V. I. Mazurov, S. Erdes, I. Z. Gaydukova, T. Dubinina, A. Pristrom, E. Kunder, N. Soroka, A. Kastanayan, T. Povarova, E. Zhugrova, T. Plaksina, P. Shesternya, T. Kropotina, O. Antipova, E. Smolyarchuk, O. A. Tsyupa, D. Abdulganieva, S. A. Lapshina, D. Krechikova, I. G. Gordeev, O. Nesmeyanova, E. Ilivanova, A. Strelkova, V. V. Tyrenko, E. A. Mikhailova, A. Eremeeva
{"title":"奈达单抗对活动性强直性脊柱炎患者的长期疗效和安全性:BCD-085-5/ASTERA 国际多中心随机双盲 III 期临床试验三年的结果","authors":"V. I. Mazurov, S. Erdes, I. Z. Gaydukova, T. Dubinina, A. Pristrom, E. Kunder, N. Soroka, A. Kastanayan, T. Povarova, E. Zhugrova, T. Plaksina, P. Shesternya, T. Kropotina, O. Antipova, E. Smolyarchuk, O. A. Tsyupa, D. Abdulganieva, S. A. Lapshina, D. Krechikova, I. G. Gordeev, O. Nesmeyanova, E. Ilivanova, A. Strelkova, V. V. Tyrenko, E. A. Mikhailova, A. Eremeeva","doi":"10.14412/1996-7012-2024-1-35-46","DOIUrl":null,"url":null,"abstract":"The article presents the results of the three-year use of netakimab (NTK) in patients with ankylosing spondylitis (AS) as part of the phase III BCD-085-5/ASTERA study.Objective: to evaluate the long-term efficacy and safety of NTK over a three-year period in patients with active AS.Material and methods. BCD-085-5/ASTERA – double-blind, multicenter, randomized phase III clinical trial that enrolled patients with active AS (BASDAI ≥4) and a back pain intensity ≥4 on a numeric rating scale with inefficacy or intolerance of non-steroidal anti-inflammatory drugs or biologic drugs. A total of 228 patients were randomized in a 1:1 ratio and assigned to either the NTK group or the placebo/NTK group. Starting at week 16, patients who did not achieve ASAS20 (20% improvement according to ASAS criteria) received NTK 120 mg once every 2 weeks in an open-label regimen. Patients who achieved ASAS20 response at week 52 in the NTK group and week 68 in the placebo/NTK group continued to receive NTK (120 mg every 2 weeks) until week 156 in the NTK group and until week 172 in the placebo/NTK group.Results and discussion. Over the course of three years of NTK use, most patients experienced a sustained decline in AS activity (according to ASDAS-CRP, BASDAI) with sustained response (ASAS20/40, ASAS5/6) to therapy. Most adverse events reported were mild to moderate. 36.7% of patients had adverse events, which were mainly laboratory abnormalities, blood and lymphatic system abnormalities and infectious complications.Conclusion. The clinical effect of NTK was maintained in most patients with AS over a three-year period, with no significant loss of response. NTK was well tolerated and the safety profile remained favorable.","PeriodicalId":18651,"journal":{"name":"Modern Rheumatology Journal","volume":"187 ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Long-term efficacy and safety of netakimab in patients with active ankylosing spondylitis: results of three years of use in the international multicentre, randomized, double-blind, phase III clinical trial BCD-085-5/ASTERA\",\"authors\":\"V. I. Mazurov, S. Erdes, I. Z. Gaydukova, T. Dubinina, A. Pristrom, E. Kunder, N. Soroka, A. Kastanayan, T. Povarova, E. Zhugrova, T. Plaksina, P. Shesternya, T. Kropotina, O. Antipova, E. Smolyarchuk, O. A. Tsyupa, D. Abdulganieva, S. A. Lapshina, D. Krechikova, I. G. Gordeev, O. Nesmeyanova, E. Ilivanova, A. Strelkova, V. V. Tyrenko, E. A. Mikhailova, A. Eremeeva\",\"doi\":\"10.14412/1996-7012-2024-1-35-46\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The article presents the results of the three-year use of netakimab (NTK) in patients with ankylosing spondylitis (AS) as part of the phase III BCD-085-5/ASTERA study.Objective: to evaluate the long-term efficacy and safety of NTK over a three-year period in patients with active AS.Material and methods. BCD-085-5/ASTERA – double-blind, multicenter, randomized phase III clinical trial that enrolled patients with active AS (BASDAI ≥4) and a back pain intensity ≥4 on a numeric rating scale with inefficacy or intolerance of non-steroidal anti-inflammatory drugs or biologic drugs. A total of 228 patients were randomized in a 1:1 ratio and assigned to either the NTK group or the placebo/NTK group. Starting at week 16, patients who did not achieve ASAS20 (20% improvement according to ASAS criteria) received NTK 120 mg once every 2 weeks in an open-label regimen. Patients who achieved ASAS20 response at week 52 in the NTK group and week 68 in the placebo/NTK group continued to receive NTK (120 mg every 2 weeks) until week 156 in the NTK group and until week 172 in the placebo/NTK group.Results and discussion. Over the course of three years of NTK use, most patients experienced a sustained decline in AS activity (according to ASDAS-CRP, BASDAI) with sustained response (ASAS20/40, ASAS5/6) to therapy. Most adverse events reported were mild to moderate. 36.7% of patients had adverse events, which were mainly laboratory abnormalities, blood and lymphatic system abnormalities and infectious complications.Conclusion. The clinical effect of NTK was maintained in most patients with AS over a three-year period, with no significant loss of response. NTK was well tolerated and the safety profile remained favorable.\",\"PeriodicalId\":18651,\"journal\":{\"name\":\"Modern Rheumatology Journal\",\"volume\":\"187 \",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-02-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Modern Rheumatology Journal\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.14412/1996-7012-2024-1-35-46\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Modern Rheumatology Journal","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.14412/1996-7012-2024-1-35-46","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Long-term efficacy and safety of netakimab in patients with active ankylosing spondylitis: results of three years of use in the international multicentre, randomized, double-blind, phase III clinical trial BCD-085-5/ASTERA
The article presents the results of the three-year use of netakimab (NTK) in patients with ankylosing spondylitis (AS) as part of the phase III BCD-085-5/ASTERA study.Objective: to evaluate the long-term efficacy and safety of NTK over a three-year period in patients with active AS.Material and methods. BCD-085-5/ASTERA – double-blind, multicenter, randomized phase III clinical trial that enrolled patients with active AS (BASDAI ≥4) and a back pain intensity ≥4 on a numeric rating scale with inefficacy or intolerance of non-steroidal anti-inflammatory drugs or biologic drugs. A total of 228 patients were randomized in a 1:1 ratio and assigned to either the NTK group or the placebo/NTK group. Starting at week 16, patients who did not achieve ASAS20 (20% improvement according to ASAS criteria) received NTK 120 mg once every 2 weeks in an open-label regimen. Patients who achieved ASAS20 response at week 52 in the NTK group and week 68 in the placebo/NTK group continued to receive NTK (120 mg every 2 weeks) until week 156 in the NTK group and until week 172 in the placebo/NTK group.Results and discussion. Over the course of three years of NTK use, most patients experienced a sustained decline in AS activity (according to ASDAS-CRP, BASDAI) with sustained response (ASAS20/40, ASAS5/6) to therapy. Most adverse events reported were mild to moderate. 36.7% of patients had adverse events, which were mainly laboratory abnormalities, blood and lymphatic system abnormalities and infectious complications.Conclusion. The clinical effect of NTK was maintained in most patients with AS over a three-year period, with no significant loss of response. NTK was well tolerated and the safety profile remained favorable.