Santoleri Fiorenzo, Abrate Paolo, Pestrin Laura, Pasut Enrico, Modesti Germana, Musicco Felice, Fulgenzio Chiara, Zuzolo Eva, Pieri Gabriella, Roperti Martina, Gazzola Pietro, Gambera Marco, Martignoni Isabella, Montresor Valentina, Guarino Francesca, Grossi Laura, Di Fabio Letizia, Roberti Cristina, Spoltore Concetta, Tinari Gabriella, De Rosa Stefania, Giannini Romina, Langella Roberto, Mingolla Grazia, Piccoli Mariantonietta, Costantini Alberto
Pescara General Hospital, Pescara - Italy.
Hospital Pharmacy of Ivrea, ASL TO4, Ivrea - Italy.
Glob Reg Health Technol Assess. 2024 Oct 9;11:191-199. doi: 10.33393/grhta.2024.3204. eCollection 2024 Jan-Dec.
This study aims to evaluate the persistence, treatment adherence and drug cost associated with biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) in the management of psoriatic arthritis (PsA) in Italy, with a focus on biosimilar drugs.
This was a retrospective observational study involving eight hospital pharmacies, between January 2017 and December 2020, on naïve patients with at least one b/tsDMARD dispensation indicated for PsA. Patients were followed up for 12 months and persistence and adherence were evaluated by proportion of days covered (PDC). The originator and biosimilar for adalimumab and etanercept were compared. Furthermore, the real annual cost per patient based on adherence to therapy was calculated.
Patients initiating b/tsDMARDs for PsA had a mean persistence of 263 days and 48.6% remained persistent for 1 year. Adherent patients (PDC ≥ 0.8) were 47.6% for the overall population. Similar persistence and adherence were observed between patients treated with the adalimumab originator and its biosimilar, while patients treated with the etanercept originator showed lower persistence and adherence compared to those treated with its biosimilar (mean persistence: 222 vs. 267 days, patient persistent at 1 year: 29.4% vs. 51.5%, mean PDC: 0.53 vs. 0.70, adherent patients: 23.5% vs. 51.5%). The average annual drug cost ranged from €8,724 (etanercept) to €14,783 (ustekinumab), with an annual saving of more than €2,500 by using biosimilars.
Poor adherence to medications contributes to suboptimal clinical outcomes. The comparison between biosimilar and originator offers further evidence in support of the biosimilar to optimizing resources in healthcare.
本研究旨在评估生物制剂和靶向合成改善病情抗风湿药物（b/tsDMARDs）在意大利银屑病关节炎（PsA）管理中的持续性、治疗依从性和药物成本，重点关注生物类似药。
这是一项回顾性观察研究，于2017年1月至2020年12月期间，在八家医院药房对至少有一次因PsA而配发的b/tsDMARDs的初治患者进行研究。对患者进行12个月的随访，并通过覆盖天数比例（PDC）评估持续性和依从性。比较了阿达木单抗和依那西普的原研药和生物类似药。此外，计算了基于治疗依从性的每位患者的实际年度成本。
开始使用b/tsDMARDs治疗PsA的患者平均持续时间为263天，48.6%的患者持续用药1年。总体人群中依从性患者（PDC≥0.8）为47.6%。阿达木单抗原研药及其生物类似药治疗的患者之间观察到相似的持续性和依从性，而依那西普原研药治疗的患者与生物类似药治疗的患者相比，持续性和依从性较低（平均持续时间：222天对267天，1年持续用药患者：29.4%对51.5%，平均PDC：0.53对0.70，依从性患者：23.5%对51.5%）。平均年度药物成本从8724欧元（依那西普）到14783欧元（乌司奴单抗）不等，使用生物类似药每年可节省超过2500欧元。
药物依从性差导致临床结局欠佳。生物类似药与原研药的比较为支持生物类似药优化医疗资源提供了进一步证据。
