Background/Aims Filgotinib, a Janus-kinase (JAK) 1 preferential inhibitor, was approved for use in the UK in moderate or severe rheumatoid arthritis (RA) in 2021, as monotherapy or in combination with Methotrexate. Evidence of real-world effectiveness is currently limited. Methods Patients prescribed Filgotinib between December 2021 and August 2022 in NHS Lothian were identified from pharmacy registration data. All underwent clinical efficacy assessment at three months. Electronic patient records (EPR) were reviewed to record baseline data including previous and current treatments. Duration of Filgotinib treatment was recorded, and discontinuation reason if applicable. DAS-28 scores within six months prior to starting Filgotinib were recorded, along with available subsequent scores. Pre-existing interstitial lung disease (ILD), venous thromboembolism (VTE), major adverse cardiovascular events (MACE) and malignancy were recorded, along with incident events during treatment. Results 145 patients were prescribed Filgotinib; 106 (73.1%) females and 39 (26.9%) males, with median age 64 years. Median treatment duration was 447 days. 35 (24.1%) were treated with the reduced 100mg dose. 81 (55.9%) received conventional disease-modifying anti-rheumatic drugs (DMARDs) alongside Filgotinib. 41 (28.3%) patients discontinued treatment: 10 (6.9%) due to loss of effect; 16 (11.0%) due to lack of efficacy; six (4.1%) experienced side effects leading to cessation; five (3.4%) stopped for alternative reasons; one (0.7%) experienced a severe allergic drug reaction; three (2.1%) developed lung cancer and treatment was stopped in each case. 12 (8.3%) patients had ILD prior to treatment. 10 (6.9%) had prior major cardiovascular events, eight (5.5%) had previously treated malignancy, and six (4.1%) had previous VTE. During treatment, 1 (0.7%) patient developed ILD and two (1.4%) developed VTE. There were three (2.1%) new malignancies, all lung cancer. No new MACE occurred. 120 (82.8%) patients were previously treated with biologic or targeted synthetic DMARDs. 59 (40.7%) had failed multiple biologic DMARDs of different classes. 19 (13.1%) switched to Filgotinib from another JAK inhibitor. Pre-treatment DAS-28 scores were recorded in 55 (37.9%) patients with mean 5.1, and during treatment in 44 patients (30.3%) with mean 3.5. 17 (11.7%) patients had DAS-28 recorded both before and during treatment, with pre-treatment mean 5.0 and subsequent mean 2.9. Of these, 10 (58.8%) were classified as a good response by EULAR disease activity criteria, and four (23.5%) as a moderate response. Three (17.6%) were non-responders. Conclusion Our cohort includes 40.7% difficult-to-treat RA. Drug survival as a clinical efficacy surrogate was 71.7% at median duration 447 days, demonstrating patient acceptability and clinical effectiveness. Our service is poor at DAS-28 recording in the EPR, which may partly reflect imaging use at response assessment. Since this cohort was established, the European Medicines Agency has issued guidance advising caution using JAK inhibitors in high-risk groups to minimise the chance of serious side effects. Disclosure C.D. Box: None. S. Ramsay: None. N.D. McKay: Other; N.D.M. has received funding for conference registrations from Abbvie, UCB and Novartis, fees for lecturing from Gilead, and has taken part in advisory board meetings for UCB and Gilead.

中文翻译：

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P108 Filgotinib 治疗类风湿关节炎：评估单中心临床有效性的观察队列

背景/目标 Filgotinib 是一种 Janus 激酶 (JAK) 1 优先抑制剂，于 2021 年在英国被批准用于中度或重度类风湿性关节炎 (RA)，作为单一疗法或与甲氨蝶呤联合治疗。目前，现实世界有效性的证据有限。方法 根据药房注册数据确定 2021 年 12 月至 2022 年 8 月期间在 NHS Lothian 开具 Filgotinib 处方的患者。所有患者均在三个月后接受临床疗效评估。审查电子病历（EPR）以记录基线数据，包括以前和当前的治疗。记录 Filgotinib 治疗的持续时间，并记录终止原因（如果适用）。记录开始 Filgotinib 之前六个月内的 DAS-28 评分以及可用的后续评分。记录先前存在的间质性肺疾病（ILD）、静脉血栓栓塞（VTE）、主要不良心血管事件（MACE）和恶性肿瘤，以及治疗期间发生的事件。结果 145 名患者接受了 Filgotinib 处方；女性 106 名（73.1%），男性 39 名（26.9%），中位年龄 64 岁。中位治疗持续时间为 447 天。 35 名患者 (24.1%) 接受了减少的 100 毫克剂量治疗。 81 名患者 (55.9%) 与 Filgotinib 一起接受传统的缓解病情抗风湿药物 (DMARD)。 41 名 (28.3%) 患者停止治疗：10 名 (6.9%) 因疗效丧失； 16（11.0%）因缺乏疗效；六名（4.1%）经历了导致戒烟的副作用；五人 (3.4%) 因其他原因停止； 1 人 (0.7%) 经历过严重的药物过敏反应；三人 (2.1%) 患上肺癌，每人均停止治疗。 12 名 (8.3%) 患者在治疗前患有 ILD。 10 人 (6.9%) 既往有重大心血管事件，8 人 (5.5%) 曾接受过恶性肿瘤治疗，6 人 (4.1%) 既往有静脉血栓栓塞。治疗期间，1 名患者 (0.7%) 出现 ILD，2 名患者 (1.4%) 出现 VTE。新增三种恶性肿瘤（2.1%），均为肺癌。没有发生新的 MACE。 120 名 (82.8%) 患者之前接受过生物或靶向合成 DMARD 治疗。 59 人 (40.7%) 多次不同类别的生物 DMARD 失败。 19 名 (13.1%) 从另一种 JAK 抑制剂转向 Filgotinib。 55 名患者 (37.9%) 治疗前 DAS-28 评分平均为 5.1，治疗期间有 44 名患者 (30.3%) 平均评分为 3.5。 17 名 (11.7%) 患者在治疗前和治疗期间均记录了 DAS-28，治疗前平均值为 5.0，治疗后平均值为 2.9。其中，根据 EULAR 疾病活动标准，10 例 (58.8%) 被归类为良好反应，4 例 (23.5%) 被归类为中等反应。三人 (17.6%) 为无反应者。结论 我们的队列包括 40.7% 的难治性 RA。作为临床疗效替代指标的药物存活率在中位持续时间 447 天时为 71.7%，证明了患者的可接受性和临床有效性。我们在 EPR 中的 DAS-28 记录方面的服务很差，这可能部分反映了反应评估中的成像使用。自这个群体成立以来，欧洲药品管理局已发布指南，建议高危人群谨慎使用 JAK 抑制剂，以尽量减少出现严重副作用的可能性。披露 CD 盒：无。 S.拉姆齐：没有。 ND 麦凯：其他； NDM 已获得艾伯维 (Abbvie)、UCB 和诺华 (Novartis) 的会议注册资金、吉利德 (Gilead) 的演讲费，并参加了 UCB 和吉利德 (Gilead) 的顾问委员会会议。