PDF(Pubmed)
Abstract：
BACKGROUND: Real-life studies evaluating the long-term efficacy of guselkumab in moderate-to-severe psoriasis in China are limited and not available.
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.
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.
摘要：
背景：在中国，评估guselkumab在中度至重度银屑病中的长期疗效的实际研究有限且不可用。
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。
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。
