Table 3

TEAEs during certolizumab pegol plus bimekizumab and certolizumab pegol plus placebo treatment

Variable, n (%)*Certolizumab pegol–IR plus bimekizumab
(n=52)
Certolizumab pegol–IR plus placebo
(n=27)
Any TEAE41 (78.8)16 (59.3)
Serious TEAEs2 (3.8)3 (11.1)
Discontinuation due to TEAEs4 (7.7)3 (11.1)
Severe TEAEs1 (1.9)1 (3.7)
Deaths01 (3.7)
Most common TEAEs by SOC and PT (reported in ≥5% of patients)
Infections and infestations26 (50.0)6 (22.2)
 Nasopharyngitis4 (7.7)2 (7.4)
 Upper respiratory tract infection3 (5.8)1 (3.7)
 Pharyngitis3 (5.8)0 (0.0)
Musculoskeletal and connective tissue disorders5 (9.6)7 (25.9)
 Rheumatoid arthritis3 (5.8)4 (14.8)
Skin and subcutaneous disorders8 (15.4)1 (3.7)
 Dermatitis allergic3 (5.8)0 (0.0)
Gastrointestinal disorders6 (11.5)1 (3.7)
 Stomatitis3 (5.8)0 (0.0)
General disorders and administration site reactions4 (7.7)1 (3.7)
Investigations4 (7.7)1 (3.7)
Vascular disorders2 (3.8)3 (11.1)
 Hypertension0 (0.0)3 (11.1)
Blood and lymphatic system disorders3 (5.8)0 (0.0)
Injury, poisoning and procedural complications1 (1.9)2 (7.4)
  • TEAEs during treatment were defined as an adverse event that started or worsened on or after the first dose of bimekizumab or placebo up to 140 days after the final dose. TEAEs were coded using MedDRA V.19.0.

  • *n=number of patients reporting at least one TEAE within the SOC/PT.

  • csDMARD, conventional synthetic disease-modifying antirheumatic drug; PT, preferred term;SOC, system organ class;TEAE, treatment-emergent adverse event.