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Appendix 4
TABLE 71 Meta-analyses: adalimumab (s.c. or i.v. all doses) versus placebo (with or without ongoing conventional DMARDs), end of
trial
Comparison or outcome Studies N included Statistical method Effect size (95% CI)
in analysis
ACR20 responder 8112–119 ACR50 responder 8112–119 ACR70 responder 5112–115,119 RD ACR20 responder 8112–119 RD ACR50 responder 8112–119 RD ACR70 responder 5112–115,119 SJC, mean change from baseline 8112–119 Patient’s global assessment, mean change 8112–119 from baseline
HAQ, mean change from baseline 8 112–119
DAS28, mean change from baseline 2113,119 Modified van de Heijde–Sharp score, 1114 mean change from baseline
Withdrawal for any reasons 8 112–119
Withdrawal due to lack of efficacy 8112–119 Withdrawal due to adverse events 8112–119 Death 8112–119 SAEs 8112–119 Malignancy: all 6112–115,118,119 Malignancy: skin cancer excluding 6112–115,118,119 melanoma
Malignancy: all cancer excluding 6 112–115,118,119
non-melanoma skin cancer
Serious infection 7 112–115,117–119
Any infection 4 112–115
* Statistically significant result (p < 0.05).
2581 RR (fixed) 2.27 (1.99 to 2.60)*
2581 RR (fixed) 3.78 (2.96 to 4.83)*
2347 RR (fixed) 5.09 (3.36 to 7.71)*
2581 RD (fixed) 0.30 (0.27 to 0.34)*
2581 RD (random) 0.23 (0.18 to 0.28)*
2347 RD (fixed) 0.13 (0.11 to 0.15)*
2578 WMD (fixed) –5.37 (–6.11 to –4.64)*
2577 WMD (fixed) –1.74 (–1.97 to –1.51)*
2577 WMD (fixed) –0.31 (–0.35 to –0.27)*
827 WMD (fixed) –1.23 (–1.44 to –1.02)*
551 WMD (fixed) –2.20 (–3.33 to –1.07)*
2588 RR (random) 0.62 (0.46 to 0.84)*
2588 RR (fixed) 0.39 (0.32 to 0.47)*
2588 RR (fixed) 1.44 (0.93 to 2.24)
2588 RR (fixed) 1.53 (0.44 to 5.26)
2588 RR (fixed) 1.06 (0.80 to 1.40)
2414 RR (fixed) 2.84 (0.90 to 8.97)
2414 RR (fixed) 2.00 (0.55 to 7.24)
2414 RR (fixed) 2.23 (0.50 to 9.91)
2468 RR (fixed) 2.27 (1.00 to 5.18)
2070 RR (fixed) 1.19 (1.08 to 1.31)*