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348 Warning: mysql_real_escape_string(): Access denied for user 'et1ssh96'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30 Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30 Warning: mysql_query(): Access denied for user 'et1ssh96'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 530 Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 530 Warning: mysql_fetch_array() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 531 애브비, 건선치료제 '리산키주맙' 신규환자서 동일효과 입증 - 바이오스펙테이터

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애브비, 건선치료제 '리산키주맙' 신규환자서 동일효과 입증

입력 2018-09-14 15:38 수정 2018-09-14 15:38

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중등도 및 중증 판상형 건선 성인 신규환자 대상 '리산키주맙' 3개의 임상 3상 모두 개선효과 입증

애브비(AbbVie)의 건선치료제 리산키주맙(Risankizumab)이 신약 승인에 한발짝 더 다가섰다. 애브비는 중등도 및 중증 판상형 건선(Plaque Psoriasis) 성인 환자를 대상으로 IL-23 저해제 리산키주맙으로 치료한 3개의 임상3상 통합 분석(pooled analysis)결과, 신규 환자들에게서도 개선효과를 입증했다고 13일 발표했다.

이번 발표된 3개의 임상 3상 중 ultIMMa-1(참여 환자 총 500명), ultIMMa-2(참여 환자 총 500명) 임상에서는 리산키주맙을 스텔라라(Stelara®, 성분명: Ustekinumab) 및 위약과 비교했다. 16주차에 통증, 발적, 가려움을 평가한 건선 증상 점수(psoriasis symptom scale, PSS)를 확인한 결과, 스텔라라나 위약보다 리산키주맙을 투여받은 다수의 환자 평가 점수가 0(깨끗함)으로 나타났다. 건선 증상이 개선되었다는 것이다. 스텔라라와 비교한 52주차 역시 리산키주맙을 투여받은 다수의 환자 점수가 0으로 확인됐다.

또다른 임상 3상 IMMvent(참여 환자 605명)에서는 피부질환-삶의 질 영향 평가 설문 지수(Dermatology Life Quality Index, DLQI)로 리산키주맙을 휴미라(Humira®, 성분명: Adalimumab)와 비교했다. 리산키주맙을 투여받은 환자는 16주차에 건선이 더 이상 삶의 질에 영향을 미치지 않는다고 평가했으며, 44주까지 이 결과가 유지되는 것을 확인했다. 또한 리산키주맙을 투여받은 환자는 ‘환자의 불안이나 공포 대상을 파악해 정신상태를 평가하는 HAD 척도’(Hospital Anxiety and Depression Scales, HADS), ‘작업 생산성을 평가하는 작업 한계 설문’(Work Limitation Questionnaire, WLQ)에서도 향상된 점수가 확인됐다.

애브비는 결과적으로 3개의 임상 모두에서 리산키주맙으로 치료받은 환자는 건강관련 삶의 질, 정신건강, 작업 생산성이 유의미하게 향상하는 것을 확인했다고 강조했다.

자세한 임상시험 결과는 이번 달 12일부터 16일까지 프랑스 파리에서 열리는 제 27회 유럽 피부과학회(European Academy of Dermatology and Venerology, EADV)에서 발표될 예정이다.

한편, 애브비는 지난해 10월, 3개의 임상 3상(ultIMMa-1, ultIMMa-2, IMMvent)에서 나온 긍정적인 결과를 발표한 바 있으며, ultIMMa-1, ultIMMa-2에서 나온 리산키주맙의 효과와 안전성 결과는 지난 8월 The Lancet에 게재하기도 했다.

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