Efficacy and safety of netakimab in patients with psoriatic arthritis: results of the phase III PATERA clinical study
| Autor: | 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 |
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| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Immunology Diseases of the musculoskeletal system Placebo Gastroenterology 03 medical and health sciences Psoriatic arthritis 0302 clinical medicine Rheumatology Internal medicine medicine Clinical endpoint Immunology and Allergy In patient 030212 general & internal medicine psoriatic arthritis 030203 arthritis & rheumatology Ankylosing spondylitis business.industry interleukin-17 inhibitors medicine.disease Acr20 response Safety profile RC925-935 netakimab business |
| Zdroj: | Научно-практическая ревматология, Vol 58, Iss 5, Pp 480-488 (2020) |
| ISSN: | 1995-4492 1995-4484 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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