Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial.

Brett King; Xingqi Zhang; Walter Gubelin Harcha; Jacek C. Szepietowski; Jerry Shapiro; Charles Lynde; Natasha Atanaskova Mesinkovska; Samuel H. Zwillich; Lynne Napatalung; Dalia Wajsbrot; Rana Fayyad; Amy Freyman; Debanjali Mitra; Vivek S. Purohit; Rodney Sinclair; Robert Wołk

doi:10.1016/S0140-6736(23)00222-2

← 뒤로

Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial.

✂️ 성형 🦱 탈모 🔵 RCT

무작위 임상시험 5/5 보강

Lancet (London, England) 📖 저널 OA 13.5% 2021~2026 2023 Vol.401(10387) p. 1518-1529 피인용 75회 cited 243 OA RCR 25.37 Hair Growth and Disorders

TL;DR This study investigated the efficacy and safety of ritlecitinib, an oral, selective dual JAK3/TEC family kinase inhibitor, in patients with alopecia areata in a randomised, double-blind, multicentre, phase 2b-3 trial.

🔎 핵심 키워드 원형 탈모증 ×6 원형 탈모증 ×6 원형 탈모증 ×6 두피 ×2 두피 ×2 두피 ×2 전체 NER ↓

PICO 자동 추출 (휴리스틱, conf 3/4)

유사 논문

P · Population 대상 환자/모집단

1097 patients were screened and 718 were randomly assigned to receive ritlecitinib 200 mg + 50 mg (n=132), 200 mg + 30 mg (n=130), 50 mg (n=130), 30 mg (n=132), 10 mg (n=63), placebo to 50 mg (n=66), or placebo to 200 mg + 50 mg (n=65).

I · Intervention 중재 / 시술

the same number of tablets to maintain masking

C · Comparison 대조 / 비교

추출되지 않음

O · Outcome 결과 / 결론

Ritlecitinib might be a suitable treatment option for alopecia areata in patients who are candidates for systemic therapy. [FUNDING] Pfizer.

📑 코퍼스 인용 관계 · 인용됨 75

📑 인용한 논문 (6) ▾

SALT score distribution with ritlecitinib treatment up to 24 months in alopecia areata. Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
Evidence Synthesis Gone Awry: The Perils of Aggregating Ineffective or Unsafe Doses in Alo… Cureus · 2026
Responses to Tetanus and Meningococcal Vaccines in Patients with Alopecia Areata Treated w… Dermatology and therapy · 2026
Dermatologists' Perspectives and Real-World Assessment of Alopecia Areata Severity in Adul… Dermatology and therapy · 2026
Ritlecitinib for Severe Alopecia Areata: A 24-Week, Multicentre, Real-World Study. American journal of clinical dermatology · 2026
Long-Term Efficacy and Safety of Ritlecitinib in Adults and Adolescents with Alopecia Area… American journal of clinical dermatology · 2026

연도별 인용 (2012–2026) · 합계 242

OpenAlex 토픽 · Hair Growth and Disorders Cytokine Signaling Pathways and Interactions Psoriasis: Treatment and Pathogenesis

King B, Zhang X, Harcha WG, Szepietowski JC, Shapiro J, Lynde C

📖 무료 전문 🔓 OA PDF oa

PubMed ↗ DOI ↗ BibTeX ↓ RIS ↓

🇰🇷 한글 요약

【연구 목적】
경구용 선택적 JAK3/TEC 계열 키나아제 억제제인 리틀레시티닙(ritlecitinib)이 12세 이상 원형 탈모증(alopecia areata) 환자에서 보이는 유효성과 안전성을 평가하고자 함.

【방법】
18개국 118개 기관에서 진행된 무작위배정·이중맹검·다기관 2b-3상 임상시험으로, 두피(scalp) 모발 50% 이상 소실 환자 718명을 리틀레시티닙(10·30·50 mg, 200 mg 부하 후 30 또는 50 mg) 또는 위약군에 배정해 24주간 투여 후 24주 연장 관찰함. 1차 평가변수는 24주차 SALT(Severity of Alopecia Tool) 점수 20 이하 도달률.

【주요 결과】
24주차 SALT≤20 반응률은 200 mg+50 mg군 31%, 200 mg+30 mg군 22%, 50 mg군 23%, 30 mg군 14%, 위약군 2%로 모든 활성 용량군이 위약 대비 유의하게 우수했음(p≤0.0002). 이상반응 발생률은 군 간 유사(76~86%)했고 사망은 없었음.

【임상적 시사점 (성형외과 의사 관점)】
모발이식만으로 해결이 어려운 광범위 원형 탈모증 환자에게 전신요법 옵션으로 제시 가능한 약물이며, 12세 이상 청소년에도 적용 가능해 적응증 폭이 넓음. 다만 200 mg 부하 후 50 mg 용량에서도 31%만 SALT≤20에 도달하므로 환자 상담 시 현실적 반응률과 JAK 억제제 특유의 안전성 모니터링(감염·검사실 수치) 필요성을 함께 안내해야 함.

[BACKGROUND] Alopecia areata is characterised by non-scarring loss of scalp, face, or body hair. We investigated the efficacy and safety of ritlecitinib, an oral, selective dual JAK3/TEC family kinase inhibitor, in patients with alopecia areata.

[METHODS] In this randomised, double-blind, multicentre, phase 2b-3 trial done at 118 sites in 18 countries, patients aged 12 years and older with alopecia areata and at least 50% scalp hair loss were randomly assigned to oral ritlecitinib or placebo once-daily for 24 weeks, with or without a 4-week loading dose (50 mg, 30 mg, 10 mg, 200 mg loading dose followed by 50 mg, or 200 mg loading dose followed by 30 mg), followed by a 24-week extension period during which ritlecitinib groups continued their assigned doses and patients initially assigned to placebo switched to ritlecitinib 50 mg or 200 mg loading dose followed by 50 mg. Randomisation was done by use of an interactive response system and was stratified by baseline disease severity and age. The sponsor, patients, and investigators were masked to treatment, and all patients received the same number of tablets to maintain masking. The primary endpoint was Severity of Alopecia Tool (SALT) score 20 or less at week 24. The primary endpoint was assessed in all assigned patients, regardless of whether they received treatment. This study was registered with ClinicalTrials.gov, NCT03732807.

[FINDINGS] Between Dec 3, 2018, and June 24, 2021, 1097 patients were screened and 718 were randomly assigned to receive ritlecitinib 200 mg + 50 mg (n=132), 200 mg + 30 mg (n=130), 50 mg (n=130), 30 mg (n=132), 10 mg (n=63), placebo to 50 mg (n=66), or placebo to 200 mg + 50 mg (n=65). 446 (62%) of 718 patients were female and 272 (38%) were male. 488 (68%) were White, 186 (26%) were Asian, and 27 (4%) were Black or African American. Of 718 patients randomly assigned, 104 patients discontinued treatment (34 withdrew, 19 adverse events [AEs], 12 physician decision, 12 lack of efficacy, 13 lost to follow up, five rolled over to long-term study transfer, four pregnancies, two protocol deviations, one declined to attend follow-up due to COVID-19, one attended last visit very late due to COVID-19, and one non-compliance). At week 24, 38 (31%) of 124 patients in the ritlecitinib 200 mg + 50 mg group, 27 (22%) of 121 patients in the 200 mg + 30 mg group, 29 (23%) of 124 patients in the 50 mg group, 17 (14%) of 119 patients in the 30 mg group, and two (2%) of 130 patients in the placebo group had a response based on SALT score 20 or less. The difference in response rate based on SALT score 20 or less between the placebo and the ritlecitinib 200 mg + 50 mg group was 29·1% (95% CI 21·2-37·9; p<0·0001), 20·8% (13·7-29·2; p<0·0001) for the 200 mg + 30 mg group, 21·9% (14·7-30·2; p<0·0001) for the 50 mg group, and 12·8% (6·7-20·4; p=0·0002) for the 30 mg group. Up to week 48 and including the follow-up period, AEs had been reported in 108 (82%) of 131 patients in the ritlecitinib 200 mg + 50 mg group, 105 (81%) of 129 patients in the 200 mg + 30 mg group, 110 (85%) of 130 patients in the 50 mg group, 106 (80%) of 132 patients in the 30 mg group, 47 (76%) of 62 patients in the 10 mg group, 54 (83%) of 65 patients placebo to ritlecitinib 200 mg + 50 mg in the extension period, and 57 (86%) of 66 patients in the placebo to 50 mg group. The incidence of each AE was similar between groups, and there were no deaths.

[INTERPRETATION] Ritlecitinib was effective and well tolerated in patients aged 12 years and older with alopecia areata. Ritlecitinib might be a suitable treatment option for alopecia areata in patients who are candidates for systemic therapy.

[FUNDING] Pfizer.

🔬 핵심 임상 통계 (초록에서 자동 추출 — 원문 검증 권장)

표본수 (n) 132

📝 환자 설명용 한 줄

【연구 목적】 경구용 선택적 JAK3/TEC 계열 키나아제 억제제인 리틀레시티닙(ritlecitinib)이 12세 이상 원형 탈모증(alopecia areata) 환자에서 보이는 유효성과 안전성을 평가하고자 함.

이 논문을 인용하기

↓ .bib ↓ .ris

APA 7 King, B., Zhang, X., Harcha, W. G., Szepietowski, J. C., Shapiro, J., Lynde, C., Mesinkovska, N. A., Zwillich, S. H., Napatalung, L., Wajsbrot, D., Fayyad, R., Freyman, A., Mitra, D., Purohit, V., Sinclair, R., & Wolk, R. (2023). Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: A randomised, double-blind, multicentre, phase 2b-3 trial.. Lancet (London, England), 401(10387), 1518-1529. https://doi.org/10.1016/S0140-6736(23)00222-2

Vancouver King B, Zhang X, Harcha WG, Szepietowski JC, Shapiro J, Lynde C, et al. Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial. Lancet (London, England). 2023;401(10387):1518-1529. doi:10.1016/S0140-6736(23)00222-2

AMA 11 King B, Zhang X, Harcha WG, Szepietowski JC, Shapiro J, Lynde C, et al. Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial. Lancet (London, England). 2023;401(10387):1518-1529. doi:10.1016/S0140-6736(23)00222-2

Chicago King, B., Zhang, X., Harcha, W. G., Szepietowski, J. C., Shapiro, J., Lynde, C., Mesinkovska, N. A., Zwillich, S. H., Napatalung, L., Wajsbrot, D., and .... 2023. "Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial." Lancet (London, England) 401 (10387): 1518-1529. https://doi.org/10.1016/S0140-6736(23)00222-2

MLA 9 King, B., et al. "Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial." Lancet (London, England), vol. 401, no. 10387, 2023, pp. 1518-1529. doi:10.1016/S0140-6736(23)00222-2.

PMID 37062298 ↗

DOI 10.1016/S0140-6736(23)00222-2

추출된 의학 개체 (NER)

해부 두피 scalp ×2 두피 scalp ×2 두피 scalp ×2

상태/진단 원형 탈모증 alopecia areata ×6 원형 탈모증 alopecia areata ×6 원형 탈모증 alopecia areata ×6

전체 NER 표 보기

유형	영어 표현	한국어 / 풀이	출처	등장
질환	`alopecia areata`	원형 탈모증	dict	6
질환	`alopecia areata`	원형 탈모증	dict	6
질환	`alopecia areata`	원형 탈모증	dict	6
해부	`scalp`	두피	dict	2
해부	`scalp`	두피	dict	2
해부	`scalp`	두피	dict	2

🏷️ 키워드 / MeSH 📖 같은 키워드 OA만

인용 관계

그래프 OA 노드: 6/8 (75%) · 참조 0편 · 후속 6편

📖 비슷한 OA 논문 — 같은 카테고리, 무료 전문 가능

Alopecia areata.
Nature reviews. Disease primers 2017 Pratt CH 외 cited 267 📖 OA

TL;DRAlopecia areata is difficult to manage medically, but recent advances in understanding the molecular mechanisms have revealed new treatments and the possibility of remission in the…
Epidemiology and burden of alopecia areata: a systematic review.
Clinical, cosmetic and investigational dermatology 2015 Villasante Fricke AC 외 cited 173 📖 OA

TL;DRAA is the most prevalent autoimmune disorder and the second most prevalent hair loss disorder after androgenetic alopecia, and the lifetime risk in the global population is approxi…
Two Phase 3 Trials of Baricitinib for Alopecia Areata.
The New England journal of medicine 2022 King B 외 cited 129 📖 OA

TL;DRIn two phase 3 trials involving patients with severe alopecia areata, oral baricitinib was superior to placebo with respect to hair regrowth at 36 weeks.
Treatment options for androgenetic alopecia: Efficacy, side effects, compliance, financial considerations, and ethics.
Journal of cosmetic dermatology 2021 Nestor MS 외 cited 124 📖 OA

TL;DRAlthough a variety of medical, surgical, light‐based and nutraceutical treatment options are available to slow or reverse the progression of AGA, it can be challenging to select ap…
Hair follicle immune privilege and its collapse in alopecia areata.
Experimental dermatology 2020 Bertolini M 외 cited 103 📖 OA

TL;DRA key goal for effective AA management is the re‐establishment of a functional HF IP, which will also provide superior protection from disease relapse, and may confer increased sus…

관련 도메인

🇰🇷 한글 요약 🌐 Abstract

이 논문을 인용하기

추출된 의학 개체 (NER)

🏷️ 키워드 / MeSH 📖 같은 키워드 OA만

인용 관계

이 논문을 인용한 후속 연구 20

같은 제1저자의 인용 많은 논문 (5)

🏷️ 같은 키워드 · 무료전문 — 이 논문 MeSH/keyword 기반

📖 비슷한 OA 논문 — 같은 카테고리, 무료 전문 가능

비슷한 논문 — 같은 카테고리, 인용 많은 순 전체 5 📖 OA 2 (40%)

🇰🇷 한글 요약

비슷한 논문 — 같은 카테고리, 인용 많은 순