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Nowy niesteroidowy lek na łuszczycę w III fazie badań klinicznych

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Benvitimod to niesteroidowy lek, który wykazał w badaniach wysoki stopień bezpieczeństwa i skuteczność w miejscowym leczeniu objawów łuszczycy plackowatej. W Chinach właśnie zakończyła się III faza badań klinicznych nad tym lekiem.

Zespół naukowców pod kierownictwem prof. Jian-Zhong Zhanga z ośrodka Peking University People’s Hospital opracował nową metodę leczenia łuszczycy plackowatej. Wyniki badania opublikowano w czasopiśmie naukowym „Chinese Medical Journal”.

Obiecujące wyniki badań

W III fazie badań klinicznych nad skutecznością i bezpieczeństwem stosowania benvitimodu wzięli udział pacjenci z 23 ośrodków dermatologicznych w Chinach. Do badań zaangażowano 686 osób z lekką lub średnio zaawansowaną postacią łuszczycy plackowatej. Część pacjentów otrzymała krem z 1-procentową zawartością benvitimodu, natomiast pozostali byli leczeni za pomocą maści z kalcypotriolem (0,005%) lub otrzymywali placebo. Badania nad skutecznością leczenia trwały 12 tygodni.

Wyniki badań wykazały, że spośród pacjentów leczonych benvitimodem 50,4% uzyskało 75-procentowe lub większe ograniczenie rozległości i nasilenia objawów w porównaniu do stanu sprzed terapii. W przypadku leczenia kalcypotriolem podobne efekty zaobserwowano u 38,5% pacjentów. Oceny dokonano w skali PASI (ang. Psoriasis Area And Severity Index), która uwzględnia rozległość i nasilenie zmian skórnych.

W badaniach przeprowadzono również ewaluację wyników w skali PGA (ang. Physician’s Global Assessment). Jest to skala, w ramach której określa się średnie nasilenie objawów łuszczycy takich jak rumień, łuska i naciek. W statycznym wariancie skali, który został wykorzystany w testach klinicznych, oceny dokonuje się jednorazowo w momencie badania. 66,3% pacjentów, którzy otrzymywali benvitimod, uzyskało w skali wynik 0 lub 1 świadczący o łagodności objawów.

Wysoka tolerancja leku

Wyniki badań klinicznych wykazały również, że benvitimod jest dobrze tolerowany i nie powoduje systemowych skutków ubocznych. U części pacjentów obserwowano jedynie lekkie podrażnienie i świąd w miejscu aplikacji preparatu. Symptomy te w większości przypadków ustępowały samoczynnie.

Potrzebny zamiennik

Powszechną w leczeniu łuszczycy opcją terapeutyczną są stosowane miejscowo kortykosteroidy oraz analogi witaminy 3D. Stosowanie tych leków wiąże się jednak z poważnymi skutkami ubocznymi. W przypadku sterydów jest to m.in. atrofia skóry, hipo- oraz hiperpigmentacja, teleangiektazje oraz infekcje skórne. Pacjenci stosujący analogi witaminy D3 mogą natomiast wymagać dodatkowej regulacji gospodarki potasu i wapnia.

Z tego powodu udostępnienie pacjentom nowej opcji terapeutycznej to bardzo ważny krok naprzód w leczeniu łuszczycy.

20 lat badań

Jak wyjaśnia prof. Jian-Zhong Zhang, stworzenie nowej opcji terapeutycznej dla pacjentów z cukrzycą to efekt wieloletnich badań:

– Benvitimod to mała cząsteczka, którą po raz pierwszy wyizolowano ze szczepu bakterii Photorhabdus luminescens. Została zsyntetyzowana przez zespół prof. Genhui Chena z Beijing Wenfeng Tianji Pharma. Badania nad mechanizmem działania cząsteczki, formułą leku oraz jego efektywnością i bezpieczeństwem w terapii łuszczycy zajęły ponad 20 lat.

Prof. Jian-Zhong Zhang podkreśla, że wyniki badań klinicznych są bardzo obiecujące. Benvitimod wkrótce będzie mógł wkrótce zostać wprowadzony w Chinach do użytku jako nowa opcja terapeutyczna w leczeniu łuszczycy plackowatej.

Autorzy projektu mają nadzieję, że w dalszej perspektywie możliwe będzie wprowadzenie go do użytku na całym świecie.

Źródło: eurekalert.org

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