Mease Philip J, Ferrante Shannon A, Shiff Natalie J, Fitzgerald Timothy P, Chakravarty Soumya D, Walsh Jessica A
Rheumatology Research, Providence Swedish Medical Center, 601 Broadway, Suite 600, Seattle, WA, 98122, USA.
University of Washington School of Medicine, Seattle, WA, USA.
Adv Ther. 2025 Feb;42(2):734-751. doi: 10.1007/s12325-024-03042-1. Epub 2024 Dec 2.
Psoriatic arthritis (PsA) is a chronic, multidomain, inflammatory disease requiring long-term treatment. Guselkumab, a fully human interleukin [IL]-23p19-subunit inhibitor, and the IL-17A inhibitors (IL-17Ai) ixekizumab and secukinumab are approved by the US Food and Drug Administration (FDA) for adults with active PsA. Real-world data evaluating on-label treatment persistence is an important consideration for patients.
This retrospective claim-based analysis (IQVIA PharMetrics® Plus) included adults with PsA receiving guselkumab or their first subcutaneous (SC) IL-17Ai (ixekizumab/secukinumab) per FDA label ("on-label") between July 14, 2020, and June 30, 2022. Baseline demographic and disease characteristics were collected in the 12 months preceding the index date (date of first guselkumab or SC IL-17Ai claim); follow-up extended through the earlier of the end of continuous insurance eligibility or end of data availability. Baseline characteristics were balanced between the cohorts by propensity score weighting (standardized mortality ratio [SMR]). Discontinuation was defined as a gap 2 × the FDA-approved maintenance dosing interval (guselkumab:112 days; SC IL-17Ai: 56 days); on-label persistence in the weighted cohorts was assessed using Kaplan-Meier curves and compared with a Cox proportional hazards model.
Weighted demographic and disease characteristics were well balanced between the cohorts (guselkumab: N = 910, mean age = 50.4 years, 60.4% female; SC IL-17Ai: N = 2740, mean age = 50.2, 59.4% female). At 12 months, the guselkumab cohort was 1.85 × more likely to remain persistent with on-label therapy vs the SC IL-17Ai cohort (p < 0.001); median time to discontinuation was not reached for guselkumab and was 12.3 months for SC IL-17Ai. At 3, 6, 9, and 12 months, persistence rates in the weighted cohorts were higher with guselkumab than with SC IL-17Ai (p < 0.001).
In this real-world claims data analysis in adults with PsA, on-label persistence rates were statistically significantly higher with guselkumab, as early as 3 months, with ~ 2 × greater likelihood of persistence at 12 months relative to SC IL-17Ai.
银屑病关节炎（PsA）是一种慢性、多领域的炎症性疾病，需要长期治疗。古塞库单抗是一种全人源白细胞介素[IL]-23p19亚基抑制剂，白细胞介素-17A抑制剂（IL-17Ai）司库奇尤单抗和依奇珠单抗已被美国食品药品监督管理局（FDA）批准用于治疗活动性PsA的成人患者。评估标签内治疗持续性的真实世界数据对患者来说是一个重要的考虑因素。
这项基于索赔数据的回顾性分析（IQVIA PharMetrics® Plus）纳入了2020年7月14日至2022年6月30日期间根据FDA标签接受古塞库单抗治疗或首次皮下注射（SC）IL-17Ai（司库奇尤单抗/依奇珠单抗）治疗（“标签内”）的PsA成人患者。在索引日期（首次使用古塞库单抗或SC IL-17Ai的索赔日期）前12个月收集基线人口统计学和疾病特征；随访持续至连续保险资格结束或数据可用结束两者中较早的时间。通过倾向得分加权（标准化死亡率[SMR]）使各队列之间的基线特征达到平衡。停药定义为间隔2倍FDA批准的维持给药间隔时间（古塞库单抗：112天；SC IL-17Ai：56天）；使用Kaplan-Meier曲线评估加权队列中的标签内持续性，并与Cox比例风险模型进行比较。
各队列之间加权后的人口统计学和疾病特征平衡良好（古塞库单抗：N = 910，平均年龄 = 50.4岁，女性占60.4%；SC IL-17Ai：N = 2740，平均年龄 = 50.2岁，女性占59.4%）。在12个月时，与SC IL-17Ai队列相比，古塞库单抗队列维持标签内治疗的可能性高1.85倍（p < 0.001）；古塞库单抗未达到停药的中位时间，SC IL-17Ai为12.3个月。在3、6、9和12个月时，加权队列中古塞库单抗的持续性率高于SC IL-17Ai（p < 0.001）。
在这项针对PsA成人患者的真实世界索赔数据分析中，古塞库单抗的标签内持续性率在统计学上显著更高，早在3个月时就如此，在12个月时持续治疗的可能性比SC IL-17Ai高约2倍。
