Department of Medical Sciences, Surgery and Neurosciences, Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, University of Siena, Siena, Italy.
Clinical Pediatrics, Department of Molecular Medicine and Development, University of Siena, Siena, Italy.
Asia Pac J Ophthalmol (Phila). 2021 Mar 19;10(4):360-365. doi: 10.1097/APO.0000000000000380.
Several concerns have arisen with biosimilars in terms of immunogenicity, safety issues, loss of efficacy, and extrapolation to other indications. The study aim was to evaluate the efficacy of SB5, an adalimumab biosimilar, in noninfectious uveitis (NIU).
Retrospective nonrandomized study.
Data from patients with refractory NIU treated with SB5 (Imraldi, Biogen) were analyzed at baseline, 3 months after SB5 initiation and at the last follow-up in terms of uveitis relapses, occurrence of retinal vasculitis, resolution of uveitic macular edema (UME), best-corrected visual acuity, glucocorticoids (GCs)-sparing effect and drug survival.
Uveitis relapses decreased from 121 relapses/100 patients/year in the 12 months before SB5 initiation to 4 relapses/100 patients/year during the first 12 months of treatment (P = 0.0004). Uveitis was inactive in 46/47 eyes at the end of the study period. The number of eyes with active retinal vasculitis decreased during the study period (P < 0.0001). At baseline, 6 eyes presented UME, whereas no eye had UME at the last follow-up. Mean best-corrected visual acuity increased from 7.7 ± 3.41 at baseline to 8.9 ± 2.46 at the last follow-up (P = 0.0045). Mean GCs daily dosage decreased from 18.33 ± 10.33 mg at baseline to 5.75 ± 2.29 mg at the last follow-up (P = 0.018). The cumulative SB5 retention rate was 91.8% at both 12- and 20-month follow-up.
SB5 biosimilar is effective in NIU by drastically reducing uveitis relapses and the occurrence of retinal vasculitis. Moreover, SB5 biosimilar improved visual acuity, allowed a significant GCs-sparing effect and showed an excellent drug retention rate.
生物类似药在免疫原性、安全性问题、疗效丧失以及推广至其他适应证方面存在一些问题。本研究旨在评估阿达木单抗生物类似药 SB5 治疗非感染性葡萄膜炎（NIU）的疗效。
回顾性非随机研究。
对接受 SB5（Imraldi，Biogen）治疗的难治性 NIU 患者的数据进行分析，在 SB5 起始后 3 个月以及末次随访时，评估葡萄膜炎复发、视网膜血管炎的发生、葡萄膜炎性黄斑水肿（UME）的消退、最佳矫正视力、糖皮质激素（GCs）的节省效应和药物的存续率。
在 SB5 起始前 12 个月，葡萄膜炎复发率为 121 例/100 例/年，而在治疗的前 12 个月，复发率降至 4 例/100 例/年（P=0.0004）。在研究结束时，46/47 只眼的葡萄膜炎处于静止状态。在研究期间，患有活动性视网膜血管炎的眼数减少（P＜0.0001）。基线时有 6 只眼存在 UME，而末次随访时无一眼存在 UME。最佳矫正视力从基线时的 7.7±3.41 增加至末次随访时的 8.9±2.46（P=0.0045）。GCs 的日剂量从基线时的 18.33±10.33mg 降至末次随访时的 5.75±2.29mg（P=0.018）。在 12 个月和 20 个月的随访中，SB5 累计保留率分别为 91.8%。
SB5 生物类似药通过显著减少葡萄膜炎的复发和视网膜血管炎的发生，对 NIU 有效。此外，SB5 生物类似药改善了视力，实现了显著的 GCs 节省效应，并显示出了极好的药物存续率。
