Jan Hamouz, Agnieszka Nowosielska, Anna Święch-Zubilewicz, Santiago Abengoechea, Kristine Baumane, Attila Vajas, Małgorzata Siewierska, Milan Veselovsky, Miroslav Veith, Ágnes Kerényi, Shobhana Mange, Krishnapada Baidya, Guna Laganovska, Ignasi Jürgens, András Papp, Jignesh Gosai, Jana Štefanickova, Mei Han, Piotr Fryczkowski, Dominik Zalewski, Jing Wang, Wenbin Wei
{"title":"雷珠单抗生物类似物 QL1205 对新生血管性老年性黄斑变性的疗效和安全性:3期随机试验","authors":"Jan Hamouz, Agnieszka Nowosielska, Anna Święch-Zubilewicz, Santiago Abengoechea, Kristine Baumane, Attila Vajas, Małgorzata Siewierska, Milan Veselovsky, Miroslav Veith, Ágnes Kerényi, Shobhana Mange, Krishnapada Baidya, Guna Laganovska, Ignasi Jürgens, András Papp, Jignesh Gosai, Jana Štefanickova, Mei Han, Piotr Fryczkowski, Dominik Zalewski, Jing Wang, Wenbin Wei","doi":"10.1016/j.oret.2024.10.001","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to demonstrate the clinical equivalence of biosimilar QL1205 and reference ranibizumab, Lucentis, in patients with neovascular age-related macular degeneration (nAMD).</p><p><strong>Design: </strong>This was a multicenter, double-masked, randomized, controlled phase III trial.</p><p><strong>Participants: </strong>Treatment-naive patients with active nAMD were randomly assigned to receive QL1205 or reference ranibizumab.</p><p><strong>Methods: </strong>Patients received intravitreal injection of QL1205 or reference ranibizumab at a dose of 0.5 mg in the study eye once every 4 weeks for 48 weeks.</p><p><strong>Main outcome measures: </strong>The primary end point was change in best-corrected visual acuity (BCVA) by ETDRS letters at week 8 compared with baseline level. Biosimilarity of QL1205 to reference ranibizumab was assessed with an equivalence range for the difference in BCVA letters between -3.49 and +3.49.</p><p><strong>Results: </strong>Between June 27, 2019 and June 8, 2021, 616 patients were randomized to the QL1205 group (n = 308) and the reference ranibizumab group (n = 308). The mean improvement of BCVA was +6.3 ± 9.13 ETDRS letters in the QL1205 group and +7.3 ± 8.82 ETDRS letters in the reference ranibizumab group at week 8. Both the 90% confidence interval (CI, -2.23 to 0.13) and 95% CI (-2.46 to 0.36) of the difference between the 2 treatment groups (P = 0.1434) were within the predefined equivalence range. Safety profiles were manageable in both groups.</p><p><strong>Conclusions: </strong>QL1205 was biosimilar to reference ranibizumab regarding clinical efficacy, ocular and systemic safety, as well as immunogenicity and pharmacokinetics profiles in the treatment of patients with nAMD.</p><p><strong>Financial disclosure(s): </strong>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</p>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. 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Biosimilarity of QL1205 to reference ranibizumab was assessed with an equivalence range for the difference in BCVA letters between -3.49 and +3.49.</p><p><strong>Results: </strong>Between June 27, 2019 and June 8, 2021, 616 patients were randomized to the QL1205 group (n = 308) and the reference ranibizumab group (n = 308). The mean improvement of BCVA was +6.3 ± 9.13 ETDRS letters in the QL1205 group and +7.3 ± 8.82 ETDRS letters in the reference ranibizumab group at week 8. Both the 90% confidence interval (CI, -2.23 to 0.13) and 95% CI (-2.46 to 0.36) of the difference between the 2 treatment groups (P = 0.1434) were within the predefined equivalence range. Safety profiles were manageable in both groups.</p><p><strong>Conclusions: </strong>QL1205 was biosimilar to reference ranibizumab regarding clinical efficacy, ocular and systemic safety, as well as immunogenicity and pharmacokinetics profiles in the treatment of patients with nAMD.</p><p><strong>Financial disclosure(s): </strong>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</p>\",\"PeriodicalId\":19501,\"journal\":{\"name\":\"Ophthalmology. Retina\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":4.4000,\"publicationDate\":\"2024-10-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Ophthalmology. 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Efficacy and Safety of Ranibizumab Biosimilar QL1205 in Neovascular Age-Related Macular Degeneration: A Phase III Randomized Trial.
Objective: This study aimed to demonstrate the clinical equivalence of biosimilar QL1205 and reference ranibizumab, Lucentis, in patients with neovascular age-related macular degeneration (nAMD).
Design: This was a multicenter, double-masked, randomized, controlled phase III trial.
Participants: Treatment-naive patients with active nAMD were randomly assigned to receive QL1205 or reference ranibizumab.
Methods: Patients received intravitreal injection of QL1205 or reference ranibizumab at a dose of 0.5 mg in the study eye once every 4 weeks for 48 weeks.
Main outcome measures: The primary end point was change in best-corrected visual acuity (BCVA) by ETDRS letters at week 8 compared with baseline level. Biosimilarity of QL1205 to reference ranibizumab was assessed with an equivalence range for the difference in BCVA letters between -3.49 and +3.49.
Results: Between June 27, 2019 and June 8, 2021, 616 patients were randomized to the QL1205 group (n = 308) and the reference ranibizumab group (n = 308). The mean improvement of BCVA was +6.3 ± 9.13 ETDRS letters in the QL1205 group and +7.3 ± 8.82 ETDRS letters in the reference ranibizumab group at week 8. Both the 90% confidence interval (CI, -2.23 to 0.13) and 95% CI (-2.46 to 0.36) of the difference between the 2 treatment groups (P = 0.1434) were within the predefined equivalence range. Safety profiles were manageable in both groups.
Conclusions: QL1205 was biosimilar to reference ranibizumab regarding clinical efficacy, ocular and systemic safety, as well as immunogenicity and pharmacokinetics profiles in the treatment of patients with nAMD.
Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.