Satralizumab Reduces Neuromyelitis Optica Relapse Risk in Clinical Trials
In the SAkuraStar study (NCT02073279), satralizumab (Genentech, South San Francisco, CA) treatment reduced relapse risk for people with neuromyelitis optica spectrum disorder (NMOSD) significantly. For the 64 participants with NMOSD who have antibodies to the aquaporin-4 receptor (anti-AQP4+), risk of relapse was reduced by 74% with satralizumab monotherapy vs placebo (hazard ratio [HR] = 0.26, 95% CI: 0.11-0.63; P = .0014). For all participants with or without antibodies to AQP4 (n = 95), those treated with satralizumab monotherapy vs placebo had a 55% reduction in risk of relapse (HR= 0.45, 95% CI: 0.23-0.89; P = .0184).
These results were presented at the European Committee on Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress in Stockholm, Sweden September 11-13, 2019.
These data add to what has previously been reported from the SAkuraSky study (NCT02028884). Those results showed that individuals with NMOSD who were AQP4+ and all individuals with NMOSD (AQP4+/-) treated with adjunctive satralizumab therapy had 79% and 62% reductions in relapse risk, respectively, compared with those on standard treatment alone (HR=0.21, 95% CI: 0.06-0.75; P = .0086 and HR = 0.38, 95% CI: 0.16-0.88;P = .0184, respectively).
Hideki Garren, MD, global head of Multiple Sclerosis and Neuroimmunology at Genentech said, “We are working as fast as we can to make this treatment available to people with NMOSD, who before this year had no treatment specific to their disease. If approved, satralizumab will give these individuals another treatment option. We are excited about the broad coverage that satralizumab may provide, having been studied in adolescents and adults who are both anti-AQP4 positive and negative.”
Incidence of serious adverse events was similar to placebo across groups treated with satralizumab monotherapy or adjunctive therapy. Interestingly, the rate of serious infections was lower in participants treated with satralizumab vs placebo. Most adverse events were mild to moderate, consisting of urinary tract and respiratory infections, headache, and nasopharyngitis.
“The positive phase 3 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.”