ECTRIMS 2022 focuses on the latest research advances in Sinimod

Multiple sclerosis (MS) is a severe, lifelong, progressive inflammatory demyelinating disease of the central nervous system characterized by
recurrent acute relapses and remissions.
Among MS patients, 85% are initially diagnosed with relapsing-remitting MS (RRMS).

As the disease progresses, approximately 60% of RRMS patients may develop secondary progressive MS (SPMS)
within 20 years.
Progressive motor dysfunction and cognitive decline are typical features of SPMS and can seriously affect the quality of life of
patients.

Disease-modifying therapy (DMT) is the standard of care for MS remission, which can effectively reduce the annual recurrence rate, delay the natural progression of the disease and improve the prognosis
of patients.
Cenimod is the world's first oral DMT drug
that can achieve nerve repair and delay the progression of disability for progressive relapsed MS (RMS).
At present, it has been approved for marketing
in many countries/regions.
At the 38th Annual Meeting of the European Commission for Multiple Sclerosis Treatment and Research (ECTRIMS) in 2022, several new studies
on siponimod were unveiled.
The results of the study showed that siponimod could stabilize the progression of disability in patients with SPMS and had high satisfaction with treatment.
In addition, patients with progressive MS who switched to siponimod experienced improvements
in disability, cognitive function, and treatment satisfaction.
Next, let's review the highlights of this conference
.

Stable EDSS scores for 2 years in patients treated with siponimod in SPMS – an analysis from Novartis' Globally Managed Drug Supply Program

• The results of the study showed that 91% of the patients for whom data were available remained stable or improved
  in their EDSS scores at 24 months.
  EDSS scores appear to be more variable in the active group, while the non-active group tends to remain stable (Figure 1).
  
  
  

Figure 1 Changes in EDSS status relative to baseline over time

• Regardless of disease status at baseline, patients also had very low rates of progression as assessed as 6 months of confirmed disability progression (CDP) (Figure 2).
  
  
  

  Fig.
  2 Kaplan-Meier analysis of time to 6 months CDP based on baseline MS disease status

  
  

• Annual recurrence rate (ARR) remained low over 24 months (0.
  023 for the overall cohort; 0.
  031 for the active group; 0.
  009 for the non-active group; 0.
  024 for the unknown group).
  
  

  
  

Disability progression remained stable and satisfaction was high in patients with active SPMS after 12 months of treatment with siponimod – AMASIA real-world study

The AMASIA study is a long-term, non-interventionive, real-world study conducted in Germany that for the first time analyzed the long-term efficacy and safety of siponimod and its impact
on quality of life and socioeconomic status.
The AMASIA study followed 1200 patients with active SPMS treated with siponimod for 3 years, with follow-up every 6 months
.
Disability progression and treatment satisfaction
were assessed by EDSS and the Medication Satisfaction Questionnaire (TSQM), respectively.
Subgroup analyses were performed
according to age, time from diagnosis to enrollment, and intermediate-potency DMT drugs used prior to enrollment.

• The results of the study showed that EDSS remained stable
  during the first 12 months of taking siponimod regardless of patient age, time from diagnosis to enrollment (Figure 3), and DMT drugs used prior to enrollment (intermediate-potency DMT therapy) (Figure 4).
  
  

Fig.
3 By patient age (≤ 50 years vs.
>50 years old) and time from diagnosis to enrollment (≤10 years vs.
EDSS scores at baseline (BL) and 12 months later (12M) were divided >10 years).

Figure 4 EDSS scores at baseline (BL) and 12 months later (12M) by type of last treatment before the study

• Regardless of the previous intermediate-potency DMT treatment, "effectiveness," "convenience," and "overall satisfaction" were high on TSQM scores after 12 months of siponimod (Figure 5).
  
  

Fig.
5 TSQM scores of "effectiveness", "convenience" and "overall satisfaction" after 12 months of use of siponimod (grouped by DMT drugs used before enrollment)

Patients with progressive MS who switched to siponimod improved disability, cognitive function, and treatment satisfaction – EXCHANGE interim results

• The results of the study showed an improvement in PDDS from baseline to day 168 (Figure 6).
  
  At baseline, 20.
  3% of patients were classified as normal; By day 168, 23.
  0% of patients were classified as normal
  .
  
  

• In terms of cognitive processing speed, the mean PST scores on days 84 and 168 improved compared to baseline (PST scores 40.
  0 at baseline; 43.
  1 at day 84; 46.
  0 at day 168, respectively) (Figure 7A).
  
  Compared to baseline, the mean number of correct numbers (SD) recorded at day 84 increased by 1.
  9 (14.
  2) and the mean number of correct numbers (SD) recorded on day 168 increased by 5.
  8 (13.
  6) (Figure 7B).