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A systematic review of the effectiveness of adalimumab

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28<br />

Effectiveness<br />

Review: Adalimumab for rheumatoid arthritis 2006<br />

Comparison: 03 Adalimumab s.c. licensed dose only (40 mg every o<strong>the</strong>r week or equivalent) vs placebo, end <strong>of</strong> trial<br />

Outcome: 02 ACR50 responder<br />

Study<br />

or subcategory<br />

Adalimumab<br />

n/N<br />

Control<br />

n/N<br />

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

van de Putte, 2003119 [12 weeks] (–)<br />

van de Putte, 2004113 [26 weeks] (–)<br />

STAR115 [24 weeks] (±)<br />

ARMADA112 [24 weeks] (+)<br />

Keystone, 2004114 [52 weeks] (+)<br />

Subtotal (95% CI)<br />

Total events: 360 (<strong>adalimumab</strong>), 69 (control)<br />

Test for heterogeneity: 2 = 8.66, df = 4 (p = 0.07), I2 17/71 1/70<br />

48/225 9/110<br />

92/315 35/315<br />

37/67 5/62<br />

166/419 19/200<br />

1097 757<br />

= 53.8%<br />

Test for overall effect: z = 10.25 (p < 0.00001)<br />

02 With concurrent, newly initiated MTX (<strong>adalimumab</strong> + MTX vs MTX)<br />

PREMIER 102,109 [104 weeks] (+)<br />

Subtotal (95% CI)<br />

Total events: 158 (<strong>adalimumab</strong>), 110 (control)<br />

Test for heterogeneity: NA<br />

Test for overall effect: z = 3.63 (p = 0.0003)<br />

158/268 110/257<br />

268 257<br />

Subtotal (95% CI)<br />

Total events: 518 (<strong>adalimumab</strong>), 179 (control)<br />

Test for heterogeneity: 2 = 50.80, df = 5 (p < 0.00001), I2 1365 1014<br />

= 90.2%<br />

Test for overall effect: z = 10.91 (p < 0.00001)<br />

RR (fixed)<br />

(95% CI)<br />

0.1 0.2 0.5 1 2 5 10<br />

Favours control Favours <strong>adalimumab</strong><br />

Weight<br />

(%)<br />

0.53<br />

6.32<br />

18.29<br />

2.71<br />

13.44<br />

41.30<br />

58.70<br />

58.70<br />

100.00<br />

FIGURE 4 ACR50 RR: <strong>adalimumab</strong> licensed dose versus placebo (including <strong>adalimumab</strong> plus MTX versus MTX)<br />

Review: Adalimumab for rheumatoid arthritis 2006<br />

Comparison: 03 Adalimumab s.c. licensed dose only (40 mg every o<strong>the</strong>r week or equivalent) vs placebo, end <strong>of</strong> trial<br />

Outcome: 02 ACR50 responder<br />

Study<br />

or subcategory<br />

Adalimumab<br />

n/N<br />

Control<br />

n/N<br />

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

van de Putte, 2003119 [12 weeks] (–)<br />

van de Putte, 2004113 [26 weeks] (–)<br />

STAR115 [24 weeks] (±)<br />

ARMADA112 [24 weeks] (+)<br />

Keystone, 2004114 [52 weeks] (+)<br />

Subtotal (95% CI)<br />

Total events: 360 (<strong>adalimumab</strong>), 69 (control)<br />

Test for heterogeneity: 2 = 26.38, df = 4 (p < 0.0001), I2 17/71 1/70<br />

48/225 9/110<br />

92/315 35/315<br />

37/67 5/62<br />

166/419 19/200<br />

1097 757<br />

= 84.8%<br />

Test for overall effect: z = 13.33 (p < 0.00001)<br />

02 With concurrent, newly initiated MTX (<strong>adalimumab</strong> + MTX vs MTX)<br />

PREMIER 102,109 [104 weeks] (+)<br />

Subtotal (95% CI)<br />

Total events: 158 (<strong>adalimumab</strong>), 110 (control)<br />

Test for heterogeneity: NA<br />

Test for overall effect: z = 3.75 (p = 0.0002)<br />

158/268 110/257<br />

268 257<br />

Subtotal (95% CI)<br />

Total events: 518 (<strong>adalimumab</strong>), 179 (control)<br />

Test for heterogeneity: 2 = 28.46, df = 5 (p < 0.0001), I2 1365 1014<br />

= 82.4%<br />

Test for overall effect: z = 12.95 (p < 0.00001)<br />

RD (fixed)<br />

(95% CI)<br />

–1 –0.5 1 0.5 1<br />

Favours control Favours <strong>adalimumab</strong><br />

Weight<br />

(%)<br />

6.23<br />

13.07<br />

27.86<br />

5.70<br />

23.94<br />

76.80<br />

23.20<br />

23.20<br />

100.00<br />

FIGURE 5 ACR50 RD: <strong>adalimumab</strong> licensed dose versus placebo (including <strong>adalimumab</strong> plus MTX versus MTX)<br />

RR (fixed)<br />

(95% CI)<br />

16.76 (2.29 to 122.56)<br />

2.61 (1.33 to 5.12)<br />

2.63 (1.84 to 3.75)<br />

6.85 (2.88 to 16.31)<br />

4.17 (2.68 to 6.50)<br />

3.58 (2.81 to 4.58)<br />

1.38 (1.16 to 1.64)<br />

1.38 (1.16 to 1.64)<br />

RD (fixed)<br />

(95% CI)<br />

0.23 (0.12 to 0.33)<br />

0.13 (0.06 to 0.21)<br />

0.18 (0.12 to 0.24)<br />

0.47 (0.33 to 0.61)<br />

0.30 (0.24 to 0.36)<br />

0.24 (0.20 to 0.27)<br />

0.16 (0.08 to 0.25)<br />

0.16 (0.08 to 0.25)

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