TEAEs during 96 weeks of the RAPID-PsA trial
| CZP 200 mg Q2W N=198 n (%) [ER] | CZP 400 mg Q4W N=195 n (%) [ER] | All CZP N=393 n (%) [ER] | |
|---|---|---|---|
| Any TEAE | 175 (88.4) [339.2] | 170 (87.2) [320.0] | 345 (87.8) [329.8] |
| TEAEs by intensity* | |||
| Mild | 151 (76.3) | 148 (75.9) | 299 (76.1) |
| Moderate | 113 (57.1) | 103 (52.8) | 216 (55.0) |
| Severe | 23 (11.6) | 22 (11.3) | 45 (11.5) |
| Drug-related TEAEs | 82 (41.4) | 86 (44.1) | 168 (42.7) |
| Infections† | 125 (63.1) [95.6] | 113 (57.9) [96.9] | 238 (60.6) [96.2] |
| Upper respiratory infections‡ | 25 (12.6) [13.7] | 31 (15.9) [13.7] | 56 (14.2) [13.7] |
| Serious infections | 7 (3.5) [2.6] | 9 (4.6) [4.0] | 16 (4.1) [3.3] |
| Serious TEAEs | 31 (15.7) [13.4] | 36 (18.5) [15.7] | 67 (17.0) [14.5] |
| Death | 3 (1.5) | 3 (1.5) | 6 (1.5) |
| Withdrawal due to TEAEs§ | 22 (11.1) | 14 (7.2) | 36 (9.2) |
| Cardiac disorders | 4 (2.0) | 0 | 4 (1.0) |
| Eye disorders | 2 (1.0) | 0 | 2 (0.5) |
| General disorders and administration site conditions | 0 | 1 (0.5) | 1 (0.3) |
| Infections and infestations | 6 (3.0) | 6 (3.1) | 12 (3.1) |
| Investigations | 4 (2.0) | 1 (0.5) | 5 (1.3) |
| Musculoskeletal and connective tissue disorders | 1 (0.5) | 2 (1.0) | 2 (0.8) |
| Neoplasms benign, malignant and unspecified, including cysts and polyps | 1 (0.5) | 2 (1.0) | 3 (0.8) |
| Nervous system disorders | 0 | 1 (0.5) | 1 (0.3) |
| Pregnancy, puerperium and perinatal conditions | 0 | 1 (0.5) | 1 (0.3) |
| Respiratory, thoracic and mediastinal disorders | 1 (0.5) | 0 | 1 (0.3) |
| Skin and subcutaneous tissue disorders | 5 (2.5) | 0 | 5 (1.3) |
Data shown for the Safety Set of all patients who received at least one dose of CZP at any stage of the 96-week trial period.
*As determined by the investigator.
†System Organ Class.
‡Preferred Term; ER per 100 patient-years.
§A patient could have more than one discontinuation reason.
CZP, certolizumab pegol; ER, event rate; Q2W, every 2 weeks; TEAE, treatment emergent adverse event.