Kristensen Lars Erik, Tillett William, Nash Peter, Coates Laura C, Mease Philip J, Ogdie Alexis, Gisondi Paolo, Ink Barbara, Prickett Adam R, Bajracharya Rajan, Taieb Vanessa, Lyris Nikos, Lambert Jérémy, Walsh Jessica A
The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Nordre Fasanvej 57, Road 8, Entrance 19, DK-2000 Frederiksberg, Denmark.
Royal National Hospital of Rheumatic Diseases, Bath, UK.
Ther Adv Musculoskelet Dis. 2024 Nov 11;16:1759720X241288071. doi: 10.1177/1759720X241288071. eCollection 2024.
Psoriatic arthritis (PsA) is a chronic inflammatory disease that causes pain and fatigue, reduces physical function, and negatively impacts health-related quality of life (HRQoL). In the phase III BE OPTIMAL and BE COMPLETE studies, bimekizumab demonstrated clinical efficacy and meaningful improvements in patient-reported outcome (PRO) measures in biologic disease-modifying antirheumatic drug (bDMARD)-naïve patients, and those who had prior inadequate response/intolerance to tumor necrosis factor inhibitors (TNFi-IR).
To examine the association between achieving increasingly stringent clinical disease control criteria and improvements in PRO measures in patients with active PsA receiving bimekizumab.
Post hoc analysis of two phase III studies.
BE OPTIMAL and BE COMPLETE assessed subcutaneous bimekizumab 160 mg every 4 weeks in bDMARD-naïve and TNFi-IR patients with active PsA. Disease control was assessed using American College of Rheumatology (ACR) response criteria, Minimal Disease Activity, Disease Activity Index for Psoriatic Arthritis, and the composite outcome of ACR50 and 100% improvement in Psoriasis Area and Severity Index. Associations between clinical disease control criteria and PRO measures of pain, fatigue, physical function, and HRQoL were assessed at week 16 and week 52/40 (BE OPTIMAL/BE COMPLETE).
Achievement of increasingly stringent clinical disease control criteria was generally associated with sequentially greater improvements in all PRO measures, including pain. At week 52/40, 94.7% of bDMARD-naïve and 97.6% of TNFi-IR patients achieving ACR70 reported ⩾50% improvements in pain from baseline, and the greatest numerical improvements (-48.5 bDMARD-naïve; -54.7 TNFi-IR). This pattern was evident as early as week 16 and sustained when assessed at week 52/40 across the majority of clinical disease control criteria and PRO measures reported.
The achievement of increasingly stringent thresholds of disease control was associated with corresponding greater improvements in PROs, for patients receiving bimekizumab treatment, irrespective of prior TNFi use.
NCT03895203, NCT03896581, and NCT04009499.
银屑病关节炎（PsA）是一种慢性炎症性疾病，会导致疼痛和疲劳，降低身体功能，并对健康相关生活质量（HRQoL）产生负面影响。在III期BE OPTIMAL和BE COMPLETE研究中，比美吉珠单抗在初治生物改善病情抗风湿药（bDMARD）的患者以及先前对肿瘤坏死因子抑制剂反应不足/不耐受（TNFi-IR）的患者中显示出临床疗效，并在患者报告结局（PRO）指标上有显著改善。
探讨在接受比美吉珠单抗治疗的活动性PsA患者中，达到日益严格的临床疾病控制标准与PRO指标改善之间的关联。
两项III期研究的事后分析。
BE OPTIMAL和BE COMPLETE评估了初治bDMARD和TNFi-IR的活动性PsA患者每4周皮下注射160mg比美吉珠单抗的情况。使用美国风湿病学会（ACR）反应标准、最小疾病活动度、银屑病关节炎疾病活动指数以及ACR50和银屑病面积和严重程度指数改善100%的综合结局来评估疾病控制情况。在第16周和第52/40周（BE OPTIMAL/BE COMPLETE）评估临床疾病控制标准与疼痛、疲劳、身体功能和HRQoL的PRO指标之间的关联。
达到日益严格的临床疾病控制标准通常与所有PRO指标（包括疼痛）的逐步更大改善相关。在第52/40周，达到ACR70的初治bDMARD患者中有94.7%、TNFi-IR患者中有97.6%报告疼痛较基线改善≥50%，且数值改善最大（初治bDMARD患者为-48.5；TNFi-IR患者为-54.7）。这种模式早在第16周就很明显，并在第52/40周根据大多数临床疾病控制标准和报告的PRO指标进行评估时持续存在。
对于接受比美吉珠单抗治疗的患者，无论先前是否使用过TNFi，达到日益严格的疾病控制阈值与PRO的相应更大改善相关。
ClinicalTrials.gov：NCT03895203、NCT03896581和NCT04009499。
