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- Title
(RTH01) Safety of Satralizumab Based on Pooled Data from Phase 3 Studies in Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD).
- Authors
Greenberg, Benjamin M.; de Seze, Jerome; Fox, Edward; Saiz, Albert; Takashi Yamamura; Marcillat, Carole; Xiujing Kou; Weber, Kristina; Weinshenker, Brian G.
- Abstract
Background: Interleukin-6 (IL-6) is implicated in the immunopathology of neuromyelitis optica spectrum disorder (NMOSD). Satralizumab, a humanized recycling monoclonal antibody that binds to the IL-6 receptor, demonstrated a reduction in NMOSD relapse risk in two phase 3 studies: SAkuraSky (satralizumab in combination with baseline immunosuppressants; trial registration: NCT02028884), and SAkuraStar (satralizumab monotherapy; NCT02073279). Objectives: To evaluate the safety of satralizumab vs placebo in a pooled population of patients with NMOSD from the SAkura studies, using the latest data from their open-label extension (OLE) periods. Methods: SAkuraStar and SAkuraSky are randomized studies comprising a double-blind (DB) period (satralizumab 120 mg every 4 weeks vs placebo) followed by an OLE period (satralizumab only). The combined DB and extension period was defined as the overall satralizumab treatment (OST) period (cutoff June 7, 2019). Safety was evaluated in the DB and OST periods and reported as adverse event (AE) rates per 100 patient-years (PYs). Results: The pooled DB population included 178 patients (satralizumab, n = 104; placebo, n = 74), and a total of 166 patients received satralizumab in the OLE. Mean and median satralizumab exposures in the OST period were 133.3 and 128.6 weeks. Rates of AEs and serious AEs were comparable between satralizumab and placebo groups in the DB period (AEs: 478.49 vs 506.51 events/100 PYs, respectively; serious AEs: 14.97 vs 17.98 events/100 PYs, respectively), and were consistent in the OST period. In the DB period, 4 patients (3.8%) in the satralizumab group and 6 (8.1%) in the placebo group withdrew from study due to an AE. Infection rates were lower with satralizumab vs placebo in the DB period (113.04 vs 154.85 events/100 PYs), with no increased risk of opportunistic infections. Infection rates with satralizumab were similar between the DB and OST periods. The injection-related reaction rate was higher with satralizumab vs placebo in the DB period (17.03 vs 8.99 events/100 PYs); injection-related reactions were mostly mild-to-moderate and did not lead to treatment discontinuation. No deaths or anaphylactic reactions were reported. Conclusions: In patients with NMOSD, satralizumab was well tolerated and showed a favorable safety profile. Results from the overall satralizumab treatment period, which expanded on the DB periods by adding data from the ongoing OLE periods, were consistent with the DB period results.
- Subjects
THERAPEUTIC use of monoclonal antibodies; CONFERENCES &; conventions; PATIENT safety; NEUROMYELITIS optica
- Publication
International Journal of MS Care, 2020, Vol 22, Issue S2, p77
- ISSN
1537-2073
- Publication type
Article