Soliris(R) Improved Fatigue Independent of Changes in Anemia in Patients with PNH by Controlling...(o the same period oftime prior to treatm...),Health

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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