病、抑郁和对古塞库单抗的超反应（第20周和第28周时PASI = 0）定义的亚组中评估结局。
这些分析共纳入295例患者。基线时平均病程、PASI和aPGA评分分别为17.4年、15.3和2.7。共有26.4%的患者曾接受过生物治疗。在第76周时，87.5%的患者PASI≤3，47.3%的患者PASI = 0；病程较短的患者缓解率更高。总体而言，18.3%的患者为超反应者。在基线时NAPSI≥1或aPGA≥1的患者中，第76周时分别有52.2%和75.8%的患者NAPSI = 0和aPGA = 0。在所有BMI亚组中均观察到较高的aPGA = 0缓解率。在第76周期间，在DLQI、RSS和PSQ的各个项目以及所有评估的亚组中均观察到改善。病程较短与某些结局的额外获益相关。在第76周时，88.1%的患者记录到PBI>3，药物生存概率为88.7%。未检测到新的安全信号。
无论BMI、年龄、病程、性别、是否存在肛门生殖器银屑病或抑郁，古塞库单抗治疗在76周内持续改善银屑病、性功能障碍、QoL和感知污名化。
