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A systematic review of the effectiveness of adalimumab

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66<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: 03 ACR70 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: 57 (infliximab), 18 (placebo)<br />

Test for heterogeneity: 2 = 0.07, df = 1 (p = 0.79), I2 48/343 16/341<br />

9/86 2/88<br />

429 429<br />

= 0%<br />

Test for overall effect: z = 4.77 (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: 121 (infliximab), 61 (placebo)<br />

Test for heterogeneity: 2 = 1.90, df = 1 (p = 0.17), I2 7/10 3/10<br />

114/351 58/274<br />

361 284<br />

= 47.5%<br />

Test for overall effect: z = 3.53 (p = 0.0004)<br />

Total (95% CI)<br />

Total events: 178 (infliximab), 79 (placebo)<br />

Test for heterogeneity: 2 = 2.77, df = 3 (p = 0.43), I2 790 713<br />

= 0%<br />

Test for overall effect: z = 5.68 (p < 0.00001)<br />

FIGURE 40 ACR70 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: 12 HAQ, mean change from baseline<br />

Study<br />

or subcategory<br />

01 With concurrent, ongoing MTX<br />

START, 111 [22 weeks] (+)<br />

ATTRACT, 132,133 [54 weeks] (+)<br />

Subtotal (95% CI)<br />

N<br />

Inflaximab<br />

mean (SD) N<br />

Test for heterogeneity: 2 = 0.46, df = 1 (p = 0.50), I 2 = 0%<br />

Test for overall effect: z = 6.74 (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 />

Placebo<br />

mean (SD)<br />

337 –0.39 (0.60) 336 –0.11 (0.51)<br />

77 –0.50 (0.66 68 –0.30 (0.66)<br />

414 404<br />

10 –1.09 (0.65) 10 –0.22 (0.72)<br />

311 –0.83 (0.71) 232 –0.72 (0.72)<br />

321 242<br />

Test for heterogeneity: 2 = 5.90, df = 1 (p = 0.02), I 2 = 83.0%<br />

Test for overall effect: z = 2.30 (p = 0.02)<br />

Total (95% CI)<br />

Test for heterogeneity: 2 = 9.52, df = 3 (p = 0.02), I2 735 646<br />

= 68.5%<br />

Test for overall effect: z = 6.89 (p < 0.00001)<br />

WMD (fixed)<br />

95% CI<br />

–1 –0.5 0 0.5 1<br />

Favours infliximab Favours placebo<br />

FIGURE 41 HAQ change: infliximab licensed dose only versus placebo (with concurrent MTX)<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 />

60.60<br />

9.26<br />

69.85<br />

1.19<br />

28.96<br />

30.15<br />

100.00<br />

RD (fixed)<br />

95% CI<br />

0.09 (0.05 to 0.14)<br />

0.08 (0.01 to 0.15)<br />

0.09 (0.05 to 0.13)<br />

0.40 (0.00 to 0.80)<br />

0.11 (0.04 to 0.18)<br />

0.12 (0.05 to 0.19)<br />

0.10 (0.07 to 0.14)<br />

WMD (fixed)<br />

95% CI<br />

–0.20 (–0.36 to –0.20)<br />

–0.20 (–0.42 to 0.02)<br />

–0.27 (–0.35 to –0.19)<br />

–0.87 (–1.47 to –0.27)<br />

–0.11 (–0.23 to 0.01)<br />

–0.14 (–0.26 to –0.02)<br />

–0.23 (–0.30 to –0.16)

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