Table 5

Incidences of rare safety events during the placebo-controlled period and up to week 160: pooled data from phase IIb and phase III studies of SC golimumab in rheumatological indications (RA, PsA and AS)

 Placebo-controlled period*Week 160
Placebo±MTXGolimumab 50 mg±MTXGolimumab 100 mg±MTXPlacebo±MTXGolimumab 50 mg±MTXGolimumab 100 mg±MTX
Number of treated patients†674750104467413171571
Death, n (%)1 (0.1)1 (0.1)3 (0.3)1 (0.1)7 (0.5)14 (0.9)
 Incidence per 100 pt-yrs (95% CI)0.32 (0.01 to 1.79)0.27 (0.01 to 1.53)0.52 (0.11 to 1.53)0.28 (0.01 to 1.56)0.30 (0.12 to 0.62)0.41 (0.23 to 0.69)
Serious infection, n (%)17 (2.5)12 (1.6)27 (2.6)17 (2.5)57 (4.3)117 (7.4)
 Incidence per 100 pt-yrs (95% CI)5.50 (3.21 to 8.81)3.31 (1.71 to 5.78)4.76 (3.14 to 6.92)5.31 (3.20 to 8.30)3.03 (2.36 to 3.82)5.09 (4.36 to 5.90)
Tuberculosis, n (%)0 (0.0)2 (0.3)0 (0.0)0 (0.0)4 (0.3)12 (0.8)
 Incidence per 100 pt-yrs (95% CI)0.00 (0.00 to 0.96)0.55 (0.07 to 1.98)0.00 (0.00 to 0.52)0.00 (0.00 to 0.84)0.17 (0.05 to 0.44)0.35 (0.18 to 0.62)
Opportunistic infection, n (%)‡0 (0.0)0 (0.0)1 (0.1)0 (0.0)3 (0.2)8 (0.5)
 Incidence per 100 pt-yrs (95% CI)0.00 (0.00 to 0.96)0.00 (0.00 to 0.82)0.17 (0.00 to 0.97)0.00 (0.00 to 0.84)0.13 (0.03 to 0.38)0.24 (0.10 to 0.46)
Malignancy
 All malignancies, n (%)6 (0.9)3 (0.4)10 (1.0)7 (1.0)29 (2.2)38 (2.4)
  Incidence per 100 pt-yrs (95% CI)1.93 (0.71 to 4.21)0.82 (0.17 to 2.41)1.75 (0.84 to 3.21)1.97 (0.79 to 4.05)1.26 (0.84 to 1.81)1.13 (0.80 to 1.55)
  SIR (95% CI)§ vs SEER database1.07 (0.13 to 3.87)0.97 (0.12 to 3.49)1.25 (0.34 to 3.21)0.94 (0.11 to 3.38)1.48 (0.89 to 2.31)0.99 (0.61 to 1.53)
 Non-melanoma skin cancer, n (%)4 (0.6)1 (0.1)6 (0.6)5 (0.7)10 (0.8)18 (1.1)
  Incidence per 100 pt-yrs (95% CI)1.29 (0.35 to 3.30)0.27 (0.01 to 1.53)1.05 (0.38 to 2.28)1.40 (0.46 to 3.28)0.43 (0.21 to 0.80)0.53 (0.32 to 0.84)
 Lymphoma, n (%)0 (0.0)0 (0.0)2 (0.2)0 (0.0)1 (0.08)¶6 (0.4)**
  Incidence per 100 pt-yrs (95% CI)0.00 (0.00 to 0.96)0.00 (0.00 to 0.82)0.35 (0.04 to 1.26)0.00 (0.00 to 0.84)0.04 (0.00 to 0.24)0.18 (0.06 to 0.38)
  SIR (95% CI)§ vs SEER database0.00 (0.00 to 36.43)0.00 (0.00 to 32.66)14.13 (1.71 to 51.03)0.00 (0.00 to 31.98)1.71 (0.04 to 9.55)6.69 (2.45 to 14.56)
Demyelinating disorder, n (%)0 (0.0)0 (0.0)1 (0.1)0 (0.0)0 (0.0)3 (0.2)
 Incidence per 100 pt-yrs (95% CI)0.00 (0.00 to 0.96)0.00 (0.00 to 0.82)0.17 (0.00 to 0.97)0.00 (0.00 to 0.84)0.00 (0.00 to 0.13)0.12 (0.03 to 0.30)
  • *The controlled study period could extend up to week 52 per trial design.

  • †Patients may appear in ≥1 treatment column.

  • ‡Identified events included histoplasmosis, listeria sepsis, oesophageal candidiasis, pneumonia legionella, coccidioidomycosis, eye infection toxoplasmal, Pneumocystis jiroveci pneumonia and Mycobacterium kansasii infection.

  • §95% CIs not containing 1 (in bold) indicate a significant difference from the SEER database.

  • ¶This patient had AS.

  • **All six patients had RA. Two patients were diagnosed with lymphoma during the placebo-controlled period; the other four were diagnosed with lymphoma after the placebo-controlled period and by week 160.

  • AS, ankylosing spondylitis; MTX, methotrexate; PsA, psoriatic arthritis; pt-yrs, patient-years; RA, rheumatoid arthritis; SC, subcutaneous; SEER, Surveillance, Epidemiology and End Results; SIR, standardised incidence ratio.