Efficacy of netakimab in key psoriatic arthritis domains: 54-week results from the phase III BCD-085-8/PATERA study
Netakimab is a humanized anti-interleukin-17А monoclonal antibody approved for the treatment of psoriatic arthritis, ankylosing spondylitis, moderate to severe psoriasis. Herein, we report the accumulated efficacy data and safety findings of 54-week netakimab treatment during the PATERA study.The ai...
Saved in:
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
IMA PRESS LLC
2021-03-01
|
| Series: | Научно-практическая ревматология |
| Subjects: | |
| Online Access: | https://rsp.mediar-press.net/rsp/article/view/2989 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850043219380797440 |
|---|---|
| author | T. V. Korotaeva V. I. Mazurov A. M. Lila I. Z. Gaydukova A. L. Bakulev A. V. Samtsov V. R. Khairutdinov A. V. Zinkina-Orikhan Yu. A. Sevastyanova A. V. Eremeeva |
| 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. Zinkina-Orikhan Yu. A. Sevastyanova A. V. Eremeeva |
| author_sort | T. V. Korotaeva |
| collection | DOAJ |
| description | Netakimab is a humanized anti-interleukin-17А monoclonal antibody approved for the treatment of psoriatic arthritis, ankylosing spondylitis, moderate to severe psoriasis. Herein, we report the accumulated efficacy data and safety findings of 54-week netakimab treatment during the PATERA study.The aim of the study was to assess the long-term efficacy and safety of netakimab in patients with active psoriatic arthritis.Materials and methods. 194 patients with active psoriatic arthritis despite the previous therapy with nonsteroidal anti-inflammatory drugs, conventional or biologic disease-modifying antirheumatic drugs were initially randomized to receive 120 mg netakimab or placebo (1:1) at weeks 0, 1, 2, 4, 6, 8, 10, 14, 18, 22. At week 16 inadequate responders in placebo group were reassigned to netakimab in a blinded manner. From week 24 all patients receive open-label netakimab. The analyzed period includes 54 weeks.Results. Netakimab demonstrated sustained treatment response. 94.9% of patients in the netakimab group achieved ACR20 at week 54; 89.5% achieved PASI75 response. Axial disease, dactylitis, and enthesitis significantly improved with netakimab. A similar pattern was observed for placebo/netakimab treated patients. Netakimab was well tolerated. The majority of adverse events were mild and moderate. The most frequent treatment-related adverse events were lymphopenia, increased alanine aminotransferase, hypercholesterolemia. Adverse events of grade 3–4 were observed in 2%.Conclusion. Netakimab demonstrated sustained efficacy in key psoriatic arthritis domains at week 54 with a favorable longterm safety profile. |
| format | Article |
| id | doaj-art-4cf1afa40e2e4cf69285a9061fcc7d8f |
| institution | DOAJ |
| issn | 1995-4484 1995-4492 |
| language | Russian |
| publishDate | 2021-03-01 |
| publisher | IMA PRESS LLC |
| record_format | Article |
| series | Научно-практическая ревматология |
| spelling | doaj-art-4cf1afa40e2e4cf69285a9061fcc7d8f2025-08-20T02:55:17ZrusIMA PRESS LLCНаучно-практическая ревматология1995-44841995-44922021-03-01591475510.47360/1995-4484-2021-47-552680Efficacy of netakimab in key psoriatic arthritis domains: 54-week results from the phase III BCD-085-8/PATERA studyT. V. Korotaeva0V. I. Mazurov1A. M. Lila2I. Z. Gaydukova3A. L. Bakulev4A. V. Samtsov5V. R. Khairutdinov6A. V. Zinkina-Orikhan7Yu. A. Sevastyanova8A. V. Eremeeva9VA Nasonova Research Institute of RheumatologyNorth-Western StateMedical University named after I.I. Mechnikov; Saint Petersburg Clinical Rheumatology Hospital N 25VA Nasonova Research Institute of Rheumatology; Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of the Russian FederationNorth-Western StateMedical University named after I.I. Mechnikov; Saint Petersburg Clinical Rheumatology Hospital N 25Saratov State Medical University named after V.I. RazumovskyMilitary Medical Academy of S.M. KirovMilitary Medical Academy of S.M. KirovZAO BIOCADZAO BIOCADZAO BIOCADNetakimab is a humanized anti-interleukin-17А monoclonal antibody approved for the treatment of psoriatic arthritis, ankylosing spondylitis, moderate to severe psoriasis. Herein, we report the accumulated efficacy data and safety findings of 54-week netakimab treatment during the PATERA study.The aim of the study was to assess the long-term efficacy and safety of netakimab in patients with active psoriatic arthritis.Materials and methods. 194 patients with active psoriatic arthritis despite the previous therapy with nonsteroidal anti-inflammatory drugs, conventional or biologic disease-modifying antirheumatic drugs were initially randomized to receive 120 mg netakimab or placebo (1:1) at weeks 0, 1, 2, 4, 6, 8, 10, 14, 18, 22. At week 16 inadequate responders in placebo group were reassigned to netakimab in a blinded manner. From week 24 all patients receive open-label netakimab. The analyzed period includes 54 weeks.Results. Netakimab demonstrated sustained treatment response. 94.9% of patients in the netakimab group achieved ACR20 at week 54; 89.5% achieved PASI75 response. Axial disease, dactylitis, and enthesitis significantly improved with netakimab. A similar pattern was observed for placebo/netakimab treated patients. Netakimab was well tolerated. The majority of adverse events were mild and moderate. The most frequent treatment-related adverse events were lymphopenia, increased alanine aminotransferase, hypercholesterolemia. Adverse events of grade 3–4 were observed in 2%.Conclusion. Netakimab demonstrated sustained efficacy in key psoriatic arthritis domains at week 54 with a favorable longterm safety profile.https://rsp.mediar-press.net/rsp/article/view/2989netakimabpsoriatic 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. Zinkina-Orikhan Yu. A. Sevastyanova A. V. Eremeeva Efficacy of netakimab in key psoriatic arthritis domains: 54-week results from the phase III BCD-085-8/PATERA study Научно-практическая ревматология netakimab psoriatic arthritis interleukin-17 inhibitors |
| title | Efficacy of netakimab in key psoriatic arthritis domains: 54-week results from the phase III BCD-085-8/PATERA study |
| title_full | Efficacy of netakimab in key psoriatic arthritis domains: 54-week results from the phase III BCD-085-8/PATERA study |
| title_fullStr | Efficacy of netakimab in key psoriatic arthritis domains: 54-week results from the phase III BCD-085-8/PATERA study |
| title_full_unstemmed | Efficacy of netakimab in key psoriatic arthritis domains: 54-week results from the phase III BCD-085-8/PATERA study |
| title_short | Efficacy of netakimab in key psoriatic arthritis domains: 54-week results from the phase III BCD-085-8/PATERA study |
| title_sort | efficacy of netakimab in key psoriatic arthritis domains 54 week results from the phase iii bcd 085 8 patera study |
| topic | netakimab psoriatic arthritis interleukin-17 inhibitors |
| url | https://rsp.mediar-press.net/rsp/article/view/2989 |
| work_keys_str_mv | AT tvkorotaeva efficacyofnetakimabinkeypsoriaticarthritisdomains54weekresultsfromthephaseiiibcd0858paterastudy AT vimazurov efficacyofnetakimabinkeypsoriaticarthritisdomains54weekresultsfromthephaseiiibcd0858paterastudy AT amlila efficacyofnetakimabinkeypsoriaticarthritisdomains54weekresultsfromthephaseiiibcd0858paterastudy AT izgaydukova efficacyofnetakimabinkeypsoriaticarthritisdomains54weekresultsfromthephaseiiibcd0858paterastudy AT albakulev efficacyofnetakimabinkeypsoriaticarthritisdomains54weekresultsfromthephaseiiibcd0858paterastudy AT avsamtsov efficacyofnetakimabinkeypsoriaticarthritisdomains54weekresultsfromthephaseiiibcd0858paterastudy AT vrkhairutdinov efficacyofnetakimabinkeypsoriaticarthritisdomains54weekresultsfromthephaseiiibcd0858paterastudy AT avzinkinaorikhan efficacyofnetakimabinkeypsoriaticarthritisdomains54weekresultsfromthephaseiiibcd0858paterastudy AT yuasevastyanova efficacyofnetakimabinkeypsoriaticarthritisdomains54weekresultsfromthephaseiiibcd0858paterastudy AT averemeeva efficacyofnetakimabinkeypsoriaticarthritisdomains54weekresultsfromthephaseiiibcd0858paterastudy |