Efficacy and safety of a new original interleukin 17A inhibitor in the treatment of patients with active ankylosing spondylitis: results of a basic (BCD-085-3/AILAS) and extended (BCD-085-3ext/AILAS-II) phase II clinical trial
The paper presents the results of a double-blind (BCD-085-3/AILAS) phase II clinical trial of the original interleukin 17A (IL17A) inhibitor BCD-085 prescribed at different doses to patients with active ankylosing spondylitis (AS) and those of an extended (BCD-085-3ext/AILAS-II) trial characterizing...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
IMA PRESS LLC
2019-12-01
|
| Series: | Научно-практическая ревматология |
| Subjects: | |
| Online Access: | https://rsp.mediar-press.net/rsp/article/view/2804 |
| _version_ | 1797862609998839808 |
|---|---|
| author | Sh. Erdes V. I. Mazurov T. V. Dubinina I. Z. Gaydukova S. A. Lapshina E. V. Zonova D. G. Krechikova T. V. Plaksina O. V. Reshetko S. A. Smakotina P. А. Shesternya I. G. Gordeev T. G. Makulova T. V. Povarova T. A. Raskina N. F. Soroka A. M. Pristrom E. V. Kunder Yu. V. Usacheva E. Yu. Stukalina A. V. Eremeeva E. V. Chernyaeva R. A. Ivanov |
| author_facet | Sh. Erdes V. I. Mazurov T. V. Dubinina I. Z. Gaydukova S. A. Lapshina E. V. Zonova D. G. Krechikova T. V. Plaksina O. V. Reshetko S. A. Smakotina P. А. Shesternya I. G. Gordeev T. G. Makulova T. V. Povarova T. A. Raskina N. F. Soroka A. M. Pristrom E. V. Kunder Yu. V. Usacheva E. Yu. Stukalina A. V. Eremeeva E. V. Chernyaeva R. A. Ivanov |
| author_sort | Sh. Erdes |
| collection | DOAJ |
| description | The paper presents the results of a double-blind (BCD-085-3/AILAS) phase II clinical trial of the original interleukin 17A (IL17A) inhibitor BCD-085 prescribed at different doses to patients with active ankylosing spondylitis (AS) and those of an extended (BCD-085-3ext/AILAS-II) trial characterizing the efficacy and safety of this drug when used for a year.The objective of the AILAS study is to determine the therapeutically effective and safe dose of BCD-085 in the treatment of active AS. The efficacy, safety, and immunogenicity of BCD-085 during its annual use were additionally evaluated in the extended trial.Subjects and methods. The investigation enrolled 89 patients diagnosed as having active (BASDAI scores >4.0; mean spinal pain scores >4.0) AS that met the 1984 New York classification criteria. After the end of the screening period, the patients were randomized at a ratio of 1:1:1:1 in one of four groups that received 40; 80 or 120 mg of BCD-085 subcutaneously or placebo on day 1 of weeks 0, 1, 2 and then once every two weeks up to week 12. The primary end point was the number of patients who achieved an ASAS20 response at week 16. The investigation evaluated the safety of the drug, by calculating the total incidence of adverse events (AEs) and serious AEs (SAEs) and the number of cases of premature therapy termination because of AEs.Results and discussion. An ASAS20 response at week 16 was achieved in 72.7% of patients receiving 40 mg of BCD-085, in 81.8% of those receiving 80 mg, in 90.9% of those receiving 120 mg, and in 42.9% of cases in the placebo group (p=0.004). The superiority of BCD-085 over placebo was proven for 80- and 120-mg doses. The fastest and most pronounced effect was observed in patients treated with 120 mg of BCD-085. In the extended study, an ASAS20 response at week 52 was recorded in 86.4% of patients. One or more AEs during the first 16 weeks of therapy were reported in 11 (50.0%) patients of the 40-mg group; in 6 (27.3%) of the 80 mg group; in 4 (18.2%) of the 120 mg group and in 7 (31.8%) of the placebo group (p=0.183). The frequency and spectrum of AEs did not significantly differ in patients who received placebo and BCD-085 in different doses. No SAE was recorded.Conclusion. Phase II study yielded data demonstrating the high efficacy and good tolerance of BCD-085 in the treatment of active AS. The best effect and optimal tolerance were demonstrated for a dose of 120 mg. |
| first_indexed | 2024-04-09T22:23:26Z |
| format | Article |
| id | doaj.art-d4904fdfb8d74d86b07500bfba5201ae |
| institution | Directory Open Access Journal |
| issn | 1995-4484 1995-4492 |
| language | Russian |
| last_indexed | 2024-04-09T22:23:26Z |
| publishDate | 2019-12-01 |
| publisher | IMA PRESS LLC |
| record_format | Article |
| series | Научно-практическая ревматология |
| spelling | doaj.art-d4904fdfb8d74d86b07500bfba5201ae2023-03-22T13:45:55ZrusIMA PRESS LLCНаучно-практическая ревматология1995-44841995-44922019-12-0157666867710.14412/1995-4484-2019-668-6772553Efficacy and safety of a new original interleukin 17A inhibitor in the treatment of patients with active ankylosing spondylitis: results of a basic (BCD-085-3/AILAS) and extended (BCD-085-3ext/AILAS-II) phase II clinical trialSh. Erdes0V. I. Mazurov1T. V. Dubinina2I. Z. Gaydukova3S. A. Lapshina4E. V. Zonova5D. G. Krechikova6T. V. Plaksina7O. V. Reshetko8S. A. Smakotina9P. А. Shesternya10I. G. Gordeev11T. G. Makulova12T. V. Povarova13T. A. Raskina14N. F. Soroka15A. M. Pristrom16E. V. Kunder17Yu. V. Usacheva18E. Yu. Stukalina19A. V. Eremeeva20E. V. Chernyaeva21R. A. Ivanov22V.A. Nasonova Research Institute of RheumatologyI.I. Mechnikov NorthWestern State Medical University, Ministry of Health of RussiaV.A. Nasonova Research Institute of RheumatologyI.I. Mechnikov NorthWestern State Medical University, Ministry of Health of RussiaKazan State Medical University, Ministry of Health of RussiaCity Clinical Polyclinic OneRegonal Hospital at the Smolensk Station, OAO «RZhD»N.A. Semashko Nizhny Novgorod Regional Clinical HospitalRegional Clinical HospitalS.V. Belyaev Kemerovo Regional Clinical HospitalProfessor V.F. Voino-Yasenetsky Krasnoyarsk State Medical University, Ministry of Health of RussiaO.M. Filatov City Clinical Hospital Fifteen, Moscow Healthcare DepartmentMedical Research Institute, OOORailway Clinical Hospital at the Saratov II Station, OAO «RZhD»Kemerovo State Medical University, Ministry of Health of RussiaCity Clinical Hospital NineCity Clinical Hospital OneCity Clinical Hospital OneBIOCAD, ZAOBIOCAD, ZAOBIOCAD, ZAOBIOCAD, ZAOBIOCAD, ZAOThe paper presents the results of a double-blind (BCD-085-3/AILAS) phase II clinical trial of the original interleukin 17A (IL17A) inhibitor BCD-085 prescribed at different doses to patients with active ankylosing spondylitis (AS) and those of an extended (BCD-085-3ext/AILAS-II) trial characterizing the efficacy and safety of this drug when used for a year.The objective of the AILAS study is to determine the therapeutically effective and safe dose of BCD-085 in the treatment of active AS. The efficacy, safety, and immunogenicity of BCD-085 during its annual use were additionally evaluated in the extended trial.Subjects and methods. The investigation enrolled 89 patients diagnosed as having active (BASDAI scores >4.0; mean spinal pain scores >4.0) AS that met the 1984 New York classification criteria. After the end of the screening period, the patients were randomized at a ratio of 1:1:1:1 in one of four groups that received 40; 80 or 120 mg of BCD-085 subcutaneously or placebo on day 1 of weeks 0, 1, 2 and then once every two weeks up to week 12. The primary end point was the number of patients who achieved an ASAS20 response at week 16. The investigation evaluated the safety of the drug, by calculating the total incidence of adverse events (AEs) and serious AEs (SAEs) and the number of cases of premature therapy termination because of AEs.Results and discussion. An ASAS20 response at week 16 was achieved in 72.7% of patients receiving 40 mg of BCD-085, in 81.8% of those receiving 80 mg, in 90.9% of those receiving 120 mg, and in 42.9% of cases in the placebo group (p=0.004). The superiority of BCD-085 over placebo was proven for 80- and 120-mg doses. The fastest and most pronounced effect was observed in patients treated with 120 mg of BCD-085. In the extended study, an ASAS20 response at week 52 was recorded in 86.4% of patients. One or more AEs during the first 16 weeks of therapy were reported in 11 (50.0%) patients of the 40-mg group; in 6 (27.3%) of the 80 mg group; in 4 (18.2%) of the 120 mg group and in 7 (31.8%) of the placebo group (p=0.183). The frequency and spectrum of AEs did not significantly differ in patients who received placebo and BCD-085 in different doses. No SAE was recorded.Conclusion. Phase II study yielded data demonstrating the high efficacy and good tolerance of BCD-085 in the treatment of active AS. The best effect and optimal tolerance were demonstrated for a dose of 120 mg.https://rsp.mediar-press.net/rsp/article/view/2804ankylosing spondylitisradiographic axial spondyloarthritisbcd-085interleukin 17a inhibitor |
| spellingShingle | Sh. Erdes V. I. Mazurov T. V. Dubinina I. Z. Gaydukova S. A. Lapshina E. V. Zonova D. G. Krechikova T. V. Plaksina O. V. Reshetko S. A. Smakotina P. А. Shesternya I. G. Gordeev T. G. Makulova T. V. Povarova T. A. Raskina N. F. Soroka A. M. Pristrom E. V. Kunder Yu. V. Usacheva E. Yu. Stukalina A. V. Eremeeva E. V. Chernyaeva R. A. Ivanov Efficacy and safety of a new original interleukin 17A inhibitor in the treatment of patients with active ankylosing spondylitis: results of a basic (BCD-085-3/AILAS) and extended (BCD-085-3ext/AILAS-II) phase II clinical trial Научно-практическая ревматология ankylosing spondylitis radiographic axial spondyloarthritis bcd-085 interleukin 17a inhibitor |
| title | Efficacy and safety of a new original interleukin 17A inhibitor in the treatment of patients with active ankylosing spondylitis: results of a basic (BCD-085-3/AILAS) and extended (BCD-085-3ext/AILAS-II) phase II clinical trial |
| title_full | Efficacy and safety of a new original interleukin 17A inhibitor in the treatment of patients with active ankylosing spondylitis: results of a basic (BCD-085-3/AILAS) and extended (BCD-085-3ext/AILAS-II) phase II clinical trial |
| title_fullStr | Efficacy and safety of a new original interleukin 17A inhibitor in the treatment of patients with active ankylosing spondylitis: results of a basic (BCD-085-3/AILAS) and extended (BCD-085-3ext/AILAS-II) phase II clinical trial |
| title_full_unstemmed | Efficacy and safety of a new original interleukin 17A inhibitor in the treatment of patients with active ankylosing spondylitis: results of a basic (BCD-085-3/AILAS) and extended (BCD-085-3ext/AILAS-II) phase II clinical trial |
| title_short | Efficacy and safety of a new original interleukin 17A inhibitor in the treatment of patients with active ankylosing spondylitis: results of a basic (BCD-085-3/AILAS) and extended (BCD-085-3ext/AILAS-II) phase II clinical trial |
| title_sort | efficacy and safety of a new original interleukin 17a inhibitor in the treatment of patients with active ankylosing spondylitis results of a basic bcd 085 3 ailas and extended bcd 085 3ext ailas ii phase ii clinical trial |
| topic | ankylosing spondylitis radiographic axial spondyloarthritis bcd-085 interleukin 17a inhibitor |
| url | https://rsp.mediar-press.net/rsp/article/view/2804 |
| work_keys_str_mv | AT sherdes efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial AT vimazurov efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial AT tvdubinina efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial AT izgaydukova efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial AT salapshina efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial AT evzonova efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial AT dgkrechikova efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial AT tvplaksina efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial AT ovreshetko efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial AT sasmakotina efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial AT pashesternya efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial AT iggordeev efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial AT tgmakulova efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial AT tvpovarova efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial AT taraskina efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial AT nfsoroka efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial AT ampristrom efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial AT evkunder efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial AT yuvusacheva efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial AT eyustukalina efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial AT averemeeva efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial AT evchernyaeva efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial AT raivanov efficacyandsafetyofaneworiginalinterleukin17ainhibitorinthetreatmentofpatientswithactiveankylosingspondylitisresultsofabasicbcd0853ailasandextendedbcd0853extailasiiphaseiiclinicaltrial |