Montero-Vilchez Trinidad, Cuenca-Barrales Carlos, Rodriguez-Tejero Andrea, Martinez-Lopez Antonio, Arias-Santiago Salvador, Molina-Leyva Alejandro
Hidradenitis Suppurativa Clinic, Dermatology, Hospital Universitario Virgen de las Nieves, 18012 Granada, Spain.
Instituto de Investigación Biosanitaria Granada, 18012 Granada, Spain.
J Clin Med. 2022 Feb 15;11(4):1007. doi: 10.3390/jcm11041007.
Adalimumab is currently the only biological medicine approved by the FDA for the treatment of hidradenitis suppurativa (HS). The breakout of biosimilar drugs made them more accessible due to their impact on pharmacoeconomics. However, packaging, formulation, or excipients are unique characteristics of each drug. In that way, switching from adalimumab originator to biosimilar and between biosimilars could have implications in the clinical practice. The objective of this study is to describe our clinical experience in switching from adalimumab originator to biosimilar and switching back again. A single-center retrospective cohort study was conducted that included seventeen patients with HS treated with adalimumab originator in the maintenance phase, and that achieved Hidradenitis Suppurativa Clinical Response (HiSCR), who were switched to adalimumab biosimilar for no medical reasons. The reason for the change was to improve pharmacoeconomic efficiency, following our hospital policies on biologics. Median duration with adalimumab originator treatment before switching was 48 weeks. After switching, 41.2% of patients maintained HiSCR response without additional issues, while 58.8% (10/17) reported problems after the change. Switching from adalimumab originator to biosimilar in well-controlled patients could imply problems in efficacy and adherence. Switching back to adalimumab originator appears to solve most of the problems, but some patients can lose confidence in the drug and discontinue it. It would be worthwhile to evaluate the benefit-risk ratio individually when switching an HS patient to adalimumab biosimilar.
阿达木单抗是目前美国食品药品监督管理局(FDA)批准用于治疗化脓性汗腺炎(HS)的唯一生物药物。生物类似药的出现因其对药物经济学的影响而使其更容易获得。然而,包装、剂型或辅料是每种药物的独特特性。因此,从阿达木单抗原研药转换为生物类似药以及在不同生物类似药之间转换可能会对临床实践产生影响。本研究的目的是描述我们从阿达木单抗原研药转换为生物类似药再转换回原研药的临床经验。我们进行了一项单中心回顾性队列研究,纳入了17例在维持期接受阿达木单抗原研药治疗且达到化脓性汗腺炎临床缓解(HiSCR)的HS患者,这些患者因非医学原因转换为阿达木单抗生物类似药。转换的原因是为了提高药物经济学效率,遵循我们医院关于生物制剂的政策。转换前使用阿达木单抗原研药治疗的中位持续时间为48周。转换后,41.2%的患者维持了HiSCR反应且无其他问题,而58.8%(10/17)的患者在转换后报告出现了问题。在病情控制良好的患者中从阿达木单抗原研药转换为生物类似药可能意味着疗效和依从性方面的问题。再次转换回阿达木单抗原研药似乎可以解决大多数问题,但一些患者可能会对该药物失去信心并停药。在将HS患者转换为阿达木单抗生物类似药时,单独评估其获益风险比是值得的。