Incidence of TEAEs during the double-blind period and safety follow-up extension
| n (%) [EAIR] | Double-blind period: Weeks 0–52 | SFE: Weeks 52–156 | |||
| CZP 200 mg Q2W (n=159) PY=144.4 | Placebo (n=158) PY=93.3 | CZP 200 mg Q2W (n=120) PY=232.0 | Placebo→CZP 200 mg Q2W (n=123) PY=227.9 | All SFE patients (N=243) PY=459.8 | |
| Any TEAE | 120 (75.5) [196.4] | 101 (63.9) [208.6] | 73 (60.8) [54.5] | 76 (61.8) [60.2] | 149 (61.3) [57.3] |
| Severe TEAEs | 5 (3.1) | 4 (2.5) | 4 (3.3) [1.8] | 5 (4.1) [2.2] | 9 (3.7) |
| Subject discontinuations due to TEAEs | 3 (1.9) | 3 (1.9) | 1 (0.8) [0.4] | 4 (3.3) [1.8] | 5 (2.1) |
| Permanent withdrawal of study medication due to TEAEs | 3 (1.9) [2.1] | 3 (1.9) [3.2] | 1 (0.8) [0.4] | 5 (4.1) [2.2] | 6 (2.5) [1.3] |
| Drug-related TEAEs | 48 (30.2) | 23 (14.6) | 13 (10.8) [6.0] | 23 (18.7) [11.4] | 36 (14.8) |
| Serious TEAEs | 8 (5.0) [5.6] | 4 (2.5) [4.4] | 6 (5.0) [2.7] | 9 (7.3) [4.1] | 15 (6.2) [3.3] |
| Deaths | 0 | 0 | 0 | 0 | 0 |
| TEAEs of interest | |||||
| Opportunistic infections | 0 | 0 | 1 (0.8) [0.4] | 2 (1.6) [0.9] | 3 (1.2) [0.7] |
| Hepatic events | 9 (5.7) [6.5] | 4 (2.5) [4.4] | 1 (0.8) [0.4] | 1 (0.8) [0.4] | 2 (0.8) [0.4] |
| Hypersensitivity and anaphylactic events | 0 | 0 | 0 | 1 (0.8) [0.4] | 1 (0.4) [0.2] |
| Malignancies (including lymphoma) | 2 (1.3) [1.4] | 1 (0.6) [1.1] | 0 | 0 | 0 |
| Serious cardiovascular events | 0 | 0 | 0 | 0 | 0 |
| Haematopoietic cytopenia | 0 | 0 | 0 | 0 | 0 |
| Serious bleeding events | 0 | 0 | 0 | 0 | 0 |
| Demyelinating-like disorders | 0 | 0 | 0 | 0 | 0 |
| Frequently reported TEAEs* | |||||
| Nasopharyngitis | 21 (13.2) [16.0] | 13 (8.2) [14.9] | 18 (15.0) | 8 (6.5) | 26 (10.7) [6.0] |
| Upper respiratory tract infection | 30 (18.9) [23.6] | 16 (10.1) [18.8] | 14 (11.7) | 7 (5.7) | 21 (8.6) [4.8] |
| Tonsilitis | 7 (4.4) [5.0] | 2 (1.3) [2.2] | 6 (5.0) | 6 (4.9) | 12 (4.9) [2.7] |
| Bronchitis | 8 (5.0) [5.8] | 5 (3.2) [5.4] | 5 (4.2) | 5 (4.1) | 10 (4.1) [2.2] |
| Headache | 11 (6.9) [7.9] | 7 (4.4) [7.8] | 4 (3.3) | 5 (4.1) | 9 (3.7) [2.0] |
| Arthralgia | 9 (5.7) [6.4] | 10 (6.3) [11.2] | 3 (2.5) | 3 (2.4) | 6 (2.5) [1.3] |
| Axial spondyloarthritis† | 11 (6.9) [7.9] | 12 (7.6) [13.1] | 4 (3.3) | 1 (0.8) | 5 (2.1) [1.1] |
| Diarrhoea | 8 (5.0) [5.7] | 10 (6.3) [11.3] | 1 (0.8) | 3 (2.4) | 4 (1.6) [0.9] |
| Increased blood creatine phosphokinase | 8 (5.0) [5.7] | 4 (2.5) [4.5] | 1 (0.8) | 2 (1.6) | 3 (1.2) [0.7] |
| Cough | 6 (3.8) [4.2] | 8 (5.1) [8.9] | 1 (0.8) | 2 (1.6) | 3 (1.2) [0.7] |
| Extra musculoskeletal manifestations | |||||
| Uveitis | 5 (3.1) [3.5] | 11 (7.0) [12.2] | 5 (4.2) | 2 (1.6) | 7 (2.9) [1.5] |
| IBD‡ | 0 | 0 | 2 (1.7) | 0 | 2 (0.8) [0.4] |
| Psoriasis | 3 (1.9) [2.1] | 1 (0.6) [1.1] | 1 (0.8) | 0 | 1 (0.4) [0.2] |
| Candida infections | 1 (0.6) [0.7] | 0 | 0 | 1 (0.8) | 1 (0.4) [0.2] |
| Oral candidiasis | 0 | 0 | 0 | 1 (0.8) | 1 (0.4) [0.2] |
| Vulvovaginal candidiasis | 1 (0.6) [0.7] | 0 | 0 | 0 | 0 |
For weeks 0–52, data are reported for double-blind safety set (N=317), and for Weeks 52–156 for the SFE safety set (N=243). Data are reported by number of patients, as a percentage of the total number of patients in each randomisation group and by EAIRs.
*Frequently reported TEAEs are those reported in ≥5% of patients in any randomisation group shown.
†A TEAE of axial spondyloarthritis was recorded upon exacerbation or worsening of axial spondyloarthritis and the symptoms therein.
‡IBD TEAEs were obtained from the ‘Colitis (excl. infective)’ high level term.
CZP, certolizumab pegol; EAIR, exposure-adjusted incidence rate per 100 patient years; IBD, inflammatory bowel disease; Q2W, every 2 weeks; SFE, safety follow-up extension; TEAE, treatment-emergent adverse event.