Benucci Maurizio, Gobbi Francesca Li, Cassarà Emanuele Antonio Maria, Marigliano Anna Lucia, Mannoni Alessandro, Benvenuti Enrico
Rheumatology Unit, S. Giovanni di Dio Hospital, USL-Toscana-Centro, 50143 Florence, Italy.
Pharmaceutical Governance and Appropriateness of Prescription Unit, Hospital S. Stefano, USL-Toscana-Centro, 59100 Prato, Italy.
J Pers Med. 2025 Aug 11;15(8):366. doi: 10.3390/jpm15080366.
. The Italian Committee for Tailored BIOlogic Therapy (ITABIO), in a first report, has reviewed the literature to identify the best strategy for the choice of second-line biologic therapy in patients with rheumatoid arthritis (RA), spondyloarthritis (SpA), and psoriatic arthritis (PsA). To verify the application of ITABIO recommendations in real life and how the recommendations perform in maintaining the health status of patients affected by inflammatory arthritis (RA, SpA, PsA), a database has been developed by Pharmaceutical Governance to evaluate the appropriateness of prescriptions. . We have analyzed retrospectively 616 patients, 288 (46.7%) affected by RA, 117 (19%) affected by SpA, and 211 (34.3%) affected by PsA. Age, sex, diagnosis, current treatment, previous treatments with csDMARDs, b-DMARDs, ts-DMARDs, presence of risk factors for cardiovascular (CV) events, liver disease, infections, extra-articular manifestations such as interstitial lung disease (ILD) for RA, enthesitis, dactylitis, uveitis, inflammatory bowel disease for SpA and PsA, neoplasms, diabetes, presence or absence of rheumatoid factor (RF) and anti-citrullinated peptide antibodies (ACPA) for RA were evaluated. . The percentage of treatments with anti-TNF biosimilars was 65.1, 52.4, and 24.3% in SpA (76 patients(pt)), PsA (110 pt), and RA (69 pt), respectively. The percentage of monotherapy was 68% (418 pt) in the three diseases. For RA, 34.2% of patients were difficult to treat (D2T) (98 pt), 54.8% (157 pt) were in monotherapy (tocilizumab-sarilumab-upadacitinib-filgotinib). Abatacept was the most prescribed treatment in RF and ACPA-positive patients and in those with ILD. The anti-IL-17A secukinumab was prescribed in 12% of SpA, of which 71% had enthesitis and dactylitis (14 pt). Ixekizumab was prescribed in 10.4% of PsA patients over 65 years with previous CV events, enthesitis, and dactylitis (21 pt). Apremilast was present in 71% of PsA with previous cancer. . The cross-sectional analysis of prescriptions in patients with RA, SpA, and PsA demonstrates how the ITABIO recommendations can guide towards the correct appropriateness of prescription. RA and especially D2T-RA remains the disease with the greatest therapeutic failures, with the highest percentage of monotherapy (anti-IL-6 and Jak-i) and of discontinuation of MTX.
意大利个性化生物治疗委员会（ITABIO）在首份报告中回顾了相关文献，以确定类风湿关节炎（RA）、脊柱关节炎（SpA）和银屑病关节炎（PsA）患者二线生物治疗选择的最佳策略。为验证ITABIO建议在现实生活中的应用情况以及这些建议在维持炎性关节炎（RA、SpA、PsA）患者健康状况方面的表现，药物管理部门建立了一个数据库来评估处方的合理性。我们对616例患者进行了回顾性分析，其中288例（46.7%）为RA患者，117例（19%）为SpA患者，211例（34.3%）为PsA患者。评估了患者的年龄、性别、诊断、当前治疗、既往使用传统合成改善病情抗风湿药（csDMARDs）、生物改善病情抗风湿药（b-DMARDs）、靶向合成改善病情抗风湿药（ts-DMARDs）的治疗情况，心血管（CV）事件、肝病、感染等危险因素的存在情况，RA患者的关节外表现如间质性肺病（ILD）、SpA和PsA患者的附着点炎、指（趾）炎、葡萄膜炎、炎性肠病，肿瘤、糖尿病，RA患者类风湿因子（RF）和抗瓜氨酸化肽抗体（ACPA）的有无。SpA（76例患者（pt））、PsA（110例pt）和RA（69例pt）中使用抗TNF生物类似药治疗的比例分别为65.1%、52.4%和24.3%。三种疾病中单一疗法的比例为68%（418例pt）。对于RA，34.2%的患者为难治性（D2T）（98例pt），54.8%（157例pt）接受单一疗法（托珠单抗-萨瑞鲁单抗-乌帕替尼-非戈替尼）。阿巴西普是RF和ACPA阳性患者以及有ILD患者中最常开具的治疗药物。抗IL-17A司库奇尤单抗在12%的SpA患者中使用，其中71%有附着点炎和指（趾）炎（14例pt）。在65岁以上有既往CV事件、附着点炎和指（趾）炎的PsA患者中，10.4%使用了依奇珠单抗（21例pt）。在既往有癌症的PsA患者中，71%使用了阿普米司特。对RA、SpA和PsA患者处方的横断面分析表明，ITABIO建议可如何指导实现正确的处方合理性。RA尤其是D2T-RA仍然是治疗失败率最高的疾病，单一疗法（抗IL-6和JAK抑制剂）和停用甲氨蝶呤的比例最高。
