- EXCHANGE untersuchte das allgemeine Sicherheits- und Verträglichkeitsprofil bei Patienten mit fortschreitendem RMS oder RMS in der Vorgeschichte, die von injizierbaren und oralen DMTs auf dosistitriertes Siponimod ohne Washout umgestellt wurden.
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Prospektive, multizentrische, offene, einarmige Studie
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113 Patienten aus 42 Zentren in den USA in die Zwischenanalyse einbezogen; 1 Patient im virtuellen Arm
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Patienten mit ≥ 1 UE (34,8 %)
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SUE und UE, die zum Absetzen des Medikaments führten, waren gering.
‒ Fünf Patienten hatten ≥ 1 SUE*; sechs Patienten hatten ≥ 1 UE^
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Keine nennenswerte Verringerung der durchschnittlichen Herzfrequenz 6 Stunden nach Tag-1-Dosis gegenüber der Baseline
- EXCHANGE study enrolled a diverse patient population and presents opportunity to assess MS treatment patterns and safety/tolerability in conversion to siponimod
- Prospective, multicenter, open-label, single-arm trial
- Of 163 patients in the overall EXCHANGE interim population 126 (77.3%) identified as White, non-Hispanic/Latino – 23 (14.1%) identified as Black/African American – 36 (22.1%) identified as Hispanic/Latino
- Mean heart rate at baseline and 6-hour post first dose in both patient subgroups were comparable to the findings observed in the overall EXCHANGE interim population
- The most common AE related to siponimod treatment by preferred term was headache in the overall population (n=13; 8.0%), 11 of whom were Hispanic/Latino
- EXCHANGE is a 6-month, open-label, single-arm Phase 3b trial of safety and tolerability of immediate conversion to dose-titrated SIPO from other DMTs in patients with advancing RMS
- To report results of a sub-study assessing humoral immune response to mRNA COVID-19 vaccines (Pfizer/Moderna) in a subset of patients enrolled in EXCHANGE
- Overall, 70% (7/10) achieved a positive humoral immune response to COVID-19 vaccine at the post-vaccination assessment
- 57.1% (4/7) and 100% (3/3) achieved a positive response after two and three vaccine doses, respectively
Immune response to COVID-19 vaccine
