METHODS: In this real-life study, we retrospectively examined a total of 27 patients with moderate-to-severe psoriasis treated with guselkumab [100 mg, subcutaneous (s.c.)] with a follow-up period of at least 52 weeks in a real-life setting conducted at the Department of Dermatology, Xiangya Hospital, Central South University and Department of Psoriasis, Dalian Dermatosis Hospital. The primary endpoint of the study was long-term effectiveness [reduction of Psoriasis Area and Severity Index (PASI) score, improvement of Dermatology Life Quality Index (DLQI)], safety, and tolerability of guselkumab.
RESULTS: Guselkumab treatment decreased the mean PASI score from 12.46 ± 6.34 at baseline to 4.03 ± 3.25 (P < 0.001) and 0.77 ± 1.25 (P < 0.001) at 12 and 52 weeks. At 12 weeks, PASI 75, 90, and 100 response was achieved in 44.4%, 18.5%, and 11.1% of patients, respectively. At 1 year, PASI 75, 90, and 100 response was achieved in 88%, 72%, and 48% of patients, respectively. At 52 weeks, 96% of patients achieved a PASI score of ≤ 3 and 80% of patients achieved DLQI (0/1). No patients withdrewed from the study due to primary or secondary ineffectiveness or failure to adhere to the medication. During the follow-up period, only two adverse events were reported (tinea capitis and diarrhea).
CONCLUSIONS: Our findings confirm that guselkumab is an appropriate therapeutic option in routine clinical practice, particularly when treating sophisticated patients with comorbidities or who failed to previous biologic therapy.
方法:在这项现实生活中的研究中,我们回顾性检查了总共27例接受guselkumab[100mg,皮下(s.c.)]在皮肤科进行的现实生活中至少52周的随访期,湘雅医院,中南大学银屑病系,大连皮肤病医院。研究的主要终点是长期有效性[减少银屑病面积和严重程度指数(PASI)评分,皮肤病生活质量指数(DLQI)的改善],安全,和guselkumab的耐受性。
结果:Guselkumab治疗在12周和52周时,平均PASI评分从基线时的12.46±6.34降至4.03±3.25(P<0.001)和0.77±1.25(P<0.001)。12周时,PASI75、90和100应答率达到44.4%,18.5%,和11.1%的患者,分别。在1年,PASI75、90和100反应在88%中实现,72%,48%的病人,分别。52周时,96%的患者达到PASI评分≤3,80%的患者达到DLQI(0/1)。没有患者因原发性或继发性无效或未能坚持药物治疗而退出研究。在后续期间,仅报告了2起不良事件(头癣和腹泻).
结论:我们的发现证实guselkumab在常规临床实践中是一种合适的治疗选择。特别是在治疗有合并症或以前生物治疗失败的复杂患者时。