Roche?s satralizumab significantly reduced relapse risk in second positive phase III study for neuromyelitis optica spectrum
- Pivotal phase III SAkuraStar study shows 55% reduction in the risk of relapse for satralizumab monotherapy versus placebo presented at ECTRIMS congress 2019
- 74% reduction in the risk of relapse for satralizumab monotherapy versus placebo in people with neuromyelitis optica spectrum disorder (NMOSD) with aquaporin-4 antibodies (AQP4-IgG seropositive patients)
- Satralizumab demonstrated a similar safety profile compared to placebo in two phase III studies across a broad population
- Satralizumab targets the interleukin-6 (IL-6) receptor, a key driver of NMOSD
About SAkuraStar and SAkuraSky in NMOSD
SAkuraStar is a phase III multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of satralizumab monotherapy administered to patients with NMOSD. The primary endpoint is the time to first protocol-defined relapse (PDR), adjudicated by an independent review committee in the double-blind period. Secondary endpoints included the Visual Analogue Scale (VAS) score for pain and Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score. Ninety-five patients aged from 20-70 years were randomised to either of the following two treatment groups in a 2:1 ratio: satralizumab (120 mg) or placebo. Both treatments were administered subcutaneously at Week 0, 2, and 4. The subsequent treatment was continued at 4-week intervals. The double-blind treatment period ended when the total number of PDRs had reached 44 or at 1.5 years after the enrollment of the last patient, whichever occurred first. After experiencing a PDR or upon completion of the study, patients in both groups were offered treatment with satralizumab in an open-label extension period. Patients with AQP4-IgG seropositive or seronegative neuromyelitis optica (NMO, as defined by the diagnostic criteria in 2006) and those with AQP4-IgG seropositive NMOSD were enrolled. SAkuraSky is a phase III multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of satralizumab added to baseline immunosuppressant therapy in patients with NMOSD. The primary endpoint was the time to first relapse as adjudicated by an independent review committee in the double-blind period. Main secondary endpoints included change in VAS score for pain and change in FACIT Fatigue score. Eighty-three male and female patients aged from 13 to 73 years were randomised to either of the following two treatment groups in a 1:1 ratio: satralizumab (120 mg) or placebo added to baseline therapy (azathioprine, mycophenolate mofetil and/or corticosteroids). Both treatments were administered subcutaneously at Week 0, 2, and 4. The subsequent treatment was continued at 4-week intervals. The double-blind treatment ended when patients experienced a PDR; the study ended when the total number of PDRs reached 26. After experiencing a PDR or upon completion of the study, patients in both groups were offered treatment with satralizumab in an open-label extension period. Patients with AQP4-IgG seropositive or seronegative neuromyelitis optica (NMO, as defined by diagnostic criteria in 2006) and those with AQP4-IgG seropositive NMOSD were enrolled.About neuromyelitis optica spectrum disorder (NMOSD)
NMOSD is a rare, lifelong and debilitating autoimmune disease of the central nervous system that primarily damages the optic nerve(s) and spinal cord, causing blindness, muscle weakness and paralysis. People with NMOSD experience unpredictable, severe relapses directly causing cumulative, permanent, neurological damage and disability. In some cases, relapse can result in death. NMOSD affects over 10,000 people in Europe, 15,000 people in the US and up to hundreds of thousands of people worldwide. The disease is most common among non-Caucasian women in their 30s and 40s. NMOSD is commonly associated with pathogenic antibodies (AQP4-IgG) that target and damage a specific cell type, called astrocytes resulting in inflammatory lesions of the optic nerve(s), spinal cord and brain. AQP4-IgG antibodies are detectable in the blood serum of around two-thirds of NMOSD patients. Although most cases of NMOSD can be confirmed through a diagnostic test, people living with the condition are still frequently misdiagnosed with multiple sclerosis. This is due to overlapping features of the two disorders, including a higher prevalence in women, similar symptoms and the fact that both are relapse-based conditions.About satralizumab
Satralizumab is an investigational humanised monoclonal antibody that targets the IL-6 receptor. The cytokine IL-6 is thought to be a key driver in NMOSD, triggering the inflammation cascade and leading to damage and disability. Positive phase III results for satralizumab, as both monotherapy and in combination with baseline therapy, suggest that IL-6 inhibition may be an effective therapeutic approach for NMOSD. The phase III clinical development programme for satralizumab includes two studies: SAkuraStar and SAkuraSky.About Roche in neuroscience
Neuroscience is a major focus of research and development at Roche. The company?s goal is to develop treatment options based on the biology of the nervous system to help improve the lives of people with chronic and potentially devastating diseases. Roche has more than a dozen investigational medicines in clinical development for diseases that include multiple sclerosis, Alzheimer?s disease, Huntington?s disease, spinal muscular atrophy, Parkinson?s disease and autism.About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people?s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare ? a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world?s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the tenth consecutive year, Roche has been recognised as the most sustainable company in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2018 employed about 94,000 people worldwide. In 2018, Roche invested CHF 11 billion in R&D and posted sales of CHF 56.8 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit?www.roche.com.All trademarks used or mentioned in this release are protected by law.