Summary of safety through week 104
| Golimumab* | |||
|---|---|---|---|
| 50 mg | 100 mg | Combined | |
| No. treated pts† | 248 | 227 | 394 |
| Average duration of follow-up (weeks) | 75.1 | 76.3 | 91.2 |
| Average number of administrations | 18.2 | 18.5 | 22.1 |
| Pts with ≥1 adverse event | 194 (78.2%) | 161 (70.9%) | 331 (84.0%) |
| Pts with ≥1 serious adverse event | 16 (6.5%) | 18 (7.9%) | 34 (8.6%) |
| Pts who discontinued study agent because of an adverse event | 11 (4.4%) | 12 (5.3%) | 23 (5.8%) |
| Pts with ≥1 infection | 136 (54.8%) | 115 (50.7%) | 248 (62.9%) |
| All malignancies | |||
| Pts with event | 3 | 5 | 8 |
| Incidence/100 pt-yrs (95% CI) | 0.84 (0.17 to 2.45) | 1.51 (0.49 to 3.52) | 1.16 (0.50 to 2.29) |
| SIR (95% CI) relative to SEER (excluding NMSC) | 1.22 (0.15 to 4.41) | 1.10 (0.13 to 3.99) | 1.16 (0.32 to 2.97) |
| Type of malignancies | |||
| Pts with lymphoma | 0 | 0 | 0 |
| Incidence/100 pt-yrs (95% CI) | 0.00 (0.00 to 0.84) | 0.00 (0.00 to 0.90) | 0.00 (0.00 to 0.43) |
| SIR (95% CI) relative to SEER | 0.00 (0.00 to 35.70) | 0.00 (0.00 to 33.76) | 0.00 (0.00 to 17.35) |
| Pts with NMSC | 1 | 3 | 4 |
| Incidence/100 pt-yrs (95% CI) | 0.28 (0.01 to 1.56) | 0.90 (0.19 to 2.64) | 0.58 (0.16 to 1.48) |
| Pts with other malignancies (excluding NMSC) | 2 | 2 | 4 |
| Incidence/100 pt-yrs (95% CI) | 0.56 (0.07 to 2.02) | 0.60 (0.07 to 2.17) | 0.58 (0.16 to 1.48) |
| SIR (95% CI) relative to SEER | 1.28 (0.16 to 4.63) | 1.16 (0.14 to 4.18) | 1.22 (0.33 to 3.12) |
| Golimumab injection-site reaction | |||
| Pts | 15 (6.0%) | 16 (7.0%) | 31 (7.9%) |
| Injections | 38/4524 (0.8%) | 35/4196 (0.8%) | 73/8720 (0.8%) |
| Pts with >1 markedly abnormal postbaseline value, N= | 248 | 208 | 394 |
| Haematology parameter‡ | |||
| Decreased neutrophil count | 0 (0.0%) | 2 (1.0%) | 2 (0.5%) |
| Decreased lymphocyte count | 2 (0.8%) | 1 (0.5%) | 3 (0.8%) |
| Elevated eosinophil count | 1 (0.4%) | 3 (1.4%) | 4 (1.0%) |
| Clinical chemistry parameter§ | (N=207) | ||
| Elevated ALT | 3 (1.2%) | 2 (1.0%) | 5 (1.3%) |
| Elevated AST | 2 (0.8%) | 1 (0.5%) | 3 (0.8%) |
| Elevated total bilirubin | 2 (0.8%) | 4 (1.9%) | 6 (1.5%) |
| Elevated glucose | 1 (0.4%) | 2 (1.0%) | 3 (0.8%) |
Data shown are number (%) of patients at week 104, unless otherwise specified.
*With or without methotrexate.
†Patients may appear in more than one column.
‡Markedly abnormal neutrophil count and lymphocyte count decreases defined as ≥ 33% decrease and value <1.0×103/µl; markedly abnormal eosinophil count increase defined as ≥ 100% increase and value >0.8×103/µl.
§Markedly elevated total bilirubin value defined as ≥100% increase and value >1.5 mg/dl, markedly elevated ALT/AST value defined as ≥100% increase and value >150 IU/l, markedly elevated glucose value defined as ≥100% and value >250 mg/dl.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; CI, confidence interval; NMSC, non-melanoma skin cancer; pt, patients; pt-yrs, patient-years; SEER, Surveillance, Epidemiology and End Results database; SIR, standardised incidence ratio (observed/expected based on the SEER database (2004), adjusted for age, gender and race).