生物制剂对老年银屑病患者的实际安全性和疗效:一项多中心观察研究。

Chika Ohata, Hisataka Anezaki, Tetsuji Yanase, Eri Katayama, Sakae Kaneko, Kanami Saito, Mariko Yamane, Sei Nakamaru, Noriko Tsuruta, Fusako Okazaki, Kotaro Ito, Satoko Kikuchi, Yuta Koike, Takuya Miyagi, Kazunari Sugita, Takeshi Nakahara, Daiki Takezaki, Hiroshi Saruwatari, Yuichi Yoshida, Kentaro Yonekura, Yuko Higashi, Yu Sawada, Yuko Chinuki, Kazuki Yamaguchi, Shinichi Imafuku
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引用次数: 0

摘要

生物制剂的临床试验经常将老年患者排除在外,导致有关其安全性和有效性的数据不足。此外,尽管有一些真实世界的研究,但有关生物制剂安全性和疗效的证据仍然有限。为了评估生物制剂对老年银屑病患者的安全性和疗效,我们利用西日本银屑病登记处(WJPR)的数据对年轻患者的疗效进行了比较。西日本银屑病登记处由西日本约 30 家机构组成,包括各种医疗机构。这项研究招募了 1395 名患者,他们参加了 2022 年的 WJPR 随访调查,并且在调查期间正在使用或曾经使用过生物制剂。其中包括 456 名老年组患者(≥65 岁)和 939 名年轻组患者(≥65 岁)。
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Real-world safety and efficacy of biologics in elderly patients with psoriasis: A multicenter observational study.

Clinical trials of biologics have frequently excluded elderly patients, resulting in inadequate data on their safety and efficacy. Additionally, evidence of their safety and efficacy remains limited, despite some real-world studies. To assess the safety and efficacy of biologics in elderly patients with psoriasis, we compared these outcomes in younger patients using data from the West Japan Psoriasis Registry (WJPR). The WJPR consists of approximately 30 facilities in Western Japan, including various healthcare settings. This study enrolled 1395 patients who participated in the 2022 follow-up survey of the WJPR and were either using or had used biologics during the survey. These included 456 patients in the elderly group (≥65 years) and 939 patients in the younger group (<65 years). Treatment-ending adverse events (TEAEs) occurred in 15.8% and 11.3% of elderly and younger patients, respectively. The incidence rate per 1000 patient-years (PY) for TEAEs was significantly higher in elderly patients than in younger patients (32.9 vs 23.2, p = 0.0234). Infectious diseases were more prevalent in the elderly group than the younger group; however, no significant difference in the frequency of infectious diseases was found between the two groups (p = 0.0807). Malignant neoplasms occurred significantly more frequently in the elderly group than in the younger group (p = 0.0169). Our results indicate a few concerns about infection when prescribing biologics to elderly patients. Biologics were effective for both elderly and younger patients. We found no significant differences in the proportion of patients with a body surface area score ≤3%, Physician's Global Assessment score 0/1, or Patient's Global Assessment score 0/1, as well as in the mean Dermatology Life Quality Index and the Itch Numerical Rating Scale between the younger and the elderly groups. Overall, our results confirm the appropriateness of using biologics in elderly patients with regard to safety and efficacy.

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