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애브비, 'JAK저해제' 아토피 3상 “경쟁약물보다 우수” - 바이오스펙테이터

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애브비, 'JAK저해제' 아토피 3상 “경쟁약물보다 우수”

입력 2020-07-24 07:21 수정 2020-07-31 16:40

바이오스펙테이터 서윤석 기자

이 기사는 '프리미엄 뉴스서비스 BioS+' 기사입니다.
경구용 JAK 저해제 ‘린버크’..아토피피부염 임상서 가려움증, EASI75 지표 유의미하게 개선 1차ㆍ2차 종결점 충족

애브비(Abbvie)가 개발중인 JAK 저해제 '린버크'가 아토피피부염(atopic dermatitis) 임상 3상에서 가려움증(itch)과 피부증상(skin clearance)을 개선한 결과를 내놨다. 경쟁약물인 화이자의 '아브로시티닙(abrocitinib)'과 사노피/리제네론의 '듀피젠트(Dupixent, dupilumab)'보다 효과가 상대적으로 우수했다.

애브비는 21일(현지시간) JAK 저해제 ‘린버크(Rinvoq, upadacitinib)’ 단일요법(monotherapy)으로 진행한 아토피피부염 임상 3상(Measure Up2, NCT03607422)에서 가려움증과 피부증상을 유의미하게 개선하며 1차ㆍ2차 종결점을 충족시킨 긍정적인 결과를 발표했다. 린버크는 류마티스관절염 치료제로 미국 식품의약국(FDA)에서 2019년 승인된 약물이다.

발표에 따르면 애브비는 중등도에서 중증(moderate to severe) 아토피피부염 환자 801명을 대상으로 위약과 15mg, 30mg용량의 린버크를 투여해 임상을 진행했다. 애브비는 공동 1차 종결점으로 치료 16주차에 임상의의 전반적 평가(Investigator’s Global Assessment, IGA)를 통해 환자의 피부 염증이 거의(1) 또는 완전히 제거(0)됐는지 관찰했으며, ‘피부 염증이 75% 이상 개선됐음’을 의미하는 'EASI(Eczema Area and Severity Index) 75' 달성 비율을 평가했다. 2차 종결점으로는 가려움증 평가지표의 개선(Improvement in Worst Pruritus NRS≥4), 16주차 EASI75의 변동률 등을 설정해 린버크의 약효를 평가했다.

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