Base case point estimate (95% CI) (probability of heterogeneity) | Sensitivity analyses* | ||||
Peto method no continuity correction | Random effects reciprocal correction method | MH method 0.5 continuity correction | MH method excludes zero event trials | ||
Unadjusted analyses (OR) | |||||
Serious adverse events | |||||
Recommended dose, ADA | 1.12 (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, ADA | 5.77 (0.90 to 36.91) p = 0.90 | 3.40 (1.01 to 11.57) | 5.45 (0.84 to 35.24) | 4.81 (0.85 to 27.37) | NA |
High dose, IFX | 1.89 (1.18 to 3.02) p = 0.24 | 1.84 (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-TNF | 2.07 (1.31 to 3.26) p = 0.43 | 1.98 (1.32 to 2.99) | 1.93 (1.22 to 3.08 | 2.03 (1.29 to 3.19) | NA |
Exposure-adjusted analyses (RR) | |||||
Serious adverse events | |||||
Recommended dose, ADA | 1.06 (0.82 to 1.36) p = 0.02† | NA | 0.75 (0.40 to 1.44) | 1.06 (0.82 to 1.36)† | 1.06 (0.82 to 1.36)† |
Recommended dose, all anti-TNF | 1.01 (0.87 to 1.16) p = 0.08† | NA | 0.94 (0.77 to 1.15) | 1.00 (0.85 to 1.19)† | 0.99 (0.83 to 1.17)† |
High dose, IFX | 0.92 (0.73 to 1.17) p<0.01† | NA | 0.97 (0.55 to 1.71) | 0.92 (0.73 to 1.17)† | 0.92 (0.73 to 1.17)† |
High dose, all anti-TNF | 0.86 (0.70 to 1.07) p<0.01† | NA | 0.84 (0.57 to 1.24) | 0.86 (0.70 to 1.07)† | 0.86 (0.70 to 1.07)† |
Serious infection | |||||
High dose, IFX | 1.54 (1.01 to 2.32) p = 0.01† | NA | 1.76 (0.70 to 4.43) | 1.52 (1.07 to 2.15)‡ | 1.57 (0.98 to 2.53)§ |
High dose, all anti-TNF | 1.68 (1.12 to 2.52) p = 0.04† | NA | 1.99 (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.