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/

Articles

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.

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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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Diabetes Dialogue

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Strategic Alliance Partnership

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.

Once-daily oral ICP-332 therapy has demonstrated notable efficacy and a favorable safety profile in the treatment of patients with 

Jinhua Xu, PhD, of Fudan University’s Huashan Hospital in Shanghai, authored this paper alongside a team of other investigators, and it was published in 

. Xu and coauthors set out to assess ICP-332, a tyrosine kinase 2 (TYK2) inhibitor, in moderate to severe atopic dermatitis.

This oral small-molecule TYK2 inhibitor was formulated to selectively bind to the TYK2 catalytic domain JH1. The drug can help to block signal transduction of inflammatory cytokines among patients.

 It was evaluted by the investigators in this new, phase 2 study.

“Herein, we evaluate the safety and efficacy of ICP-332 in patients with moderate to severe [atopic dermatitis] in a double-blind, placebo-controlled phase 2 randomized clinical trial,” Xu and colleagues wrote.

Xu et al’s phase 2 randomized clinical trial implemented a double-blind, placebo-controlled, multi-center design, with their research being conducted across 19 clinical sites within China. The study took place between February - November 2023. A screening phase was included during the protocol, lasting up to 35 days. This was followed by a 4-week double-blind treatment period and then a safety follow-up period lasting 28 days.

Adults between 18 - 75 years of age were considered eligible if they had a documented history of atopic dermatitis for a single year minimum prior to the initial dose of ICP-332. The diagnosis of this condition was confirmed at the time of patient screening via the Williams criteria. Subjects were required, to qualify as having moderate to severe disease, to have an Eczema Area and Severity Index (EASI) score of 16 or greater. They would also have to show involvement of at least 10% of body surface area as well as a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 3 or greater at the point of baseline.

Race and ethnicity were self-identified by participants and collected to explore whether these factors influenced treatment outcomes. Eligible individuals also needed a documented inadequate response to topical corticosteroids or topical calcineurin inhibitors, defined as use for a minimum of 4 weeks within the year prior to screening, or a clinical reason that made topical therapy inappropriate. To minimize confounding effects from prior therapies, use of Janus kinase inhibitors or other biologic agents within 12 weeks before the first dose was not permitted, and conventional systemic treatments were prohibited within 4 weeks of study entry.

In a 1:1:1 ratio, participants were randomly assigned to be treated with oral ICP-332 at a 80 mg dose, at 120 mg, or placebo once-per-day for 4 weeks. The trial subjects and study investigators remained blinded to treatment allocation throughout the study’s double-blind period. Safety served as the analysis’s main endpoint. Xu and coauthors’ principal efficacy endpoint was the percentage change from baseline in participants’ EASI score at the 4-week mark. Among other efficacy assessments, the team also evaluated the proportion of participants attaining at least a 75% reduction in EASI (EASI-75) and the proportion achieving a vIGA-AD score of 0 (clear) or 1, with an improvement of at least 2 points from the point of baseline.

There were 75 patients recruited in Xu et al’s study. ICP-332 demonstrated a favorable safety profile among these patients, with most adverse events (AEs) classified as mild in their level of disease severity. There were no instances of death or any AEs considered to be serious taking place during the analysis. By the 4-week mark, mean placebo-adjusted EASI reductions from baseline were −61.6% for individuals on 80 mg of ICP-332 and −55.8% for those in the 120-mg dosing cohort. These findings indicated substantial disease severity improvements compared with placebo.

“In this phase 2 randomized clinical trial, ICP-332 monotherapy was efficacious and demonstrated a favorable benefit-risk profile compared with placebo in adults with moderate to severe [atopic dermatitis], supporting initiation of larger randomized, controlled, phase 3 studies to confirm its potential as an effective treatment for this population,” the team concluded.

Xu J, Zhang L, Liang Y, et al. Safety and Efficacy of ICP-332 for Moderate to Severe Atopic Dermatitis: A Phase 2 Randomized Clinical Trial. JAMA Dermatol. Published online January 14, 2026. 

Brandt EB﻿, Sivaprasad U﻿. Th2 cytokines and atopic dermatitis. J Clin Cell Immunol. 2011;2(3):110. doi:10.4172/2155-9899.1000110.

Once-daily oral ICP-332 therapy has shown significant efficacy and a favorable safety profile in treating moderate to severe atopic dermatitis. Conducted across 19 clinical sites in China, the phase 2 double-blind, placebo-controlled trial involved 75 patients. Participants were randomly assigned to receive either 80 mg, 120 mg of ICP-332, or placebo. The primary endpoint was safety, while efficacy was measured by changes in EASI scores. Results indicated substantial improvements in disease severity, supporting further phase 3 trials to confirm its potential as an effective treatment.

Once-daily treatment of atopic dermatitis with oral ICP-332 showed a favorable safety profile and meaningful efficacy in a new study.

Atopic Dermatitis

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ICP-332 Effective, Safe for Treating Moderate to Severe Atopic Dermatitis

Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

Experts discussed how biologics revolutionize asthma and COPD management, emphasizing personalized treatment strategies and proactive care.

From GOLD to Ground Level: Navigating Biologic Use in COPD Care

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.

A retrospective analysis does not link gentamicin with decreased risks of urinary tract infections after kidney transplantation.


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Gentamicin May Not Reduce Post Kidney Transplant Urinary Tract Infection Risk 

A study found that bronchodilator responsiveness more accurately forecasts FEV₁ decline and COPD development than polygenic risk scores.

Bronchodilator Response Outperforms Genetic Risk in Predicting COPD Progression

Jamie Scott, PhD, is an EiC senior chemist at the University of Edinburgh.

Scott describes current unmet needs in IBD diagnosis and monitoring but points to the potential of a new GzmA activity-based optical assay.

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Advancing Noninvasive Diagnostics for Inflammatory Bowel Disease, With Jamie Scott, PhD

Despite an OTC approval in 2023, recent data highlights a carry rate of only 10% in the general population.

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FDA Approves New Narcan Packaging, Aiming to Boost Carry Rates

Roxana Mehran, MD, is a professor of medicine and director of interventional cardiovascular research and clinical trials at the Zena and Michael A. Wiener Cardiovascular Institute at the Icahn School of Medicine at Mount Sinai.

Mehran addresses roadblocks to inclusivity in new drug trials, emphasizing the need for a more diverse patient population for more broadly applicable evidence.

Cardiology

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Making Cardiology Trials Work for Every Patient, With Roxana Mehran, MD

Global analysis links elevated BMI and low physical activity to rising hypertension-related chronic kidney disease burden, with deaths projected to increase through 2050.


Hypertension

The HCPLive hypertension page is a resource for medical news and expert insights on high blood pressure. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for hypertension, and more.

Elevated BMI and Physical Inactivity Drive Rising Global Hypertension-CKD Burden

Both ethnicity and skin phototype were found in this analysis not to independently influence patients’ level of atopic dermatitis severity or their quality of life (QoL).

Pediatric Eczema Severity, Quality of Life Not Influenced by Phototype, Ethnicity

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.

This episode focuses on translating clinical evidence into everyday treatment decisions.

Evolving Therapeutic Strategies and Real-World Application in IgAN

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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Latest News

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

ICP-332 Effective, Safe for Treating Moderate to Severe Atopic Dermatitis