Efficacy and safety of netakimab, anti-IL-17A monoclonal antibody, in patients with ankylosing spondylitis. Results of phase III international, multicenter, randomized double-blind clinical trial BCD-085-5/ASTERA
Netakimab (NTK) is a humanized monoclonal antibody targeting interleukin-17A.Objective. The main objective of BCD-085-5/ASTERA study was to prove superiority of NTK over placebo and assess its’ safety in patients with active AS.Subjects and methods. BCD-085-5/ASTERA was a double-blind, multicenter,...
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| author | V. I. Mazurov I. Z. Gaydukova Sh. Erdes T. V. Dubinina A. M. Pristrom E. V. Kunder N. F. Soroka A. A. Kastanayan T. V. Povarova E. S. Zhugrova T. V. Plaksina P. A. Shesternya T. V. Kropotina O. V. Antipova E. A. Smolyarchuk O. A. Tciupa D. I. Abdulganieva S. A. Lapshina D. G. Krechikova I. G. Gordeev O. B. Nesmeyanova V. V. Tyrenko E. P. Ilivanova A. V. Strelkova A. V. Eremeeva |
| author_facet | V. I. Mazurov I. Z. Gaydukova Sh. Erdes T. V. Dubinina A. M. Pristrom E. V. Kunder N. F. Soroka A. A. Kastanayan T. V. Povarova E. S. Zhugrova T. V. Plaksina P. A. Shesternya T. V. Kropotina O. V. Antipova E. A. Smolyarchuk O. A. Tciupa D. I. Abdulganieva S. A. Lapshina D. G. Krechikova I. G. Gordeev O. B. Nesmeyanova V. V. Tyrenko E. P. Ilivanova A. V. Strelkova A. V. Eremeeva |
| author_sort | V. I. Mazurov |
| collection | DOAJ |
| description | Netakimab (NTK) is a humanized monoclonal antibody targeting interleukin-17A.Objective. The main objective of BCD-085-5/ASTERA study was to prove superiority of NTK over placebo and assess its’ safety in patients with active AS.Subjects and methods. BCD-085-5/ASTERA was a double-blind, multicenter, randomized, placebo-controlled, phase III study, which included 228 adult patients with active AS, persisting despite active treatment with NSAIDs. AS was considered active at BASDAI score ≥ 4.0. Patients were blindly randomized (1:1) to receive subcutaneous injections of NTK (120 mg) or placebo at weeks 0, 1, 2 and then every other week up to week 14. Starting from week 16 all patients from NTK group and patients from placebo group not achieving ASAS20 were switched to open label 120 mg NTK s/c once every two weeks. The total duration of treatment with NTK was 3 years.Results. Higher proportion of patients had ASAS40 response at week 16 (primary endpoint) in NTK arm compared to placebo (40,4 vs 2,6%, р <0,0001, 95% CI [27,4%; 48,1%]). Spinal pain subsided and laboratory inflammation markers decreased within one week after the first NTK injection. NTK safety profile was comparable to that of placebo. The most common for NTK adverse events were neutropenia (7,0%) and ALT increase (6,1%).Conclusion. Subcutaneous NTK at 120 mg dose demonstrated superior efficacy vs placebo, with fast onset of response and favorable safety profile when used in patients with ankylosing spondylitis. |
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| issn | 1995-4484 1995-4492 |
| language | Russian |
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| spelling | doaj.art-7a1a0bd45df54172a1cd35efba0113872023-03-22T13:45:56ZrusIMA PRESS LLCНаучно-практическая ревматология1995-44841995-44922020-09-0158437638610.47360/1995-4484-2020-376-3862629Efficacy and safety of netakimab, anti-IL-17A monoclonal antibody, in patients with ankylosing spondylitis. Results of phase III international, multicenter, randomized double-blind clinical trial BCD-085-5/ASTERAV. I. Mazurov0I. Z. Gaydukova1Sh. Erdes2T. V. Dubinina3A. M. Pristrom4E. V. Kunder5N. F. Soroka6A. A. Kastanayan7T. V. Povarova8E. S. Zhugrova9T. V. Plaksina10P. A. Shesternya11T. V. Kropotina12O. V. Antipova13E. A. Smolyarchuk14O. A. Tciupa15D. I. Abdulganieva16S. A. Lapshina17D. G. Krechikova18I. G. Gordeev19O. B. Nesmeyanova20V. V. Tyrenko21E. P. Ilivanova22A. V. Strelkova23A. V. Eremeeva24North-Western State Medical University named after I.I. Mechnikov, Ministry of Health of Russia; St-Petersburg Clinical Rheumatology Hospital No 25North-Western State Medical University named after I.I. Mechnikov, Ministry of Health of Russia; St-Petersburg Clinical Rheumatology Hospital No 25V.A. Nasonova Research Institute of RheumatologyV.A. Nasonova Research Institute of RheumatologyCity Clinical Hospital OneCity Clinical Hospital OneCity Clinical Hospital 9Rostov State Medical University, Ministry of Healthcare of RussiaRailway Clinical Hospital at the Saratov II Station OAO «RZhD»North-Western State Medical University named after I.I. Mechnikov, Ministry of Health of Russia; City Polyclinic No. 38N.A. Semashko Nizhny Novgorod Regional Clinical Hospitalprof. V.F. Voino-Yasenetsky Krasnoyarsk State Medical UniversityRegional Clinical HospitalIrkutsk Clinical Hospital №1First Moscow State Medical University of the Ministry of Healthcare of the Russian Federation (Sechenovskiy University)City Hospital No. 4Kazan State Medical University, Ministry of Health of RussiaKazan State Medical University, Ministry of Health of RussiaSectional Hospital at the Smolensk Station, OAO «RZhD»O.M.Filatov Moscow City Clinical Hospital 15State Budgetary Institution of Healthcare “Chelyabinsk Regional Clinical Hospital”Military Medical Academy named after S.M. Kirov, Ministry of Defense of the Russian FederationLeningrad Regional Clinical HospitalThe first city clinical hospital named after E.E. VolosevichJSC BIOCADNetakimab (NTK) is a humanized monoclonal antibody targeting interleukin-17A.Objective. The main objective of BCD-085-5/ASTERA study was to prove superiority of NTK over placebo and assess its’ safety in patients with active AS.Subjects and methods. BCD-085-5/ASTERA was a double-blind, multicenter, randomized, placebo-controlled, phase III study, which included 228 adult patients with active AS, persisting despite active treatment with NSAIDs. AS was considered active at BASDAI score ≥ 4.0. Patients were blindly randomized (1:1) to receive subcutaneous injections of NTK (120 mg) or placebo at weeks 0, 1, 2 and then every other week up to week 14. Starting from week 16 all patients from NTK group and patients from placebo group not achieving ASAS20 were switched to open label 120 mg NTK s/c once every two weeks. The total duration of treatment with NTK was 3 years.Results. Higher proportion of patients had ASAS40 response at week 16 (primary endpoint) in NTK arm compared to placebo (40,4 vs 2,6%, р <0,0001, 95% CI [27,4%; 48,1%]). Spinal pain subsided and laboratory inflammation markers decreased within one week after the first NTK injection. NTK safety profile was comparable to that of placebo. The most common for NTK adverse events were neutropenia (7,0%) and ALT increase (6,1%).Conclusion. Subcutaneous NTK at 120 mg dose demonstrated superior efficacy vs placebo, with fast onset of response and favorable safety profile when used in patients with ankylosing spondylitis.https://rsp.mediar-press.net/rsp/article/view/2925netakimabbcd-085monoclonal antibodyinterleukin 17aankylosing spondylitisaxial spondyloarthritis |
| spellingShingle | V. I. Mazurov I. Z. Gaydukova Sh. Erdes T. V. Dubinina A. M. Pristrom E. V. Kunder N. F. Soroka A. A. Kastanayan T. V. Povarova E. S. Zhugrova T. V. Plaksina P. A. Shesternya T. V. Kropotina O. V. Antipova E. A. Smolyarchuk O. A. Tciupa D. I. Abdulganieva S. A. Lapshina D. G. Krechikova I. G. Gordeev O. B. Nesmeyanova V. V. Tyrenko E. P. Ilivanova A. V. Strelkova A. V. Eremeeva Efficacy and safety of netakimab, anti-IL-17A monoclonal antibody, in patients with ankylosing spondylitis. Results of phase III international, multicenter, randomized double-blind clinical trial BCD-085-5/ASTERA Научно-практическая ревматология netakimab bcd-085 monoclonal antibody interleukin 17a ankylosing spondylitis axial spondyloarthritis |
| title | Efficacy and safety of netakimab, anti-IL-17A monoclonal antibody, in patients with ankylosing spondylitis. Results of phase III international, multicenter, randomized double-blind clinical trial BCD-085-5/ASTERA |
| title_full | Efficacy and safety of netakimab, anti-IL-17A monoclonal antibody, in patients with ankylosing spondylitis. Results of phase III international, multicenter, randomized double-blind clinical trial BCD-085-5/ASTERA |
| title_fullStr | Efficacy and safety of netakimab, anti-IL-17A monoclonal antibody, in patients with ankylosing spondylitis. Results of phase III international, multicenter, randomized double-blind clinical trial BCD-085-5/ASTERA |
| title_full_unstemmed | Efficacy and safety of netakimab, anti-IL-17A monoclonal antibody, in patients with ankylosing spondylitis. Results of phase III international, multicenter, randomized double-blind clinical trial BCD-085-5/ASTERA |
| title_short | Efficacy and safety of netakimab, anti-IL-17A monoclonal antibody, in patients with ankylosing spondylitis. Results of phase III international, multicenter, randomized double-blind clinical trial BCD-085-5/ASTERA |
| title_sort | efficacy and safety of netakimab anti il 17a monoclonal antibody in patients with ankylosing spondylitis results of phase iii international multicenter randomized double blind clinical trial bcd 085 5 astera |
| topic | netakimab bcd-085 monoclonal antibody interleukin 17a ankylosing spondylitis axial spondyloarthritis |
| url | https://rsp.mediar-press.net/rsp/article/view/2925 |
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