Variables | Placebo | GOL 50 mg Only | GOL 50 and 100 mg | GOL 100 mg Only | GOL Combined |
---|---|---|---|---|---|
No. treated patients | 639 | 671 | 765 | 792 | 2228 |
Death1 | |||||
Pts treated at beginning of Yr 1 | 1/639 (0.2), 0.31 (0.01–1.73) | 3/638 (0.5), 0.64 (0.13–1.86) | 0/742 (0), 0.00 (0.00–0.48) | 4/792 (0.5), 0.54 (0.15–1.37) | 7/2172 (0.3), 0.38 (0.15–0.78) |
Pts treated at beginning of Yr 2 | 0/50 (0), 0.00 (0.00–17.83) | 3/570 (0.5), 0.58 (0.12–1.69) | 0/744 (0), 0.00 (0.00–0.41) | 4/674 (0.6), 0.63 (0.17–1.62) | 7/1988 (0.4), 0.37 (0.15–0.77) |
Pts treated at beginning of Yr 3 | 0/9 (0), 0.00 (0.00–53.17) | 1/484 (0.2), 0.21 (0.01–1.18) | 3/709 (0.4), 0.44 (0.09–1.28) | 1/594 (0.2), 0.18 (0.00–0.98) | 5/1787 (0.3), 0.29 (0.09–0.68) |
Pts treated at beginning of Yr 4 | 0/5 (0), 0.00 (0.00–74.59) | 1/457 (0.2), 0.22 (0.01–1.24) | 2/659 (0.3), 0.31 (0.04–1.11) | 3/543 (0.6), 0.58 (0.12–1.71) | 6/1659 (0.4), 0.37 (0.14–0.81) |
Pts treated at beginning of Yr 5 | 0/3 (0), 0.00 (0.00–193.34) | 2/437 (0.5), 0.43 (0.05–1.56) | 2/627 (0.3), 0.30 (0.04–1.09) | 3/489 (0.6), 0.58 (0.12–1.68) | 7/1553 (0.5), 0.42 (0.17–0.88) |
Pts treated yrs 1–5 | 1/639 (0.2), 0.29 (0.01–1.59) | 11/671 (1.6), 0.46 (0.23–0.83) | 9/765 (1.2), 0.27 (0.12–0.51) | 16/792 (2.0), 0.54 (0.31–0.87) | 36/2228 (1.6), 0.41 (0.29–0.57) |
Serious infection | |||||
Pts treated at beginning of Yr 1 | 16/639 (2.5), 4.97 (2.84–8.08) | 15/638 (2.4), 3.18 (1.78–5.24) | 13/742 (1.8), 2.23 (1.22–3.75) | 42/792 (5.3), 6.56 (4.85–8.67) | 70/2172 (3.2), 4.22 (3.34–5.27) |
Pts treated at beginning of Yr 2 | 0/50 (0), 0.00 (0.00–17.83) | 17/570 (3.0), 4.05 (2.50–6.18) | 22/744 (3.0), 3.45 (2.23–5.09) | 22/674 (3.3), 3.96 (2.56–5.84) | 61/1988 (3.1), 3.79 (2.96–4.78) |
Pts treated at beginning of Yr 3 | 0/9 (0), 0.00 (0.00–53.17) | 8/484 (1.7), 1.70 (0.73–3.35) | 23/709 (3.2), 3.80 (2.48–5.57) | 19/594 (3.2), 3.87 (2.42–5.85) | 50/1787 (2.8), 3.25 (2.45–4.22) |
Pts treated at beginning of Yr 4 | 1/5 (20.0), 24.90 (0.63–138.72) | 6/457 (1.3), 1.56 (0.63–3.22) | 22/659 (3.3), 4.63 (3.12–6.60) | 9/543 (1.7), 1.75 (0.80–3.32) | 37/1659 (2.2), 2.86 (2.09–3.81) |
Pts treated at beginning of Yr 5 | 0/3 (0), 0.00 (0.00–193.34) | 7/437 (1.6), 1.72 (0.74–3.39) | 12/627 (1.9), 2.11 (1.16–3.55) | 12/489 (2.5), 2.50 (1.33–4.27) | 31/1553 (2.0), 2.12 (1.48–2.95) |
Pts treated yrs 1–5 | 17/639 (2.7), 4.86 (2.83–7.78) | 50/671 (7.5), 2.48 (1.89–3.20) | 80/765 (10.5), 3.26 (2.67–3.93) | 91/792 (11.5), 3.96 (3.27–4.74) | 221/2228 (9.9), 3.29 (2.92–3.69) |
Tuberculosis | |||||
Pts treated at beginning of Yr 1 | 0/639 (0), 0.00 (0.00–0.93) | 3/638 (0.5), 0.64 (0.13–1.86) | 0/742 (0), 0.00 (0.00–0.48) | 2/792 (0.3), 0.27 (0.03–0.97) | 5/2172 (0.2), 0.27 (0.09–0.63) |
Pts treated at beginning of Yr 2 | 0/50 (0), 0.00 (0.00–17.83) | 0/570 (0), 0.00 (0.00–0.58) | 3/744 (0.4), 0.41 (0.09–1.21) | 6/674 (0.9), 0.95 (0.35–2.07) | 9/1988 (0.5), 0.48 (0.22–0.91) |
Pts treated at beginning of Yr 3 | 0/9 (0), 0.00 (0.00–53.17) | 0/484 (0), 0.00 (0.00–0.64) | 2/709 (0.3), 0.29 (0.04–1.06) | 0/594 (0), 0.00 (0.00–0.53) | 2/1787 (0.1), 0.12 (0.01–0.42) |
Pts treated at beginning of Yr 4 | 0/5 (0), 0.00 (0.00–74.59) | 1/457 (0.2), 0.22 (0.01–1.24) | 1/659 (0.2), 0.15 (0.00–0.86) | 0/543 (0), 0.00 (0.00–0.58) | 2/1659 (0.1), 0.12 (0.02–0.45) |
Pts treated at beginning of Yr 5 | 0/3 (0), 0.00 (0.00–193.34) | 0/437 (0), 0.00 (0.00–0.65) | 1/627 (0.2), 0.15 (0.00–0.84) | 1/489 (0.2), 0.19 (0.00–1.07) | 2/1553 (0.1), 0.12 (0.01–0.44) |
Pts treated yrs 1–5 | 0/639 (0), 0.00 (0.00–0.86) | 4/671 (0.6), 0.17 (0.05–0.43) | 7/765 (0.9), 0.21 (0.08–0.43) | 9/792 (1.1), 0.30 (0.14–0.57) | 20/2228 (0.9), 0.23 (0.14–0.35) |
Opportunistic infection | |||||
Pts treated at beginning of Yr 1 | 0/639 (0), 0.00 (0.00–0.93) | 1/638 (0.2), 0.21 (0.01–1.18) | 1/742 (0.1), 0.16 (0.00–0.89) | 1/792 (0.1), 0.13 (0.00–0.75) | 3/2172 (0.1), 0.16 (0.03–0.47) |
Pts treated at beginning of Yr 2 | 0/50 (0), 0.00 (0.00–17.83) | 0/570 (0), 0.00 (0.00–0.58) | 2/744 (0.3), 0.28 (0.03–1.00) | 2/674 (0.3), 0.32 (0.04–1.14) | 4/1988 (0.2), 0.21 (0.06–0.55) |
Pts treated at beginning of Yr 3 | 0/9 (0), 0.00 (0.00–53.17) | 1/484 (0.2), 0.21 (0.01–1.18) | 0/709 (0), 0.00 (0.00–0.44) | 5/594 (0.8), 0.88 (0.29–2.05) | 6/1787 (0.3), 0.35 (0.13–0.76) |
Pts treated at beginning of Yr 4 | 0/5 (0), 0.00 (0.00–74.59) | 1/457 (0.2), 0.22 (0.01–1.24) | 1/659 (0.2), 0.15 (0.00–0.86) | 3/543 (0.6), 0.58 (0.12–1.71) | 5/1659 (0.3), 0.31 (0.10–0.72) |
Pts treated at beginning of Yr 5 | 0/3 (0), 0.00 (0.00–193.34) | 0/437 (0), 0.00 (0.00–0.65) | 1/627 (0.2), 0.15 (0.00–0.84) | 0/489 (0), 0.00 (0.00–0.57) | 1/1553 (0.1), 0.06 (0.00–0.34) |
Pts treated yrs 1–5 | 0/639 (0), 0.00 (0.00–0.86) | 3/671 (0.4), 0.13 (0.03–0.37) | 5/765 (0.7), 0.15 (0.05–0.35) | 10/792 (1.3), 0.37 (0.18–0.66) | 18/2228 (0.8), 0.22 (0.13–0.34) |
Malignancy | |||||
All malignancies | |||||
Pts treated at beginning of Yr 1 | 9/639 (1.4), 2.82 (1.29–5.35) | 5/638 (0.8), 1.06 (0.34–2.48) | 2/742 (0.3), 0.32 (0.04–1.16) | 13/792 (1.6), 1.75 (0.93–2.99) | 20/2172 (0.9), 1.09 (0.66–1.68) |
Pts treated at beginning of Yr 2 | 0/48 (0), 0.00 (0.00–17.86) | 7/568 (1.2), 1.36 (0.54–2.79) | 4/742 (0.5), 0.55 (0.15–1.42) | 9/669 (1.3), 1.44 (0.66–2.74) | 20/1979 (1.0), 1.07 (0.66–1.66) |
Pts treated at beginning of Yr 3 | 0/9 (0), 0.00 (0.00–53.17) | 8/484 (1.7), 1.71 (0.74–3.36) | 8/706 (1.1), 1.18 (0.51–2.32) | 4/584 (0.7), 0.72 (0.20–1.83) | 20/1774 (1.1), 1.17 (0.72–1.81) |
Pts treated at beginning of Yr 4 | 0/5 (0), 0.00 (0.00–74.59) | 2/453 (0.4), 0.45 (0.05–1.62) | 8/653 (1.2), 1.25 (0.54–2.47) | 3/532 (0.6), 0.60 (0.12–1.74) | 13/1638 (0.8), 0.82 (0.44–1.40) |
Pts treated at beginning of Yr 5 | 0/3 (0), 0.00 (0.00–193.34) | 4/437 (0.9), 0.86 (0.24–2.21) | 6/617 (1.0), 0.92 (0.34–2.01) | 9/481 (1.9), 1.76 (0.81–3.34) | 19/1535 (1.2), 1.17 (0.70–1.83) |
Pts treated yrs 1–5 | 9/639 (1.4), 2.59 (1.19–4.92) | 26/671 (3.9), 1.10 (0.72–1.61) | 28/765 (3.7), 0.84 (0.56–1.22) | 38/792 (4.8), 1.29 (0.91–1.77) | 92/2228 (4.1), 1.07 (0.86–1.31) |
SIR (95% CI) vs SEER database | 1.46 (0.30–4.26) | 1.55 (0.95–2.40) | 0.60 (0.32–1.03) | 1.32 (0.84–1.98) | 1.08 (0.82–1.40) |
Non-melanoma skin cancer | |||||
Pts treated at beginning of Yr 1 | 6/639 (0.9), 1.88 (0.69–4.09) | 1/638 (0.2), 0.21 (0.01–1.18) | 2/742 (0.3), 0.32 (0.04–1.16) | 7/792 (0.9), 0.94 (0.38–1.94) | 10/2172 (0.5), 0.54 (0.26–1.00) |
Pts treated at beginning of Yr 2 | 0/48 (0), 0.00 (0.00–17.86) | 2/569 (0.4), 0.39 (0.05–1.40) | 3/742 (0.4), 0.42 (0.09–1.21) | 3/669 (0.4), 0.48 (0.10–1.40) | 8/1980 (0.4), 0.43 (0.19–0.85) |
Pts treated at beginning of Yr 3 | 0/9 (0), 0.00 (0.00–53.17) | 2/484 (0.4), 0.42 (0.05–1.53) | 3/706 (0.4), 0.44 (0.09–1.29) | 3/587 (0.5), 0.54 (0.11–1.57) | 8/1777 (0.5), 0.47 (0.20–0.92) |
Pts treated at beginning of Yr 4 | 0/5 (0), 0.00 (0.00–74.59) | 0/455 (0), 0.00 (0.00–0.67) | 4/653 (0.6), 0.63 (0.17–1.60) | 0/533 (0), 0.00 (0.00–0.59) | 4/1641 (0.2), 0.25 (0.07–0.64) |
Pts treated at beginning of Yr 5 | 0/3 (0), 0.00 (0.00–193.34) | 1/437 (0.2), 0.22 (0.01–1.20) | 4/617 (0.6), 0.61 (0.17–1.57) | 2/481 (0.4), 0.39 (0.05–1.41) | 7/1535 (0.5), 0.43 (0.17–0.89) |
Pts treated yrs 1–5 | 6/639 (0.9), 1.73 (0.63–3.76) | 6/671 (0.9), 0.25 (0.09–0.55) | 16/765 (2.1), 0.48 (0.28–0.78) | 15/792 (1.9), 0.51 (0.28–0.84) | 37/2228 (1.7), 0.43 (0.30–0.59) |
Lymphoma | |||||
Pts treated at beginning of Yr 1 | 0/639 (0), 0.00 (0.00–0.93) | 0/638 (0), 0.00 (0.00–0.63) | 0/742 (0), 0.00 (0.00–0.48) | 2/792 (0.3), 0.27 (0.03–0.97) | 2/2172 (0.1), 0.11 (0.01–0.39) |
Pts treated at beginning of Yr 2 | 0/50 (0), 0.00 (0.00–17.83) | 0/570 (0), 0.00 (0.00–0.58) | 0/744 (0), 0.00 (0.00–0.41) | 2/674 (0.3), 0.32 (0.04–1.14) | 2/1988 (0.1), 0.11 (0.01–0.39) |
Pts treated at beginning of Yr 3 | 0/9 (0), 0.00 (0.00–53.17) | 0/484 (0), 0.00 (0.00–0.64) | 1/709 (0.1), 0.15 (0.00–0.81) | 0/593 (0), 0.00 (0.00–0.53) | 1/1786 (0.1), 0.06 (0.00–0.32) |
Pts treated at beginning of Yr 4 | 0/5 (0), 0.00 (0.00–74.59) | 1/457 (0.2), 0.22 (0.01–1.24) | 1/659 (0.2), 0.15 (0.00–0.86) | 1/543 (0.2), 0.19 (0.00–1.08) | 3/1659 (0.2), 0.19 (0.04–0.54) |
Pts treated at beginning of Yr 5 | 0/3 (0), 0.00 (0.00–193.34) | 0/437 (0), 0.00 (0.00–0.65) | 0/627 (0), 0.00 (0.00–0.45) | 1/489 (0.2), 0.19 (0.00–1.07) | 1/1553 (0.1), 0.06 (0.00–0.34) |
Pts treated yrs 1–5 | 0/639 (0), 0.00 (0.00–0.86) | 1/671 (0.1), 0.04 (0.00–0.23) | 2/765 (0.3), 0.06 (0.01–0.22) | 6/792 (0.8), 0.20 (0.07–0.44) | 9/2228 (0.4), 0.10 (0.05–0.20) |
SIR (95% CI)2 vs SEER database | 0.00 (0.00–33.23) | 1.71 (0.04–9.50) | 2.11 (0.26–7.61) | 7.71 (2.83–16.78) | 3.89 (1.78–7.38) |
Demyelinating disorder | |||||
Pts treated at beginning of Yr 1 | 0/639 (0), 0.00 (0.00–0.93) | 0/638 (0), 0.00 (0.00–0.63) | 0/742 (0), 0.00 (0.00–0.48) | 1/792 (0.1), 0.13 (0.00–0.75) | 1/2172 (< 0.1), 0.05 (0.00–0.30) |
Pts treated at beginning of Yr 2 | 0/50 (0), 0.00 (0.00–17.83) | 0/570 (0), 0.00 (0.00–0.58) | 0/744 (0), 0.00 (0.00–0.41) | 1/674 (0.1), 0.16 (0.00–0.88) | 1/1988 (0.1), 0.05 (0.00–0.30) |
Pts treated at beginning of Yr 3 | 0/9 (0), 0.00 (0.00–53.17) | 0/484 (0), 0.00 (0.00–0.64) | 0/709 (0), 0.00 (0.00–0.44) | 1/593 (0.2), 0.18 (0.00–0.98) | 1/1786 (0.1), 0.06 (0.00–0.32) |
Pts treated at beginning of Yr 4 | 0/5 (0), 0.00 (0.00–74.59) | 0/457 (0), 0.00 (0.00–0.67) | 0/659 (0), 0.00 (0.00–0.46) | 3/542 (0.6), 0.59 (0.12–1.71) | 3/1658 (0.2), 0.19 (0.04–0.54) |
Pts treated at beginning of Yr 5 | 0/3 (0), 0.00 (0.00–193.34) | 0/437 (0), 0.00 (0.00–0.65) | 1/627 (0.2), 0.15 (0.00–0.84) | 0/489 (0), 0.00 (0.00–0.57) | 1/1553 (0.1), 0.06 (0.00–0.34) |
Pts treated yrs 1–5 | 0/639 (0), 0.00 (0.00–0.86) | 0/671 (0), 0.00 (0.00–0.13) | 1/765 (0.1), 0.03 (0.00–0.17) | 6/792 (0.8), 0.20 (0.07–0.44) | 7/2228 (0.3), 0.08 (0.03–0.17) |
↵1 The incidence of death does not include 1 GOL patient who died at the start of Year 4 and 3 GOL patients who died at the start of Year 5, none of whom had exposure data in the year of death. All 4 patients, thus, had an unknown length of followup (required for determination of incidence).
↵2 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; PsA: psoriatic arthritis; AS: ankylosing spondylitis; pts: patients; SIR: standardized incidence ratio; SEER: Surveillance, Epidemiology, and End Results.