It looks like you are using an older version of Internet Explorer which is not supported. We advise that you update your browser to the latest version of Microsoft Edge, or consider using other browsers such as Chrome, Firefox or Safari.

Medical information request
Medical information request

EXCHANGE: Interim analysis results1

Bar-Or A, et al. Safety and tolerability of conversion to siponimod in patients with relapsing multiple sclerosis: interim results of the EXCHANGE study. Poster presentation at ACTRIMS-ECTRIMS. 2020;P0233.

  • EXCHANGE evaluated overall safety and tolerability profile in patients with advancing RMS or a history of RMS who convert from injectable and oral DMTs to dose-titrated siponimod without washout

  • Prospective, multicenter, open-label, single-arm trial

  • 113 patients included in interim analysis from 42 centers in the USA; 1 patient in the virtual arm

  • Patients with ≥1 AE (34.8%)

  • SAEs and AEs leading to drug discontinuation was low

    ‒Five patients had ≥1 SAE*, six patients had ≥1 AE**

  • No notable reductions from baseline in mean heart rate at 6-hour post Day-1 dose

Exchange

Immediate conversion over 6 days from other DMTs to siponimod was generally well tolerated, with no unexpected findings

Download PDF

Bar-Or A, et al., Safety and Tolerability of Conversion to Siponimod in Patients with Advancing Relapsing Multiple Sclerosis: A Subgroup Analysis by Race and Ethnicity of EXCHANGE Interim Data, Poster presentation at ACTRIMS 2022, P109

  • 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
Table2


Findings of this subgroup analysis by race/ethnicity provide some insights into treatment patterns and safety/tolerability in minority MS patient populations. Siponimod safety/tolerability profile remained consistent with no new or unexpected safety findings identified through this analysis

Download PDF



Bar-Or A, et al., Evaluating Humoral Immune Response to mRNA COVID-19 Vaccines in Siponimod-treated Patients with Advancing Forms of Relapsing Multiple Sclerosis: A COVID-19 Vaccine Sub-study of Phase 3b EXCHANGE Trial, Poster presented at ACTRIMS 2022, P133

 

  • 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

Table updated-2


Albeit limited by small sample size, this preliminary sub-study adds to our understanding of humoral immune responses to mRNA COVID-19 vaccination in patients with advancing forms of RMS who switched to SIPO treatment

Download PDF
Abbreviations
AEs, adverse events; CI, confidence interval; DMTs, disease-modifying therapies; RMS, relapsing multiple sclerosis; SAEs, serious adverse events**^

 

 

 

Reference
1. Bar-Or A, et al. Poster presentation at ACTRIMS-ECTRIMS. 2020;P0233.

The Pregnancy outcome Intensive Monitoring (PRIM) program is based on enhanced pharmacovigilance of the Novartis spontaneous reporting system. PRIM is an adverse event outcomes intensive monitoring program to collect information (targeted follow-up checklists) about pregnancy in patients exposed to siponimod immediately before or during pregnancy and infant outcomes 12 months after delivery.