Table 4.

Incidence of safety events of special interest through 5 years: pooled data from 5 phase 3 studies of SC GOL (with or without MTX) in rheumatological indications (RA, PsA, AS). Values are n/N (%), incidence/100 patient-years (95% CI) unless otherwise specified.

VariablesPlaceboGOL 50 mg OnlyGOL 50 and 100 mgGOL 100 mg OnlyGOL Combined
No. treated patients6396717657922228
Death1
  Pts treated at beginning of Yr 11/639 (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 20/50 (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 30/9 (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 40/5 (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 50/3 (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 1–51/639 (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 116/639 (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 20/50 (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 30/9 (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 41/5 (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 50/3 (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 1–517/639 (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 10/639 (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 20/50 (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 30/9 (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 40/5 (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 50/3 (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 1–50/639 (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 10/639 (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 20/50 (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 30/9 (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 40/5 (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 50/3 (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 1–50/639 (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 19/639 (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 20/48 (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 30/9 (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 40/5 (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 50/3 (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 1–59/639 (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 database1.46 (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 16/639 (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 20/48 (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 30/9 (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 40/5 (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 50/3 (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 1–56/639 (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 10/639 (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 20/50 (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 30/9 (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 40/5 (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 50/3 (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 1–50/639 (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 database0.00 (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 10/639 (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 20/50 (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 30/9 (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 40/5 (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 50/3 (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 1–50/639 (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.