Table 2

Treatment-emergent adverse events (TEAEs) during the 24-week, placebo-controlled, double-blind phase, by treatment group in the axSpA population

Placebo* n=107 n (%)CZP 200 mg Q2W n=111 n (%)CZP 400 mg Q4W n=107 n (%)
Any TEAEs67 (62.6)85 (76.6)80 (74.8)
TEAEs by intensity
 Mild52 (48.6)65 (58.6)64 (59.8)
 Moderate36 (33.6)46 (41.4)43 (40.2)
 Severe7 (6.5)4 (3.6)3 (2.8)
Drug-related TEAEs22 (20.6)41 (36.9)36 (33.6)
Infections†25 (23.4)43 (38.7)41 (38.3)
 Nasopharyngitis7 (6.5)11 (9.9)11 (10.3)
 Upper respiratory tract infections3 (2.8)6 (5.4)4 (3.7)
 Serious infections‡02 (1.8)0
Investigations
 Blood creatine phosphokinase increased2 (1.9)7 (6.3)6 (5.6)
Injection site reactions§1 (0.9)10 (9.0)5 (4.7)
 Injection site pain‡1 (0.9)1 (0.9)0
Serious TEAEs by SOC5 (4.7)4 (3.6)7 (6.5)
 Blood and lymphatic system disorder01 (0.9)0
 Cardiac disorders001 (0.9)
 Eye disorders01 (0.9)0
 Gastrointestinal disorders1 (0.9)01 (0.9)
 General disorders and administration site conditions¶2 (1.9)00
 Hepatobiliary disorders002 (1.9)
 Immune system disorders1 (0.9)01 (0.9)
 Infections and infestations02 (1.8)0
 Investigations¶01 (0.9)0
 Renal and urinary disorders1 (0.9)01 (0.9)
 Respiratory, thoracic and mediastinal disorders001 (0.9)
Discontinuations due to TEAEs2 (1.9)2 (1.8)4 (3.7)
Death000
  • *placebo escape at week 16.

  • †Preferred terms.

  • Serious infections reported: haemophilus infection and laryngitis.

  • §High-level term.

  • ¶Serious general disorders and administration site conditions was two cases of non-cardiac chest pain; serious investigation TEAE was one case of gamma-glutamyltransferase increased.

  • CZP, certolizumab pegol.