| Autor: |
Karel Pavelka, Alan J. Kivitz, Eva Dokoupilova, Ricardo Blanco, Marco Maradiaga, Hasan Tahir, Yi Wang, Brian O. Porter, Anna Stefanska, Hanno B. Richards, Susanne Rohrer, the MEASURE 3 study group |
| Jazyk: |
angličtina |
| Rok vydání: |
2020 |
| Předmět: |
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| Zdroj: |
ACR Open Rheumatology, Vol 2, Iss 2, Pp 119-127 (2020) |
| Druh dokumentu: |
article |
| ISSN: |
2578-5745 |
| DOI: |
10.1002/acr2.11102 |
| Popis: |
Objective Secukinumab 150 mg has demonstrated significant improvement in signs and symptoms of ankylosing spondylitis (AS), with response rates sustained for up to 5 years. Here, we report end‐of‐study 3‐year efficacy and safety results of secukinumab 150 and 300 mg from the MEASURE 3 study. Methods A total of 226 patients was randomized to intravenous secukinumab 10 mg/kg (baseline, weeks 2 and 4) followed by subcutaneous (s.c.) secukinumab 300/150 mg every 4 weeks or a matched placebo. At week 16, placebo patients were re‐randomized to s.c. secukinumab 300/150 mg. Analysis at week 156 included patients initially randomized to secukinumab and those who switched from placebo to secukinumab at week 16 (any secukinumab 300/150 mg). Outcome measures at week 156 included Assessment of Spondyloarthritis International Society (ASAS) 20/40, Bath Ankylosing Spondylitis Disease Activity Index, ASAS partial remission (PR), ASAS 5/6, and Ankylosing Spondylitis Disease Activity Score–C‐reactive protein inactive disease. Results The retention rates from weeks 16 to 156 were 80.5% and 80.9% in secukinumab 300 and 150 mg, respectively. ASAS 20/40 response rates at week 156 were 75.0%/56.5% and 68.2%/47.7% for secukinumab 300 and 150 mg, respectively. At week 156, response rates on more stringent clinical end points (eg, ASAS 40, ASAS‐PR) were higher with the 300‐mg dose, particularly in tumor necrosis factor (TNF)–inadequate responder (IR) patients. No new safety findings were observed. Conclusion Secukinumab (300 and 150 mg) provided sustained improvements through 3 years in the signs and symptoms of active AS. Improvements with secukinumab 300 mg were numerically higher compared with the 150‐mg dose for some higher hurdle end points and in TNF‐IR patients. The safety profile of secukinumab was consistent with previous reports. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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