Two Phase 3 Trials of Baricitinib for Alopecia Areata.
무작위 임상시험
5/5 보강
TL;DR
In two phase 3 trials involving patients with severe alopecia areata, oral baricitinib was superior to placebo with respect to hair regrowth at 36 weeks.
PICO 자동 추출 (휴리스틱, conf 2/4)
유사 논문P · Population 대상 환자/모집단
654 patients in the BRAVE-AA1 trial and 546 in the BRAVE-AA2 trial.
I · Intervention 중재 / 시술
추출되지 않음
C · Comparison 대조 / 비교
추출되지 않음
O · Outcome 결과 / 결론
Longer trials are required to assess the efficacy and safety of baricitinib for alopecia areata. (Funded by Eli Lilly under license from Incyte; BRAVE-AA1 and BRAVE-AA2 ClinicalTrials.gov numbers, NCT03570749 and NCT03899259.).
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· 인용됨 129
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연도별 인용 (2022–2026) · 합계 436
OpenAlex 토픽 ·
Hair Growth and Disorders
Facial Rejuvenation and Surgery Techniques
Chronic Myeloid Leukemia Treatments
🇰🇷 한글 요약 🌐 Abstract
【연구 목적】
중증 원형 탈모증(alopecia areata) 환자를 대상으로 경구 JAK1/2 억제제인 바리시티닙(baricitinib)의 모발 재생 효과와 안전성을 평가하기 위해 두 건의 3상 임상시험(BRAVE-AA1, BRAVE-AA2)을 시행하였다.
【방법】
SALT(Severity of Alopecia Tool) 점수 50 이상(두피 모발 50% 이상 소실)인 성인 1,200명(AA1 654명, AA2 546명)을 바리시티닙 4mg, 2mg, 위약군에 3:2:2로 무작위 배정하여 1일 1회 경구 투여하였다. 1차 평가지표는 36주 시점 SALT 점수 20 이하(두피 모발 80% 이상 유지) 도달률이었다.
【주요 결과】
36주 시점 SALT ≤20 도달률은 4mg군 35.9~38.8%, 2mg군 19.4~22.8%, 위약군 3.3~6.2%로 두 용량 모두 위약 대비 유의하게 우월하였다(P<0.001). 4mg 용량은 눈썹·속눈썹 재생 등 2차 평가지표에서도 우수했으며, 이상반응으로 여드름, CK(크레아틴키나아제) 상승, LDL·HDL 콜레스테롤 상승이 보고되었다.
【임상적 시사점 (성형외과 의사 관점)】
모발이식(hair transplantation) 적응증이 되지 않는 광범위·중증 원형 탈모 환자에게 바리시티닙은 의미 있는 비수술적 치료 옵션이 될 수 있어, 이식 상담 시 자가면역성 탈모 감별과 약물치료 선의뢰가 중요하다. 다만 36주 이상 장기 투여가 필요하고 여드름·지질이상·감염 등 JAK 억제제 특유의 부작용 모니터링이 요구되므로, 피부과·내과와의 협진 체계를 갖춘 후 안내하는 것이 바람직하다.
[BACKGROUND] Alopecia areata is an autoimmune condition characterized by rapid hair loss in the scalp, eyebrows, and eyelashes, for which treatments are limited. Baricitinib, an oral, selective, reversible inhibitor of Janus kinases 1 and 2, may interrupt cytokine signaling implicated in the pathogenesis of alopecia areata.
[METHODS] We conducted two randomized, placebo-controlled, phase 3 trials (BRAVE-AA1 and BRAVE-AA2) involving adults with severe alopecia areata with a Severity of Alopecia Tool (SALT) score of 50 or higher (range, 0 [no scalp hair loss] to 100 [complete scalp hair loss]). Patients were randomly assigned in a 3:2:2 ratio to receive once-daily baricitinib at a dose of 4 mg, baricitinib at a dose of 2 mg, or placebo. The primary outcome was a SALT score of 20 or less at week 36.
[RESULTS] We enrolled 654 patients in the BRAVE-AA1 trial and 546 in the BRAVE-AA2 trial. The estimated percentage of patients with a SALT score of 20 or less at week 36 was 38.8% with 4-mg baricitinib, 22.8% with 2-mg baricitinib, and 6.2% with placebo in BRAVE-AA1 and 35.9%, 19.4%, and 3.3%, respectively, in BRAVE-AA2. In BRAVE-AA1, the difference between 4-mg baricitinib and placebo was 32.6 percentage points (95% confidence interval [CI], 25.6 to 39.5), and the difference between 2-mg baricitinib and placebo was 16.6 percentage points (95% CI, 9.5 to 23.8) (P<0.001 for each dose vs. placebo). In BRAVE-AA2, the corresponding values were 32.6 percentage points (95% CI, 25.6 to 39.6) and 16.1 percentage points (95% CI, 9.1 to 23.2) (P<0.001 for each dose vs. placebo). Secondary outcomes for baricitinib at a dose of 4 mg but not at a dose of 2 mg generally favored baricitinib over placebo. Acne, elevated levels of creatine kinase, and increased levels of low- and high-density lipoprotein cholesterol were more common with baricitinib than with placebo.
[CONCLUSIONS] In two phase 3 trials involving patients with severe alopecia areata, oral baricitinib was superior to placebo with respect to hair regrowth at 36 weeks. Longer trials are required to assess the efficacy and safety of baricitinib for alopecia areata. (Funded by Eli Lilly under license from Incyte; BRAVE-AA1 and BRAVE-AA2 ClinicalTrials.gov numbers, NCT03570749 and NCT03899259.).
[METHODS] We conducted two randomized, placebo-controlled, phase 3 trials (BRAVE-AA1 and BRAVE-AA2) involving adults with severe alopecia areata with a Severity of Alopecia Tool (SALT) score of 50 or higher (range, 0 [no scalp hair loss] to 100 [complete scalp hair loss]). Patients were randomly assigned in a 3:2:2 ratio to receive once-daily baricitinib at a dose of 4 mg, baricitinib at a dose of 2 mg, or placebo. The primary outcome was a SALT score of 20 or less at week 36.
[RESULTS] We enrolled 654 patients in the BRAVE-AA1 trial and 546 in the BRAVE-AA2 trial. The estimated percentage of patients with a SALT score of 20 or less at week 36 was 38.8% with 4-mg baricitinib, 22.8% with 2-mg baricitinib, and 6.2% with placebo in BRAVE-AA1 and 35.9%, 19.4%, and 3.3%, respectively, in BRAVE-AA2. In BRAVE-AA1, the difference between 4-mg baricitinib and placebo was 32.6 percentage points (95% confidence interval [CI], 25.6 to 39.5), and the difference between 2-mg baricitinib and placebo was 16.6 percentage points (95% CI, 9.5 to 23.8) (P<0.001 for each dose vs. placebo). In BRAVE-AA2, the corresponding values were 32.6 percentage points (95% CI, 25.6 to 39.6) and 16.1 percentage points (95% CI, 9.1 to 23.2) (P<0.001 for each dose vs. placebo). Secondary outcomes for baricitinib at a dose of 4 mg but not at a dose of 2 mg generally favored baricitinib over placebo. Acne, elevated levels of creatine kinase, and increased levels of low- and high-density lipoprotein cholesterol were more common with baricitinib than with placebo.
[CONCLUSIONS] In two phase 3 trials involving patients with severe alopecia areata, oral baricitinib was superior to placebo with respect to hair regrowth at 36 weeks. Longer trials are required to assess the efficacy and safety of baricitinib for alopecia areata. (Funded by Eli Lilly under license from Incyte; BRAVE-AA1 and BRAVE-AA2 ClinicalTrials.gov numbers, NCT03570749 and NCT03899259.).
- p-value P<0.001
- 95% CI 9.5 to 23.8
【연구 목적】 중증 원형 탈모증(alopecia areata) 환자를 대상으로 경구 JAK1/2 억제제인 바리시티닙(baricitinib)의 모발 재생 효과와 안전성을 평가하기 위해 두 건의 3상 임상시험(BRAVE-AA1, BRAVE-AA2)을 시행하였다.
APA 7
King, B., Ohyama, M., Kwon, O., Zlotogorski, A., Ko, J., Mesinkovska, N. A., Hordinsky, M., Dutronc, Y., Wu, W. S., McCollam, J., Chiasserini, C., Yu, G., Stanley, S., Holzwarth, K., DeLozier, A. M., & Sinclair, R. (2022). Two phase 3 trials of baricitinib for alopecia areata.. The New England journal of medicine, 386(18), 1687-1699. https://doi.org/10.1056/NEJMoa2110343
Vancouver
King B, Ohyama M, Kwon O, Zlotogorski A, Ko J, Mesinkovska NA, et al. Two Phase 3 Trials of Baricitinib for Alopecia Areata. New Engl. jour. medi.. 2022;386(18):1687-1699. doi:10.1056/NEJMoa2110343
AMA 11
King B, Ohyama M, Kwon O, Zlotogorski A, Ko J, Mesinkovska NA, et al. Two Phase 3 Trials of Baricitinib for Alopecia Areata. New Engl. jour. medi.. 2022;386(18):1687-1699. doi:10.1056/NEJMoa2110343
Chicago
King, B., Ohyama, M., Kwon, O., Zlotogorski, A., Ko, J., Mesinkovska, N. A., Hordinsky, M., Dutronc, Y., Wu, W. S., McCollam, J., and .... 2022. "Two Phase 3 Trials of Baricitinib for Alopecia Areata." The New England journal of medicine 386 (18): 1687-1699. https://doi.org/10.1056/NEJMoa2110343
MLA 9
King, B., et al. "Two Phase 3 Trials of Baricitinib for Alopecia Areata." The New England journal of medicine, vol. 386, no. 18, 2022, pp. 1687-1699. doi:10.1056/NEJMoa2110343.
PMID
35334197 ↗
추출된 의학 개체 (NER)
해부
두피 scalp
×3
전체 NER 표 보기
| 유형 | 영어 표현 | 한국어 / 풀이 | UMLS CUI | 출처 | 등장 |
|---|---|---|---|---|---|
| 질환 | alopecia areata
|
원형 탈모증 | dict | 6 | |
| 해부 | scalp
|
두피 | dict | 3 |
🏷️ 키워드 / MeSH 📖 같은 키워드 OA만
인용 관계
그래프 OA 노드: 6/8 (75%)
· 참조 0편 · 후속 6편
이 논문을 인용한 후속 연구 20
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🏷️ 같은 키워드 · 무료전문 — 이 논문 MeSH/keyword 기반
📖 비슷한 OA 논문 — 같은 카테고리, 무료 전문 가능
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Alopecia areata.
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