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Soliris(R) Improved Fatigue Independent of Changes in Anemia in Patients with PNH by Controlling Hemolysis
Date:6/14/2008

o the same period of time prior to treatment. (5-7)

In the presentation by Dr. Hill, data on 164 patients with PNH were derived from two Phase 3 studies of Soliris as a treatment for PNH: TRIUMPH, a six-month, double-blind, placebo-controlled study, and SHEPHERD, a 12-month, open-label study. Data on anemic cancer patients were obtained from a published report.(8) Patient-reported fatigue in both groups of patients was determined utilizing the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale. Anemia was measured by levels of hemoglobin, and hemolysis was measured by levels of lactate dehydrogenase (LDH). Key findings included the following:

* While intravascular hemolysis reduction (decreased LDH) and anemia

improvement (increased hemoglobin) were both significantly associated

with fatigue improvement (odds ratio 1.11, P<0.001 and 1.29, P=0.005,

respectively), hemolysis reduction was predictive of an improvement in

fatigue independent of an improvement in anemia in patients with PNH

(1.07, P=0.028).

* The improvement in fatigue was greater (P=0.002) in Soliris-treated PNH

patients compared to EPO-treated anemic cancer patients.

* When the magnitude of clinical impact was analyzed by using standard

descriptors for the Effect Size (ES) measurement of fatigue in both

groups, (9)

* PNH patients treated with Soliris experienced a large improvement in

fatigue, (ES: +1.0) when the hemoglobin level increased as compared to

anemic cancer patients treated with EPO who experienced only a small

improvement in fatigue (ES: +0.48).

* Similarly, PNH patients treated with Soliris experienced a moderate

improvement in fatigue (ES:+0.72) when hemoglobin levels did not

improve compared to EPO-treated anemic cancer patients for whom

fatigue scores did not change meaningfully (ES:+0.15) when hem
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SOURCE Alexion Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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3. 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
4. Long-Term Soliris(R) Therapy Improved or Stabilized Kidney Function in Patients With PNH
5. Soliris(R) Demonstrates Reductions in Hemolysis and Improvements in Fatigue, Overall Quality of Life and Anemia in a Broad Population of PNH Patients
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