Physician†?s Assessments

   Tender/painful joints^c

20.0

11.0

23.0

9.0

   Physician global assessment^b

59.0

31.0

59.0

26.0

   Swollen joints^d

18.0

10.5

17.0

9.0

^a    Health Assessment Questionnaire; 0 = best, 3 = worst; includes eight categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities.

^b    Visual analog scale; 0 = best, 100 = worst

^c    Scale 0 to 68

^d    Scale 0 to 66

A 24-week study was conducted in 242 patients with active RA on background methotrexate who were randomized to receive either etanercept alone or the combination of Kineret^® and etanercept. The ACR₅₀ response rate was 31% for patients treated with the combination of Kineret^® and etanercept and 41% for patients treated with etanercept alone, indicating no added clincal benefit of the combination over etanercept alone. Serious infections were increased with the combination compared to etanercept alone (see WARNINGS).

In study 1 , the effect of Kineret^® on the progression of structural damage was assessed by measuring the change from baseline at month 12 in the Total Modified Sharp Score (TSS) and its subcomponents, erosion score, and joint space narrowing (JSN) score.⁸ Radiographs of hands/wrists and forefeet were obtained at baseline, 6 months and 12 months and scored by readers who were unaware of treatment group. A difference between placebo and Kineret^® for change in TSS, erosion score (ES) and JSN score was observed at 6 months and at 12 months (Table 3).

Table 3: Mean Radiographic Changes Over 12 Months in Study 1
	Placebo/MTX (N = 450)		Kineret® 100 mg/day /MTX (N= 449)		Placebo/MTX VS Kineret®/ MTX
	Baseline	Change at Month 12	Baseline	Change at Month 12	95% Confidence Interval*	p-value**
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