Positive outcome from study for Chugai’s satralizumab
April 24, 2020Satralizumab monotherapy significantly reduced risk of relapse in patients with NMOSD, following a previous positive study where satralizumab was added to baseline immunosuppressant therapy.
TOKYO–(BUSINESS WIRE)–#NMOSD—Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that the results of the SAkuraStar Study of satralizumab were published on April, 22 (local time) in The Lancet Neurology. Satralizumab is an anti-IL6 receptor humanized recycling antibody under development for the treatment of neuromyelitis optica spectrum disorder (NMOSD). The phase III study examined the efficacy and safety of satralizumab as monotherapy for adults with NMOSD.
The article can be found here: https://doi.org/10.1016/S1474-4422(20)30078-8
“The longer-term efficacy in satralizumab monotherapy study reinforces the important role of IL-6 inhibition in treating NMOSD following the previous combination therapy study,” said Chugai’s President and COO, Dr. Osamu Okuda. “We are collaborating with Roche to obtain global regulatory approval this year so that we can bring satralizumab as a new treatment option to patients as soon as possible.”
In the SAkuraStar Study, satralizumab significantly reduced the risk of relapse by 55% (hazard ratio=0.45 [95% confidence interval: 0.23-0.89], p=0.018 [stratified log-rank test]) in the overall population, representative of the broad real-world spectrum of NMOSD patients (including AQP4-IgG seropositive and seronegative patients), achieving the primary endpoint of time to first protocol-defined relapse in the double-blind period. Importantly, 76.1%, 72.1% and 62.8% of patients on satralizumab were relapse-free at weeks 48, 96 and 144 compared to 61.9%, 51.2% and 34.1 with placebo, respectively. In a prespecified subgroup analysis for time to relapse, hazard ratio of satralizumab to placebo in AQP4-IgG seropositive patients was 0.26 (N=64, 95% confidence interval: 0.11-0.63). The proportion of serious adverse events was similar between the satralizumab and placebo treatment groups. The most common adverse events in the satralizumab group were urinary tract infection and upper respiratory tract infection.