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A systematic review of the effectiveness of adalimumab

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Review: Etanercept for rheumatoid arthritis 2006<br />

Comparison: 01 Etanercept s.c. licensed dose only (25 mg twice weekly or 50 mg once weekly) vs placebo, end <strong>of</strong> trial<br />

Outcome: 12 HAQ, end <strong>of</strong> study result<br />

Study<br />

or subcategory<br />

N<br />

Etanercept<br />

mean (SD) N<br />

01 With (+) or without (–) concurrent, ongoing conventional DMARDs<br />

Wadjula, 2000 126 [12 weeks] (–)<br />

Moreland, 1999 122 [26 weeks] (–)<br />

Keystone, 2004 129 [8 weeks] (±)<br />

Lan, 2004 130 [12 weeks] (+)<br />

Weinblatt, 1999 125 [24 weeks] (+)<br />

Codreanu, 2003 103 [24 weeks] (+)<br />

Subtotal (95% CI)<br />

Test for heterogeneity: 2 = 6.28, df = 5 (p = 0.28), I 2 = 20.4%<br />

Test for overall effect: z = 11.36 (p < 0.00001)<br />

Control<br />

mean (SD)<br />

99 1.30 (0.60) 81 1.70 (0.60)<br />

78 1.00 (0.80) 80 1.70 (0.70)<br />

367 1.00 (0.60) 53 1.50 (0.60)<br />

29 0.34 (0.60) 29 0.99 (0.60)<br />

59 0.90 (0.70) 30 1.20 (0.80)<br />

100 1.00 (0.60) 50 1.50 (0.50)<br />

732 323<br />

02 With concurrent, newly initiated MTX (etanercept + MTX)<br />

TEMPO110 [100 weeks] (+) 231 0.70 (0.60) 228 1.10 (0.70)<br />

Subtotal (95% CI)<br />

Test for heterogeneity: NA<br />

231 228<br />

Test for overall effect: z = 6.57 (p < 0.00001)<br />

Total (95% CI)<br />

Test for heterogeneity: 2 = 8.11, df = 6 (p = 0.23), I2 963 551<br />

= 26.0%<br />

Test for overall effect: z = 13.05 (p < 0.00001)<br />

© Queen’s Printer and Controller <strong>of</strong> HMSO 2006. All rights reserved.<br />

Health Technology Assessment 2006; Vol. 10: No. 42<br />

WMD (fixed)<br />

95% CI<br />

–1 –0.5 0 0.5 1<br />

Favours etanercept Favours control<br />

Weight<br />

%<br />

FIGURE 30 HAQ change: etanercept licensed dose only versus placebo (including etanercept plus MTX versus MTX)<br />

Review: Etanercept for rheumatoid arthritis 2006<br />

Comparison: 01 Etanercept s.c. licensed dose only (25 mg twice weekly or 50 mg once weekly) vs placebo, end <strong>of</strong> trial<br />

Outcome: 07 SAEs<br />

Study<br />

or subcategory<br />

Etanercept<br />

n/N<br />

Control<br />

n/N<br />

01 With (+) or without (–) concurrent, ongoing conventional DMARDs<br />

Moreland, 1999122 [26 weeks] (–)<br />

Keystone, 2004129 [8 weeks] (±)<br />

Baumgartner, 2004104 [20 weeks] (±)<br />

Weinblatt, 1999125 [24 weeks] (+)<br />

Codreanu, 2003103 [24 weeks] (+)<br />

Subtotal (95% CI)<br />

Total events: 37 (etanercept), 23 (control)<br />

Test for heterogeneity: 2 = 3.28, df = 4 (p = 0.51), I2 2/78<br />

5/367<br />

23/266<br />

2/59<br />

5/101<br />

3/80<br />

0/53<br />

16/269<br />

3/30<br />

1/50<br />

871 482<br />

= 0%<br />

Test for overall effect: z = 0.84 (p = 0.40)<br />

02 With concurrent, newly initiated MTX (etanercept + MTX)<br />

TEMPO 110 [104 weeks] (+)<br />

Subtotal (95% CI)<br />

Total events: 52 (etanercept), 41 (control)<br />

Test for heterogeneity: NA<br />

Test for overall effect: z = 1.20 (p = 0.23)<br />

52/231 41/228<br />

231 228<br />

Total (95% CI)<br />

Total events: 89 (etanercept), 64 (control)<br />

Test for heterogeneity: 2 = 3.29, df = 5 (p = 0.66), I2 1102 710<br />

= 0%<br />

Test for overall effect: z = 1.46 (p = 0.14)<br />

RR (fixed)<br />

95% CI<br />

0.01 0.1 1 10 100<br />

Favours etanercept Favours control<br />

15.82<br />

8.92<br />

16.45<br />

5.15<br />

4.31<br />

14.87<br />

65.52<br />

34.48<br />

34.48<br />

100.00<br />

Weight<br />

%<br />

4.47<br />

1.31<br />

23.99<br />

6.00<br />

2.02<br />

37.78<br />

62.22<br />

62.22<br />

100.00<br />

FIGURE 31 SAE RR: etanercept licensed dose only versus placebo (including etanercept plus MTX versus MTX)<br />

WMD (fixed)<br />

95% CI<br />

–0.40 (–0.58 to –0.22)<br />

–0.70 (–0.93 to –0.47)<br />

–0.50 (–0.67 to –0.33)<br />

–0.65 (–0.96 to –0.34)<br />

–0.30 (–0.64 to 0.04)<br />

–0.50 (–0.68 to –0.32)<br />

–0.50 (–0.59 to –0.42)<br />

–0.40 (–0.52 to –0.28)<br />

–0.40 (–0.52 to –0.28)<br />

–0.47 (–0.54 to –0.40)<br />

RR (fixed)<br />

95% CI<br />

0.68 (0.12 to 3.98)<br />

1.61 (0.09 to 28.78)<br />

1.45 (0.79 to 2.69)<br />

0.34 (0.06 to 1.92)<br />

2.48 (0.30 to 20.62)<br />

1.25 (0.75 to 2.08)<br />

1.25 (0.87 to 1.81)<br />

1.25 (0.87 to 1.81)<br />

1.25 (0.93 to 1.68)<br />

51

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