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Table 3 Treatment-emergent adverse events (safety population)

From: Efficacy and safety of biosimilar CT-P17 versus reference adalimumab in subjects with rheumatoid arthritis: 24-week results from a randomized study

  CT-P17 (N = 324) EU-adalimumab (N = 324)
Subjects with ≥ 1 TEAE, n (%) 169 (52.2) 184 (56.8)
 Study drug-related 88 (27.2) 99 (30.6)
 TEAEs reported in ≥ 5% of subjects in either treatment group
  ISR 16 (4.9) 22 (6.8)
  Nasopharyngitis 17 (5.2) 20 (6.2)
  Upper respiratory tract infection 17 (5.2) 20 (6.2)
  Neutropenia 14 (4.3) 17 (5.2)
Subjects with ≥ 1 TESAE, n (%) 10 (3.1) 16 (4.9)
Subjects with ≥ 1 TEAE leading to study drug discontinuation, n (%) 5 (1.5) 8 (2.5)
Subjects with ≥ 1 TEAE classified as hypersensitivity/allergic reactions, n (%) 2 (0.6) 4 (1.2)
Subjects with ≥ 1 TEAE classified as ISR, n (%) 16 (4.9) 22 (6.8)
Subjects with ≥ 1 TEAE classified as infection, n (%) 97 (29.9) 103 (31.8)
Subjects with ≥ 1 TEAE classified as malignancy, n (%) 1 (0.3)a 0
Total number of TEAEs leading to death 0 0
  1. Note: There were no significant differences between the CT-P17 and EU-adalimumab groups for any parameter (p > 0.05)
  2. aBreast cancer that was considered unrelated to study drug; the subject’s family history of breast cancer was considered a risk factor by the investigator
  3. TEAE treatment-emergent adverse event, EU-adalimumab European Union-approved adalimumab, ISR injection-site reaction, TESAE treatment-emergent serious adverse event
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Arthritis Research & Therapy

ISSN: 1478-6362

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