Publication date: Dec 02, 2019
SOUTH SAN FRANCISCO, Calif. –(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that data from SAkuraSky, a pivotal Phase III study of the investigational medicine satralizumab for the treatment of neuromyelitis optica spectrum disorder (NMOSD), were published in the November 27, 2019 online issue of the New England Journal of Medicine (NEJM).
-The positive results from the pivotal SAkuraSky study of satralizumab support the hypothesis that IL-6 plays a key role in NMOSD, which is a debilitating and potentially fatal condition,” said Levi Garraway, M. D., Ph. D., chief medical officer and head of Global Product Development.
-Satralizumab has shown robust efficacy sustained for 144 weeks across a broad patient population in two Phase III studies, whether given as a monotherapy or in combination with baseline therapy.
Detailed results published in NEJM highlight that in the overall study population, only eight of 41 patients (20%) treated with satralizumab in combination with baseline immunosuppressant therapy experienced a protocol-defined relapse (PDR) compared to 18 of 42 patients (43%) treated with placebo in combination with baseline therapy (Hazard Ratio [HR]=0. 38, 95% CI: 0. 16-0. 88; p=0. 02).
In the AQP4-IgG seropositive subgroup analysis, three of 27 patients (11%) treated with satralizumab experienced a PDR compared to 12 of 28 patients (43%) treated with placebo (HR=0. 21, 95% CI: 0. 06-0. 75).
In the AQP4-IgG seronegative subgroup analysis, five of 14 patients (36%) treated with satralizumab experienced a PDR compared to six of 14 patients (43%) receiving placebo (HR= 0. 66, 95% CI: 0. 20-2. 24).
About the SAkuraSky study in NMOSD SAkuraSky is a Phase III multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of satralizumab added to baseline immunosuppressant therapy in patients with NMOSD.
Eighty-three male and female patients 13-73 years of age were randomized 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).
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.
Positive Phase III results for satralizumab, as both monotherapy and in combination with baseline immunosuppressant therapy, suggest that IL-6 inhibition may be an effective therapeutic approach for NMOSD.
|disease||MESH||Neuromyelitis Optica Spectrum Disorder|
|disease||MESH||spinal muscular atrophy|
- A highly specific and sensitive nanoimmunosensor for the diagnosis of neuromyelitis optica spectrum disorders.