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 TEAE | 41 (78.8) | 16 (59.3) |
| Serious TEAEs | 2 (3.8) | 3 (11.1) |
| Discontinuation due to TEAEs | 4 (7.7) | 3 (11.1) |
| Severe TEAEs | 1 (1.9) | 1 (3.7) |
| Deaths | 0 | 1 (3.7) |
| Most common TEAEs by SOC and PT (reported in ≥5% of patients) | ||
| Infections and infestations | 26 (50.0) | 6 (22.2) |
| Nasopharyngitis | 4 (7.7) | 2 (7.4) |
| Upper respiratory tract infection | 3 (5.8) | 1 (3.7) |
| Pharyngitis | 3 (5.8) | 0 (0.0) |
| Musculoskeletal and connective tissue disorders | 5 (9.6) | 7 (25.9) |
| Rheumatoid arthritis | 3 (5.8) | 4 (14.8) |
| Skin and subcutaneous disorders | 8 (15.4) | 1 (3.7) |
| Dermatitis allergic | 3 (5.8) | 0 (0.0) |
| Gastrointestinal disorders | 6 (11.5) | 1 (3.7) |
| Stomatitis | 3 (5.8) | 0 (0.0) |
| General disorders and administration site reactions | 4 (7.7) | 1 (3.7) |
| Investigations | 4 (7.7) | 1 (3.7) |
| Vascular disorders | 2 (3.8) | 3 (11.1) |
| Hypertension | 0 (0.0) | 3 (11.1) |
| Blood and lymphatic system disorders | 3 (5.8) | 0 (0.0) |
| Injury, poisoning and procedural complications | 1 (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.