Adverse events reporting | 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 |
EXPLORATORY ENDPOINTS2,3 | • 27% Relative Reduction in Brain Volume Loss |
*These differences were not statistically significant.1
Annualised relapse rates (ARR)
PRIMARY ENDPOINT: CONFIRMED ARR up to EOS
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 ARR† compared 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
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
EXPLORATORY ENDPOINT:
TIME TO 24-WEEK 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
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
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
References
- Ponvory Summary of Product Characteristics Available at: www.medicines.ie
- 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.
- 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.
