INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Université, Paris, France
Rheumatology Department, AP-HP, University Hospital Pitié Salpêtrière, Paris, France.
Ann Rheum Dis. 2022 Jun;81(6):823-830. doi: 10.1136/annrheumdis-2021-221640. Epub 2022 Feb 24.
We evaluated real-world treatment persistence and effectiveness at 1 year following initiation of IL-12/23 inhibitor ustekinumab or a tumour necrosis factor inhibitor (TNFi) for psoriatic arthritis (PsA).
PsABio (NCT02627768), a prospective, observational study, followed patients with PsA prescribed first-line to third-line ustekinumab or TNFi. Drug persistence, effectiveness (achievement of clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) low disease activity (LDA)/remission and minimal disease activity/very low disease activity (MDA/VLDA)), and safety were assessed every 6 months. In addition to descriptive statistics, propensity score (PS)-adjusted comparisons across cohorts were performed.
At 1 year, overall persistence was similar in the ustekinumab (n=317/438, 72.4%) and TNFi (n=321/455, 70.5%) groups. PS-adjusted HR (95% CI) for stopping/switching ustekinumab versus TNFi was 0.82 (0.60; 1.13). cDAPSA LDA (including remission)/remission was achieved in 55.9%/22.1% of ustekinumab-treated and 67.1%/31.7% of TNFi-treated patients; PS-adjusted ORs (95% CI) were 0.80 (0.57; 1.10) for cDAPSA LDA and 0.73 (0.49; 1.07) for remission. MDA/VLDA was achieved in 34.2%/11.9% of ustekinumab-treated and 43.1%/12.6% of TNFi-treated patients; PS-adjusted ORs (95% CI) were 0.89 (0.63; 1.26) for MDA and 0.90 (0.54; 1.49) for VLDA. The safety profiles were similar in both groups.
In the real-world PsABio Study, after 1 year of treatment, although unadjusted persistence was numerically slightly higher for ustekinumab versus TNFi and unadjusted effectiveness was numerically slightly higher for TNFi versus ustekinumab, the PS-adjusted comparisons demonstrated comparable overall persistence, effectiveness and safety for both modes of action in PsA.
我们评估了白细胞介素 12/23 抑制剂乌司奴单抗或肿瘤坏死因子抑制剂(TNFi)治疗银屑病关节炎(PsA)患者起始治疗后 1 年的真实世界治疗持久性和疗效。
PsABio(NCT02627768)是一项前瞻性、观察性研究,对接受一线至三线乌司奴单抗或 TNFi 治疗的 PsA 患者进行随访。每 6 个月评估药物持久性、疗效(达到银屑病关节炎临床疾病活动指数(cDAPSA)低疾病活动度(LDA)/缓解和最小疾病活动度/非常低疾病活动度(MDA/VLDA))和安全性。除了描述性统计数据外,还对队列进行了倾向评分(PS)调整后的比较。
在 1 年时,乌司奴单抗组(n=317/438,72.4%)和 TNFi 组(n=321/455,70.5%)的总体持久性相似。乌司奴单抗与 TNFi 停药/换药的 PS 调整后的 HR(95%CI)为 0.82(0.60;1.13)。乌司奴单抗治疗患者达到 cDAPSA LDA(包括缓解)/缓解的比例为 55.9%/22.1%,TNFi 治疗患者为 67.1%/31.7%;cDAPSA LDA 的 PS 调整后的 OR(95%CI)为 0.80(0.57;1.10),缓解的 OR 为 0.73(0.49;1.07)。乌司奴单抗治疗患者达到 MDA/VLDA 的比例为 34.2%/11.9%,TNFi 治疗患者为 43.1%/12.6%;MDA 的 PS 调整后的 OR(95%CI)为 0.89(0.63;1.26),VLDA 的 OR 为 0.90(0.54;1.49)。两组的安全性谱相似。
在真实世界的 PsABio 研究中,治疗 1 年后,尽管乌司奴单抗与 TNFi 相比,未调整的持久性略有升高,而 TNFi 与乌司奴单抗相比,未调整的疗效略有升高,但 PS 调整后的比较显示,两种作用模式在 PsA 中的总体持久性、疗效和安全性相当。