| Prescribing informationPONVORY® (ponesimod) ( This product is under additional monitoring)

PONVORY® is the first S1PR modulator that delivered superior efficacy for patients with active RMS versus an established oral comparator, teriflunomide, in a large Phase III study over 2 years1,2

PRIMARY ENDPOINT1,2

• 30.5% Relative Reduction in ARR

SECONDARY ENDPOINTS1,2

• 56% Relative Reduction in CUALs on MRI

• Similar Rates of Disability Accumulation*

EXPLORATORY ENDPOINTS2,3

• 27% Relative Reduction in Brain Volume Loss

• Improved NEDA-3 & NEDA-4 Status

*These differences were not statistically significant.1

Annualised relapse rates (ARR)

PRIMARY ENDPOINT: CONFIRMED ARR up to EOS
ARRs

Adapted from Kappos et al. 2021

PONVORY® achieved a nearly one-third greater reduction in annualised relapse rates vs teriflunomide1,2*

PONVORY® demonstrated a 30.5% relative reduction* in ARRcompared to teriflunomide up to EOS, p<0.0011,2

*Mean ARR=0.202 for PONVORY® 20 mg versus 0.290 for teriflunomide 14 mg, rate ratio: 0.695 (99% CL: 0.536, 0.902, p<0.001).1,2
ARR was defined as the number of confirmed relapses per year up to EOS.1

Combined unique active lesions (CUALs)

SECONDARY ENDPOINT: CUALs
CUALs

Adapted from Kappos et al. 2021

PONVORY® more than halved the number of combined unique active lesions per year vs teriflunomide1,2*

PONVORY® demonstrated a 56% relative reduction* in the number of new or enlarging CUALs on brain MRI compared to teriflunomide from baseline to Week 108, p<0.0011,2

*Mean CUALs per year=1.405 for PONVORY® 20 mg versus 3.164 for teriflunomide 14 mg, rate ratio: 0.444 (95% CL: 0.364, 0.542, p<0.001).1,2
CUALs were defined as new gadolinium-enhancing (Gd+) T1 lesions plus new or enlarging T2 lesions per year from baseline up to EOS.1

Confirmed disability accumulation (CDA)

SECONDARY ENDPOINT:
TIME TO 12-WEEK CDA
time to 12-week CDA
EXPLORATORY ENDPOINT:
TIME TO 24-WEEK CDA
time to 24week CDA

Adapted from Kappos et al. 2021

PONVORY® demonstrated a comparable impact on confirmed disability accumulation to teriflunomide1-3*

No significant difference on 12- or 24-week confirmed disability accumulation was observed between PONVORY® and teriflunomide at Week 1081-3*†

*12-week CDA=10.8% for PONVORY® 20 mg versus 13.2% for teriflunomide 14 mg up to EOS (95% CL: -18%, 42%, p=0.29). The risk of 12-week CDA was not different in the 2 groups, and the formal testing procedure stopped, rendering the subsequent analyses exploratory. 24-week CDA=8.7% for PONVORY® 20 mg versus 10.5% for teriflunomide 14 mg up to EOS (95% CL: -24%, 43%, p=0.37).2,3
CDA was defined as time to 12-Week/24-Week CDA from baseline to EOS. A CDA was defined as an increase of at least 1.5 in EDSS for subjects with a baseline EDSS score of 0 or an increase of at least 1.0 in EDSS for subjects with a baseline EDSS score of 1.0 to 5.0, or an increase of at least 0.5 in EDSS for subjects with a baseline EDSS score ≥5.5 which was confirmed after 12 or 24 weeks, respectively.1

Brain volume loss (BVL)

EXPLORATORY ENDPOINT: BVL
BVL

Adapted from Kappos et al. 2021

PONVORY® significantly reduced brain volume loss vs teriflunomide2,3*

In an exploratory analysis, PONVORY® demonstrated a 27% relative reduction* in brain volume vs teriflunomide at EOS, nominal p<0.00012,3

*The least squares (LS) mean percent change from baseline to Week 108 was -0.91% in the PONVORY® 20 mg group (n=436) and -1.25% in the teriflunomide 14 mg group (n=434). Mean difference was 0.34% (95% CL: 0.17, 0.50, p<0.0001). The percentage change was measured using the Structural Image Evaluation, using Normalisation, of Atrophy (SIENA) methodology.2

No evidence of disease activity (NEDA-3 & NEDA-4)

EXPLORATORY ENDPOINTS: NEDA-3 & NEDA-4
NEDA

Adapted from Kappos et al. 2021

A greater proportion of patients receiving PONVORY® achieved NEDA-3* & NEDA-4† status vs teriflunomide2

In an exploratory analysis, PONVORY® improved NEDA-3 (p<0.001)* and NEDA-4 (p=0.003) status compared to teriflunomide at Week 1082

*NEDA-3 odds ratio: 1.70 (95% CL: 1.27, 2.28, p<0.001). NEDA-3 status was defined by a composite of no relapse, no 12-week CDA, and no Gd+ T1 or new or enlarging T2 lesions from baseline to EOS.2
NEDA-4 odds ratio: 1.85 (95% CL: 1.24, 2.76, p=0.003). NEDA-4 status was defined by a composite of NEDA-3 and no brain volume decrease of ≥0.4% from baseline to EOS.2

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CL=confidence limit; EDSS=expanded disability status scale; EOS=end of study; MRI=magnetic resonance imaging; NEDA=no evidence of disease activity; RMS=relapsing multiple sclerosis; S1PR=sphinogosine-1-phosphate receptor


  1. Ponvory Summary of Product Characteristics Available at: www.medicines.ie
  2. Kappos L, et al. Ponesimod Compared With Teriflunomide in Patients With Relapsing Multiple Sclerosis in the Active-Comparator Phase 3 OPTIMUM Study: A Randomized Clinical Trial. JAMA Neurol. 2021;78(5):558-567. doi:10.1001/jamaneurol.2021.0405.
  3. Kappos L, et al. Supplement 1. Ponesimod Compared With Teriflunomide in Patients With Relapsing Multiple Sclerosis in the Active-Comparator Phase 3 OPTIMUM Study: A Randomized Clinical Trial. JAMA Neurol. 2021. doi:10.1001/jamaneurol.2021.0405.