Table 5

Subgroup analysis for risk of composite serious infections, propensity score-matched as-treated analyses

Tocilizumab (n=16 074)TNFi
(n=33 109)
HR
(95% CI)
Rate difference†
Subjects (n)EventsPerson-yearsIR* (95% CI)Subjects (n)EventsPerson-yearsIR* (95% CI)
Age <65913420775432.74 (2.37 to 3.12)20 13139217 9512.18 (1.97 to 2.40)1.18 (1.00 to 1.40)0.56 (0.13, 0.99)
Age ≥65680338255816.84 (6.16 to 7.53)12 72074510 7186.95 (6.45 to 7.45)0.93 (0.82 to 1.06)−0.11 (−0.96, 0.74)
Male271512023325.15 (4.23 to 6.07)573322152514.21 (3.65 to 4.76)1.08 (0.85 to 1.36)0.94 (−0.13, 2.01)
Female13 28948610 8014.50 (4.10 to 4.90)27 13992723 5093.94 (3.69 to 4.20)1.03 (0.92 to 1.15)0.56 (0.09, 1.03)
Baseline methotrexate use986739383294.72 (4.25 to 5.18)20 57775618 2924.13 (3.84 to 4.43)1.00 (0.88 to 1.13)0.59 (0.04, 1.14)
No baseline methotrexate use605321047274.44 (3.84 to 5.04)11 93639710 1473.91 (3.53 to 4.30)1.02 (0.86 to 1.21)0.53 (−0.18, 1.24)
Baseline oral steroid use12 20049799694.99 (4.55 to 5.42)24 72999921 4584.66 (4.37 to 4.94)0.97 (0.87 to 1.08)0.33 (−0.19, 0.85)
No baseline oral steroid use36579830333.23 (2.59 to 3.87)781916370662.31 (1.95 to 2.66)1.30 (1.00 to 1.70)0.92 (0.19, 1.65)
Recent (prior 60 days) oral steroid use887440172075.56 (5.02 to 6.11)17 49478115 1515.15 (4.79 to 5.52)0.98 (0.86 to 1.11)0.41 (−0.24, 1.06)
No recent (prior 60 days) oral steroid use698819157983.29 (2.83 to 3.76)14 95738513 2982.90 (2.61 to 3.18)1.03 (0.86 to 1.23)0.39 (−0.16, 0.94)
Baseline antibiotic use835336266375.45 (4.89 to 6.02)17 05176314 4675.27 (4.90 to 5.65)0.93 (0.82 to 1.06)0.18 (−0.50, 0.86)
No baseline antibiotic use754323464123.65 (3.18 to 4.12)15 61339813 9172.86 (2.58 to 3.14)1.15 (0.97 to 1.37)0.79 (0.24, 1.34)
  • *Incidence rate (IR) is per 100 person-years.

  • †Rate difference per 100 patients (tocilizumab-TNFi).

  • TNFi, tumour necrosis factor inhibitors.