Table 2.
Summary of AEsa
| CZP standard dose (n = 83), no. (%) | CZP reduced frequency (n = 127), no. (%) | CZP stopped (n = 81), no. (%) | MTX responders (n = 66), no. (%) | CZP at any time (n = 223), no. (%)/event rateb | |
|---|---|---|---|---|---|
| Any treatment‐emergent AEs (≥5% in any system organ class) | 53 (63.9) | 81 (63.8) | 48 (59.3) | 33 (50.0) | 145 (65.0)/163.5 |
| Gastrointestinal disorders | 5 (6.0) | 6 (4.7) | 8 (9.9) | 7 (10.6) | 13 (5.8)/6.9 |
| General disorders and administration site conditions | 4 (4.8) | 10 (7.9) | 4 (4.9) | 5 (7.6) | 16 (7.2)/6.9 |
| Infections and infestations | 26 (31.3) | 49 (38.6) | 22 (27.2) | 10 (15.2) | 82 (36.8)/57.8 |
| Injury, poisoning, and procedural complications | 5 (6.0) | 14 (11.0) | 7 (8.6) | 1 (1.5) | 20 (9.0)/9.0 |
| Investigations | 11 (13.3) | 12 (9.4) | 8 (9.9) | 8 (12.1) | 23 (10.3)/13.3 |
| Metabolism and nutrition disorders | 3 (3.6) | 14 (11.0) | 6 (7.4) | 5 (7.6) | 17 (7.6)/9.0 |
| Musculoskeletal and connective tissue disorders | 8 (9.6) | 12 (9.4) | 12 (14.8) | 6 (9.1) | 23 (10.3)/12.0 |
| Nervous system disorders | 6 (7.2) | 7 (5.5) | 1 (1.2) | 1 (1.5) | 15 (6.7)/14.1 |
| Renal and urinary disorders | 5 (6.0) | 2 (1.6) | 0 | 1 (1.5) | 8 (3.6)/3.9 |
| Respiratory, thoracic, and mediastinal disorders | 5 (6.0) | 8 (6.3) | 3 (3.7) | 1 (1.5) | 13 (5.8)/6.9 |
| Skin and subcutaneous tissue disorders | 8 (9.6) | 9 (7.1) | 3 (3.7) | 2 (3.0) | 17 (7.6)/8.6 |
| Any malignant tumor | 0 | 3 (2.4) | 2 (2.5) | 0 | 4 (1.8)/1.7 |
| Serious treatment‐emergent AEs | 4 (4.8) | 9 (7.1) | 6 (7.4) | 4 (6.1) | 16 (7.2)/6.9 |
| Serious infections and infestations | 1 (1.2) | 1 (0.8) | 2 (2.5) | 1 (1.5) | 2 (0.9)/0.9 |
| Discontinuation due to treatment‐emergent AEs | 2 (2.4) | 7 (5.5) | 4 (4.9) | 1 (1.5) | 10 (4.5)/NA |
| Treatment‐emergent AEs requiring MTX reduction | 0 | 5 (3.9) | 1 (1.2) | 1 (1.5) | NA |
| Drug‐related treatment‐emergent AEs | 25 (30.1) | 30 (23.6) | 14 (17.3) | 10 (15.2) | 60 (26.9)/NA |
| Severe treatment‐emergent AEs | 1 (1.2) | 4 (3.1) | 2 (2.5) | 3 (4.5) | 5 (2.2)/NA |
| Deaths (treatment‐emergent AEs leading to death) | 0 | 0 | 0 | 1 (1.5) | 0 |
a
Safety set, comprising all patients who received at least 1 dose of study medication. Terms are from Medical Dictionary for Regulatory Activities, version 17.0. NA = not available.
b
Includes adverse events (AEs) occurring in period 2 in any group after receiving certolizumab pegol (CZP) in period 2, including treatment‐emergent AEs occurring after induction/reinduction with CZP for patients in the methotrexate (MTX) responder and CZP stopped groups. The total number of patients exposed to CZP in period 2 was used as the denominator; event rates are per 100 patient‐years.