Amerykańska Agencja ds. Żywności i Leków (FDA) zatwierdziła dwa doustne leki w leczeniu atopowego zapalenia skóry: Rinvoq (upadacytynib; AbbVie) oraz Cibinqo (abrocitinib; Pfizer). Obydwa preparaty są inhibitorami kinaz janusowych JAK-1 i mogą być stosowane w leczeniu umiarkowanego do ciężkiego przebiegu atopowego zapalenia skóry (AZS).
Rinvoq i Cibinqo są pierwszymi doustnymi inhibitorami kinaz janusowych (JAK) dostępnymi w Stanach Zjednoczonych do leczenia AZS. Zdaniem prof. Emmy Guttman-Yassky, z w Icahn School Medicine w Mount Sinai w Nowym Jorku, to wielka wiadomość, ponieważ od kilku lat w USA nie było żadnej terapii ogólnoustrojowej w leczeniu AZS, która byłaby bezpieczniejsza niż klasyczne immunosupresanty, takie jak cyklosporyna i metotreksat.
Rinvoq może być stosowany u dorosłych i dzieci od 12. roku życia
Terapia upadacytynibem skierowana jest do pacjentów w wieku od 12 lat z umiarkowanym i ciężkim przebiegiem AZS, którzy są oporni na inne metody leczenia. Preparat został zatwierdzony w dwóch mocach dawek – 15 mg i 30 mg.
Badanie dotyczące bezpieczeństwa i skuteczności Rinvoqu zostały przeprowadzone w trzech etapach z udziałem ponad 2,5 tys. pacjentów w wieku od 12 lat i starszych z umiarkowanym lub ciężkim przebiegiem atopowego zapalenia skóry. Około 52 proc. uczestników było wcześniej poddanych leczeniu układowemu. Pacjenci otrzymywali raz dziennie doustną tabletkę Rinvoqu w dawce 15 mg lub 30 mg. Po 16. tygodniu badania eksperci zauważyli odpowiedź kliniczną na leczenie, m.in. ustępowanie zmian skórnych i świądu. We wszystkich trzech etapach badania zaobserwowano znaczną poprawę w zakresie świądu już po pierwszym tygodniu leczenia. Badanie wykazało również, że lek jest na ogół bezpieczny. Niepożądane objawy najczęściej dotyczyły wyprysku opryszczkowego lub wykwitu ospowego Kaposiego. Rinvoq może również powodować inne skutki uboczne, np.:
- osłabienie odporności organizmu i jego zdolności do zwalczania infekcji;
- zwiększone ryzyko zgonu u osób w wieku 50 lat i starszych z co najmniej jednym czynnikiem wystąpienia chorób sercowo-naczyniowych;
- zwiększenie ryzyka wystąpienia niektórych nowotworów np. chłoniaka, skóry, płuc (zwłaszcza u osób palących);
- zwiększenie ryzyka poważnych zdarzeń sercowo-naczyniowych, takich jak zawał serca, zgon, szczególnie u osób w wieku 50 lat i starszych z co najmniej jednym czynnikiem ryzyka wystąpienia chorób serca, a także obecnych i byłych palaczy;
- zakrzepy krwi w żyłach kończyn dolnych, płucach lub tętnicach, zwłaszcza u osób powyżej 50. roku życia.
Leku Rinvoq nie należy przyjmować w przypadku uczulenia na upadacytynib lub któregokolwiek ze składników leku, a także w przypadku czynnej infekcji.
Cibinqo znacznie łagodzi i ogranicza zmiany skórne oraz świąd
Cibinqo przeznaczony jest do leczenia osób dorosłych z opornym na leczenie, umiarkowanym do ciężkiego atopowego zapalenia skóry. Lek został zatwierdzony w dwóch dawkach – 100 mg i 200 mg.
W trzyetapowym badaniu klinicznym udział wzięło 1,6 tys. pacjentów. We wszystkich analizach Cibinqo wykazał spójny profil bezpieczeństwa oraz znaczną skuteczność w łagodzeniu i ograniczaniu zmian skórnych oraz świądu. Już po dwóch tygodniach obserwowano zmniejszenia nasilenia swędzenia. Najczęstsze niepożądane działania leku dotyczyły zapalenia nosogardzieli, nudności, bólu głowy. Producenci podkreślają również możliwość wystąpienia niektórych skutków ubocznych, m.in.:
- zwiększonego ryzyka wystąpienia poważnych infekcji (opryszczka, półpasiec, zapalenie płuc);
- zwiększonego ryzyka śmiertelności u osób powyżej 50. roku życia z co najmniej jednym czynnikiem ryzyka chorób sercowo-naczyniowych;
- zwiększonego ryzyka zachorowania na nowotwór złośliwy chłoniaka, skóry, raka płuc (zwłaszcza u obecnych lub byłych palaczy);
- zdarzeń sercowo-naczyniowych, szczególnie u osób powyżej 50. roku życia z co najmniej jednym czynnikiem wystąpienia chorób sercowo-naczyniowych;
Cibinqo nie należy stosować w przypadku aktywnej infekcji lub alergii na którykolwiek ze składników leku.
Źródła: Pfizer, AbbVie, Medscape
Przeczytaj także: Upadacitinib skuteczny w leczeniu atopowego zapalenia skóry
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