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Efficacy and safety of the oral JAK3/TEC family kinase inhibitor ritlecitinib over 24 months: integrated analysis of the ALLEGRO phase 2b/3 and long-term phase 3 clinical studies in alopecia areata

Piliang, Melissa; Soung, Jennifer; King, Brett; Shapiro, Jerry; Rudnicka, Lidia; Farrant, Paul; Magnolo, Nina; Piraccini, Bianca Maria; Luo, Xin; Wolk, Robert; Woodworth, Deborah; Schaefer, Gregor; Lejeune, Alexandre
BACKGROUND:The ALLEGRO phase 2a and 2b/3 studies demonstrated that ritlecitinib is efficacious and well tolerated in adult and adolescent patients with alopecia areata (AA) up to 48 weeks. OBJECTIVE:The efficacy of ritlecitinib through Month 24 and safety through data cutoff were assessed in the ALLEGRO phase 2b/3 study and the ongoing long-term, open-label, phase 3 ALLEGRO-LT study. METHODS:Patients aged ≥12 years with AA and ≥50% scalp hair loss from ALLEGRO-2b/3 who rolled over to ALLEGRO-LT after up to 48 weeks were included. Proportions of patients with responses based on clinician-reported Severity of Alopecia Tool (SALT) score of ≤20 and ≤10, eyebrow assessment (EBA) and eyelash assessment (ELA), patient global impression of change (PGI-C) and patient satisfaction with hair growth are reported through Month 24 for patients who received ritlecitinib 50 mg daily with or without a 200-mg 4-week daily loading dose. Observed and imputed data (last observation carried forward [LOCF]) were reported until December 9, 2022. Safety was assessed throughout. RESULTS:At Month 12, SALT score ≤20 was achieved by 45.1% and 45.9% (observed) and 40.3% and 41.8% (LOCF) of the 191 and 194 patients who received ritlecitinib 50 mg and ritlecitinib 200/50 mg, respectively. At Month 24, proportions increased to 60.8% and 63.1% (observed) and 46.1% and 50.8% (LOCF), respectively. Patients with abnormal EBA or ELA scores at baseline achieved responses at Month 24 (EBA observed: 57.6% [50 mg], 61.0% [200/50 mg]; EBA LOCF: 46.8% [50 mg], 50.9% [200/50 mg]; ELA observed: 51.2% [50 mg], 62.7% [200/50 mg]; ELA LOCF: 43.2% [50 mg], 51.7% [200/50 mg]). PGI-C response was achieved by patients at Month 24 (observed: 70.0% [50 mg], 76.4% [200/50 mg]; LOCF: 56.6% [50 mg], 65.5% [200/50 mg]). Safety profiles for both treatment groups were consistent with the known safety profile of ritlecitinib. CONCLUSION/CONCLUSIONS:Ritlecitinib has clinically meaningful and sustained efficacy beyond 1 year with a favourable safety and tolerability profile, supporting its long-term use in patients aged ≥12 years with AA. TRIAL REGISTRIES/BACKGROUND:ClinicalTrials.gov: NCT03732807, NCT04006457.
PMID: 39432738
ISSN: 1365-2133
CID: 5739572

Low-dose oral minoxidil in alopecia: evaluating blood pressure changes in patients with abnormal blood pressure-a retrospective study [Letter]

Desai, Deesha; Nohria, Ambika; Brinks, Anna L; Needle, Carli D; Sikora, Michelle; Anyanwu, Nnaemeka; Garshick, Michael; Shapiro, Jerry; Lo Sicco, Kristen I
PMID: 39803788
ISSN: 1365-4632
CID: 5776262

Exploring the Rise in Pediatric "Skincare Routines" on Social Media [Letter]

Brinks, Anna L; Needle, Carli D; Pulavarty, Akshay; Kearney, Caitlin A; Maguire, Ciara A; Calderón, Daniela; Sharoff, Aditya N; Shapiro, Jerry; Orlow, Seth J; Lo Sicco, Kristen I; Oza, Vikash S
PMID: 39803709
ISSN: 1365-4632
CID: 5776242

Low-Dose Oral Minoxidil Initiation for Patients With Hair Loss: An International Modified Delphi Consensus Statement

Akiska, Yagiz Matthew; Mirmirani, Paradi; Roseborough, Ingrid; Mathes, Erin; Bhutani, Tina; Ambrosy, Andrew; Aguh, Crystal; Bergfeld, Wilma; Callender, Valerie D; Castelo-Soccio, Leslie; Cotsarelis, George; Craiglow, Brittany Gareth; Desai, Nisha S; Doche, Isabella; Duque-Estrada, Bruna; Elston, Dirk M; Goh, Carolyn; Goldberg, Lynne J; Grimalt, Ramon; Jabbari, Ali; Jolliffe, Victoria; King, Brett A; LaSenna, Charlotte; Lenzy, Yolanda; Lester, Jenna C; Lortkipanidze, Nino; Lo Sicco, Kristen I; McMichael, Amy; Meah, Nekma; Mesinkovska, Natasha; Miteva, Mariya; Mostaghimi, Arash; Ovcharenko, Yuliya; Piliang, Melissa; Piraccini, Bianca Maria; Rakowska, Adriana; Salkey, Kimberly S; Schmidt, Adriana; Shapiro, Jerry; Sibbald, Cathryn; Sinclair, Rodney; Suchonwanit, Poonkiat; Taylor, Susan; Tosti, Antonella; Vañó-Galván, Sergio; Wall, Dmitri Robert; Fu, Jennifer M
IMPORTANCE/UNASSIGNED:The results of small studies suggest that off-label use of low-dose oral minoxidil (LDOM) may be safe and effective for patients with hair loss, but larger trials and standardized guidelines are lacking. OBJECTIVE/UNASSIGNED:To create an expert consensus statement for LDOM prescribing for patients with hair loss. EVIDENCE REVIEW/UNASSIGNED:The current literature on the pharmacological properties, adverse effect profile, and use of LDOM for patients with hair loss was reviewed. Topics of interest were identified, and a modified Delphi consensus process was created. A total of 43 hair loss specialist dermatologists from 12 countries participated in a modified Delphi process. Consensus was reached if at least 70% agreed or strongly agreed on a 5-point Likert scale. FINDINGS/UNASSIGNED:Over 4 survey rounds, 180 items in the first round, 121 items in the second round, 16 items in the third round, and 11 items in the fourth round were considered and revised. A total of 76 items achieved consensus including diagnoses for which LDOM may provide direct or supportive benefit, indications for LDOM compared to topical minoxidil, dosing for adults (18 years and older) and adolescents (aged 12 to 17 years), contraindications, precautions, baseline evaluation, monitoring, adjunctive therapy, and specialty consultation. Pediatric use and dosing items for children younger than 12 years, and LDOM titration protocols fell short of consensus. CONCLUSIONS AND RELEVANCE/UNASSIGNED:This international expert consensus statement regarding the off-label prescribing of LDOM for patients with hair loss can help guide clinical practice until more data emerge. Hair loss experts with experience treating pediatric patients were underrepresented on this expert panel. Future research should investigate best practices for LDOM use in pediatric patients. Other critical topics for further investigation include the comparative efficacy of topical minoxidil vs oral minoxidil, the safety of oral minoxidil for patients with a history of allergic contact dermatitis to topical minoxidil, the long-term safety of LDOM, and the use of other off-label forms of minoxidil, such as compounded formulations of oral minoxidil and sublingual minoxidil. As additional evidence-based data emerge, these recommendations should be updated.
PMID: 39565602
ISSN: 2168-6084
CID: 5758572

Response to Kang et al.'s "Efficacy of low-dose oral minoxidil in the management of anticancer therapy-induced alopecia in patients with breast cancer: A retrospective cohort study" [Letter]

Kearney, Caitlin A; Brinks, Anna L; Needle, Carli D; Shapiro, Jerry; Lacouture, Mario E; Lo Sicco, Kristen I
PMID: 39725217
ISSN: 1097-6787
CID: 5767762

Premature hair graying: a multifaceted phenomenon

Desai, Deesha D; Karim, Maria; Nohria, Ambika; Needle, Carli; Brinks, Anna; Kearney, Caitlin A; Ridge, Amy; Mesinkovska, Natasha; Shapiro, Jerry; Lo Sicco, Kristen I
Premature hair graying (PHG) is the early loss of natural hair color, influenced by genetic, biological, and environmental factors. This review discusses the significant psychological impacts of PHG and explores its underlying mechanisms, related health conditions, and available treatments. The review examines the roles of genetics, oxidative stress, and lifestyle factors such as smoking and diet in premature graying. It also considers associated medical conditions and current and emerging treatment options. This overview aims to improve understanding of PHG and its broader implications.
PMID: 39697103
ISSN: 1365-4632
CID: 5764672

Response to "No increased risk of breast or gynecologic malignancies in women exposed to spironolactone for dermatologic conditions: A retrospective cohort study" [Letter]

Desai, Deesha; Sikora, Michelle; Nohria, Ambika; Caplan, Avrom S; Lacouture, Mario; Shapiro, Jerry; Lo Sicco, Kristen I
PMID: 39168312
ISSN: 1097-6787
CID: 5680802

Improving efficacy and maintaining safety in the treatment of alopecia with low-dose oral minoxidil and spironolactone combination therapy: A retrospective review

Nohria, Ambika; Desai, Deesha; Sikora, Michelle; Anyanwu, Nnaemeka; Caplan, Avrom; Shapiro, Jerry; Lo Sicco, Kristen
PMCID:11470514
PMID: 39399339
ISSN: 2666-3287
CID: 5718332

Examining blood pressure changes with spironolactone for alopecia: A retrospective analysis

Desai, Deesha; Nohria, Ambika; Sikora, Michelle; Anyanwu, Nnaemeka; Caplan, Avrom S; Garshick, Michael; Shapiro, Jerry; Lo Sicco, Kristen I
PMID: 39197494
ISSN: 1097-6787
CID: 5729792

Assessing the influence of medications with antagonistic effects on low-dose oral minoxidil in patients with alopecia: A retrospective study

Desai, Deesha; Nohria, Ambika; Sikora, Michelle; Buontempo, Michael; Shapiro, Jerry; Caplan, Avrom S; Garshick, Michael; Lo Sicco, Kristen I
PMCID:11387517
PMID: 39268196
ISSN: 2666-3287
CID: 5690722