Treatment-emergent adverse events for all patients treated with CZP during the combined double-blind, dose-blind and open-label periods of RAPID-PsA
| All CZP* 200 mg Q2W (n=198) | All CZP* 400 mg Q4W (n=195) | All CZP* dose combined (n=393) | |
| n (%) (ER), unless otherwise stated | |||
| Exposure to CZP (medication duration, patient-years) | 674.4 | 646.4 | 1320.8 |
| Any TEAE | 184 (92.9) (266.6) | 183 (93.8) (248.7) | 367 (93.4) (257.9) |
| Mild, n (%) | 169 (85.4) | 167 (85.6) | 336 (85.5) |
| Moderate, n (%) | 132 (66.7) | 129 (66.2) | 261 (66.4) |
| Severe, n (%) | 37 (18.7) | 34 (17.4) | 71 (18.1) |
| Most common serious TEAEs | |||
| Infections and infestations | 13 (6.6) (2.4) | 10 (5.1) (2.2) | 23 (5.9) (2.3) |
| Musculoskeletal and connective tissue disorders | 9 (4.5) (1.3) | 8 (4.1) (2.0) | 17 (4.3) (1.7) |
| Other adverse events of interest | |||
| Serious cardiac disorders† | 8 (4.0) (1.2) | 2 (1.0) (0.3) | 10 (2.5) (0.8) |
| Malignancies‡ | 3 (1.5) (0.6) | 4 (2.1) (0.6) | 7 (1.8) (0.6) |
| Withdrawals due to TEAEs, n (%) | 27 (13.6) | 27 (13.8) | 54 (13.7) |
| Serious TEAEs | 49 (24.7) (11.7) | 51 (26.2) (12.1) | 100 (25.4) (11.9) |
| Withdrawals due to serious TEAEs, n (%) | 13 (6.6) | 14 (7.2) | 27 (6.9) |
| Deaths§ , n (%) | 3 (1.5) | 3 (1.5) | 6 (1.5) |
Data are shown for the Safety Set during the combined double-blind, dose-blind and open-label periods of RAPID-PsA.
*Includes all patients exposed to ≥1 dose of CZP (including patients randomised to placebo re-randomised to CZP).
† Serious cardiac disorders reported are serious TEAEs within the ‘Cardiac Disorders’ system organ class.
‡ Malignancies, including lymphoma, were identified using the Standardised MedDRA Query, ‘malignancies.’
§ Deaths due to cardiac disorders or infection may have been associated with more than one event.
CZP, certolizumab pegol; ER, event rate per 100 patient-years; Q2W, every 2 weeks; Q4W, every 4 weeks; TEAE, treatment-emergent adverse event.