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- Title
(RTH02) Adolescents with Neuromyelitis Optica Spectrum Disorder Achieved Similar Exposures and Favorable Safety Profile When Treated with the Adult Satralizumab Dosing Regimen.
- Authors
Hemingway, Cheryl; Silber Baumann, Hanna; Xiujing Kou; Stokmaier, Daniela; Sanwald Ducray, Patricia; Anania, Veronica G.; Hajime Ito; von Buedingen, H.-Christian; Lennon-Chrimes, Sian
- 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 (IL-6R), 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 describe satralizumab exposure in adolescents with NMOSD to support dose selection. Methods: Patients in both studies (N = 178) received placebo or satralizumab 120 mg at weeks 0, 2, and 4, and every 4 weeks thereafter. Data on clinical and protocol-defined relapses (PDRs), aquaporin-4 autoantibody (AQP4-IgG) serostatus, safety end points, and pharmacokinetic (PK) and pharmacodynamic markers were evaluated in adolescent patients. A popPK model, developed using data from a phase 1 satralizumab trial (healthy volunteers) and both phase 3 studies, was used to analyze PK data. Results: Eight adolescent patients were enrolled in SAkuraSky (adolescents were not permitted in SAkuraStar). Seven were evaluated for efficacy (1 patient had PK data only). The mean age was 15.4 (range 13-17) years; mean weight (79.3 [range 47.5-140.4] kg) was similar to the adult population. Six patients were female; 3 patients were AQP4-IgG seropositive. The range of model-predicted exposures was similar to those in adults, correlating inversely with body weight, and not age. Treatment effects on soluble IL-6R levels, a marker of target engagement, were similar between adults and adolescents, with similar predicted median IL-6R occupancy (>95% maintained over the dose interval). One of 4 patients receiving satralizumab had a relapse (PDR, n = 1); all 3 patients receiving placebo relapsed (PDR, n = 1; clinical relapse, n = 2). The safety profile of satralizumab in adolescents was consistent with the adult patient population; no new safety signals were identified. Conclusions: These findings support the recommendation that adolescent patients with NMOSD receive the adult 120 mg loading and every 4 weeks maintenance regimen of satralizumab.
- Subjects
THERAPEUTIC use of monoclonal antibodies; CONFERENCES &; conventions; MONOCLONAL antibodies; TREATMENT effectiveness; NEUROMYELITIS optica; ADOLESCENCE
- Publication
International Journal of MS Care, 2020, Vol 22, Issue S2, p77
- ISSN
1537-2073
- Publication type
Article