Table 2

Safety assessments

AEs, n (%)
HD203 (n=147)ETN (n=146)
Any AE113 (76.9)114 (78.1)
Any drug-related AE*51 (34.7)54 (37.0)
Serious AEs19 (12.9)18 (12.3)
Withdrawal due to AEs10 (6.8)11 (7.5)
Deaths02 (1.4)
AEs occurring in ≥5% of patients
 Nasopharyngitis22 (15.0)34 (23.3)
 Latent tuberculosis†14 (9.5)8 (5.5)
 Arthralgia11 (7.5)15 (10.3)
 Anaemia10 (6.8)0
 Upper abdominal pain9 (6.1)5 (3.4)
 URTI8 (5.4)10 (6.9)
 Pruritus8 (5.4)9 (6.2)
 Rash8 (5.4)8 (5.5)
 Cough8 (5.4)7 (4.8)
 Dizziness4 (2.7)9 (6.2)
 Injection-site reaction‡3 (2.0)8 (5.5)
  • Data from the safety analysis set, which included all patients who received at least one dose of study medication.

  • *Possible, probable, definite in the opinion of investigators.

  • †Based on a positive QuantiFERON test assessment on two determinations (ie, no clinical and/or chest X-ray confirmation of active tuberculosis, no physical examination abnormality, no serious AE reported, no withdrawal from study and no chest X-ray abnormality recorded).

  • ‡Injection-site reactions led to treatment discontinuation for two patients in each group.

  • AE, adverse event; ETN, etanercept; URTI, upper respiratory tract infection.