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Two-Year Data Show Long-Term Benefits Of Chronic Soliris® Therapy In Patients With AHUS

Soliris was well-tolerated in the study. The most common drug-related adverse events (AEs) were leukopenia, vomiting, nausea, and accelerated hypertension. 1

Soliris in aHUS Patients with a Long Duration of Disease and Chronic Kidney Damage (Previously Receiving Prolonged PE/PI)

In a separate oral presentation today, researchers presented two-year findings from a prospective, open-label, single-arm phase 2 trial of Soliris in adult and adolescent patients with a long duration of aHUS and chronic kidney damage who were undergoing prolonged PE/PI before starting treatment with Soliris. Patients had been diagnosed with aHUS a median of 48 months prior to starting the study. Twenty patients were enrolled in the initial study and received Soliris for 26 weeks. Nineteen of the 20 patients continued into a long-term extension phase. Patients were evaluated for a median duration of 114 weeks. Data for all 20 patients were analyzed using repeated measures models and response through data cutoff for each patient. 2

The study achieved its primary endpoint, TMA event-free status, in 16 of 20 (80%) patients through 26 weeks. TMA-event free status was achieved and maintained by 19 of 20 (95%) patients through two years, indicating that chronic treatment with Soliris continued to significantly inhibit complement-mediated TMA. Patients achieved TMA event-free status regardless of the identification of a genetic complement mutation. Hematologic normalization was achieved in 18 of 20 patients (90%) through week 26 and was maintained through two years. Importantly, no patient required new dialysis and only one patient required any PE/PI through data cutoff. Of the 19 patients who entered the long-term extension phase, with a median duration of over two years of treatment, 18 were alive as of data cutoff (one died of causes deemed unrelated to eculizumab). 2

Investigators also observed that chronic Soliris treatment was associated with a sustained improvement in eGFR, with a mean change from baseline of 6.1 mL/min/1.73m 2 through 26 weeks (p=0.0001) and 7.2 mL/min/1.73m 2 through two years (p<0.05). Improvement in eGFR was rapid over the first 4 weeks (positive rate of change p=0.005), and sustained with further Soliris treatment from week 4 through two years. By 26 weeks, one of 20 patients (5%) achieved an eGFR increase of at least 15 mL/min/1.73m 2, compared to 8 of 20 (40%) patients by two years. Seven of 20 patients (35%) experienced CKD improvement of at least one stage by 26 weeks, compared to 12 of 20 patients (60%) by two years, indicating that kidney function continues to improve with ongoing Soliris treatment. Additionally, patients reported significantly improved quality of life over the two years of ongoing eculizumab treatment (p<0.001). 2

“By following patients during Soliris treatment for more than two years, we have accumulated additional evidence of the beneficial effects of chronic Soliris therapy in aHUS patients with long disease duration, which represents a very sick patient population,” stated Christoph Licht, M.D., FASN, Associate Professor of Paediatrics Division of Nephrology at The Hospital for Sick Children, University of Toronto, who presented the results of the extension study. “With these long-term, two-year data, we can confirm what we previously reported: that sustained Soliris treatment helps to stabilize and improve renal function and provides an ongoing positive benefit/risk advantage for patients with aHUS.”

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