Long-Term Soliris(R) Therapy Improved or Stabilized Kidney Function in Patient...(is Therapy Reduces Thrombosis and Transf...),Health

At the ASH annual meeting today, researchers also presented data from an ongoing open-label extension study examining the long-term efficacy of Soliris in 187 PNH patients. Long-term clinical efficacy measures included hemolysis, fatigue, quality of life, thrombotic events and transfusion requirements during a median 22-month treatment period. The long-term safety profile of Soliris was also assessed.

The study findings show that Soliris therapy provided significant long- term clinical improvements for patients with PNH:

-- Soliris significantly and consistently reduced hemolysis, as assessed

by levels of lactate dehydrogenase, from a mean of 2286 +/- 87 U/L at

baseline to 300 +/- 15 U/L in patients after 2 years of therapy

(P<0.001; N = 68).

-- Soliris significantly improved the fatigue score by 6.8 +/- 0.67 points

during the first six months of therapy and by 8.5 +/- 0.83 points

during the most recent six months of therapy using the FACIT-Fatigue

instrument (P<0.001); an increase of 3 or more points is clinically

meaningful in this instrument. A similar improvement in fatigue was

demonstrated with the EORTC instrument (P<0.001). Results obtained

from both fatigue scales showed more improvement in the latter time

period.

-- Other quality of life parameters also significantly improved both

during the first and the most recent six months of Soliris therapy

including five measures of patient functioning, global health status

and dyspnea (P<0.001 for each measure at both the first six and most

recent six months).

-- When comparing matched time periods prior to and during Soliris

therapy, thrombotic events were reduced 89 percent (from 45 events

before treatment to 5 eve
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