1. Additional file 1 of Efficacy and safety of biosimilar CT-P17 versus reference adalimumab in subjects with rheumatoid arthritis: 24-week results from a randomized study
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Kay, Jonathan, Jaworski, Janusz, Wojciechowski, Rafal, Wiland, Piotr, Dudek, Anna, Krogulec, Marek, Slawomir Jeka, Zielinska, Agnieszka, Trefler, Jakub, Bartnicka-Maslowska, Katarzyna, Krajewska-Wlodarczyk, Magdalena, Klimiuk, Piotr A., Lee, Sang Joon, Bae, Yun Ju, Yang, Go Eun, Yoo, Jae Kyoung, Furst, Daniel E., and Keystone, Edward
- Abstract
Additional file 1: Supplementary methods, including Table S1 Study centers and IRB/IEC information, Full inclusion and exclusion criteria, Table S2 Schedule of assessments (screening and treatment period 1), and Analysis populations. Table S3 ACR50 and ACR70 response rates and hybrid ACR scores up to week 24 (ITT population). Table S4 Mean (SD) Ctrough overall and by ADA status (PK population). Figure S1 Mean (±SD) Ctrough by ADA status (PK population). Table S5 Mean (SD) scores by domain for PRE-SIAQ and POST-SIAQ (usability population). Table S6 Study drug–related TESAEs (safety population). Table S7 TEAEs by System Organ Class reported by ≥2% of subjects in either treatment group (safety population). Table S8 Summary of immunogenicity results (safety population). Table S9 ACR20 response rate at week 24 by ADA status (ITT population). Table S10 Treatment-emergent adverse events by ADA status (safety population). Figure S2 Historical data for ACR20 response rate at week 24 for reference or biosimilar adalimumab (50 mg/ml), compared with CT-P17 or reference adalimumab (100 mg/ml) treatment in the current study (ITT population).
- Published
- 2021
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