Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

Ritlecitinib is effective across various subgroups of patients with non-segmental vitiligo up to 48 weeks, new findings suggest.

This drug was evaluated in a recent study authored by investigators such as Yuji Yamaguchi, the Executive Director of Clinical Research at Pfizer. Yamaguchi and colleagues highlighted ritlecitinib’s use as an oral, selective, dual inhibitor of JAK3 and the TEC family kinases.

The drug is currently under phase 3 investigation for its use in treating non-segmental vitiligo. Prior research noted by the investigators points to ritlecitinib’s demonstrated efficacy and safety in a phase 2b analysis.

“...[Data] are limited on how other demographic and clinical characteristics affect the efficacy of ritlecitinib in patients with NSV,” the investigative team wrote.

 “This post hoc analysis explored the efficacy of ritlecitinib in patients with NSV stratified by baseline demographic and clinical characteristics.”

Previous information reported in a phase 2b clinical study was used in this post hoc evaluation (NCT03715829). This trial had looked at treatment with ritlecitinib among adult patients living with active non-segmental vitiligo. The study had consisted of a 24-week dose-ranging phase, a period then followed by a 24-week extension phase. Those between the ages of 18 - 65 years of age were deemed eligible, provided they had active non-segmental vitiligo.

The presence of patient disease was defined by the observation of at least a single active vitiligo-related lesion. In terms of activity criteria, examples included newly appearing or enlarging lesions within the prior 3 months and/or confetti-like, trichrome, or Koebner lesions. Yamaguchi et al did not include historical isomorphic reactions.

All of those involved as participants were also required to have facial involvement of their vitiligo, with the disease affecting .25% of body surface area (BSA) at minimum. In the study’s initial 24-week dose-ranging period, those evaluated were treated with a maintenance dose of ritlecitinib at 50 mg once-per-day. The drug was administered either alone or after the conclusion of a 4-week loading regimen of 200 mg or 100 mg, taking place once daily.

Within the investigators’ subsequent extension period, trial subjects at Week 16 who had not succeeded in attaining at least an improvement of 50% from the point of baseline in their Total Vitiligo Area Scoring Index (T-VASI) were shifted to 1 of several different potential treatment strategies. These strategies would include open-label ritlecitinib 200/50 mg combined with narrowband UVB phototherapy, open-label brepocitinib, or blinded ritlecitinib on a 200/50 mg dosing regimen.

In Yamaguchi and coauthors’ present analysis, they focused on individuals featured in the extension phase who were randomized to the blinded ritlecitinib 200/50 mg arm of the study. In this particular cohort, trial participants were given a 200-mg loading dose over 4 weeks followed by 50 mg on a once-per-day regimen. Efficacy of ritlecitinib’s use was assessed by the investigators through a determination of the percentage of individuals attaining at least a 75% improvement from the point of baseline on their centrally read Facial Vitiligo Area Scoring Index (F-VASI75) score at the 24 and 48-week marks. Outcomes were then further evaluated across baseline demographic and clinical subgroups.

Findings on Ritlecitinib in Non-Segmental Vitiligo

There were 184 patients in total from the dose-ranging phase and 90 individuals from the extension phase who Yamaguchi and colleagues involved in their post hoc analysis. The proportion of those showing a F-VASI75 score was 8.7% at 24 weeks and rose to 26.7% by the 48-week mark. The investigative team noted, across all of the subgroups of patients with non-segmental vitiligo, ritlecitinib demonstrated clinically meaningful levels of facial re-pigmentation.

By the 24-week mark, the team highlighted numerical but statistically non-significant differences in subjects’ responses, specifically among certain subgroups. Yamaguchi et al observed increased rates of disease response among men versus women. These greater rates were also observed in individuals with Fitzpatrick skin types III–VI as opposed to I–II.

Other subgroups in this category were those with facial BSA involvement of at least 0.5% versus less than 0.5%, patients without leukotrichia versus those with leukotrichia, and treatment-naïve individuals versus those previously given treatment. These subgroup differences were noted by the team as less apparent by the 48-week mark.

By the extension period’s conclusion, there remained only modest, non-significant trends. These data favored patients with a body mass index of 30 kg/m² or lower, individuals without leukotrichia, and those without comorbid conditions. There were no notable distinctions detected by the investigative team across the remaining baseline characteristics.

“Overall, ritlecitinib was efficacious across different patient subgroups up to 48 weeks,” the team concluded.

 “These findings contribute to the understanding of how demographic and clinical characteristics affect clinical response to ritlecitinib in patients with active vitiligo, potentially guiding more personalized therapeutic approaches and improving patient outcomes.”

Pandya AG, Hamzavi I, Yamaguchi Y, et al. Efficacy of Ritlecitinib for Vitiligo Treatment Stratified by Baseline Demographic and Clinical Characteristics: Post Hoc Analysis of a Phase 2b Study. JEADV Clinical Practice. 

Ezzedine K, Peeva E, King B, et al. Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trial. J Am Acad Dermatol. 2023 Feb;88(2):395-403. doi: 10.1016/j.jaad.2022.11.005. Epub 2022 Nov 9. Erratum in: J Am Acad Dermatol. 2023 Sep;89(3):639. doi: 10.1016/j.jaad.2023.04.001. PMID: 36370907.

Articles

Ritlecitinib has shown efficacy in treating non-segmental vitiligo across various patient subgroups up to 48 weeks. The drug, a selective dual inhibitor of JAK3 and TEC family kinases, is under phase 3 investigation. A post hoc analysis of a phase 2b study evaluated its efficacy based on baseline demographic and clinical characteristics. Results indicated clinically meaningful facial re-pigmentation, with some subgroup differences noted at 24 weeks but less apparent by 48 weeks. These findings may guide personalized therapeutic approaches and improve patient outcomes.

Ritlecitinib was evaluated for the treatment of non-segmental vitiligo (NSV) in different subgroups, stratified by demographics as well as various clinical characteristics.

Vitiligo

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Ritlecitinib Efficacious for Non-Segmental Vitiligo Across Various Subgroups

Stone is professor of medicine at Harvard Medical School and the Edward A Fox Chair in Medicine at the Massachusetts General Hospital. He has treated IgG4-related disease (IgG4-RD) since its emergence in recent years and is passionate about educating patients and fellow healthcare providers (HCPs) about the indolent and systemic nature of this disease.

Clinical Experience with Tocilizumab and Upadacitinib in GCA Treatment

This video covers the following questions:

Please share your clinical experience with tocilizumab and upadacitinib.

Let’s discuss treatment selection criteria for approved therapies. What patient subgroups would you consider for targeted agents, and what factors would contribute towards selecting one treatment over another?

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Clinical Experience with Tocilizumab and Upadacitinib in GCA Treatment 

Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

A new study demonstrated the association between inhaled corticosteroid discontinuation and a transient increase in moderate-to-severe exacerbations during the first quarter among patients with 

chronic obstructive pulmonary disease (COPD)

“This study reveals for the first time that [long-acting muscarinic antagonists (LAMA)] discontinuation results in potent withdrawal effects on exacerbations, while also reinforcing evidence of [inhaled corticosteroid] withdrawal effects,” wrote study investigator Alexander G. Mathioudakis, MD, PhD, from the biology department at The University of Manchester, and colleagues.

COPD affected approximately 480 million adults worldwide in 2020 and ranks as the 5th leading cause of years lost due to disability-adjusted life expectancy.

 By 2050, this number is projected to reach 600 million, driven by an aging population and increased exposure to air pollution and biomass.

Medication adherence in COPD is low, with only 20–30% of patients following prescribed treatments.

 Low medication adherence exacerbates disease progression, increases hospitalization risk, and worsens symptoms and quality of life. Poor adherence often leads to treatment discontinuation.

Discontinuing inhaled corticosteroids can trigger withdrawal effects and, consequently, a transient increase in exacerbations. Investigators performed a post-hoc analysis of the 52-week double-blind trial, Effect of Indacaterol Glycopyrronium versus Fluticasone Salmeterol on COPD Exacerbations (FLAME), which compared the long-acting beta-2 agonist (LABA) plus long-acting muscarinic antagonists (LAMA) with LAMA plus inhaled corticosteroids in 3362 patients with moderate-to-severe COPD and exacerbation history.

The trial stratified participants by baseline use of these therapies and compared outcomes between the first and subsequent quarters among those who continued versus discontinued each treatment. Multivariable mixed-effects models were used to evaluate differences in exacerbation rates, with temporal variations in treatment effects suggesting potential withdrawal effects.

The study found that discontinuing LAMA was associated with a transient increase in moderate-to-severe exacerbations during the first quarter versus subsequent quarters (

 =.001; rate ratio up to 2.2 (95% confidence interval [CI], 1.2 to 4.1) in the subgroup least influenced by concomitant ICS use. The study did not confirm this observation for only severe exacerbations, likely due to the low number of events.

However, the study found that discontinuing inhaled corticosteroids was associated with a significantly earlier increase in severe exacerbations (P = .023), though the difference in moderate-to-severe events was not statistically significant. Due to the insignificant data, the study could not demonstrate the inhaled corticosteroid withdrawal effect on moderate to severe exacerbations. The analysis saw consistent inhaled corticosteroid withdrawal effects regardless of baseline blood eosinophil count.

“These early peaks in exacerbations likely reflect withdrawal effects from LAMA and ICS, respectively,” investigators wrote.

The study observed a potentially strong LAMA withdrawal effect among patients who were only receiving LAMA (risk ratio, 2.7 to 3.7) or inhaled corticosteroids (risk ratio, 0.23 to 0.33) at baseline.

 Additionally, investigators said that inhaled corticosteroid withdrawal effects persisted beyond 4 weeks.

A sensitivity analysis, which only included participants who completed ≥ 300 days of trial treatment, also showed early peaks in exacerbations, although this was a less pronounced finding.

“Our results indicate that both LAMA and ICS have a potential treatment withdrawal effect on exacerbations that needs to be prospectively validated,” investigators concluded.

 “These findings emphasize the critical role of monitoring treatment adherence at every clinical visit and increasing awareness among both patients and healthcare professionals about the risks associated with intermittent use of maintenance COPD therapies. Finally, our study highlights the importance of accounting for potential withdrawal effects when evaluating treatment efficacy or effectiveness in clinical research.”

Mathioudakis AG, Bate S, Chatzimavridou-Grigoriadou V, et al. Disproportionate increase in COPD exacerbation risk for 3 months after discontinuing LAMA or ICS: insights from the FLAME trial. 

Medication adherence as the keystone in COPD management success. 

https://acarepro.abbott.com/articles/general-topics/medication-adherence-copd-management-success/

Inhaled corticosteroid (ICS) discontinuation in COPD patients is linked to a transient rise in moderate-to-severe exacerbations, particularly in the first quarter post-discontinuation. The study also highlights the withdrawal effects of long-acting muscarinic antagonists (LAMA), with a notable increase in exacerbations upon discontinuation. Medication adherence remains a challenge, with only 20-30% of COPD patients adhering to prescribed treatments, exacerbating disease progression. The findings underscore the importance of monitoring treatment adherence and considering withdrawal effects when evaluating treatment efficacy in clinical research.

Post-hoc analysis of the FLAME trial shows treatment discontinuation in COPD is associated with transient withdrawal effects and increased exacerbation risk.

Pulmonology

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Stopping Inhaled Corticosteroids or LAMA in COPD Linked to Early Exacerbations

Reflecting on the Trial Landscape in GCA and History of Approved Agents

Please provide an overview of clinical trial data for FDA-approved targeted therapies for GCA (such as tocilizumab and upadacitinib). (

Reflecting on the Trial Landscape in GCA and History of Approved Agents 

Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

Susan Weiner, MS, is a diabetes care and education specialist and the founder and owner of Susan Weiner Nutrition, PLLC.

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!

Diabetes Dialogue: Reviewing the New US Dietary Guidelines with Susan Weiner, MS

In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, welcome Susan Weiner, MS, a nationally recognized dietitian and diabetes care and education specialist, for an in-depth discussion of the newly released US Dietary Guidelines and the inverted food pyramid. The conversation is framed for clinicians navigating nutrition counseling in diabetes and cardiometabolic care, with a focus on how these recommendations translate - or fail to translate - into real-world practice.

00:01:00 The new food pyramid and a history of diet guidelines

00:03:36 Shortcomings of the new guidelines

00:14:55 How professional organizations deal with the guidelines

00:17:38 Linoleic acid in processed foods

00:30:32 Translating the guidelines for patients

Weiner begins by providing critical historical context, noting that the traditional food pyramid has not been used since 2011 and that the current changes effectively replace the MyPlate model rather than revising the pyramid. She explains that the Dietary Guidelines are updated every five years and are informed by an extensive scientific advisory report exceeding 400 pages, while the public-facing guidance consists of a condensed narrative and visual summary. A central theme of the discussion is the disconnect between these two documents, with Weiner highlighting that several evidence-based findings did not clearly carry through to the final recommendations.

The panel examines major shifts in emphasis, including an increase in recommended protein intake and greater prominence of animal-based foods and full-fat dairy. Weiner raises concerns about internal inconsistencies, particularly the continued recommendation to limit saturated fat to less than 10% of total calories while simultaneously promoting food patterns that could easily exceed that threshold. The group discusses how these recommendations may unintentionally displace fiber-rich foods such as fruits, vegetables, legumes, and whole grains—an issue of particular relevance for people with diabetes, cardiovascular disease, kidney disease, and those treated with GLP-1 receptor agonists.

Additional areas of ambiguity are explored, including the lack of explicit guidance on processed meats, minimal discussion of fiber targets despite references to gut health and fermented foods, and confusing messaging around sodium use. The episode also highlights the removal of specific quantitative alcohol limits, replaced by the vague directive to “drink less,” which Weiner argues weakens clinical counseling and may have downstream implications for public health messaging and policy.

The discussion broadens to consider equity, affordability, environmental impact, and feasibility, questioning how these guidelines will affect federal nutrition programs, school meals, and food access in resource-limited communities. The episode concludes with a call for clinicians to rely on individualized medical nutrition therapy and professional judgment, while anticipating that organizations such as the American Diabetes Association and American Heart Association may issue more targeted guidance in response to these controversial updates.

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Diana Isaacs, PharmD, and Natalie Bellini, DNP, are joined by Susan Weiner, MS, to discuss the recently released US Dietary Guidelines.

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Strategic Alliance Partnership

Analysis of > 9,000 FDA reports highlights previously unrecognized adverse events, including myocardial stunning, nerve damage, and real-world drug ineffectiveness.

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Sayna Norouzi, MD, is an assistant professor of medicine, clinical nephrologist, and founder and director of the glomerular disease and polycystic kidney disease clinics at Loma Linda University Medical Center.

The KDIGO 2025 guidelines update emphasizes a more aggressive approach to treating IgA Nephropathy.

2025 KDIGO Guideline Update for IgAN

Jennifer Manne-Goehler, MD, is a physician in the division of infectious diseases at Brigham and Women’s Hospital and the department of medicine at Mass General Brigham.

Manne-Goehler discusses a recent study highlighting the scope and scale at which GLP-1 receptor agonists can reduce obesity and its associated risks.

1 in 4 Adults Worldwide Eligible for GLP-1 Treatment for Obesity, With Jennifer Manne-Goehler, MD

Investigators ranked the short-term effectiveness of 4 oral JAKis, upadacitinib, abrocitinib, baricitinib, and ivarmacitinib in moderate-to-severe atopic dermatitis.

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Upadacitinib Outperforms 4 JAK Inhibitors in Atopic Dermatitis Meta-Analysis

CMTX-101 met safety endpoints in a phase 1b/2a cystic fibrosis study, with meaningful reductions in inflammatory biomarkers and pulmonary Pseudomonas aeruginosa burden.

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Pulmonary Fibrosis

CMTX-101 Shows Safety and Bacterial Reductions in Cystic Fibrosis Trial

Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

The FDA has extended its review of the sNDA, delaying the previous January 13, 2026, PDUFA date, to April 13, 2026.



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FDA Extends Sparsentan (Filspari) sNDA Review for Focal Segmental Glomerulosclerosis

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She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

An FDA review found no increased risk of SI/B associated with the use of GLP-1 RA medications, including liraglutide, semaglutide, and tirzepatide.

FDA Requests Removal of Suicidal Ideation and Behavior Warning From GLP-1 RA Therapies

Open-label RCT findings suggest a short-term, calorie-restrictive diet may be an effective intervention for mild and moderate Crohn’s disease.

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Fasting-Mimicking Diet Elicits Clinical, Biochemical Response in Mild Crohn’s Disease

Angel S. Byrd, MD, PhD, is an associate professor at Howard University College of Medicine.

This episode of Skin of Color Savvy was filmed on-site at the Skin of Color Society's 'Meeting the Challenge Summit' in Washington, DC.

Skin of Color Savvy: The Art and Science of Treating Patients of Color

Hosted by Skin of Color Society and produced by HCPLive, 

 delves into the latest research, clinical insights, and culturally intelligent care practices in dermatology with leading experts. 

Whether it’s groundbreaking research, practice-changing insights, or highlights from the SOCS community, this twice-monthly program provides dermatologists and care providers with expert perspectives on treating patients with skin of color.

Skin of Color Savvy: On-Site Interviews at the Meeting the Challenge Summit

Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

The KAI 12L program is now cleared to determine short PR interval, atrial bigeminy, ventricular bigeminy, left axis deviation, and right axis deviation.

Cardiology

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Latest News

Ritlecitinib Efficacious for Non-Segmental Vitiligo Across Various Subgroups

Clinical Experience with Tocilizumab and Upadacitinib in GCA Treatment

Stopping Inhaled Corticosteroids or LAMA in COPD Linked to Early Exacerbations

Reflecting on the Trial Landscape in GCA and History of Approved Agents

Diabetes Dialogue: Reviewing the New US Dietary Guidelines with Susan Weiner, MS