Effectiveness and safety of levilimab in combination with methotrexate in treatment of patients with active rheumatoid arthritis resistant to methotrexate monotherapy (double-blinded randomized placebo controlled phase III clinical study SOLAR)
| Autor: | V. I. Mazurov, M. A. Korolev, A. M. Prystrom, E. V. Kunder, N. F. Soroka, A. A. Kastanayan, T. V. Povarova, T. V. Plaksina, O. V. Antipova, D. G. Kretchikova, S. A. Smakotina, O. A. Tciupa, E. V. Puntus, T. A. Raskina, L. N. Shilova, T. V. Kropotina, O. B. Nesmeyanova, T. A. Popova, I. B. Vinogradova, Yu. N. Linkova, E. A. Dokukina, A. V. Plotnikova, P. S. Pukhtinskaia, A. V. Zinkina-Orikhan, A. V. Eremeeva, A. A. Lutckii |
|---|---|
| Jazyk: | ruština |
| Rok vydání: | 2021 |
| Předmět: | |
| Zdroj: | Современная ревматология, Vol 15, Iss 4, Pp 13-23 (2021) |
| Druh dokumentu: | article |
| ISSN: | 1996-7012 2310-158X |
| DOI: | 10.14412/1996-7012-2021-4-13-23 |
| Popis: | Levilimab is anti-interleukin-6 receptor (IL6R) monoclonal antibody. The article presents data obtained during 24 weeks of the SOLAR phase III study.Objective: to confirm efficacy and safety of levilimab in combination with methotrexate (MTX) in patients with methotrexate resistant active rheumatoid arthritis (RA).Patients and methods. 154 adult patients, aged ≥18 years with the diagnosis of RA (ACR/EULAR 2010) and confirmed disease activity at screening despite treatment with MTX for at least 12 weeks (in a stable dose 15-25 mg/week). Patients were randomized 2:1 in levilimab (162 mg once a week, subcutaneously) + MTX (n=102) or placebo + MTX (n=52) group.The hypothesis of superiority of levilimab over placebo was tested for two co-primary efficacy endpoints: proportion of subjects who achieved ACR20 at week 12 and proportion of subjects who achieved low disease activity (LDA) of RA (DAS28-CRP |
| Databáze: | Directory of Open Access Journals |
| Externí odkaz: |
|