Overview of treatment-emergent and treatment-related AEs during TP2 (TP2 safety population)
| PF-SZ-IFX/PF-SZ-IFX (n=280) | Ref-IFX/Ref-IFX (n=143) | Ref-IFX/PF-SZ-IFX (n=143) | |
| Number of TEAEs | 191 | 127 | 99 |
| Treatment-related | 50 | 54 | 32 |
| Patients with ≥1 TEAE, n (%) | 103 (36.8) | 48 (33.6) | 54 (37.8) |
| Treatment-related | 32 (11.4) | 20 (14.0) | 16 (11.2) |
| Patients with ≥1 serious TEAEs, n (%) | 13 (4.6) | 11 (7.7) | 4 (2.8) |
| Treatment-related | 2 (0.7) | 5 (3.5) | 0 |
| Patients with ≥1 grade ≥3 TEAE, n (%) | 20 (7.1) | 11 (7.7) | 6 (4.2) |
| Treatment-related | 5 (1.8) | 4 (2.8) | 1 (0.7) |
| Patients discontinuing treatment due to TEAEs, n (%) | 14 (5.0) | 10 (7.0) | 7 (4.9) |
| Treatment-related | 9 (3.2) | 7 (4.9) | 5 (3.5) |
| Deaths, n (%) | 1 (0.4)* | 0 | 0 |
| Treatment-related | 0 | 0 | 0 |
| TEAEs reported in ≥2% of patients in any treatment group, n (%) | |||
| IRR | 9 (3.2) | 12 (8.4) | 6 (4.2) |
| Nasopharyngitis | 9 (3.2) | 5 (3.5) | 2 (1.4) |
| RA | 5 (1.8) | 4 (2.8) | 3 (2.1) |
| Nausea | 1 (0.4) | 4 (2.8) | 1 (0.7) |
| URTI | 6 (2.1) | 2 (1.4) | 3 (2.1) |
| Bronchitis | 3 (1.1) | 3 (2.1) | 2 (1.4) |
| UTI | 3 (1.1) | 2 (1.4) | 3 (2.1) |
| Arthralgia | 0 | 1 (0.7) | 3 (2.1) |
| Joint swelling | 6 (2.1) | 1 (0.7) | 1 (0.7) |
| Dyspnoea | 0 | 3 (2.1) | 1 (0.7) |
| Erythema | 0 | 3 (2.1) | 0 |
| Rash | 3 (1.1) | 0 | 3 (2.1) |
| Flushing | 0 | 0 | 3 (2.1) |
| Hypertension | 4 (1.4) | 3 (2.1) | 2 (1.4) |
| Treatment-related AEs reported in ≥2% of patients in any treatment group, n (%) | |||
| IRR | 9 (3.2) | 11 (7.7) | 6 (4.2) |
| Rash | 3 (1.1) | 0 | 3 (2.1) |
| Dyspnoea | 0 | 3 (2.1) | 1 (0.7) |
| Nausea | 1 (0.4) | 3 (2.1) | 0 |
| Erythema | 0 | 3 (2.1) | 0 |
| Flushing | 0 | 0 | 3 (2.1) |
*Sudden cardiac death (updated to cardiac arrest) on study day 283 (16 days after last drug administration) in a male, aged 70, with a history of hyperlipidaemia, hypertension and RA.
AE, adverse event;IRR, infusion-related reaction;PF-SZ-IFX, PF-06438179/GP1111;RA, rheumatoid arthritis;ref-IFX, European reference infliximab; TEAE, treatment-emergent adverse event;TP2, treatment period 2; URTI, upper respiratory tract infection;UTI, urinary tract infection.