Infection in NMOSD: Analyzing the Patterns of Infection in the SAkura Studies, Satralizumab Post-marketing Data, and NMOSD US PharMetrics Claims Data
Benjamin M. Greenberg1, Kazuo Fujihara2, Brian Weinshenker3, Francesco Patti4, Ingo Kleiter5, Jeffrey L. Bennett6, Jacqueline Palace7, Miriam Triyatni8, Kathleen Blondeau8, Alexander Burdeska8, Innocent Ngwa8, Gaëlle Klingelschmitt8, Takashi Yamamura9
1University of Texas Southwestern Medical Center, Dallas, Texas, USA, 2Fukushima Medical University School of Medicine, Fukushima, Japan, 3University of Virginia, Charlottesville, Virginia, USA, 4Department of Medical and Surgical Sciences and Advanced Technologies “GF Ingrassia” and Multiple Sclerosis Center, AOU Policlinico "G Rodolico" San Marco, University of Catania, Catania, Italy, 5Ruhr University Bochum, Bochum, Germany, 6University of Colorado School of Medicine, Aurora, Colorado, USA, 7John Radcliffe Hospital, Oxford, United Kingdom, 8F. Hoffmann-La Roche Ltd, Basel, Switzerland, 9Department of Immunology, National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan
Objective:
To evaluate infection patterns in satralizumab-treated patients from the SAkura studies after long-term treatment and compare satralizumab post-marketing (PM) data to US claims data.
Background:
Satralizumab showed a favorable safety profile vs placebo in the SAkuraSky and SakuraStar NMOSD studies. During the double-blind periods (DBP), infection represented 20% (satralizumab) and 30% (placebo) of all adverse events.
Design/Methods:
Analyses included: SAkuraSky, SAkuraStar and SAkuraMoon data from patients’ first dose of satralizumab to the clinical cut-off date (CCOD: January 31, 2023); Satralizumab PM data (June 1, 2020–May 31, 2023); and US PharMetrics claims data in NMOSD patients (January 1, 2017–October 31, 2022; >99% not receiving satralizumab). Preferred terms in the MedDRA queries used in the SAkura studies and PM data were mapped to corresponding ICD10 codes. Incidence rates of infection/serious infection/sepsis per 100 patient-years (IR/100 PY) were analyzed in the SAkura studies, and cumulative incidence (%) in the PM data and US claims data.
Results:
166 patients from the SAkura studies, 2,951 satralizumab-treated patients in PM data, and 2,872 adults from US claims data were included. In the SAkura studies, at CCOD (median exposure ~5.9 years), the incidence of infection, serious infection, and sepsis was lower vs DBP (IR/100 PY [95% CI]) infection 91.7 [85.5–98.3] vs 113.1 [98.8–129.0]; serious infection 2.6 [1.7–3.9] vs 4.1[1.8–8.0]; and sepsis 0.56 [0.2–1.3] vs 1.01 [0.1–3.7]). Most patients with serious infection had baseline EDSS scores of ≥4. In PM data (≤3-year exposure), the cumulative incidence of infection, serious infection, and sepsis was 7.3%, 3.8%, and 0.6%, respectively. In US claims data (4-year follow-up), the cumulative incidence of infection, serious infection and sepsis was 67.3%, 8.4% and 4.4%, respectively.
Conclusions:
US claims data indicates infections are major comorbidities in NMOSD. The incidence of infection, serious infection, and sepsis was consistently lower in satralizumab-treated patients than in US claims data.