Table 6 Base case risk estimates displaying heterogeneity or with discordant sensitivity analyses
Base case point estimate (95% CI) (probability of heterogeneity)Sensitivity analyses*
Peto method no continuity correctionRandom effects reciprocal correction methodMH method 0.5 continuity correctionMH method excludes zero event trials
Unadjusted analyses (OR)
    Serious adverse events
        Recommended dose, ADA1.12 (0.86 to 1.45) p = 0.09†1.12 (0.86 to 1.45)0.94 (0.58 to 1.53)1.12 (0.86 to 1.45)†1.12 (0.86 to 1.45)†
    Serious infection
        High dose, ADA5.77 (0.90 to 36.91) p = 0.903.40 (1.01 to 11.57)5.45 (0.84 to 35.24)4.81 (0.85 to 27.37)NA
        High dose, IFX1.89 (1.18 to 3.02) p = 0.241.84 (1.19 to 2.84)1.94 (1.06 to 3.55)1.86 (1.16 to 2.98)1.87 (1.17 to 3.01)
        High dose, all anti-TNF2.07 (1.31 to 3.26) p = 0.431.98 (1.32 to 2.99)1.93 (1.22 to 3.082.03 (1.29 to 3.19)NA
Exposure-adjusted analyses (RR)
    Serious adverse events
        Recommended dose, ADA1.06 (0.82 to 1.36) p = 0.02†NA0.75 (0.40 to 1.44)1.06 (0.82 to 1.36)†1.06 (0.82 to 1.36)†
        Recommended dose, all anti-TNF1.01 (0.87 to 1.16) p = 0.08†NA0.94 (0.77 to 1.15)1.00 (0.85 to 1.19)†0.99 (0.83 to 1.17)†
        High dose, IFX0.92 (0.73 to 1.17) p<0.01†NA0.97 (0.55 to 1.71)0.92 (0.73 to 1.17)†0.92 (0.73 to 1.17)†
        High dose, all anti-TNF0.86 (0.70 to 1.07) p<0.01†NA0.84 (0.57 to 1.24)0.86 (0.70 to 1.07)†0.86 (0.70 to 1.07)†
    Serious infection
        High dose, IFX1.54 (1.01 to 2.32) p = 0.01†NA1.76 (0.70 to 4.43)1.52 (1.07 to 2.15)‡1.57 (0.98 to 2.53)§
        High dose, all anti-TNF1.68 (1.12 to 2.52) p = 0.04†NA1.99 (0.90 to 4.37)1.64 (1.16 to 2.29)¶1.57 (0.98 to 2.53)§
  • *Four of the five/six sensitivity analyses shown. †Classified as heterogeneous as per predefined statistical plan. ‡Classified as heterogeneous, p = 0.0124, I2  =  68.70%, random effects model (risk ratio (RR) 1.68; 95% CI 0.78 to 3.59; p = 0.25). §Classified as heterogeneous, p<0.0001, I2  =  75.82%, random effects model (RR 1.82; 95% CI 0.62 to 5.33; p = 0.27). ¶Classified as heterogeneous, p = 0.0465, I2  =  50.95%, random effects model (RR 1.96; 95% CI 0.89 to 4.36; p = 0.10). ADA, adalimumab; IFX, infliximab; MH, Mantel–Haenszel; OR, odds ratio; TNF, tumour necrosis factor.