Incidence of safety events of special interest through 5 years: pooled data from 3 phase 3 studies of SC GOL (with or without MTX) in RA. Values are n/N (%), incidence/100 patient-years (95% CI) unless otherwise specified.
| Variables | Placebo | GOL 50 mg Only | GOL 50 and 100 mg | GOL 100 mg Only | GOL Combined |
|---|---|---|---|---|---|
| No. treated patients | 449 | 374 | 542 | 565 | 1481 |
| Serious infection | |||||
| Pts treated at beginning of Yr 1 | 11/449 (2.4), 4.40 (2.20–7.87) | 12/341 (3.5), 5.02 (2.59–8.77) | 11/519 (2.1), 2.82 (1.46–4.93) | 37/565 (6.5), 8.34 (6.06–11.20) | 60/1425 (4.2), 5.71 (4.43–7.24) |
| Pts treated at beginning of Yr 2 | 0/50 (0), 0.00 (0.00–17.83) | 15/310 (4.8), 6.92 (4.16–10.80) | 19/527 (3.6), 4.31 (2.70–6.52) | 20/470 (4.3), 5.28 (3.35–7.93) | 54/1307 (4.1), 5.24 (4.04–6.69) |
| Pts treated at beginning of Yr 3 | 0/9 (0), 0.00 (0.00–53.17) | 4/253 (1.6), 1.62 (0.44–4.16) | 19/500 (3.8), 4.59 (2.88–6.95) | 15/408 (3.7), 4.41 (2.57–7.06) | 38/1161 (3.3), 3.87 (2.80–5.21) |
| Pts treated at beginning of Yr 4 | 1/5 (20.0), 24.90 (0.63–138.72) | 6/238 (2.5), 3.02 (1.22–6.23) | 19/458 (4.1), 6.02 (3.97–8.75) | 9/367 (2.5), 2.61 (1.20–4.96) | 34/1063 (3.2), 4.20 (3.04–5.65) |
| Pts treated at beginning of Yr 5 | 0/3 (0), 0.00 (0.00–193.34) | 4/227 (1.8), 1.63 (0.44–4.17) | 7/434 (1.6), 1.96 (0.89–3.71) | 9/328 (2.7), 2.83 (1.36–5.21) | 20/989 (2.0), 2.17 (1.38–3.26) |
| Pts treated yrs 1–5 | 12/449 (2.7), 4.31 (2.23–7.54) | 39/374 (10.4), 3.72 (2.72–4.96) | 68/542 (12.5), 3.96 (3.19–4.86) | 78/565 (13.8), 5.04 (4.11–6.11) | 185/1481 (12.5), 4.30 (3.77–4.88) |
| Malignancy | |||||
| All malignancies | |||||
| Pts treated at beginning of Yr 1 | 8/449 (1.8), 3.23 (1.40–6.37) | 3/341 (0.9), 1.26 (0.26–3.68) | 2/519 (0.4), 0.47 (0.06–1.70) | 9/565 (1.6), 1.72 (0.78–3.26) | 14/1425 (1.0), 1.18 (0.65–1.98) |
| Pts treated at beginning of Yr 2 | 0/48 (0), 0.00 (0.00–17.86) | 6/308 (1.9), 2.20 (0.81–4.79) | 3/525 (0.6), 0.59 (0.12–1.73) | 7/466 (1.5), 1.63 (0.65–3.36) | 16/1299 (1.2), 1.32 (0.76–2.15) |
| Pts treated at beginning of Yr 3 | 0/9 (0), 0.00 (0.00–53.17) | 5/253 (2.0), 2.04 (0.66–4.77) | 8/497 (1.6), 1.69 (0.73–3.32) | 4/400 (1.0), 1.06 (0.29–2.72) | 17/1150 (1.5), 1.55 (0.90–2.48) |
| Pts treated at beginning of Yr 4 | 0/5 (0), 0.00 (0.00–74.59) | 0/236 (0), 0.00 (0.00–1.30) | 5/452 (1.1), 1.13 (0.37–2.65) | 3/358 (0.8), 0.90 (0.18–2.62) | 8/1046 (0.8), 0.79 (0.34–1.57) |
| Pts treated at beginning of Yr 5 | 0/3 (0), 0.00 (0.00–193.34) | 3/227 (1.3), 1.23 (0.25–3.59) | 4/425 (0.9), 0.89 (0.24–2.28) | 6/321 (1.9), 1.74 (0.64–3.79) | 13/973 (1.3), 1.25 (0.67–2.14) |
| Pts treated yrs 1–5 | 8/449 (1.8), 2.90 (1.25–5.72) | 17/374 (4.5), 1.38 (0.80–2.21) | 22/542 (4.1), 0.96 (0.60–1.45) | 29/565 (5.1), 1.44 (0.97–2.07) | 68/1481 (4.6), 1.23 (0.95–1.56) |
| SIR (95% CI) vs SEER database | 1.70 (0.35–4.97) | 1.66 (0.91–2.78) | 0.67 (0.34–1.21) | 1.42 (0.86–2.22) | 1.15 (0.84–1.55) |
| Lymphoma | |||||
| Pts treated at beginning of Yr 1 | 0/449 (0), 0.00 (0.00–1.20) | 0/341 (0), 0.00 (0.00–1.25) | 0/519 (0), 0.00 (0.00–0.71) | 2/565 (0.4), 0.38 (0.05–1.37) | 2/1425 (0.1), 0.17 (0.02–0.61) |
| Pts treated at beginning of Yr 2 | 0/50 (0), 0.00 (0.00–17.83) | 0/310 (0), 0.00 (0.00–1.09) | 0/527 (0), 0.00 (0.00–0.59) | 2/470 (0.4), 0.46 (0.06–1.66) | 2/1307 (0.2), 0.16 (0.02–0.59) |
| Pts treated at beginning of Yr 3 | 0/9 (0), 0.00 (0.00–53.17) | 0/253 (0), 0.00 (0.00–1.22) | 1/500 (0.2), 0.21 (0.01–1.16) | 0/407 (0), 0.00 (0.00–0.78) | 1/1160 (0.1), 0.09 (0.00–0.50) |
| Pts treated at beginning of Yr 4 | 0/5 (0), 0.00 (0.00–74.59) | 0/238 (0), 0.00 (0.00–1.29) | 1/458 (0.2), 0.22 (0.01–1.24) | 1/367 (0.3), 0.29 (0.01–1.62) | 2/1063 (0.2), 0.20 (0.02–0.71 |
| Pts treated at beginning of Yr 5 | 0/3 (0), 0.00 (0.00–193.34) | 0/227 (0), 0.00 (0.00–1.22) | 0/434 (0), 0.00 (0.00–0.65) | 1/328 (0.3), 0.28 (0.01–1.58) | 1/989 (0.1), 0.09 (0.00–0.53) |
| Pts treated yrs 1–5 | 0/449 (0), 0.00 (0.00–1.08) | 0/374 (0), 0.00 (0.00–0.24) | 2/542 (0.4), 0.09 (0.01–0.31) | 6/565 (1.1), 0.29 (0.11–0.64) | 8/1481 (0.5), 0.14 (0.06–0.28) |
| SIR (95% CI)1 vs SEER database | 0.00 (0.00–40.12) | 0.00 (0.00–8.50) | 2.91 (0.35–10.53) | 10.50 (3.85–22.86) | 4.97 (2.15–9.79) |
↵1 95% CI not containing 1 (in bold face) indicate a significant difference from the SEER database. SC: subcutaneous; GOL: golimumab; MTX: methotrexate; RA: rheumatoid arthritis; pts: patients; SIR: standardized incidence ratio; SEER: Surveillance, Epidemiology, and End Results.