Summary of AEs through week 268
| GLM 50 mg only | GLM 50 mg and 100 mg | GLM 100 mg only | All GLM patients | |
|---|---|---|---|---|
| No. of patients | 158 | 77 | 118 | 353 |
| Mean weeks of follow-up | 207.6 | 232.2 | 213.0 | 214.8 |
| Pts with AE(s) | 153 (96.8%) | 76 (98.7%) | 115 (97.5%) | 344 (97.5%) |
| Pts who died | 1 (0.6%) | 0 (0.0%) | 0 (0.0%) | 1 (0.3%) |
| Incidence/100 pt-yrs* (Exact 95% CI) | 0.16 (0.00 to 0.88) | 0.00 (0.00 to 0.87) | 0.00 (0.00 to 0.62) | 0.07 (0.00 to 0.38) |
| Pts with serious AE(s) | 27 (17.1%) | 19 (24.7%) | 26 (22.0%) | 72 (20.4%) |
| Pts who discontinued study agent due to AE(s) | 12 (7.6%) | 6 (7.8%) | 14 (11.9%) | 32 (9.1%) |
| Pts with malignancy† | 1 (0.6%) | 1 (1.3%) | 1 (0.8%) | 3 (0.8%) |
| Incidence/100 pt-yrs (Exact 95% CI) | 0.16 (0.00 to 0.88) | 0.29 (0.01 to 1.63) | 0.21 (0.01 to 1.16) | 0.21 (0.04 to 0.60) |
| SIR—observed/SEER (Exact 95% CI) | 0.58 (0.01 to 3.21) | 0.00 (0.00 to 1.77) | 0.00 (0.00 to 2.37) | 0.21 (0.01 to 1.19) |
| Lymphoma‡ | 1 (0.6%) | 0 (0.0%) | 0 (0.0%) | 1 (0.3%) |
| Incidence/100 pt-yrs (Exact 95% CI) | 0.16 (0.00 to 0.88) | 0.00 (0.00 to 0.87) | 0.00 (0.00 to 0.62) | 0.07 (0.00 to 0.38) |
| SIR—observed/SEER (Exact 95% CI) | 9.67 (0.24 to 53.90) | 0.00 (0.00 to 35.60) | 0.00 (0.00 to 39.68) | 3.80 (0.10 to 21.18) |
| NMSC§ | 0 (0.0%) | 1 (1.3%) | 1 (0.8%) | 2 (0.6%) |
| Incidence/100 pt-yrs (Exact 95% CI) | 0.00 (0.00 to 0.47) | 0.29 (0.01 to 1.63) | 0.21 (0.01 to 1.16) | 0.14 (0.02 to 0.50) |
| Other malignancies¶ | 1 (0.6%) | 0 (0.0%) | 0 (0.0%) | 1 (0.3%) |
| Incidence/100 pt-yrs (Exact 95% CI) | 0.16 (0.00 to 0.88) | 0.00 (0.00 to 0.87) | 0.00 (0.00 to 0.62) | 0.07 (0.00 to 0.38) |
| SIR—observed/SEER (Exact 95% CI) | 0.61 (0.02 to 3.39) | 0.00 (0.00 to 1.85) | 0.00 (0.00 to 2.52) | 0.22 (0.01 to 1.25) |
| Pts with serious infection(s) | 6 (3.8%) | 8 (10.4%) | 7 (5.9%) | 21 (5.9%) |
| Incidence/100 pt-yrs** (Exact 95% CI) | 1.27 (0.55 to 2.50) | 3.49 (1.80 to 6.10) | 2.28 (1.14 to 4.07) | 2.13 (1.44 to 3.02) |
| Pts with injection-site reaction(s) | 17 (10.8%) | 13 (16.9%) | 13 (11.0%) | 43 (12.2%) |
Data presented are n (%) unless indicated otherwise.
*Incidence/100 pt-yrs (Exact 95% CI) of death for placebo through week 24=0.00 (0.00 to 10.42).
†Incidence/100 pt-yrs (Exact 95% CI) of all malignancies for placebo through week 24=3.50 (0.09 to 19.48); SIR (Exact 95% CI)=0.00 (0.00 to 33.37).
‡Incidence/100 pt-yrs (Exact 95% CI) of lymphoma for placebo through week 24=0.00 (0.00 to 10.42); SIR (Exact 95% CI)=0.00 (0.00 to 582.38).
§Incidence/100 pt-yrs (Exact 95% CI) of NMSC for placebo through week 24=3.50 (0.09 to 19.48).
¶Incidence/100 pt-yrs (Exact 95% CI) of other malignancies for placebo through week 24=0.00 (0.00 to 10.42); SIR (Exact 95% CI)=0.00 (0.00 to 35.31).
**Incidence/100 pt-yrs (Exact 95% CI) of serious infections for placebo through week 24=3.48 (0.09 to 19.39).
AE, adverse event; GLM, golimumab; NMSC, non-melanoma skin cancer; no., number; pts, patients; pt-yrs, patient-years; SEER, Surveillance, Epidemiology and End Results database; SIR, standardised incidence ratio.