Table 4.
Adverse events through week 268a
| 50 mg + MTX only | 50 mg and 100 mg + placebo or MTX | Golimumab 100 mg + placebo or MTX | Total golimumab | |
|---|---|---|---|---|
| Treated patients, no. | 172 | 201 | 243 | 616 |
| Mean duration of followup, weeks | 182.9 | 238.7 | 192.7 | 205.0 |
| Mean number of administrations | 41.5 | 54.9 | 44.0 | 46.9 |
| Patients with ≥1 AE | 161 (93.6) | 187 (93.0) | 234 (96.3) | 582 (94.5) |
| Patients who discontinued due to AEs | 30 (17.4) | 14 (7.0) | 67 (27.6) | 111 (18.0) |
| Common AEs (≥10%) | ||||
| Upper respiratory tract infection | 46 (26.7) | 72 (35.8) | 63 (25.9) | 181 (29.4) |
| Nausea | 22 (12.8) | 44 (21.9) | 55 (22.6) | 121 (19.6) |
| Bronchitis | 27 (15.7) | 34 (16.9) | 41 (16.9) | 102 (16.6) |
| Alanine aminotransferase increased | 31 (18.0) | 32 (15.9) | 36 (14.8) | 99 (16.1) |
| Cough | 19 (11.0) | 29 (14.4) | 37 (15.2) | 85 (13.8) |
| Patients with ≥1 injection site reaction | 15 (8.7) | 19 (9.5) | 39 (16.0) | 73 (11.9) |
| Patients with ≥1 SAE | 55 (32.0) | 55 (27.4) | 94 (38.7) | 204 (33.1) |
| Pneumonia | 5 (2.9) | 5 (2.5) | 4 (1.6) | 14 (2.3) |
| Pulmonary tuberculosis | 1 (0.6) | 1 (0.5) | 4 (1.6) | 6 (1.0) |
| Breast cancer | 1 (0.6) | 0 | 3 (1.2) | 4 (0.6) |
| Uterine leiomyoma | 1 (0.6) | 2 (1.0) | 1 (0.4) | 4 (0.6) |
| Basal cell carcinoma | 0 | 2 (1.0) | 1 (0.4) | 3 (0.5) |
| Hodgkin's disease | 0 | 0 | 2 (0.8) | 2 (0.3) |
| Non–small cell lung cancer | 2 (1.2) | 0 | 0 | 2 (0.3) |
| Patients with ≥1 serious infection | 17 (9.9) | 25 (12.4) | 33 (13.6) | 75 (12.2) |
| Incidence per 100 patient‐years (95% CI) | 3.97 (2.54–5.90) | 3.68 (2.55–5.15) | 6.00 (4.50–7.82) | 4.61 (3.80–5.55) |
| Pneumonia | 5 (2.9) | 5 (2.5) | 4 (1.6) | 14 (2.3) |
| Herpes zoster | 0 | 3 (1.5) | 2 (0.8) | 5 (0.8) |
| Pulmonary tuberculosis | 1 (0.6) | 1 (0.5) | 3 (1.2) | 5 (0.8) |
| Sepsis | 0 | 1 (0.5) | 3 (1.2) | 4 (0.6) |
| Urinary tract infection | 1 (0.6) | 2 (1.0) | 1 (0.4) | 4 (0.6) |
| Appendicitis | 0 | 2 (1.0) | 1 (0.4) | 3 (0.5) |
| Upper respiratory tract infection | 1 (0.6) | 0 | 2 (0.8) | 3 (0.5) |
| Malignancies | ||||
| Lymphoma | 0 | 0 | 2 (0.8) | 2 (0.3) |
| Incidence per 100 patient‐years (95% CI) | 0.00 (0.00–0.50) | 0.00 (0.00–0.32) | 0.22 (0.03–0.80) | 0.08 (0.01–0.30) |
| SIR (95% CI)b | 0.00 (0.00–18.91) | 0.00 (0.00–12.15) | 9.54 (1.16–34.48) | 3.26 (0.39–11.76) |
| Nonmelanoma skin cancers | 0 | 3 (1.5) | 2 (0.8) | 5 (0.8) |
| Incidence per 100 patient‐years (95% CI) | 0.00 (0.00–0.50) | 0.33 (0.07–0.95) | 0.22 (0.03–0.80) | 0.21 (0.07–0.48) |
| Other malignancies | 8 (4.7) | 2 (1.0) | 4 (1.6) | 14 (2.3) |
| Incidence per 100 patient‐years (95% CI) | 1.33 (0.57–2.62) | 0.22 (0.03–0.78) | 0.44 (0.12–1.14) | 0.58 (0.32–0.97) |
| SIR (95% CI)b | 2.21 (0.95–4.35) | 0.36 (0.04–1.28) | 0.85 (0.23–2.18) | 1.00 (0.55–1.68) |
| Total malignancies | 8 (4.7) | 5 (2.5) | 8 (3.3) | 21 (3.4) |
| Incidence per 100 patient‐years (95% CI) | 1.33 (0.57–2.62) | 0.54 (0.18–1.27) | 0.89 (0.38–1.75) | 0.87 (0.54–1.33) |
| SIR (95% CI)b | 2.12 (0.91–4.18) | 0.34 (0.04–1.23) | 1.23 (0.45–2.67) | 1.10 (0.63–1.79) |
| Deaths | 6 (3.5) | 0 | 6 (2.5) | 12 (1.9) |
| Incidence per 100 patient‐years (95% CI) | 0.99 (0.36–2.16) | 0.00 (0.00–0.32) | 0.67 (0.24–1.45) | 0.49 (0.26–0.86) |
a
Data presented as number (percentage) unless indicated otherwise. MTX = methotrexate; AE = adverse event; SAE = serious AE; 95% CI = 95% confidence interval; SIR = standardized incidence ratio.
b
The SIR is in comparison with the expected number of events in the Surveillance, Epidemiology, and End Results database (2004), which does not include nonmelanoma skin cancers.