September 12, 2019 /
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
South San Francisco, CA — September 11, 2019 —
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), presented today full pivotal Phase III study results for satralizumab as a monotherapy for neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating central nervous system disease. Results from the SAkuraStar study, presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), show that satralizumab monotherapy achieved a 55% reduction in the risk of relapses compared to placebo in the overall population, representative of NMOSD patients (Hazard Ratio [HR]=0.45, 95% Confidence Interval [CI]: 0.23-0.89; p=0.0184). In the large (~67%) subgroup of patients seropositive for AQP4-IgG antibodies, the effect was higher with a 74% reduction in risk of relapses (HR=0.26, 95% CI: 0.11-0.63; p=0.0014). People who are AQP4-IgG seropositive tend to experience a more severe disease course.
“The positive Phase III results for satralizumab, first as an add-on therapy and now as a monotherapy, are exciting to see, and importantly, satralizumab achieved efficacy in a broad range of NMOSD patients, reflective of what we see in our everyday practice. Satralizumab targets the IL-6 receptor, potentially offering a novel treatment approach,” said Professor Jeffrey Bennett, University of Colorado Neurology & Ophthalmology. “Approved treatment options demonstrating favorable safety and efficacy in controlled clinical trials are urgently needed. Even one relapse may lead to blindness and debilitating motor dysfunction for people with NMOSD.”
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