• U ponad 50% nowo zdiagnozowanych pacjentów z RMS z potwierdzonym pogorszeniem niepełnosprawności (wcześniej nieleczonych innymi lekami), to PIRA jest wyłaniającym się punktem końcowym stosowanym do mierzenia nasilenia niepełnosprawności, niezależnie od aktywności związanej
  z rzutem. Wynik potwierdza wczesne występowanie postępu choroby
  u pacjentów chorujących na SM¹.

Ofatumumab to celowany, dokładnie dawkowany i dostarczany lek ukierunkowany na limfocyty B, który zapewnia elastyczność samodzielnego podawania przez osoby dorosłe z rzutową postacią stwardnienia rozsianego (RMS). Jest to w pełni ludzki przeciwciało monoklonalne (mAb) anty-CD20 podawane samodzielnie w postaci wstrzyknięcia podskórnego raz w miesiącu^2,3.Początkowe dawki ofatumumabu podaje się w tygodniach 0., 1. i 2., a pierwsze wstrzyknięcie wykonuje się pod nadzorem fachowego personelu medycznego. Jak wykazano w badaniach przedklinicznych, uważa się, że ofatumumab działa poprzez wiązanie się z epitopem na cząsteczce CD20, indukując silną lizę i deplecję limfocytów B⁴. Selektywny mechanizm działania i podskórne podawanie ofatumumabu umożliwiają precyzyjne dostarczanie do węzłów chłonnych, w których potrzebna jest redukcja liczby limfocytów B w przebiegu SM, a w badaniach przedklinicznych wykazano, że produkt ten może oszczędzać limfocyty B w śledzionie⁵.

Stwardnienie rozsiane jest przewlekłą chorobą zapalną ośrodkowego układu nerwowego, charakteryzującą się zniszczeniem mieliny i uszkodzeniem aksonów w mózgu, nerwach wzrokowych i rdzeniu kręgowym⁶. SM, które występuje u około 2,8 miliona osób na całym świecie⁷, można podzielić na cztery główne rodzaje: zespół klinicznie izolowany (CIS), postać rzutowo-remisyjna (RRMS), postać wtórnie postępująca (SPMS) i postać pierwotnie postępująca (PPMS)⁸. Różne postacie SM można odróżnić na podstawie tego, czy u pacjenta występują rzuty choroby (wyraźnie zdefiniowane ostre, zapalne napady pogorszenia funkcji neurologicznej) i/lub progresja uszkodzenia neurologicznego i niepełnosprawności od początku choroby⁶.

 

1. Kappos L, Montalban X, Coyle P, et al. Ofatumumab reduces disability progression independent of relapse activity in patients with relapsing multiple sclerosis. ePoster presentation at Virtual AAN Meeting; April 2021.
2. Multiple Sclerosis International Federation. Atlas of MS 2020-Mapping multiple sclerosis around the world. Available from: https://www.msif.org/wp-content/uploads/2020/10/Atlas-3rd-Edition-Epidemiology-report-EN-updated-30-9-20.pdf [Last accessed: March 2021].
3. Hauser S, Bar-Or A, Cohen J, et al. Ofatumumab versus teriflunomide in relapsing multiple sclerosis. N Engl J Med. 2020;383(6):546-557.
4. Hauser S, Bar-Or A, Cohen J, et al. Ofatumumab versus teriflunomide in relapsing multiple sclerosis: analysis of no evidence of disease activity (NEDA-3) from ASCLEPIOS I and II trials. Eur J Neurol. 2020;27(S1):85-86.
5. Bar-Or A, Fox E, Goodyear A, et al. Onset of B-cell depletion with subcutaneous administration of ofatumumab in relapsing multiple sclerosis: results from the APLIOS bioequivalence study. Poster presentation at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum; February 27-29, 2020; West Palm Beach, FL.
6. Smith P, Kakarieka A, Wallstroem E. Ofatumumab is a fully human anti-CD20 antibody achieving potent B-cell depletion through binding a distinct epitope. Poster presentation at: ECTRIMS; September 2016; London, UK.
7. Smith P, Huck C, Wegert V, et al. Low-dose, subcutaneous anti-CD20 therapy effectively depletes B-cells and ameliorates CNS autoimmunity. Poster presentation at: ECTRIMS; September 2016; London, UK.
8. Guthrie E. Multiple sclerosis: a primer and update. Adv Studies Pharm. 2007;4(11):313-317.

 

 

# # #

 

NR KLIRENS: PL2105132865 

 

Aneta Poznańska

Comms& Patient Engagement Head
Novartis Poland

+48 663 874 857

aneta.poznanska@novartis.com

 

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