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Raptiva Recall News Blog 
Tuesday, 28 April 2009

All three components of the PASI (plaque induration, scaling, and erythema) contributed comparably to the improvement in PASI. Other clinical responses evaluated (Table 2) included the proportion of patients who achieved minimal or clear status by a static Physician Global Assessment (sPGA) and the proportion of patients with a reduction in PASI of at least 50% from baseline (PASI-50) 1 week following the 12-week treatment period. The sPGA is a 6 category scale ranging from "very severe" to "clear" indicating the physician's overall assessment of the psoriasis severity focusing on plaque, scaling and erythema. Treatment success of minimal or clear consisted of none or slight elevation in plaque, none or minimal white color in scaling, and up to moderate definite red coloration in erythema. Across all four studies, the percentage of patients with baseline sPGA classifications of moderate was 48−56%, severe 33−43%, and 3−6% were classified as very severe.

 

Table 2 Percentage of Patients Responding after 12 Weeks of Treatment

Outcome Measurement

Study

Placebo

RAPTIVA1 mg/kg/wk

Differencea (95% CI)

sPGA: Minimal or Clear

1

3%

26%

23% (16, 30)

2

3%

32%

29% (21, 39)

3

3%

19%

16% (8, 25)

4

4%

20%

16% (11, 22)

> 50% improvement in PASI (PASI-50)

1

14%

59%

45% (37, 53)

2

15%

61%

46% (37, 56)

3

16%

52%

36% (26, 47)

4

14%

52%

38% (31, 45)

The number of patients in each study and treatment group is the same as listed in Table 1.

a p < 0.001 for comparison of RAPTIVA group to placebo group using Fisher's exact test for all comparisons between groups.

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POSTED BY: DW AT 09:37 pm   |  Permalink   |  E-mail this
Raptiva / efalizumab recalled by FDA Raptiva Recall News about Get latest Raptiva PML side effects warnings and RaptivaLawsuit Update. Raptiva increases the risk of life-threatening infections, including bacterial sepsis, viral meningitis, invasive fungal disease, and progressive multifocal leukoencephalopathy (PML). PML is a viral disease that causes irreversible brain damage and death. Raptiva was on the market for 5 years before the public was warned about these risks. Talk to a Raptiva Lawyer or Raptiva Attorney to File a Raptiva Lawsuit & Raptiva Class Action Lawsuit. Raptiva or efalizumab has been reported to cause serious rare brain infections, PML and other raptiva side effects, progressive multifocal leukoencephalopathy (pml) Talk to a raptivalawyer about a raptivalawsuit today.

Raptiva Recall Announced by FDA on April 8, 2009

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Raptiva recalled by FDA due to serious Raptiva related injuries. Talk to a Raptiva lawyer about filing a raptiva lawsuit if you took raptiva and have been diagnosed with PML, meningitis, encephalitis, a Lymphoma, Hodgkin's Disease, Rebound or worse Psoriasis, severe psoriasis, death, paralysis, resulting in disability (after cessation of Raptiva usage) or Serious infections (bacterial or viral)resulting in hospitalization.Talk to us about the pros and cons of a raptiva class action lawsuit. Get Raptiva drug information update for any victim of raptiva.

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