statement
The 300mg low-dose group showed no maintenance effect: patients falling below ACR20 were 3 of 40 (7.5%) in 600mg, 9 of 36 (25.0%) in 300mg, and 10 of 41 (24.4%) in placebo, meaning the low-dose group was effectively without efficacy.
A statement by 현대차증권 제약/바이오/의료기기 김현석. Statements are as reported by the cited publishers — not verified by DecisionGateway.
600mg 40명 중 3명(7.5%), 300mg 36명 중 9명(25.0%), 위약군 41명 중 10명(24.4%)로 300mg 저용량군과 위약군의 차이가 없어 사실상 저용량군은 유효성이 없는 수준
Related claims
The 600mg continuous dosing group recorded an ACR20 value of 92.5%, demonstrating excellent efficacy in absolute terms.report author · statementIn the 600mg high-dose maintenance group, the ACR20 response rate was 92.5%, with nearly all patients maintaining response through week 28.현대차증권 제약/바이오/의료기기 김현석 · statementThe high placebo response rate is because all patients received 600mg high dose for 16 weeks in Period 1, not because of a large placebo effect; 75% of the placebo group maintained ACR20 through week 28.현대차증권 제약/바이오/의료기기 김현석 · statementIn the D2T RA Phase 2b Period 2 results, the 600mg continuous dosing group achieved statistical significance (p-value), a surprise exceeding market expectations.report author · statement10mg의 섬유화 개선 유효성 입증 실패는 높은 중단율(11% vs. 3~4%)에 따른 생검 누락 때문으로 보이며, 약효 문제로 단정하기 어렵다.하나증권 · statementIn the D2T RA Phase 2b Period 2 results, the 600mg continuous dosing group achieved a p-value.하나증권 제약/바이오 김선아 · statement