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Table 2 Integrated summary of TEAEs and most common TEAEs across Periods I and II

From: FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double-blind study, and its open-label extension

 FKB327RP
n = 474n = 470
n (%)*n (%)*
Summary of TEAEs
 Patients with at least one TEAE295 (62.2)311 (66.2)
 Patients with at least one severe TEAE17 (3.6)12 (2.6)
 Patients with at least one treatment-related TEAE122 (25.7)132 (28.1)
 Patients with TEAE leading to treatment discontinuation28 (5.9)21 (4.5)
 Patients with TEAE leading to treatment interruption56 (11.8)62 (13.2)
 Patients with at least one TESAE25 (5.3)34 (7.2)
 Deaths2 (0.4)1 (0.2)
Most common TEAEs (≥ 3% of patients in any group)
 Blood and lymphatic system disorders26 (5.5)25 (5.3)
  Anemia14 (3.0)13 (2.8)
 Gastrointestinal disorders48 (10.1)55 (11.7)
  Diarrhea12 (2.5)18 (3.8)
 General disorders and administration site conditions27 (5.7)32 (6.8)
 Infections and infestations151 (31.9)170 (36.2)
  Nasopharyngitis36 (7.6)46 (9.8)
  Upper respiratory tract infection18 (3.8)26 (5.5)
  Bronchitis16 (3.4)27 (5.7)
  Urinary tract infection24 (5.1)17 (3.6)
  Pharyngitis14 (3.0)15 (3.2)
  Latent tuberculosis15 (3.2)8 (1.7)
 Injury, poisoning and procedural complications27 (5.7)31 (6.6)
 Investigations54 (11.4)40 (8.5)
 Metabolism and nutrition disorders39 (8.2)35 (7.4)
  Hypercholesterolemia20 (4.2)16 (3.4)
 Musculoskeletal and connective tissue disorders67 (14.1)65 (13.8)
  RA26 (5.5)23 (4.9)
 Nervous system disorders29 (6.1)34 (7.2)
 Renal and urinary disorders23 (4.9)23 (4.9)
 Respiratory, thoracic, and mediastinal disorders21 (4.4)20 (4.3)
 Skin and subcutaneous tissue disorders40 (8.4)36 (7.7)
 Vascular disorders23 (4.9)27 (5.7)
  Hypertension12 (2.5)21 (4.5)
  1. *Percentages are based on the number of patients in the double-blind study safety set who received the given treatment in either Period I or Period II. Hence, patients who switch at week 24 are included in the N count for both treatments
  2. Each patient was counted only once for each condition
  3. RA rheumatoid arthritis, RP reference product, TEAE treatment-emergent adverse event, TESAE treatment-emergent serious adverse event