Artikel | Neurologi

PONVORY® (ponesimod): an S1PR modulator that offers efficacy, convenience and flexibility to take on RMS (1,2)


Janssen-Cilag AB
Innehållet är framtaget av: Janssen-Cilag AB

Relapsing multiple sclerosis (RMS) is a disease with a heterogenous and unpredictable disease course, patients with MS have preferences influenced by everyday-related factors which can evolve over time.3 PONVORY® could offer your patients efficacy, convenience and flexibility to help reduce relapses.1-3 

 

PONVORY® (ponesimod) is a disease modifying therapy (DMT) indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.1  

Proven efficacy for you and your patients

 

PONVORY® is the first oral DMT studied against an established oral comparator in the OPTIMUM study.1,2 

 

The OPTIMUM study was a large (n=1133) Phase III, multicentre, double-blind, active comparator (teriflunomide), superiority, randomised study over 2 years.1,2,4,5  

 

The key efficacy outcomes from the OPTIMUM study were:1,2 

  • Primary endpoint: 30.5% reduction in annualised relapse rate (ARR)* (p<0.001) 

Primary endpoint: annualised relapse rates (ARRs) up to end of study (EOS)1,2

Bild1

Adapted from Kappos et al. 2021 

  • Secondary endpoints: 56% relative reduction in combined unique active lesions (CUALs) on MRI (p<0.001) and similar rates of confirmed disability accumulation (CDA) ( non-significant, p=0.29, p=0.37) 

Secondary endpoint: combined unique active lesions (CUALS)1,2 

secondary-endpointAdapted from Kappos et al. 2021  

Secondary and exploratory endpoint: time to 12- and 24-week confirmed
disability accumulation (CDA)
1,2,3,4 

jan 4

Adapted from Kappos et al. 2021 

To find out more about the OPTIMUM study, visit the Janssen Medical Cloud » 

Convenience and flexibility that may help to manage the unexpected 

 

Using PONVORY® as a first-line therapy for DMT-naïve patients and for patients switching from another DMT can provide flexibility to respond to your patients’ changing needs.1,2 

ponvory torsdag

PONVORY® is S1P1-receptor selective for targeted disease-modifying activity1

 

PONVORY® is an orally active, highly selective, and reversible modulator of the S1P1 receptor designed to target S1P1 receptors, blocking the capacity of lymphocytes to egress from lymph nodes and reducing the number of lymphocytes in peripheral blood.1 

The safety and tolerability profile of PONVORY® has been established in the large (n=1133) Phase III OPTIMUM study 1,2

 

The safety results for PONVORY® from the OPTIMUM study were in line with previous observations in its Phase II dose-finding study and the known profile of other S1PR modulators.2

 

Overall, the proportion of patients experiencing at least 1 treatment emergent adverse event (TEAE) or severe adverse event (SAE) was similar between the 2 treatment groups.2  The majority of TEAEs were mild to moderate and did not result in treatment discontinuation.2


 Footnotes

 ARR, annualised relapse rate; AV, atrioventricular; CDA, confirmed disability accumulation; CL, confidence limit; CUAL, combined unique active lesions; DMT, disease modifying therapy; EDSS, expanded disability status scale; EOS, end of study; MRI, magnetic resonance imaging; MS, multiple sclerosis; RMS, relapsing multiple sclerosis; S1P1, sphingosine-1-phosphate subtype 1; S1PR, sphingosine-1-phosphate receptor; SAE, severe adverse event; TEAE, treatment emergent adverse event. 

 

*ARR was defined as the number of confirmed relapses per year up to EOS. Mean ARRs=0.202 for PONVORY® 20 mg versus 0.290 for teriflunomide 14 mg, rate ratio 0.695 (99% CLs: 0.536, 0.902, 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. Mean CUALs per year=1.405 for PONVORY® 20 mg versus 3.164 for teriflunomide 14 mg, rate ratio: 0.444 (95% CLs: 0.364, 0.542, p<0.001.)1,2

CDA was defined as time to 12-week/24-week CDA from baseline to EOS. 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.1,2 12-week CDA=10.8% for PONVORY® 20 mg versus 13.2% for teriflunomide 14 mg up to EOS (95% CL: -18%, 42%, p=0.29.1,2 The risk of 12-week CDA was not different in the 2 groups, and the formal testing procedure stopped, rendering the subsequent analyses exploratory.2 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).1,2


PONVORY® (ponesimod) 

 

Detta läkemedel är föremål för utökad övervakning.  

 

Immunsuppressiva medel. Filmdragerad tablett: 2, 3, 4, 5, 6, 7, 8, 9, 10 och 20 mg. ATCkod: L04AA50, Rx, F. 

 

Indikation: avsett för behandling av vuxna patienter med skovvis förlöpande multipel skleros (RMS) med aktiv sjukdom som definierats kliniskt eller med bilddiagnostik.  

 

Kontraindikationer: Överkänslighet mot den aktiva substansen. Immunbristsyndrom. Patienter som under de senaste 6 månaderna har haft hjärtinfarkt, instabil angina, stroke, transitorisk ischemisk attack (TIA), dekompenserad hjärtsvikt med sjukhusinläggning eller NYHA klass III / IV hjärtsvikt under de senaste 6 månaderna.  Mobitz typ II AV block grad III eller sjuk sinusknuta, om inte patienten har en fungerande pacemaker. Svåra aktiva infektioner, aktiva kroniska infektioner. Aktiva maligniteter. Måttligt eller gravt nedsatt leverfunktion (Child-Pugh B och C). Under graviditet och till fertila kvinnor som inte använder effektiva preventivmedel.Varningar och försiktighet: Innan behandling genomför ett elektrokardiogram (EKG) på alla patienter. Hos patienter med vissa befintliga kardiologiska tillstånd rekommenderas första dosövervakning av minst 4 timmar. Övervaka patienter för infektioner och nedsatt leverfunktion. Använd inte under amning. Interaktioner:Försiktighet bör iakttas vid samtidig administrering av antineoplastiska, andra immunmodulerande och immunsuppressiva läkemedel samt betablockerare. Samtidig användning av levande försvagade vacciner bör undvikas i upp till 1 vecka efter utsättande.   

 

För fullständig produktinformation och pris se www.fass.se. 

Datum för senaste översyn av produktresumén 2021/05.  
Janssen-Cilag AB, Box 4042, SE-169 04 Solna, Sweden. Tel +46 8 626 50 00, Fax +46 8 626 51 00, www.janssen.com/sweden. 


References 

  1. PONVORY® (ponesimod) Summary of Product Characteristics. Available at: www.fass.se.
  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 Neurology. 2021;78(5):558-567. doi:10.1001/jamaneurol.2021.0405.
  3. Mortensen GL, Rasmussen PV. The impact of quality of life on treatment preferences in multiple sclerosis patients. Patient Preference and Adherence. 2017;11:1789–1796.
  4. Kappos L, et .al. Supplement 1. Ponesimod compared with teriflunomide in patients with relapsing multiple sclerosis in the active-comparator phase 3
  5. optimum study: a randomized clinical trial. JAMA Neurology. 2021;doi:10.1001/jamaneurol.2021.0405:1-32.
  6. AUBAGIO® (teriflunomide) Summary of Product Characteristics. Available at: www.fass.se.

 

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© Janssen Pharmaceutica NV 2022. All Rights Reserved.

Date of preparation: March 2022 / CP-275744