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Medical information request
Medical information request

 

EXCHANGE

Interim analysis results1

Bar-Or A, et al. , Safety and Tolerability of Conversion to Siponimod With and Without Titration in Patients with Advancing Forms of RMS: Interim Results of the Phase 3b EXCHANGE Study. Poster presentation at AAN 2022, P7.007

 

  • EXCHANGE evaluated safety and tolerability of immediate conversion to dose-titrated siponimod from other DMTs in patients with advancing RMS
     
  • Prospective, multicenter, open-label, single-arm trial
     
  • 163 patients included in interim analysis from 42 centers in the USA
     
  • Patients with ≥1 AE (31.3%) possibly related to siponimod treatment
     
  • There was no decrease in heart rate at 6 hours post first dose from baseline in the overall or any of the prior DMT groups
update exchange

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

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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

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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

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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 AAN 2022, P7.007
2. Bar-Or A, et al. Poster presentation at ACTRIMS 2022, P109
3. Bar-Or A, et al. Poster presentation at ACTRIMS 2022, P133
 
* Indication varies in different countries. Current website is a global information resource. Local Prescribing Information/ Summary of Product Characteristics approved by individual country’s regulatory authority is the primary source of information for the indication of siponimod in the individual country.

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.