Summary of AEs
| PBO+MTX n=217 | CZP+MTX n=659 | |||
|---|---|---|---|---|
| Total patient-years (PY) at risk (per 100 PY) Median exposure (days) | 1.93 | 6.05 | ||
| 364.0 | 364.0 | |||
| n (%) | IR (95% CI) | n (%) | IR (95% CI) | |
| Any TEAE (≥5% in any SOC) | 158 (72.8) | 195.6 (166.3 to 228.7) | 525 (79.7) | 250.8 (229.8 to 273.2) |
| Blood and lymphatic system disorders | 13 (6.0) | 6.9 (3.7 to 11.8) | 45 (6.8) | 7.8 (5.7 to 10.4) |
| Eye disorders | 13 (6.0) | 7.0 (3.8 to 12.0) | 24 (3.6) | 4.1 (2.6 to 6.1) |
| Gastrointestinal disorders | 53 (24.4) | 34.0 (25.5 to 44.5) | 206 (31.3) | 44.7 (38.8 to 51.3) |
| General disorders and administration site conditions | 27 (12.4) | 15.4 (10.2 to 22.5) | 108 (16.4) | 20.2 (16.6 to 24.4) |
| Infections and infestations | 76 (35.0) | 52.7 (41.5 to 66.0) | 298 (45.2) | 71.8 (63.9 to 80.4) |
| Injury, poisoning and procedural complications | 15 (6.9) | 8.2 (4.6 to 13.5) | 62 (9.4) | 10.9 (8.4 to 14.0) |
| Investigations | 42 (19.4) | 25.2 (18.2 to 34.1) | 137 (20.8) | 26.4 (22.1 to 31.2) |
| Metabolism and nutrition disorders | 12 (5.5) | 6.5 (3.3 to 11.3) | 57 (8.6) | 10.0 (7.6 to 13.0) |
| Musculoskeletal and connective tissue disorders | 36 (16.6) | 20.5 (14.4 to 28.4) | 114 (17.3) | 21.2 (17.5 to 25.5) |
| Nervous system disorders | 26 (12.0) | 14.9 (9.7 to 21.8) | 92 (14.0) | 17.1 (13.8 to 20.9) |
| Respiratory, thoracic and mediastinal disorders | 22 (10.1) | 12.3 (7.7 to 18.6) | 76 (11.5) | 13.6 (10.7 to 17.0) |
| Skin and subcutaneous tissue disorders | 31 (14.3) | 18.2 (12.4 to 25.8) | 119 (18.1) | 22.5 (18.6 to 26.9) |
| Vascular disorders | 9 (4.1) | 4.8 (2.2 to 9.2) | 39 (5.9) | 6.7 (4.8 to 9.2) |
| Serious TEAEs, n (%) | 20 (9.2) | 10.7 (6.6 to 16.6) | 70 (10.6) | 12.1 (9.4 to 15.2) |
| Infections and infestations | 7 (3.2) | 3.7 (1.5 to 7.6) | 20 (3.0) | 3.3 (2.0 to 5.2) |
| Active tuberculosis (TB)* | 0 (0.0) | − | 1 (0.2) | 0.2 (0.0 to 0.9) |
| Drug-related TEAEs | 69 (31.8) | − | 278 (42.2) | − |
| TEAEs leading to discontinuation | 20 (9.2) | 10.6 (6.5 to 16.4) | 57 (8.6) | 9.6 (7.3 to 12.4) |
| TEAEs requiring dose change of MTX | 14 (6.5) | − | 73 (11.1) | − |
| TEAEs leading to death | 1 (0.5) | 0.5 (0.0 to 2.9) | 2 (0.3) | 0.3 (0.0 to 1.2) |
*Included both pulmonary TB and gastrointestinal TB in the same patient, diagnosis not confirmed by PCR. SS. n, number of patients reporting ≥1 AE in that category. A TEAE was defined as an AE starting on or after the date of first study medication administration and up to 70 days after the last (most recent) CZP or PBO dose. AEs with a missing relationship to study medication were counted as related. MedDRA v17.0.
AE, adverse event; CZP, certolizumab pegol; IR, incidence rate; MTX, methotrexate; PBO, placebo; SOC, system organ class; SS, safety set; TEAE, treatment emergent adverse event.