Efficacy of netakimab in key psoriatic arthritis domains: 54-week results from the phase III BCD-085-8/PATERA study

Коротаева, Т. В.; Мазуров, В. И.; Лила, А. М.; Гайдукова, И. З.; Бакулев, А. Л.; Самцов, А. В.; Хайрутдинов, В. Р.; Zinkina-Orikhan, Arina V.; Севастьянова, Ю. А.; Eremeeva, A.

doi:10.47360/1995-4484-2021-47-55

Cited by 7 publications

(2 citation statements)

References 18 publications

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“… 14 In PATERA, a higher proportion of patients reached American College of Rheumatology (ACR) 20 (82%) and ACR50 (70%) at week 24 with NTK vs placebo (9% and 6%, respectively). 15 Approved since 2016 in Japan for treating PsA, brodalumab is a fully human monoclonal antibody that binds to the IL-17 receptor subunit A (IL-17RA) and inhibits the activity of both IL-17A and F. For axSpA, a completed phase III trial showed positive results with ASAS40 response rates of 45.5% at week 16 and 61.6% at week 68. 16 Two phase III trials (AMVISION-1 and AMVISION-2) showed that significantly more patients achieved ACR20 at week 16 in both brodalumab treatment groups (45.8% and 47.9% for 140 mg and 210 mg, respectively).…”

Section: Resultsmentioning

confidence: 99%

The 2023 pipeline of disease-modifying antirheumatic drugs (DMARDs) in clinical development for spondyloarthritis (including psoriatic arthritis): a systematic review of trials

et al. 2023

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ObjectivesThe objective of this systematic review was to provide an overview of current developments and potentially available therapeutic options for spondyloarthritis (SpA) in the coming years.MethodsWe conducted a systematic review of 17 national and international clinical trial databases for all disease-modifying antirheumatic drugs (DMARDs) for SpA that are already marketed, in clinical development or withdrawn. The search was performed on February 2023 with the keywords “spondyloarthritis”, “ankylosing spondylitis” and “psoriatic arthritis”. For each molecule, we only considered the study at the most advanced stage of clinical development.ResultsConcerning axial SpA (axSpA), a total of 44 DMARDs were identified: 6 conventional synthetic DMARDs (csDMARDs), 27 biological DMARDs (bDMARDs) and 11 targeted synthetic DMARDs (tsDMARDs). Among the 18 targeted treatments (b+tsDMARDs) in current development, corresponding trials reached phase I (n=1), II (n=10) and III (n=7). Ten molecules are IL-17 inhibitors, two Janus kinase (JAK) inhibitors and two granulocyte-macrophage colony-stimulating factor inhibitors; four have another mode of action. Concerning psoriatic arthritis (PsA), 44 DMARDs were identified: 5 csDMARDs, 27 bDMARDs and 12 tsDMARDs. Among the 15 molecules in current development, corresponding trials reached phase II (n=8) and III (n=7). Six molecules are JAK inhibitors, six IL-17 inhibitors and one an IL-23 inhibitor; two have another mode of action.ConclusionThis systematic review identified 18 and 15 molecules in clinical development for axSpA and PsA, respectively, which suggests a strengthening of the therapeutic arsenal in the coming years. However, with so many DMARDs but low target diversity, we will need to develop strategies or biomarkers to help clinicians make informed treatment decisions.

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Section: Resultsmentioning

confidence: 99%

The 2023 pipeline of disease-modifying antirheumatic drugs (DMARDs) in clinical development for spondyloarthritis (including psoriatic arthritis): a systematic review of trials

et al. 2023

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“…The results of netakimab use in PsA were shown in the PATERA trial (194 patients) [161,162]. The ACR20 response was reached by 82,5% of patients, accompanied by the mitigation of clinical features and a statistically significant decrease in ASDAS-CRP and BASDAI indexes.…”

Section: Monoclonal Antibodiesmentioning

confidence: 99%

The Interleukine-17 Cytokine Family: Role in Development and Progression of Spondyloarthritis, Current and Potential Therapeutic Inhibitors

et al. 2023

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Spondyloarthritis (SpA) encompasses a group of chronic inflammatory rheumatic diseases with a predilection for the spinal and sacroiliac joints, which include axial spondyloarthritis, psoriatic arthritis, reactive arthritis, arthritis associated with chronic inflammatory bowel disease, and undifferentiated spondyloarthritis. The prevalence of SpA in the population varies from 0.5 to 2%, most commonly affecting young people. Spondyloarthritis pathogenesis is related to the hyperproduction of proinflammatory cytokines (TNFα, IL-17А, IL-23, etc.). IL-17A plays a key role in the pathogenesis of spondyloarthritis (inflammation maintenance, syndesmophites formation and radiographic progression, enthesites and anterior uveitis development, etc.). Targeted anti-IL17 therapies have established themselves as the most efficient therapies in SpA treatment. The present review summarizes literature data on the role of the IL-17 family in the pathogenesis of SpA and analyzes existing therapeutic strategies for IL-17 suppression with monoclonal antibodies and Janus kinase inhibitors. We also consider alternative targeted strategies, such as the use of other small-molecule inhibitors, therapeutic nucleic acids, or affibodies. We discuss advantages and pitfalls of these approaches and the future prospects of each method.

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Netakimab for the treatment of psoriatic arthritis: 3-year results of the phase III BCD-085-8/PATERA study

Korotaeva,

Mazurov,

Lila

et al. 2024

Sovremennaâ revmatologiâ

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This article presents the results of the 3-year use of netakimab (NTK), a monoclonal antibody against interleukin 17, in patients with psoriatic arthritis (PsA) as part of the phase III PATERA study. Objective: to evaluate the long-term efficacy and safety of NTK in patients with PsA over a period of 3 years. Material and methods. PATERA is a double-blind, multicenter, randomized, phase III clinical trial. 194 patients with active PsA were randomized 1:1 to NTX or placebo/NTX. NTX/placebo was administered at weeks 0, 1, 2, 4, 6, 8, 10 and 14. Placebo patients who did not achieve a 20% improvement according to ACR criteria (ACR20) at week 16 received NTX at weeks 18 and 22. Patients who achieved ACR20 received placebo at weeks 18 and 22. Subsequently, all patients received NTX. At week 54, patients who did not meet ACR20 criteria were withdrawn from the study and the remaining patients were treated in the extension phase. The total duration of NTX use in all groups was 3 years. Results and discussion. Therapeutic response achieved in the first year of treatment was maintained in the extended phase of the study. Against the background of NTX use, a significant long-term decrease in clinical manifestations of PsA was observed. Adverse events occurred mainly in the form of laboratory abnormalities and infectious diseases, which were mostly mild to moderate. Antibodies against NTK were detected in 9.3% of patients and in most cases they were formed at the end of the first and beginning of the second year of therapy. Conclusion. NTK showed a favorable safety profile with long-term use over 3 years. The clinical effect on all manifestations of PsA was maintained in most patients over a long period of time without significant loss of response.

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Efficacy of netakimab in key psoriatic arthritis domains: 54-week results from the phase III BCD-085-8/PATERA study

Cited by 7 publications

References 18 publications

The 2023 pipeline of disease-modifying antirheumatic drugs (DMARDs) in clinical development for spondyloarthritis (including psoriatic arthritis): a systematic review of trials

The 2023 pipeline of disease-modifying antirheumatic drugs (DMARDs) in clinical development for spondyloarthritis (including psoriatic arthritis): a systematic review of trials

The Interleukine-17 Cytokine Family: Role in Development and Progression of Spondyloarthritis, Current and Potential Therapeutic Inhibitors

Netakimab for the treatment of psoriatic arthritis: 3-year results of the phase III BCD-085-8/PATERA study

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