Faculty of Medicine, Sorbonne Université, INSERM, IPLESP, Paris, France.
Department of Rheumatology, Pitié-Salpêtrière Hospital, AP-HP, 47-83 Bd Hôpital, 75013, Paris, France.
Arthritis Res Ther. 2023 Jun 9;25(1):100. doi: 10.1186/s13075-023-03078-8.
This post-hoc analysis of PsABio (NCT02627768) evaluated safety, effectiveness and treatment persistence in patients < 60 and ≥ 60 years of age receiving ustekinumab over 3 years.
Measures included adverse events (AE), clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) low disease activity (LDA) including remission, Psoriatic Arthritis Impact of Disease-12 (PsAID-12), Minimal Disease Activity, dactylitis, nail/skin involvement and time to treatment stop. Data were analysed descriptively.
Overall, 336 patients < 60 and 103 ≥ 60 years received ustekinumab, with a similar gender balance. A numerically lower proportion of younger patients reported at least one AE: 124/379 (32.7%) vs 47/115 (40.9%) for patients < 60 and ≥ 60 years, respectively. Serious AEs were low (< 10%) in both groups. At 6 months, the proportion of patients with cDAPSA LDA was 138/267 (51.7%) and 35/80 (43.8%) for patients < 60 and ≥ 60 years, respectively, with the effectiveness being maintained through 36 months. PsAID-12 mean scores reduced for both groups from a baseline mean of 5.73 and 5.61 for patients < 60 and ≥ 60 years, respectively, to 3.81 and 3.88, respectively, at 6 months, and 2.02 and 3.24, respectively, at 36 months. Regarding treatment persistence, 173/336 (51.5%) vs 47/103 (45.6%) patients < 60 and ≥ 60 years, respectively, stopped or switched treatment.
Fewer AEs were observed over 3 years for younger versus older patients with PsA. There were no clinically meaningful treatment response differences. Persistence was numerically higher in the older age group.
本项 PsABio(NCT02627768)的事后分析评估了接受乌司奴单抗治疗 3 年的<60 岁和≥60 岁患者的安全性、有效性和治疗持续时间。
评估指标包括不良事件(AE)、银屑病关节炎的临床疾病活动指数(cDAPSA)低疾病活动(包括缓解)、银屑病关节炎患者生活质量问卷(PsAID-12)、最小疾病活动、指炎、指甲/皮肤受累以及治疗停止时间。数据进行描述性分析。
总体而言,336 名<60 岁和 103 名≥60 岁患者接受了乌司奴单抗治疗,两组的性别平衡相似。<60 岁的患者报告至少 1 例 AE 的比例略低:124/379(32.7%),≥60 岁的患者为 47/115(40.9%)。两组的严重 AE 均较低(<10%)。6 个月时,cDAPSA 低疾病活动的患者比例分别为<60 岁组的 138/267(51.7%)和≥60 岁组的 35/80(43.8%),有效性持续至 36 个月。两组患者的 PsAID-12 平均分均从基线的 5.73 和 5.61 分别降至 6 个月时的 3.81 和 3.88,以及 36 个月时的 2.02 和 3.24。在治疗持续时间方面,分别有 173/336(51.5%)和 47/103(45.6%)名<60 岁和≥60 岁患者停止或转换治疗。
与年龄较大的患者相比,年轻的银屑病关节炎患者在 3 年内观察到的 AE 较少。两组间的治疗应答差异无临床意义。年龄较大的患者组在治疗持续时间上的比例更高。