A systematic review of the effectiveness of adalimumab
A systematic review of the effectiveness of adalimumab A systematic review of the effectiveness of adalimumab
64 Effectiveness Review: Infliximab for rheumatoid arthritis 2006 Comparison: 03 Infliximab i.v. licensed dose only (3 mg kg –1 every 8 weeks) + MTX vs Placebo + MTX, end of trial Outcome: 01 ACR20 responder Study or subcategory Infliximab n/N Placebo n/N 01 With concurrent, ongoing MTX START, 111 [22 weeks] (+) ATTRACT, 132,133 [54 weeks] (+) Subtotal (95% CI) Total events: 235 (infliximab), 102 (placebo) Test for heterogeneity: 2 = 1.04, df = 1 (p = 0.31), I2 199/343 87/341 36/86 15/88 429 429 = 3.7% Test for overall effect: z = 9.85 (p < 0.00001) 02 With concurrent, newly initiated MTX (infliximab + MTX vs MTX) Quinn, 2005, 141 [54 weeks] (+) ASPIRE, 135 [54 weeks] (+) Subtotal (95% CI) Total events: 227 (infliximab), 153 (placebo) Test for heterogeneity: 2 = 0.31, df = 1 (p = 0.58), I2 8/10 6/10 219/351 147/274 361 284 = 0% Test for overall effect: z = 2.34 (p = 0.02) Total (95% CI) Total events: 462 (infliximab), 255 (placebo) Test for heterogeneity: 2 = 20.10, df = 3 (p < 0.00002), I2 790 713 = 85.1% Test for overall effect: z = 8.83 (p < 0.00001) FIGURE 36 ACR20 RD: infliximab licensed dose versus placebo (with concurrent MTX) RD (fixed) 95% CI –1 –0.5 0 0.5 1 Favours placebo Favours infliximab Review: Infliximab for rheumatoid arthritis 2006 Comparison: 03 Infliximab i.v. licensed dose only (3 mg kg –1 every 8 weeks) + MTX vs Placebo + MTX, end of trial Outcome: 02 ACR50 responder Study or subcategory Infliximab n/N Placebo n/N 01 With concurrent, ongoing MTX START, 111 [22 weeks] (+) ATTRACT, 132,133 [54 weeks] (+) Subtotal (95% CI) Total events: 128 (infliximab), 40 (placebo) Test for heterogeneity: 2 = 0.25, df = 1 (p = 0.61), I2 110/343 33/341 18/86 7/88 429 429 = 0% Test for overall effect: z = 6.93 (p < 0.00001) 02 With concurrent, newly initiated MTX (infliximab + MTX vs MTX) Quinn, 2005, 141 [54 weeks] (+) ASPIRE, 135 [54 weeks] (+) Subtotal (95% CI) Total events: 168 (infliximab), 92 (placebo) Test for heterogeneity: 2 = 0.63, df = 1 (p = 0.43), I2 8/10 4/10 160/351 88/274 361 284 = 0% Test for overall effect: z = 3.58 (p = 0.0003) Total (95% CI) Total events: 296 (infliximab), 132 (placebo) Test for heterogeneity: 2 = 17.80, df = 3 (p = 0.0005), I2 790 713 = 83.1% Test for overall effect: z = 7.51 (p < 0.00001) FIGURE 37 ACR50 RR: infliximab licensed dose versus placebo (with concurrent MTX) RR (fixed) 95% CI 0.1 0.2 0.5 1 2 5 10 Favours placebo Favours infliximab Weight % 45.80 11.65 57.45 1.34 41.21 42.55 100.00 Weight % 23.17 4.84 28.01 2.80 69.19 71.99 100.00 RD (fixed) 95% CI 0.33 (0.26 to 0.39) 0.25 (0.12 to 0.38) 0.31 (0.25 to 0.37) 0.20 (–0.19 to 0.59) 0.09 (0.01 to 0.17) 0.09 (0.01 to 0.17) RR (fixed) 95% CI 3.31 (2.31 to 4.75) 2.63 (1.16 to 5.98) 3.20 (2.30 to 4.44) 2.00 (0.88 to 4.54) 1.42 (1.15 to 1.75) 1.44 (1.18 to 1.76)
Review: Infliximab for rheumatoid arthritis 2006 Comparison: 03 Infliximab i.v. licensed dose only (3 mg kg –1 every 8 weeks) + MTX vs Placebo + MTX, end of trial Outcome: 02 ACR50 responder Study or subcategory Infliximab n/N Placebo n/N 01 With concurrent, ongoing MTX START, 111 [22 weeks] (+) ATTRACT, 132,133 [54 weeks] (+) Subtotal (95% CI) Total events: 128 (infliximab), 40 (placebo) Test for heterogeneity: 2 = 2.45, df = 1 (p = 0.12), I2 110/343 33/341 18/86 7/88 429 429 = 59.2% Test for overall effect: z = 7.86 (p < 0.00001) 02 With concurrent, newly initiated MTX (infliximab + MTX vs MTX) Quinn, 2005, 141 [54 weeks] (+) ASPIRE, 135 [54 weeks] (+) Subtotal (95% CI) Total events: 168 (infliximab), 92 (placebo) Test for heterogeneity: 2 = 1.70, df = 1 (p = 0.19), I2 8/10 4/10 160/351 88/274 361 284 = 41.1% Test for overall effect: z = 3.76 (p = 0.0002) Total (95% CI) Total events: 296 (infliximab), 132 (placebo) Test for heterogeneity: 2 = 2.68, df = 3 (p = 0.13), I2 790 713 = 47.2% Test for overall effect: z = 8.09 (p < 0.0001) FIGURE 38 ACR50 RD: infliximab licensed dose versus placebo (with concurrent MTX) © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 42 RD (fixed) 95% CI –1 –0.5 0 0.5 1 Favours placebo Favours infliximab Review: Infliximab for rheumatoid arthritis 2006 Comparison: 03 Infliximab i.v. licensed dose only (3 mg kg –1 every 8 weeks) + MTX vs Placebo + MTX, end of trial Outcome: 03 ACR70 responder Study or subcategory Infliximab n/N Placebo n/N 01 With concurrent, ongoing MTX START, 111 [22 weeks] (+) ATTRACT, 132,133 [54 weeks] (+) Subtotal (95% CI) Total events: 57 (infliximab), 18 (placebo) Test for heterogeneity: 2 = 0.28, df = 1 (p = 0.59), I2 48/343 16/341 9/86 2/88 429 429 = 0% Test for overall effect: z = 4.40 (p < 0.0001) 02 With concurrent, newly initiated MTX (infliximab + MTX vs MTX) Quinn, 2005, 141 [54 weeks] (+) ASPIRE, 135 [54 weeks] (+) Subtotal (95% CI) Total events: 121 (infliximab), 61 (placebo) Test for heterogeneity: 2 = 0.60, df = 1 (p = 0.44), I2 7/10 3/10 114/351 58/274 361 284 = 0% Test for overall effect: z = 3.34 (p = 0.0008) Total (95% CI) Total events: 178 (infliximab), 79 (placebo) Test for heterogeneity: 2 = 6.46, df = 3 (p = 0.09), I2 790 713 = 53.5% Test for overall effect: z = 5.36 (p < 0.00001) FIGURE 39 ACR70 RR: infliximab licensed dose versus placebo (with concurrent MTX) RR (fixed) 95% CI 0.1 0.2 0.5 1 2 5 10 Favours placebo Favours infliximab Weight % 45.80 11.65 57.45 1.34 41.21 42.55 100.00 Weight % 18.62 2.29 20.92 3.48 75.60 79.08 100.00 RD (fixed) 95% CI 0.22 (0.17 to 0.28) 0.13 (0.03 to 0.23) 0.20 (0.15 to 0.26) 0.40 (0.01 to 0.79) 0.13 (0.06 to 0.21) 0.14 (0.07 to 0.22) 0.18 (0.14 to 0.22) RR (fixed) 95% CI 2.98 (1.73 to 5.15) 4.60 (1.02 to 20.70) 3.16 (1.89 to 5.27) 2.33 (0.83 to 6.54) 1.53 (1.17 to 2.02) 1.57 (1.20 to 2.05) 65
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64<br />
Effectiveness<br />
Review: Infliximab for rheumatoid arthritis 2006<br />
Comparison: 03 Infliximab i.v. licensed dose only (3 mg kg –1 every 8 weeks) + MTX vs Placebo + MTX, end <strong>of</strong> trial<br />
Outcome: 01 ACR20 responder<br />
Study<br />
or subcategory<br />
Infliximab<br />
n/N<br />
Placebo<br />
n/N<br />
01 With concurrent, ongoing MTX<br />
START, 111 [22 weeks] (+)<br />
ATTRACT, 132,133 [54 weeks] (+)<br />
Subtotal (95% CI)<br />
Total events: 235 (infliximab), 102 (placebo)<br />
Test for heterogeneity: 2 = 1.04, df = 1 (p = 0.31), I2 199/343 87/341<br />
36/86 15/88<br />
429 429<br />
= 3.7%<br />
Test for overall effect: z = 9.85 (p < 0.00001)<br />
02 With concurrent, newly initiated MTX (infliximab + MTX vs MTX)<br />
Quinn, 2005, 141 [54 weeks] (+)<br />
ASPIRE, 135 [54 weeks] (+)<br />
Subtotal (95% CI)<br />
Total events: 227 (infliximab), 153 (placebo)<br />
Test for heterogeneity: 2 = 0.31, df = 1 (p = 0.58), I2 8/10 6/10<br />
219/351 147/274<br />
361 284<br />
= 0%<br />
Test for overall effect: z = 2.34 (p = 0.02)<br />
Total (95% CI)<br />
Total events: 462 (infliximab), 255 (placebo)<br />
Test for heterogeneity: 2 = 20.10, df = 3 (p < 0.00002), I2 790 713<br />
= 85.1%<br />
Test for overall effect: z = 8.83 (p < 0.00001)<br />
FIGURE 36 ACR20 RD: infliximab licensed dose versus placebo (with concurrent MTX)<br />
RD (fixed)<br />
95% CI<br />
–1 –0.5 0 0.5 1<br />
Favours placebo Favours infliximab<br />
Review: Infliximab for rheumatoid arthritis 2006<br />
Comparison: 03 Infliximab i.v. licensed dose only (3 mg kg –1 every 8 weeks) + MTX vs Placebo + MTX, end <strong>of</strong> trial<br />
Outcome: 02 ACR50 responder<br />
Study<br />
or subcategory<br />
Infliximab<br />
n/N<br />
Placebo<br />
n/N<br />
01 With concurrent, ongoing MTX<br />
START, 111 [22 weeks] (+)<br />
ATTRACT, 132,133 [54 weeks] (+)<br />
Subtotal (95% CI)<br />
Total events: 128 (infliximab), 40 (placebo)<br />
Test for heterogeneity: 2 = 0.25, df = 1 (p = 0.61), I2 110/343 33/341<br />
18/86 7/88<br />
429 429<br />
= 0%<br />
Test for overall effect: z = 6.93 (p < 0.00001)<br />
02 With concurrent, newly initiated MTX (infliximab + MTX vs MTX)<br />
Quinn, 2005, 141 [54 weeks] (+)<br />
ASPIRE, 135 [54 weeks] (+)<br />
Subtotal (95% CI)<br />
Total events: 168 (infliximab), 92 (placebo)<br />
Test for heterogeneity: 2 = 0.63, df = 1 (p = 0.43), I2 8/10 4/10<br />
160/351 88/274<br />
361 284<br />
= 0%<br />
Test for overall effect: z = 3.58 (p = 0.0003)<br />
Total (95% CI)<br />
Total events: 296 (infliximab), 132 (placebo)<br />
Test for heterogeneity: 2 = 17.80, df = 3 (p = 0.0005), I2 790 713<br />
= 83.1%<br />
Test for overall effect: z = 7.51 (p < 0.00001)<br />
FIGURE 37 ACR50 RR: infliximab licensed dose versus placebo (with concurrent MTX)<br />
RR (fixed)<br />
95% CI<br />
0.1 0.2 0.5 1 2 5 10<br />
Favours placebo Favours infliximab<br />
Weight<br />
%<br />
45.80<br />
11.65<br />
57.45<br />
1.34<br />
41.21<br />
42.55<br />
100.00<br />
Weight<br />
%<br />
23.17<br />
4.84<br />
28.01<br />
2.80<br />
69.19<br />
71.99<br />
100.00<br />
RD (fixed)<br />
95% CI<br />
0.33 (0.26 to 0.39)<br />
0.25 (0.12 to 0.38)<br />
0.31 (0.25 to 0.37)<br />
0.20 (–0.19 to 0.59)<br />
0.09 (0.01 to 0.17)<br />
0.09 (0.01 to 0.17)<br />
RR (fixed)<br />
95% CI<br />
3.31 (2.31 to 4.75)<br />
2.63 (1.16 to 5.98)<br />
3.20 (2.30 to 4.44)<br />
2.00 (0.88 to 4.54)<br />
1.42 (1.15 to 1.75)<br />
1.44 (1.18 to 1.76)
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