Efficacy and safety of netakimab in patients with psoriatic arthritis: results of the phase III PATERA clinical study
Netakimab (NTK) is a humanized anti-interleukin-17А (IL-17A) monoclonal antibody approved for the treatment of psoriatic arthritis, ankylosing spondylitis, moderate to severe psoriasis. Here, we present the results of the 24-weeks double blind period of the PATERA study.Objective. The objective of t...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | Russian |
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IMA PRESS LLC
2020-11-01
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| Series: | Научно-практическая ревматология |
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| Online Access: | https://rsp.mediar-press.net/rsp/article/view/2949 |
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| author | T. V. Korotaeva V. I. Mazurov A. M. Lila I. Z. Gaydukova A. L. Bakulev A. V. Samtsov V. R. Khairutdinov A. V. Eremeeva M. A. Morozova |
| author_facet | T. V. Korotaeva V. I. Mazurov A. M. Lila I. Z. Gaydukova A. L. Bakulev A. V. Samtsov V. R. Khairutdinov A. V. Eremeeva M. A. Morozova |
| author_sort | T. V. Korotaeva |
| collection | DOAJ |
| description | Netakimab (NTK) is a humanized anti-interleukin-17А (IL-17A) monoclonal antibody approved for the treatment of psoriatic arthritis, ankylosing spondylitis, moderate to severe psoriasis. Here, we present the results of the 24-weeks double blind period of the PATERA study.Objective. The objective of the study was to evaluate the efficacy and safety of NTK compared to placebo in patients with psoriatic arthritis (PsA).Patients and methods. 194 patients with active PsA with an inadequate response to previous therapy with nonsteroidal anti-inflammatory drugs, conventional or biologic disease-modifying antirheumatic drugs, were randomized in a 1:1 ratio to receive subcutaneous 120 mg NTK or placebo at weeks 0, 1, 2, 4, 6, 8, 10, 14, 18, 22. At week 16 ACR20 (20% improvement in the American College of Rheumatology response criteria) non-responders in placebo group were reassigned to NTK in a blinded manner. The primary endpoint was the proportion of patients achieved ACR20 response at week 24.Results. 82,5% of patients in the NTK group and 9.3% of patients in the placebo group achieved ACR20 at week 24 with the 95% CI [0,63; 0,84] (p < 0,0001). Skin manifestations and axial disease significantly improved with NTK. The safety profile of NTK was comparable to placebo. The most frequent treatment-related AEs were expected and common for all other IL-17 inhibitors: increased alanine aminotransferase (ALT), infections, lymphopenia.Conclusion. NTK in the dose of 120 mg has superior efficacy over placebo in patients with active psoriatic arthritis. The safety profile is consistent with other IL-17 inhibitors. |
| first_indexed | 2024-04-09T22:22:27Z |
| format | Article |
| id | doaj.art-140fe3665cd14bf7adce314acddb0275 |
| institution | Directory Open Access Journal |
| issn | 1995-4484 1995-4492 |
| language | Russian |
| last_indexed | 2024-04-09T22:22:27Z |
| publishDate | 2020-11-01 |
| publisher | IMA PRESS LLC |
| record_format | Article |
| series | Научно-практическая ревматология |
| spelling | doaj.art-140fe3665cd14bf7adce314acddb02752023-03-22T13:45:56ZrusIMA PRESS LLCНаучно-практическая ревматология1995-44841995-44922020-11-0158548048810.47360/1995-4484-2020-480-4882647Efficacy and safety of netakimab in patients with psoriatic arthritis: results of the phase III PATERA clinical studyT. V. Korotaeva0V. I. Mazurov1A. M. Lila2I. Z. Gaydukova3A. L. Bakulev4A. V. Samtsov5V. R. Khairutdinov6A. V. Eremeeva7M. A. Morozova8V.A. Nasonova Research Institute of RheumatologyI.I. Mechnikov North-Western State Medical UniversityV.A. Nasonova Research Institute of RheumatologyI.I. Mechnikov North-Western State Medical University; St-Petersburg Clinical Rheumatology Hospital No 25Saratov State Medical University named after V.I. RazumovskyMilitary medical academy of S.M. KirovMilitary medical academy of S.M. KirovJSC BIOCADJSC BIOCADNetakimab (NTK) is a humanized anti-interleukin-17А (IL-17A) monoclonal antibody approved for the treatment of psoriatic arthritis, ankylosing spondylitis, moderate to severe psoriasis. Here, we present the results of the 24-weeks double blind period of the PATERA study.Objective. The objective of the study was to evaluate the efficacy and safety of NTK compared to placebo in patients with psoriatic arthritis (PsA).Patients and methods. 194 patients with active PsA with an inadequate response to previous therapy with nonsteroidal anti-inflammatory drugs, conventional or biologic disease-modifying antirheumatic drugs, were randomized in a 1:1 ratio to receive subcutaneous 120 mg NTK or placebo at weeks 0, 1, 2, 4, 6, 8, 10, 14, 18, 22. At week 16 ACR20 (20% improvement in the American College of Rheumatology response criteria) non-responders in placebo group were reassigned to NTK in a blinded manner. The primary endpoint was the proportion of patients achieved ACR20 response at week 24.Results. 82,5% of patients in the NTK group and 9.3% of patients in the placebo group achieved ACR20 at week 24 with the 95% CI [0,63; 0,84] (p < 0,0001). Skin manifestations and axial disease significantly improved with NTK. The safety profile of NTK was comparable to placebo. The most frequent treatment-related AEs were expected and common for all other IL-17 inhibitors: increased alanine aminotransferase (ALT), infections, lymphopenia.Conclusion. NTK in the dose of 120 mg has superior efficacy over placebo in patients with active psoriatic arthritis. The safety profile is consistent with other IL-17 inhibitors.https://rsp.mediar-press.net/rsp/article/view/2949netakimabpsoriatic arthritisinterleukin-17 inhibitors |
| spellingShingle | T. V. Korotaeva V. I. Mazurov A. M. Lila I. Z. Gaydukova A. L. Bakulev A. V. Samtsov V. R. Khairutdinov A. V. Eremeeva M. A. Morozova Efficacy and safety of netakimab in patients with psoriatic arthritis: results of the phase III PATERA clinical study Научно-практическая ревматология netakimab psoriatic arthritis interleukin-17 inhibitors |
| title | Efficacy and safety of netakimab in patients with psoriatic arthritis: results of the phase III PATERA clinical study |
| title_full | Efficacy and safety of netakimab in patients with psoriatic arthritis: results of the phase III PATERA clinical study |
| title_fullStr | Efficacy and safety of netakimab in patients with psoriatic arthritis: results of the phase III PATERA clinical study |
| title_full_unstemmed | Efficacy and safety of netakimab in patients with psoriatic arthritis: results of the phase III PATERA clinical study |
| title_short | Efficacy and safety of netakimab in patients with psoriatic arthritis: results of the phase III PATERA clinical study |
| title_sort | efficacy and safety of netakimab in patients with psoriatic arthritis results of the phase iii patera clinical study |
| topic | netakimab psoriatic arthritis interleukin-17 inhibitors |
| url | https://rsp.mediar-press.net/rsp/article/view/2949 |
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