Netakimab in anti-TNF-naive patients with psoriatic arthritis: subanalysis of PATERA clinical trial

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Abstract

Netakimab (NTK) is a humanized anti-interleukin-17А monoclonal antibody approved for the treatment of psoriatic arthritis (PsA), ankylosing spondylitis, moderate to severe plaque psoriasis. Aim. We aimed to evaluate the safety and efficacy of NTK in anti-TNF-naive PsA patients, using a subanalysis of 24-week results of the phase III PATERA study. Materials and methods. The core population of PATERA study included 194 patients with active PsA and an inadequate response to previous therapy with nonsteroidal anti-inflammatory drugs, conventional or biologic disease-modifying antirheumatic drugs, randomized in a 1:1 ratio to receive subcutaneous 120 mg NTK or placebo. Among them 155 patients, 75 in the NTK arm and 80 in the placebo arm, were anti-TNF-naive and complied with subanalysis inclusion criterion. Results. Subanalysis results are consistent with core population data. 82.7% of patients in the NTK arm and 11.3% of patients in the placebo arm achieved ACR20 at week 24 (p<0.0001). NTK led to significant decline in PsA activity, axial disease, skin manifestations. Treatment-related adverse events (AE) were observed in 14.7% of patients in the NTK arm, 8.8% in the placebo arm and were mainly presented with laboratory abnormalities (hypercholesterolemia, increased alanine aminotransferase), blood and lymphatic disorders (lymphopenia). Most of AEs were mild and moderate. Conclusions. NTK has a preferable safety profile and significantly declines the severity of PsA symptoms when used as the first bDMARD.

About the authors

Tatiana V. Korotaeva

Nasonova Research Institute of Rheumatology

Email: tatianakorotaeva@gmail.com
д-р мед. наук, зав. лаб. спондилоартритов и псориатического артрита Moscow, Russia

Aleksei V. Samtsov

Kirov Military Medical Academy

д-р мед. наук, проф., зав каф. и клиники кожных и венерических болезней Saint Petersburg, Russia

Vladislav R. Khairutdinov

Kirov Military Medical Academy

д-р мед. наук, доц. каф. кожных и венерических болезней Saint Petersburg, Russia

Andrei L. Bakulev

Razumovsky Saratov State Medical University

д-р мед. наук, проф., зав. каф. дерматовенерологии и косметологии Saratov, Russia

Vladimir V. Mladov

CJSC BIOCAD

менеджер по оценке технологий здравоохранения Saint Petersburg, Russia

Anna V. Eremeeva

CJSC BIOCAD

анд. мед. наук, вед. медицинский эксперт Saint Petersburg, Russia

Arina V. Zinkina-Orikhan

CJSC BIOCAD

рук. отд. клинической разработки «Аутоиммунные и орфанные заболевания» Saint Petersburg, Russia

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