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Table 4 All-cause treatment-emergent adverse events (safety population)a

From: A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy

  PF-06438179/GP1111
(n = 323)
Infliximab-EU
(n = 326)
Number of AEs 486 492
Patients with events, n (%)
 AEs 185 (57.3) 176 (54.0)
 SAEs 16 (5.0) 20 (6.1)
 Grade 3 AEs 34 (10.5) 34 (10.4)
 Grade 4 AEs 1 (0.3) 6 (1.8)
 Grade 5 AEs 2 (0.6) 1 (0.3)
 Temporarily discontinued from treatment due to AEs 31 (9.6) 28 (8.6)
 Permanently discontinued from treatment due to AEs 23 (7.1) 24 (7.4)
 Discontinued from study due to AEs 16 (5.0) 14 (4.3)
  1. Abbreviations: AE Adverse event, Infliximab-EU Infliximab sourced from the European Union, SAE Serious adverse event
  2. aIncludes all AEs collected from the first infusion through week 30 study visit for each patient. AEs were graded in accordance with National Cancer Institute Common Terminology Criteria for AEs (version 4.03). Grades 1–5 AEs are defined as mild, moderate, severe, and life-threatening AEs and death related to AEs, respectively