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PNH Patients With Lower Levels of Hemolysis, Mild Anemia and Minimal Transfusion Support Have Significant Disease Burden; Soliris(R) Therapy Provided Clinical Improvements in PNH Patients Regardless of Disease Severity
Date:12/11/2007

eived a median of 22 months of treatment.

Hemolysis was significantly reduced with eculizumab treatment in patients with all levels of baseline hemolysis. In patients with the lowest quartile of hemolysis (< 1490 U/L), LDH was reduced from 1077 +/- 42 U/L pre-eculizumab to 323 +/- 22 U/L during the first six months and to 347 +/- 47 U/L during the most recent six months of Soliris therapy (P<0.001 for each comparison to baseline). Hemolysis was also significantly reduced during both the first and most recent six months of Soliris therapy in patients with mild anemia (Hgb of greater than or equal to 10.5 g/L) and minimal transfusion support prior to treatment (0 or 1 transfusion episode in the previous year) (P<0.001 for all subgroups at both time intervals).

In the study, patients who might have been considered to have less severe disease were found to have an elevated risk of blood clots prior to therapy and experienced the following reductions in the incidence of blood clots during Soliris therapy: for patients with the lowest quartile of baseline hemolysis, the rate decreased from 10.8 to 4.5 events per 100 patient years (P=0.009, n=48), for those with mild anemia from 5.2 to 0.8 events per 100 patient years (P<0.001, n=55), and for those with minimal pretreatment transfusion support from 4.9 to 0.0 events per 100 patient years (P=0.063, n=22).

Soliris treatment was associated with significant improvements in fatigue (as measured by the FACIT-Fatigue instrument), regardless of the baseline level of hemolysis, anemia, or pretreatment transfusion requirements. At baseline, patients who had the lowest levels of hemolysis, mild anemia, or minimal transfusion requirements reported fatigue. With patients in the lowest quartile of baseline hemolysis, FACIT-Fatigue scores improved by 6 points during the first six months and by 8 points during the most recent six months of Soliris therapy (P<0.001 for each comparison to baseline); an increase of 3 or
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SOURCE Alexion Pharmaceuticals, Inc.
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