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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 韓 임상3상 결과로 살펴본 코오롱 '인보사케이' 효과는? - 바이오스펙테이터

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韓 임상3상 결과로 살펴본 코오롱 '인보사케이' 효과는?

입력 2017-07-13 15:12 수정 2017-07-13 15:12

바이오스펙테이터 이은아 기자

1차, 2차 평가변수, “운동성 개선, 통증완화, 증상개선” 입증

지난 12일 식품의약품안전처로부터 시판 허가를 받은 코오롱생명과학의 '인보사케이'는 어떤 효과가 있는 것일까. 국내 최초의 유전자치료제이자 골관절염 질환에서는 세계 최초의 유전자치료제인 인사보케이의 효능을 한국에서 진행한 임상3상 결과를 통해 살펴봤다.

코오롱생명과학에 따르면 인보사케이의 안전성과 효능을 확인하기 위해 시행된 한국 임상3상은 인보사케이 투여군 78명과 대조군(생리식염수) 78명을 대상으로 무작위, 위약 대조, 이중맹검 시험을 진행했다.

인보사케이를 무릎 관절강에 한 번만 주사투여해도 1년간 추적 조사한 결과 퇴행성관절염 환자에서 IKDC(통증, 기능성, 그리고 스포츠 활동에 대한 평가지수), VAS(통증 평가변수), OMERACT-OARSI(증상개선평가) 등 에서 플라시보 대조군에 비해 통계적으로 유의미하게 뛰어난 것으로 확인됐다.

▲출처 : 코오롱생명과학 20170515 IR 자료

1차 평가변수인 IKDC와 VAS 모두 인보사케이 투여군에서 유의미한 호전을 관찰했다. 투여전, 1개월, 3개월, 6개월, 9개월, 12개월까지 인보사케이 투여군의 운동성을 평가한 IKDC 점수는 40.3, 42.9, 48.9, 53.2, 53.6, 55.4로 점차적으로 점수가 향상했다. 대조군의 IKDC 점수(39.6, 42.9, 45.2, 46.5, 47.1, 44.6)와 비교해보면 인보사케이 투여 후 6개월 만에 점수 차이가 통계적으로 유의미하게 커졌다. IKDC 점수의 기준선(baseline)과의 차이도 6개월(12.9 vs 6.9)후부터 인보사케이 투여군이 대조군에 비해 유리하게 나타났으며 9개월(13.3 vs 7.5), 12개월(15.1 vs 5.0)까지 연장되면서 운동성이 개선됐다.

인보사케이 투여군은 통증 평가변수인 VAS 점수에서도 대조군에 비해 6개월, 9개월, 12개월 경과 후 유의미하게 낮으며 통증완화 효과를 보였다. (인보사케이 투여군: 60, 47.3, 42.8, 37.7, 36.6, 35.5 vs. 플라시보 대조군: 62.3, 48.3, 49.6, 47.8, 49.1, 52.0). 인보사케이 투여군과 대조군과의 기준점으로부터 VAS 점수 차이는 6개월(-22.3 vs-14.6), 9개월(-23.4 vs -13.3), 12개월(-24.5 vs -10.3)을 보이며 통증완화 효과를 확인했다.

2차 평가변수로 확인한 증상개선평가를 나타내는 OMERACT-OARSI 반응률 역시 인보사케이 투여군이 대조군에 비해 높았다. 6개월(70% vs 52%, p=0.02), 9개월(77% vs 52%, p=0.0011), 12개월(84% vs 45%, 0.001).

이번 임상시험은 서울대병원, 서울아산병원, 삼성서울병원, 인하대병원, 울산대병원, 경북대병원, 이화여대 목동병원, 전북대병원, 한양대병원, 서울성모병원, 충북대병원, 인제대 백병원 등 전국 12개 병원에서 수행했다.

한편 식약처는 인보사케이를 3개월 이상의 약물 또는 물리치료 등에도 불구하고 통증 증상이 지속되는 중등도 무릎 골관절염(Kellgren & Lawrence grade 3)의 치료제로 허가했다. 인보사케이는 정상 연골세포와 TGF-β1(Transforming Growth Factor-beta1) 유전자를 레트로바이러스로 도입한 형질전환 연골세포를 3:1의 비율로 혼합한 동종 세포치료제로 환자의 무릎 관절강에 단회 투여만으로 활동성 개선과 통증을 완화시킨다.

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