Paroxysmal Nocturnal Haemoglobinuria (PNH) Dr Conal McConville ...

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Summary of Clinical Efficacy In clinical trials, SOLIRIS ® significantly reduced haemolysis 1 the underlying cause of morbidity and mortality in <strong>PNH</strong> • 86% sustained reduction in haemolysis as measured by LDH 2 • 92% reduction in thrombotic events across all patient types 3 • 94% reduction in thrombotic events in patients treated with anticoagulants 3 • Patients treated with SOLIRIS experienced improvement in CKD and pulmonary hypertension 4,5 • 78% clinically meaningful improvement in fatigue – Fatigue in <strong>PNH</strong> impacted by haemolysis – Significant improvement noted in pain and dyspnoea along with a broad range of QoL measures 5 • 73% reduction in need for transfusions across all patient populations 2 1. SOLIRIS® (eculizumab) [package insert]. Alexion Pharmaceuticals; 2009. 2. Hillmen P et al. N Engl J Med. 2006;355:1233-43. 3. Hillmen P et al. Blood. 2007;110(12):4123-8. 4. Hillmen P et al. Am. J. Hematol. 2010; 85:553–559 5. Hill A, et al. BJH. doi:10.1111/j.1365-2141.2010 5. Socie G et al. Blood. 2007;110(11)::Abstract 3672. August 12_10_2010Gbl 28
Adverse Reactions Reported in ≥ 5% of SOLIRIS ® Treated Patients in TRIUMPH SOLIRIS® (eculizumab) [package insert]. Alexion Pharmaceuticals; 2009. Patients, n (%) Reaction SOLIRIS ® (n = 43) Placebo (n = 44) Headache 19 (44) 12 (27) Nasopharyngitis 10 (23) 8 (18) Back pain 8 (19) 4 (9) Nausea 7 (16) 5 (11) Fatigue 5 (12) 1 (2) Cough 5 (12) 4 (9) Herpes simplex virus infections 3 (7) 0 Sinusitis 3 (7) 0 Respiratory tract infection 3 (7) 1 (2) Constipation 3 (7) 2 (5) Myalgia 3 (7) 1 (2) Pain in extremity 3 (7) 1 (2) Influenza-like illness 2 (5) 1 (2) August 12_10_2010Gbl 29
Page 1 and 2: Paroxysmal Nocturnal Haemoglobinuri
Page 3 and 4: Paroxysmal Nocturnal Haemoglobinuri
Page 5 and 6: The Defect in PNH The Somatic Mutat
Page 7 and 8: PNH is a Progressive Disease of Chr
Page 9 and 10: Thrombosis Chronic Kidney Disease F
Page 23 and 24: Common Symptoms of Haemolysis Signa
Page 25 and 26: Historical Management of PNH Bone M
Page 27: SOLIRIS ® Blocks Terminal Compleme
Page 31: August 12_10_2010Gbl Thank you Than

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