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Artikel | Neurologi

BE READY FOR THE UNEXPECTED FOR YOUR PATIENTS WITH RMS, CONSIDER PONVORY® (ponesimod)

Offer your patients with relapsing forms of multiple sclerosis (RMS) a treatment option with a combination of superior efficacy (vs. teriflunomide 14mg; p<0.001) and agility to adapt to changing clinical circumstances.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 features1.

Superior efficacy head-to-head versus teriflunomide 14mg (p<0.001)1-3

PONVORY® is the first S1PR modulator to demonstrate significantly superior efficacy (p<0.001) versus an active oral comparator, teriflunomide 14mg, over 2 years in a large (N=1,133) head-to-head Phase III study in adult patients with active RMS.*1,2 

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

  • Primary endpoint: 30.5% reduction in annualised relapse rate (ARR) (rate ratio 0.695 99% CLs: 0.536, 0.902, p<0.001)*

  • Secondary endpoints: 56% relative reduction in combined unique active lesions (CUALs) on MRI (rate ratio: 0.444 [95% CLs: 0.364, 0.542, p<0.001]) and similar rates of 12-week confirmed disability accumulation (CDA) (95% CL: -18%, 42%, p=0.29 [non-significant])

  • Exploratory endpoint: Similar rates of 24-week CDA (95% CL: -24%, 43%, p=0.37 [non-significant])

CLICK HERE TO LEARN MORE ABOUT THE OPTIMUM STUDY

PONVORY® gives you the agility to help you adapt to changing clinical circumstances.1

Lymphocyte levels returned to the normal range in >90% of healthy patients within 1 to 2 weeks of stopping therapy.ll1 PONVORY® leaves the body naturally in 7 days, so family planning can start just 1 week after stopping therapy.1

In case of infection or discontinuation of treatment, PONVORY® can be paused and resumed when clinically needed§ so you can plan around your patients’ changing clinical circumstances.1

Once-daily, oral PONVORY® can be initiated at home for most patients.¶1

Onboard with convenience using the 14-day treatment initiation pack, designed to simplify titration. Dose titration is required for initiation of treatment with PONVORY® to mitigate first-dose effects.2

Recommended dose titration:1

Refer to the SmPC for further details including when cardiologist advice should be obtained before initiation of PONVORY®.

In the event that a patient misses a dose during initiation or maintenance:1

  • <4 consecutive doses are missed, resume treatment with the first missed dose1

  • ≥4 consecutive doses are missed, reinitiate Day 1 of the dose titration (new treatment initiation pack)1

The same first-dose observation for treatment initiation is recommended when ≥4 consecutive doses are missed in patients with pre-existing cardiac conditions.1


Choose PONVORY® early for consistent, agile management – so that you and your patients could prepare for the unexpected.1,2
 


 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; RMS, relapsing multiple sclerosis; S1PR, sphingosine-1-phosphate receptor.

*ARR was defined as the number of confirmed relapses per year up to EOS. Mean ARRs=0.202 for PONVORY® 20mg versus 0.290 for teriflunomide 14mg, 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® 20mg versus 3.164 for teriflunomide 14mg, 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.1,212-week CDA=10.8% for PONVORY® 20mg versus 13.2% for teriflunomide 14mg 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® 20mg versus 10.5% for teriflunomide 14mg up to EOS (95% CL: -24%, 43%, p=0.37).1,2

§Severe exacerbations of disease, including disease rebound, have, in rare instances, been reported after discontinuation of an S1PR modulator. Patients should be observed for a severe exacerbation or return of high disease activity upon PONVORY® discontinuation and appropriate treatment should be instituted, as required.1

PONVORY® causes a reversible, dose-dependent reduction in peripheral lymphocyte levels. PONVORY® may therefore increase the risk of infections. Monitoring for signs and symptoms of infection should be continued for 1 to 2 weeks after PONVORY® is discontinued.1

4-hour first-dose observation is recommended for patients with sinus bradycardia, first- or second-degree AV blocks, Mobitz type I (Wenckebach), or a history of myocardial infarction or heart failure occurring more than 6 months prior to treatment initiation and in a stable condition.1

 


 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. ATC-kod: 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, varningar och försiktighet, fertilitet/graviditet/amning, äldre vaccination, biverkningar, dosering och pris se www.fass.se.

Datum för senaste översyn av produktresumén 2022/05.
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. AUBAGIO® (teriflunomide) Summary of Product Characteristics. Available at: https://www.fass.se/LIF/product?userType=2&nplId=20120228000034. Last updated: 2021/07.

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© Janssen Pharmaceutica NV 2022. All Rights Reserved.

Date of preparation: September 2022, CP-322297


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