previously received systemic therapy or phototherapy (PUVA) for psoriasis. Patients with clinically significant flares and patients with guttate, erythrodermic, or pustular psoriasis as the sole form of psoriasis were excluded from the studies. Patients were randomized to receive doses of 1 mg/kg or 2 mg/kg of RAPTIVA or placebo administered once a week for 12 weeks. Patients randomized to RAPTIVA received 0.7 mg/kg as the first dose prior to receiving the full assigned dose in subsequent weeks. During the studies, patients could receive concomitant low potency topical steroids. No other concomitant psoriasis therapies were allowed during treatment or the follow-up period.
Patients were evaluated using the Psoriasis Area and Severity Index (PASI) during the study. The PASI is a composite score that takes into consideration both the fraction of body surface area affected and the nature and severity of the psoriatic changes within the affected regions (erythema, infiltration/plaque thickness, and desquamation). Both treatment groups in all four studies had baseline median PASI scores of 17. Both treatment groups across all four studies had baseline median body surface area involvement ranging between 22−28%. Compared with placebo, more patients randomized to RAPTIVA had at least a 75% reduction from baseline PASI score (PASI-75) 1 week after the 12-week treatment period (Table 1). RAPTIVA 2 mg/kg was not superior to RAPTIVA 1 mg/kg.
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Table 1 Proportion of Patients with ¡İ 75% Improvement in PASI after 12 Weeks of Treatment (PASI-75) |
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Placebo |
RAPTIVA 1 mg/kg/wk |
Difference (95%CI) |
|
Study 1 |
4% n = 187 |
27%a n = 369 |
22% (16%, 29%) |
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Study 2 |
2% n = 170 |
39%a n = 162 |
37% (28%, 46%) |
|
Study 3 |
5% n = 122 |
22%a n = 232 |
17% (9%, 27%) |
|
Study 4 |
3% n = 236 |
24%a n = 450 |
21% (15%, 27%) |
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See Raptiva Page 5