Table 3.
Summary of adverse events in the maintenance phase (safety populationa)
|
CT-P13 s.c.
(n = 168) |
CT-P13 i.v.
(n = 175) |
|
|---|---|---|
| Total TEAEs, n | 309 | 313 |
| Patients with ≥1 TEAE | 92 (54.8) | 117 (66.9) |
| Treatment-related TEAE | 73 (43.5) | 72 (41.1) |
| TEAE grade ≥3 | 13 (7.7) | 8 (4.6) |
| Total TESAEs, n | 8 | 15 |
| Patients with ≥1 TESAE | 6 (3.6) | 13 (7.4) |
| Treatment-related TESAE | 3 (1.8) | 4 (2.3) |
| Patients with ≥1 TEAE leading to discontinuation of study drug | 6 (3.6) | 14 (8.0) |
| Patients with ≥1 TEAE classified as localized ISR | 30 (17.9)e | 22 (12.6)e |
| Patients with ≥1 TEAE classified IRRb | 0 | 7 (4.0)f |
| Patients with ≥1 TEAE classified as SIRb | 2 (1.2)g | 3 (1.7)g |
| Patients with ≥1 TEAE classified as delayed hypersensitivityc | 4 (2.4)h | 0 |
| Patients with ≥1 TEAE classified as infections | 49 (29.2) | 60 (34.3) |
| Most common infections and infestationsd | ||
| Viral upper respiratory tract infection | 10 (6.0) | 14 (8.0) |
| Upper respiratory tract infection | 8 (4.8) | 13 (7.4) |
| Latent tuberculosis | 8 (4.8) | 10 (5.7) |
| Urinary tract infection | 9 (5.4) | 7 (4.0) |
| Bronchitis | 5 (3.0) | 4 (2.3) |
| Patients with ≥1 TEAE classified as malignancy | 1 (0.6) | 0 |
Data are n (%) unless stated otherwise. aAll patients received CT-P13 s.c. from W30 to W54 (or W64 for patients participating in the usability assessment) and were analysed according to actual treatment received prior to W30. bIRRs occurred between start of administration and 24 h after the i.v. infusion of CT-P13 or placebo. SIRs occurred between start of administration and 24 h after the s.c. injection of CT-P13 or placebo. cTEAEs classified as delayed hypersensitivity were defined as IRRs or SIRs that occurred after 24 h from study drug or placebo administration. dReported by ≥3% of patients in either treatment arm. eAll localized ISRs were grade 1 or 2 and considered by the investigator to be related to study drug, except for one treatment-related grade 3 localized ISR in each treatment arm, and one grade 2 localized ISR considered unrelated to study treatment in the CT-P13 s.c. arm. fOne grade 3 IRR; all other IRRs were grade 1 or 2. gAll SIRs were grade 1 or 2. hThree grade 2 delayed hypersensitivity reactions and one grade 3 reaction. IRR, infusion-related reaction; ISR, injection site reaction; SIR, systemic injection reaction; TEAE, treatment-emergent adverse event; TESAE, treatment-emergent serious adverse event; W, week.