Dapirolizumab pegol (DZP) improved disease activity and fatigue in people with moderate-to-severe systemic 

 erythematosus (SLE), in new data from the phase 3 PHOENYCS GO trial.

These new data were presented at last month’s 

European Alliance of Associations for Rheumatology (EULAR) Congress 2025

 held in Barcelona, Spain, by Eric F. Morand, MBBS, Head of the Monash Health Rheumatology Unit, Monash University, Australia.

Morand and colleagues found that at Week 48, 40.9% of participants receiving DZP plus standard of care (SOC) achieved low disease activity, more than double the rate in the SOC-only group (19.6%; nominal* 

 <.0001). As early as Week 12, significantly more participants on DZP plus SOC achieved low lupus disease activity state (LLDAS) versus SOC alone (nominal* 

 <.05). Additionally, 23.6% of the DZP group maintained low disease activity in ≥50% of visits over 48 weeks, compared to 15.9% with SOC alone (nominal* 

 = .1042). At Week 48, 19.2% of participants receiving DZP achieved remission (DORIS criteria), compared to 8.4% in the SOC-only group (nominal* 

spoke with Morand to learn more about the findings and DZP’s potential in treating SLE. He also discussed the therapeutic potential of CD40L inhibition and the importance of minimizing glucocorticoid exposure.

With improvements in BICLA, disease activity, fatigue and others, from your perspective, what are the most meaningful findings and outcomes seen with DZP from PHOENYCS GO?

The BICLA and fatigue results are both equally exciting. BICLA is a validated way to measure response to therapy in an SLE trial and has been used to support the registration of anifrolumab - so these results are very supportive for the potential for DZP to be registered in the future. The Fatigue results are different - these symptoms are incredibly important to patients but have been very hard to impact on in the past…the potential to hit on disease activity AND fatigue with one therapy is really going to be welcomed by patients.

Can you discuss the significance of the LLDAS and DORIS remission endpoints in the context of SLE management today? How do you interpret the magnitude of benefit seen in these measures?

Attainment of treat to target goals is now enshrined in both the EULAR and ACR guidelines as the goal of treatment because these endpoints have been shown in study after study to be associated with improved long term outcomes including disease activity, flare, damage accrual, quality of life and even mortality. I think the gold standard for a modern lupus therapy should be to show that it safely increases attainment of these end points vs the comparator. In this EULAR abstract we can see very meaningful separation from placebo very soon after starting treatment with DZP, and strong and significant separation across time all the way to last visit.

Trials in lupus are hard, so we are left needing to interpret results that can only be reported with nominal significance. The LLDAS and remission analysis reported at EULAR were pre-specified analyses, not post hoc, so I think we can be pretty confident in them.

LLDAS and DORIS achievement requires tapering to low doses of glucocorticoids. Can you discuss why this is important for long-term SLE management?

The reason that glucocorticoid ceilings are included in both LLDAS and DORIS remission is that glucocorticoid use contributes in a dose-dependent way to net harm to patient including via damage accrual. Again, current guidelines stress minimizing glucocorticoid exposure and attainment of LLDAS and DORIS are validated metrics to ensure this is achieved while disease control is maintained.

What do these data tell us about the therapeutic potential of CD40L inhibition in SLE?

It is a positive phase 3 trial - evidence does not get much better than this. Trials in SLE are really hard to do, as the disease is heterogenous and endpoints disfavor success - this means a positive result has basically happened against the odds and is meaningful. How DZP fits into the treatment paradigm remains to be seen as the pipeline has lots of other interesting medicines in development which together will change the landscape very greatly in the next handful of years. Regardless, these data strongly suggest that CD40L has a real place in our care paradigm.

In your opinion, what gaps in current SLE care could DZP meaningfully address if approved and how could it potentially shift the treatment landscape?

Our current biologicals achieve LLDAS in only 30% of patients after one year, and remission in around half that - so it is clear there is a lot of room for improvement with the option of additional therapies to try. It isn’t currently possible to say one biologic is ‘better’ than another, but as we get used to the patient profiles that may respond differently to differently targeted medicines, or differences in safety profile that may influence our choice based on patients’ comorbidities, things will get clearer. On the basis that DZP clearly increases attainment of treatment goals, it will have a significant role if it gains regulatory approval.

REFERENCE
Dapirolizumab Pegol Phase 3 Data in SLE Presented at the Annual European Congress of Rheumatology (EULAR) Show Improvement in Fatigue and Reduction in Disease Activity. Biogen. News release. June 12, 2025. https://investors.biogen.com/news-releases/news-release-details/dapirolizumab-pegol-phase-3-data-sle-presented-annual-european

Articles

DZP Significantly Improves Disease Activity, Fatigue in People With SLE

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

Diabetes Dialogue: American Diabetes Association Trial Recap – Part 1

In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, recap some of the biggest clinical trials presented at the 

The episode begins by addressing the Vertex study, highlighting data on VX-880, an allogeneic stem cell-derived islet cell therapy for 

. Of the 12 participants with impaired hypoglycemia awareness and a history of severe hypoglycemic events, 10 achieved insulin independence with over 90% time in range at 12 months. Although the therapy requires immunosuppression, the results mark a major step toward a functional cure, with larger trials ongoing.

Next, Isaacs and Bellini discuss the ADJUNCT T1D trial evaluating semaglutide 1 mg weekly in adults with type 1 diabetes and obesity on AID systems. Semaglutide led to significant A1c reductions (–0.7%), an 8.8% increase in time-in-range, 10% average body weight loss, and reduced total daily insulin doses—without increasing time below range. Notably, 36% of participants met the composite endpoint, compared to 0% on placebo, reinforcing the need for broader access to GLP-1 therapies in type 1 diabetes.

Isaacs and Bellini also review the phase 3 ACHIEVE-1 trial of orforglipron, a novel, oral non-peptide GLP-1 receptor agonist. Orforglipron demonstrated A1c reductions of up to 1.6%, 76% target attainment (<7% A1c), and 8% weight loss without the fasting or timing restrictions of existing oral options. The hosts highlight its ease of use and potential to improve adherence and expand treatment access.

The episode highlights and emphasizes the increasing momentum behind innovative therapies in type 1 and type 2 diabetes. The rapid advancements of the last year may be priming the endocrinology field for even more progress in the future. Isaacs and Bellini preview more pivotal data to be covered in part two.

Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

Podcasts

Isaacs and Bellini cover 3 of the most pivotal trial results from the 85th annual American Diabetes Association conference in part 1 of this 2-part recap.

Credit: University of California, Riverside

At the 2025 Southern California Psychiatry (So Cal Psych) Conference from July 11 – 24 at Huntington Beach, California, Jerry McGuire, MD, director of the residency training and chair of psychiatry at the College Medical Center in Long Beach, California, presented on how to detect 

. It comes down to 1 thing: family history.

McGuire is also the founder and president of the Stuttering Treatment and Research Society (STARS), a non-profit organization that has raised over $10 million to help people who stutter and raise awareness for this neurological condition. In this interview, McGuire shared how to differentiate bipolar depression from MDD, causes and treatments for agitation, and how to treat anxiety or depression caused by stuttering.

: Today at the conference, you're talking about the difference between bipolar depression and MDD. Can you tell our audience how they tell the difference?

The key is cross-sectional. When you see someone and they're depressed, you can't tell necessarily. I wish in psychiatry we had blood tests or biomarkers, but [it] wouldn't be as much fun.

The best way we differentiate is by history, and sometimes not just from the patient, but from the family members or others around them. We look longitudinally back; if there's ever been a history of mania, then this depressive episode that we're looking at now would be a bipolar I depression. If there's history of only hypomanic episodes, and now we're looking at a depressive episode, then that would be bipolar 2 depression.

There are certainly other clues in our diagnostic schema. One, if a patient has had a… misadventure on an antidepressant, if they've been prescribed an antidepressant and they got worse, they got more agitated…that may be a clue that what you're dealing with is a bipolar depression. If there's a family history, unfortunately, of people passing from suicide, that may be a clue as well, and even sometimes coexistent substance use that patients with bipolar may, at times, self-medicate. It's important to look into these other co-existing factors that may give us clues that this is a bipolar depression, as opposed to a major depressive episode of major depressive disorder.

: Once you've made that determination, what kind of treatments are you going to consider?

We tailor our therapies based upon the diagnosis. One thing I've always tried to teach my residents, if your known treatments aren't working, is a diagnosis correct? Sometimes [after] 3 or 4 antidepressants… patients aren't responding, or they're getting worse. Is it really major depressive disorder? That's 1 clue.

Keep in mind that not many agents are approved for bipolar depression. Most of our agents that we talk about as mood stabilizers may be effective in preventing a manic episode or treating mania or mixed states. Our options are more limited when it comes to bipolar depression, and we do have some agents that are FDA-approved specifically for bipolar depression.

: You're also talking about agitation and dementia, which has been a big topic lately, right?

With agitation and dementia, our hands have been really tied as clinicians, because unfortunately, for years, patients [were] getting older, and we had nothing FDA approved to treat them. If anything, agents we were using were given a box warning not to use about the risk potentially of increased mortality, cerebrovascular adverse events with antipsychotic agents in patients with agitation associated with dementia.

Fortunately, we have one agent that is on label now, and that's been FDA approved for the treatment of patients with agitation associated with dementia due to Alzheimer's. It's nice to know that we have that option. Fortunately, it appears that we may have other options, BFD approved in the fairly recent future.

: Could there be something that's leading to the agitation? Has a patient, say, had a change in environment?

When we change the environment [of patients with dementia], they may become more restless, more agitated. Look for other things that could be leading to it. For instance, a co-morbid medical condition. Perhaps they have a urinary tract infection. Maybe this is a delirium, that there's some drug interaction [playing] a role. Maybe there's a slight infection, maybe there's a metabolic issue. So, before we go adding on another medicine, make sure that we know medically what's also going on for that patient. Make sure our patients are not in pain before we add something else [to the] board.

: What's the long-term prognosis and treatment strategy for someone with agitation dementia?

Right now, we have data that shows that we can treat this acutely. We do know that agitation, in and of itself, leads to a poor prognostic outcome for patients with dementia. We know our goal is to keep our patients in the least restrictive, most supportive environment we can. The longer we can keep them at home, surrounded [by] their family members, the better. The key is preventing those agitation episodes and treating them allows these individuals [to] have a better quality of life and to spend more time with their loved ones.

: For patients who come in and see a psychiatrist, maybe they are dealing with depression and anxiety as a result of their stuttering. What can psychiatrists do to help?

It's so important because [among] people [who stutter], over 80% may struggle with social anxiety. We also know that it's coexisting. Stuttering is a basal ganglia condition.

The key [is] to understand what treatments may make the underlying stuttering worse, and how best we can treat the underlying depression and anxiety, and attention issues. It's going to be a comprehensive approach, understanding we're developing, hopefully, newer treatments, that can help the core features of stuttering and then work toward cognitive behavioral and other forms of therapy, and even agents to treat the social anxiety or treat with the ADHD or the obsessive compulsive symptoms without worsening the underlying stuttering.

: Anything else that you want to talk about this, or anything else in psychiatry that you think is important for readers?

Well, I think what's important for individuals that psychiatry…is [often] misunderstood because we're dealing with really the most complex organ system, and that's the human brain. It's more difficult to understand than, say, the heart, the kidney.

As we learn more about neuroscience, the understanding will grow among healthcare professionals, and compassion will grow. We need better targeted treatments, and they're going to be personalized, not one size fits all, and so the diversity of what we see in psychiatric conditions will require that diverse treatment approach as well.

Differentiating bipolar depression from major depressive disorder (MDD) relies heavily on family history and longitudinal patient assessment. Misadventures with antidepressants and family history of suicide can indicate bipolar depression. Treatment options for bipolar depression are limited, with few FDA-approved agents. Agitation in dementia patients is challenging to manage, but recent FDA approvals offer new options. Environmental changes and co-morbid conditions can exacerbate agitation. For stuttering-related anxiety and depression, a comprehensive approach is essential, considering potential treatment impacts on stuttering. Psychiatry requires personalized, diverse treatment strategies due to the complexity of the brain.

At 2025 So Cal Psych, McGuire shared insights on diagnosing bipolar depression, treating agitation in dementia, and managing mental health challenges in patients who stutter.

How Family History Distinguishes Bipolar Depression From MDD, With Jerry McGuire, MD

 infection entering opioid use disorder (OUD) treatment in the United States, female sex and recent pregnancy are independent risk factors for reduced likelihood of direct-acting antiviral (DAA) prescription, according to findings from a recent study.

Leveraging data from the Merative MarketScan Commercial and Multi-State Medicaid Databases, the study found significant differences in DAA prescription between men and women, most starkly in women with recent pregnancy compared to men and women without recent pregnancy. Given findings illustrating challenges in postpartum linkage to HCV care, investigators suggest pregnancy could be a window of opportunity for HCV treatment that merits further research.

“People with hepatitis C are often asymptomatic for years after being exposed, so if you are young, otherwise healthy and have a new baby, getting prompt treatment may not be a top priority, especially if it is challenging to access,” said first study author Caroline Cary, a third-year medical student at WashU Medicine.

 “It’s imperative to make hepatitis C care more readily accessible to new moms considering the long-term consequences of the condition.”

According to the World Health Organization, an estimated 50 million people have chronic HCV infection, with about 1 million new infections occurring per year. HCV is commonly transmitted via injecting drug use through the sharing of injection equipment, which has become especially pertinent during the ongoing opioid epidemic, as well as from an infected mother to her baby.

Notably, postpartum linkage to care has been poor, with one study finding just 6% of women with Medicaid insurance with OUD and HCV infection received DAAs within 6 months of delivery.

To contextualize emerging data and evaluate the association between pregnancy in the past year and prescription of DAAs, investigators conducted a retrospective cohort study of individuals with HCV infection entering OUD treatment using the Merative MarketScan Commercial and Multi-State Medicaid Databases. The outcome variable of interest was the prescription of DAAs after the initiation of OUD treatment, with 

 defined as receiving a first-time prescription of ≥ 1 DAA.

The exposure variables of interest were sex and recent pregnancy status. To identify women with a recent pregnancy, investigators evaluated the previous 360 days for pregnancy status as > 1 claim for any pregnancy-related condition regardless of whether it culminated in live birth.

In total, the analysis included 22,347 episodes spanning 19,668 people with HCV infection who were initiating OUD treatment. This included 8864 men (45.1%), 7567 women without recent pregnancy (38.5%), and 3237 women with recent pregnancy (16.5%). Most of the sample (90.8%) was enrolled in Medicaid, among whom the majority were non-Hispanic White (89.2%).

A total of 7332 individuals (37.3%) were prescribed DAAs within 1 year of OUD treatment. Investigators noted men were the most likely to be prescribed DAAs (40.6%), followed by women without recent pregnancy (35.7%) and women with recent pregnancy (31.8%).

In adjusted analyses, men and women without recent pregnancy had greater rates of HCV treatment compared with women with recent pregnancy (adjusted hazard ratio [aHR], 1.18; 95% CI, 1.13–1.24; and aHR, 1.09; 95% CI, 1.04–1.13, respectively).

“In summary, our findings identify recent pregnancy as a barrier to HCV treatment and possible driver in observed sex-based disparities. Further research must be done to determine optimal care delivery strategies for pregnant and postpartum individuals,” investigators concluded.

“Given the challenges described regarding postpartum linkage to HCV care, we suggest that pregnancy could be a window of opportunity for HCV treatment that must be further studied.”

Cary CB, McCrary ML, Marks LR, et al. Association Between Sex and Recent Pregnancy and Hepatitis C Virus Treatment in People With Opioid Use Disorder. O&G Open. 

Washington University in St. Louis. Hepatitis C Treatment Is Not Reaching Some at-Risk Populations. Newswise. July 14, 2025. Accessed July 15, 2025. 

https://www.newswise.com/articles/hepatitis-c-treatment-is-not-reaching-some-at-risk-populations/?sc=mwhr&xy=10023887

World Health Organization. Hepatitis C. April 9, 2024. Accessed July 15, 2025. 

https://www.who.int/news-room/fact-sheets/detail/hepatitis-c

Jarlenski M, Chen Q, Ahrens KA, et al. Postpartum follow-up care for pregnant persons with opioid use disorder and hepatitis C virus infection. 

A recent study highlights that female sex and recent pregnancy are independent risk factors for reduced likelihood of direct-acting antiviral (DAA) prescription among individuals with hepatitis C virus (HCV) entering opioid use disorder (OUD) treatment. The study, using data from the Merative MarketScan databases, found significant disparities in DAA prescriptions, particularly among women with recent pregnancies. Despite the high prevalence of HCV, postpartum linkage to care remains poor. The study suggests that pregnancy could be a critical window for HCV treatment, warranting further research to optimize care delivery strategies for pregnant and postpartum individuals.

Female sex and recent pregnancy were independent risk factors for reduced likelihood of DAA prescription among people with HCV entering opioid use disorder treatment.

Female Sex, Recent Pregnancy Linked to Poor HCV Treatment Rates in Opioid Use Disorder

New findings suggest that while serum interleukin (IL)-13 levels are lower in patients with 

 compared to healthy controls, suggesting IL-13 maintains a complex role in disease pathogenesis, IL-13 levels do not correlate with bullous pemphigoid severity or prognosis.

Marwan Dawood, MD, from the Department of Dermatology at Rambam Health Care Campus in Israel, led a team of investigators who authored this analysis. Dawood et al highlighted that bullous pemphigoid is the most commonly seen autoimmune blistering disease, with prevalence that has reportedly risen in recent years.

“Our study aimed to compare IL-13 levels between DPP4-induced [bullous pemphigoid] and non-triggered [bullous pemphigoid], as well as to compare these levels with those of healthy controls and pemphigus patients,” Dawood and colleagues wrote.

The investigative team's retrospective cohort study involved an assessment of adult patients diagnosed with bullous pemphigoid between 2008 - 2023, specifically among those given a diagnosis at the dermatology department of Rambam Hospital in Haifa, Israel. Through a clinical evaluation alongside positive findings from direct immunofluorescence (DIF), specifically IgG deposition along the basement membrane, these diagnoses were confirmed. Those deemed as eligible participants were adults ≥18 years who also had a confirmed diagnosis shown to be supported by clinical, histopathological, and immunological evidence.

There were 12 healthy individuals and 4 patients with pemphigus vulgaris in the control arm of the analysis. Healthy controls were matched to subjects with bullous pemphigoid by sex and by age to diminish the possibility of demographic bias. Notably, the investigators found that none of those in the control arm had a personal history of autoimmune or inflammatory conditions. 

Serum samples, after being obtained from all study participants at the time of diagnosis, frozen prior to the initiation of any BP-specific treatment at −80°C until additional analyses were required. IL-13 levels were quantified by Dawood and colleagues via a commercially available IL-13 ELISA kit, with measurements being done at a single time point rather than throughout treatment.

The primary aim of Dewad and coauthors' assessment was to evaluate serum IL-13 concentrations and their relationship with etiology of bullous pemphigoid, with peripheral eosinophil counts, with the requirements for adjunctive treatment, and with mucosal involvement. Using electronic medical records, they collected clinical and laboratory data such as demographic characteristics, disease origin, treatment information, and results of patients' blood tests.

Overall, the investigators concluded that mean serum IL-13 levels were significantly lower among those with bullous pemphigoid (n=42; mean 62.46 pg/mL ± 16.53) compared to healthy controls (n=12; mean 87.83 pg/mL ± 8.87, 

 < .0001) and compared to those with pemphigus vulgaris (n=4; mean 87.6 pg/mL ± 5.16, 

 Within the bullous pemphigoid subgroup, it was noted that subjects with idiopathic bullous pemphigoid showed higher IL-13 levels versus those with DPP4-inhibitor–associated bullous pemphigoid (67.01 pg/mL ± 14.3 versus 57.36 pg/mL ± 21, 

The team did not observe any statistically significant associations between IL-13 levels and eosinophil counts (Pearson’s r = .18, 

 = .338), utilization of adjuvant therapy (

 = .32), or patients' disease prognosis (

 = .45). However, they did find a significant link between elevated eosinophil counts and the need for adjuvant treatment (

“This study highlights the significant variability in serum IL-13 levels among [bullous pemphigoid] patients, distinguishing idiopathic and DPP4i-induced [bullous pemphigoid],” the team concluded.

 “...With the emergence of anti-IL13 biologics, our findings emphasize the need for further research into IL-13's role in [bullous pemphigoid] pathogenesis and treatment, towards the development of future personalized approaches in [bullous pemphigoid] management.”

RL Colbert, DM Allen, D Eastwood, et al. “Mortality Rate of Bullous Pemphigoid in a US Medical Center,” Journal of Investigative Dermatology 122, no. 5 (2004): 1091–1095, 

https://doi.org/10.1111/j.0022-202X.2004.22504.x

Dawood M, Saleh ZA, Boyango I, et al. The Complex Role of IL-13 in Bullous Pemphigoid: New Insights From a Retrospective Cohort Study. JEADV Clinical Practice. 

Serum interleukin (IL)-13 levels are lower in bullous pemphigoid (BP) patients compared to healthy controls, but do not correlate with disease severity or prognosis. A retrospective cohort study led by Marwan Dawood, MD, analyzed IL-13 levels in BP patients, including those with DPP4-inhibitor–associated BP, and compared them to healthy controls and pemphigus vulgaris patients. The study found significant variability in IL-13 levels among BP patients, highlighting the need for further research into IL-13's role in BP pathogenesis and treatment.

This analysis suggests serum IL-13 levels are lower in bullous pemphigoid patients than in healthy controls and pemphigus vulgaris patients.

Study Highlights Complex Role of IL-13 Among Patients with Bullous Pemphigoid

New research is shedding light on a high prevalence of sarcopenia among patients with 

 receiving dialysis, especially those on hemodialysis.

The systematic review included 62 studies with > 15,000 participants and determined the global prevalence of sarcopenia to be 30.1% for hemodialysis and 20.5% for peritoneal dialysis. Investigators additionally noted differences in prevalence based on which criteria was used and the timing of lean muscle mass (LMM) measurement.

Defined as the gradual loss of muscle mass, strength, and function, sarcopenia commonly affects the elderly population and is widely attributed to aging. However, chronic diseases like 

, cancer, and HIV have also been identified as potential causes and exacerbating factors of sarcopenia.

“Although several studies have reported the prevalence of sarcopenia in the CKD and dialysis population, there remains a significant lack of quantitative syntheses focusing on dialysis modality assessment criteria, timing of assessment, and the tools used for measuring muscle mass,” Ritin Fernandez, a professor at the University of Newcastle and assistant dean (International) at the College of Health, Medicine, and Wellbeing, and colleagues wrote.

 “This gap limits the ability to draw meaningful comparisons and inform clinical practice.”

To address this gap in research, investigators systematically searched Ovid MEDLINE, Embase, Allied and Complementary Medicine Database, CINAHL, and Scopus electronic databases for studies assessing sarcopenia in adults ≥ 18 years of age with CKD undergoing dialysis.

Investigators retrieved an initial 174 articles, 62 of which met the inclusion criteria. These studies involved 15,382 participants (ranging from 20 to 3196 in each study), the majority of whom were receiving hemodialysis treatment (92%). All studies were published in the last 10 years, predominately in China (22%), Japan (19%), Korea (8%), and Taiwan (6%).

Results showed the global prevalence of sarcopenia was 30.1% (95% CIm 25.6%–39.9%; 

2: 97.1%) among people receiving hemodialysis and 20.5% (95% CI, 15.1–26.4%; 

2: 80.0%) among people receiving peritoneal dialysis. Investigators noted sarcopenia prevalence ranged from 23.1%-30.3% in hemodialysis and from 6.1%-26.9% in peritoneal dialysis based on the assessment criteria used.

To assess the effect of the timing of LMM assessment, investigators categorized studies using bioimpedance analysis (BIA) or bioimpedance spectroscopy (BIS) into pre- and post-dialysis. A total of 10 studies (n = 5177) investigated the LMM pre-dialysis with a sarcopenia prevalence of 24.2% (CI, 14.8%–35%; 

2: 97.8%). When the same instrument was used post-dialysis (14 studies, 

 = 3502), the prevalence of sarcopenia was 33% (CI, 24.7%–41.7%; 

Further analysis revealed measuring muscle mass after dialysis using dual-energy X-ray assessment yielded a lower prevalence of sarcopenia (22.5%; CI, 12.9–33.8; 

2: 93.3%) than BIA/BIS (33%; CI, 24.7–41.7; 

Investigators identified age, sex, diabetes, inflammation markers, nutritional indices, and dialysis vintage as risk factors for sarcopenia in the hemodialysis population but called attention to high heterogeneity between studies.

“There is a need for additional research to assess the practicality of various assessment tools and the role of other measurements or predictors of low muscle mass, strength, and sarcopenia,” investigators concluded.

 “Global research would benefit from the development of a single criterion to be applied to dialysis patients and standardize screening tools for this population.”

Stockings J, Heaney S, Chu G, et al. Prevalence and Risk Factors of Sarcopenia in People Receiving Dialysis: A Systematic Review and Meta-Analysis. 

Cleveland Clinic. Sarcopenia. June 3, 2022. Accessed July 15, 2025. 

https://my.clevelandclinic.org/health/diseases/23167-sarcopenia

Sarcopenia, characterized by the loss of muscle mass, strength, and function, is prevalent among chronic kidney disease (CKD) patients undergoing dialysis, particularly hemodialysis. A systematic review of 62 studies involving over 15,000 participants found a global sarcopenia prevalence of 30.1% in hemodialysis and 20.5% in peritoneal dialysis. Variability in prevalence was noted based on assessment criteria and timing of lean muscle mass measurement. The study highlights the need for standardized assessment tools and criteria to improve clinical practice and research in this population.

Sarcopenia was most prevalent among those on hemodialysis, but prevalence varied based on assessment criteria and timing of lean muscle mass measurement.

Sarcopenia Highly Prevalent Among Dialysis Patients, Study Finds

A new study has found that low oral health (OH) was correlated with more 

“This is the first study to investigate OH, oral microbiota and pain commonly experienced in women with fibromyalgia, with our study showing a clear and significant association between poor OH and pain," lead investigator Joanna Harnett, BHSc, MHSc, PhD, Associate Professor, University of Sydney, and Charles Perkins Centre's oral and systemic health research node, said in a statement.

Harnett and colleagues collected data on OH using the WHO OH questionnaire. They also determined body pain, migraine, and abdominal pain using validated instruments including short-form 36 (SF36) domain ‘bodily pain’ (SF36-BP), widespread pain index (WPI), headache symptom questionnaire (HSQ), and functional bowel disorder severity index (FBDSI). They evaluated saliva samples using metatranscriptomics for relative gene abundance. Lastly, they analyzed demographic and clinical characteristics for relationships between OH scores, pain measures, and the oral microbiota at 3 taxa levels.

The analysis included 168 women from Auckland, New Zealand, from December 2021 to December 2022, data from 158 that oral microbiome data were available for were included from the analysis. The healthy eating index was weakly correlated with OH (ρ = .205 [

 = .01; 95% CI, 0.05–0.35]), and inversely with BMI (

The investigators found that participants in the lowest quintiles for OH were more likely to suffer migraine headaches (χ2 = 23.24, df 4, 

 <.001) and higher body pain scores. Specifically, inverted SF36-BP had a ρ of -0.552 (95% CI, -.66 to -.43; 

<.001), WPI had a ρ of -0.555 (95% CI, -.66 to -.43; 

<.001), and migraine symptom score had a ρ of -.388 (95% CI, -.52 to -.241; 

<.001), and FBDSI had a ρ of -.475 (95% CI, -.59 to -.34; 

Participants with migraine had significantly lower OH scores compared to those without migraine (mean,188.0; standard deviation [SD], 16.8 vs 199.0; SD, 14.7; 

 <.001; 95% CI, −15.7 to −1.6). Lower OH scores were associated with greater migraine burden, with higher prevalence of both frequent and chronic migraine in lower OH groups (χ² = 34.8, df = 12; P <.001). A Kruskal–Wallis H test confirmed a significant overall association between migraine type and OH score (H = 24.5, df = 3; 

 <.001), particularly between non-migraine and both frequent and chronic migraine groups (all P ≤.001 after Bonferroni correction).

Logistic regression showed OH score was a significant inverse predictor of migraine frequency. Each unit increase in OH score was associated with lower odds of frequent (OR = 0.95; 

 <.001) and chronic migraine (OR = 0.92; 

 <.001). Higher BMI also significantly increased odds of frequent (OR = 1.10; 

 = .003) and chronic migraine (OR = 1.13; 

 = .004), while age was not a significant factor.

FBDSI severity was similarly linked to OH scores. A Kruskal–Wallis H test revealed a significant difference in OH by bowel disorder severity (H = 42.5, df = 3; P <.001), with post hoc tests confirming lower OH scores among those with mild, moderate, and severe FBDSI compared to participants without functional bowel disorders (all comparisons 

Looking at oral microbiota, they found that 4 oral pathogenic species were significantly associated with SF36 bodily pain (q <.05) after controlling for confounders (Parvimonas micra, Solobacterium moorei, Dialister pneumosintes, and Prevotella denticola). Relative abundance of Gardnerella (genus) correlated moderately with OH scores (ρ = −0.346, q = 0.001), while Lancefieldella (genus) and Mycoplasma salivarius were associated with migraine.

“Our findings are particularly important to fibromyalgia which, despite being a common rheumatological condition, is often underrecognised,” investigator Sharon Erdrich, PhD candidate in the Faculty of Medicine and Health at University of Sydney added.

 “Fibromyalgia is a chronic condition characterised by widespread musculoskeletal pain, and headaches including headaches, as well as fatigue, sleep disturbances, and cognitive problems."

Erdrich S, Gelissen IC, Vuyisich M, Toma R, Harnett JE. An association between poor oral health, oral microbiota, and pain identified in New Zealand women with central sensitisation disorders: a prospective clinical study. Frontiers in Pain Research. 2025;6. doi: 10.3389/fpain.2025.1577193

Poor oral health linked with body pain and migraines in women. The University of Sydney. Published 2025. Accessed July 15, 2025. https://www.sydney.edu.au/news-opinion/news/2025/04/10/poor-oral-health-linked-with-body-pain-and-migraines-in-women--.html

A recent study has identified a significant correlation between poor oral health and increased migraines and body pain in women, particularly those with fibromyalgia. Researchers utilized various validated instruments to assess oral health, body pain, and migraines, and analyzed saliva samples for oral microbiota. Findings revealed that lower oral health scores were associated with higher migraine frequency and body pain, with specific oral pathogens linked to pain measures. The study underscores the importance of oral health in managing pain conditions like fibromyalgia, which is often underrecognized.

A study reveals a significant link between poor oral health and increased migraines and body pain in women, highlighting implications for fibromyalgia management.

Oral Health and Body Pain, Migraines Significantly Correlated in Women

A new study showed that early introduction of baked milk supports c

 resolution in young children with baked milk tolerance.

The Food Allergy Research & Education (FARE) reported that approximately 70% of children with cow milk allergy tolerate baked cow milk.

 Children who are allergic to fresh milk, but not baked milk, may be more likely to outgrow their milk allergy at an earlier age than children who react to baked milk. FARE states on their website that when a person with a milk allergy is exposed to milk, the milk proteins bind to specific IgE antibodies in the body, triggering immune defenses.

Evidence shows baked milk intake accelerates cow’s milk allergy resolution and leads to immunity in baked milk-tolerant and baked milk-allergic phenotypes.

Investigators, led by Olga Domínguez, PhD candidate, from the pediatric allergy and clinical immunology department at Hospital Sant Joan de Déu in Barcelona, Spain, sought to assess the efficacy, safety, and immunological effects of baked milk introduction, both in regular and low doses, and their impact on tolerance development.

The 12-month prospective study included 50 children aged 12 – 72 months with cow’s milk allergy confirmed by an oral food challenge. Children were categorized as either baked milk tolerant (n = 32) or allergic (n = 18) based on baked milk oral food challenge results. The study identified several predictors of baked milk tolerance: early age (< 24 months), baked milk consumption, no asthma, immunological markers of sIgE, skin prick test, sIgG4, and reduced basophil activation test reactivity.

Children who were baked milk-tolerant were randomized into 2 groups: B2 (daily intake of 0.55 g baked milk protein) and C2 (strict avoidance of baked milk). Children allergic to baked milk who could tolerate the minimal dose were randomized to B1 (daily intake of 0.0375 g baked milk protein) and C1 (strict avoidance of baked milk). Baked milk doses doubled at 6 months.

The team collected data on skin prick tests, specific IgE, specific IgG4, basophil activation test, and T-cell cytokine profile at baseline and 12 months.

The daily baked milk intake signficantly enhanced cow’s milk tolerance among baked milk-tolerant children who took 0.55 g baked milk protein daily vs children who avoided it (77.2% vs 40%; P < .05). Not only did baked milk intake increase cow’s milk tolerance, but these children had improved safety and marked reductions in skin prick testing and sIgE markers. Baked milk intake led to a 9-fold increase in reactivity thresholds (0.9 g vs 0.05 g).

Baked milk-allergic children had no significant increase in tolerance. Only 9.3% of children in the analysis experienced mild home reactions.

“Early [baked milk] introduction appears to support [cow’s milk allergy] resolution in [baked milk-tolerant] and may enhance safety, particularly in young children,” investigators concluded. “Regular [baked milk] consumption could contribute to better outcomes, while biomarkers offer valuable insights for personalized management.”

Domínguez O, Poyatos E, C Riggioni, et al. Baked-Milk Modulates Cow's Milk Allergy in Children: Impact of Phenotype, Age, Intake. 

. Published online June 18, 2025. doi:10.1016/j.jaip.2025.06.011

Milk Allergy. Food Allergy Research & Education. 

https://www.foodallergy.org/living-food-allergy/food-allergy-essentials/common-allergens/milk. Accessed July 14

A recent study indicates that early introduction of baked milk can aid in resolving cow's milk allergy in young children who tolerate baked milk. Approximately 70% of children with cow's milk allergy can tolerate baked milk, potentially leading to earlier resolution of the allergy. The study, involving 50 children, assessed the efficacy and safety of baked milk introduction. Results showed that daily intake of baked milk significantly improved cow's milk tolerance in baked milk-tolerant children, with enhanced safety and reduced allergic markers. However, no significant tolerance increase was observed in baked milk-allergic children.

Daily intake of baked milk significantly improved tolerance and immune markers in young children with baked milk tolerance, according to a 12-month study.

Early Baked Milk Introduction Speeds Cow’s Milk Allergy Resolution in Children

Examining APP-Led Endobronchial Valve Therapy for COPD, with Haley Hoy, PhD, CRNP

Advanced practice practitioners (APPs) can have a valuable role in pulmonary care and specifically chronic obstructive pulmonary disease (COPD). One analysis looking into an APP-led care model for patients with COPD was presented at the 2nd Annual Association of Pulmonary Advanced Practice Providers (APAPP) conference, held June 26-28, 2025, in Nashville, Tennessee, by Haley Hoy, PhD, CRNP, professor of nursing at University of Alabama Huntsville and nurse practitioner and transplant coordinator at Vanderbilt University.

spoke with Hoy to learn more about her experience with APP-led care models and how these, in combination with patient-centered strategies, can significantly change the trajectory of treatment, particularly for patients being evaluated for endobronchial valve therapy in rural settings. She reflected on her experience coordinating care in a rural outreach clinic, where transportation barriers and limited specialty access often delay interventions, and emphasized that in some settings, APPs can accelerate diagnosis, streamline referrals, and advocate for appropriate treatment in complex pulmonary cases.

“I think both in outreach, patient education and patient advocacy are places where a PPS make a big difference,” Hoy said.

She also discussed findings from the analysis, presented in a poster at last month’s meeting, that examined how different coordinator roles shape the diagnostic process, care timelines, and team-based efficiency.

“It was interesting to be a little more granular in our approach as to, when it comes to an endobronchial valve clinic, how you can better utilize people working at their scope of practice,” she said.

Hoy H, Priebe R. Bronchoscopic Lung Volume Reduction with Endobronchial Valves: Advancing COPD Care Through APP-Led Coordination. Presented at: APAPP 2025, June 26-28, 2025; Nashville, Tennessee.

Videos

Explore how advanced practice practitioners enhance COPD care through innovative models, improving patient outcomes and addressing rural healthcare challenges.

A new review has been published highlighting different studies’ findings on the use of various 

 among breastfeeding mothers, with a detailed discussion provided on each medication’s transference to breast milk, blood serum levels in infants, potential adverse events among neonates, and other clinical considerations.

These data were all authored by a team of investigators, led by Carli D. Needle, an MD candidate at The Ronald O. Perelman Department of Dermatology at New York University’s Grossman School of Medicine. Needle et al noted that alopecia areata, androgenetic alopecia (AGA), and cicatricial alopecia can each lead to negative physical symptoms and notable psychological distress among patients and women in particular.

“Given the limited research in this area and the importance of avoiding interruptions in alopecia treatment, this review aims to help guide clinicians in choosing safe and appropriate hair loss therapies for women during lactation,” Needle and coauthors wrote.

The trial investigators carried out their literature searches using the Scopus, PubMed, and Web of Science databases. Searches were done only in English. Existing safety databases such as the Drugs and Lactation Database (LactMed) and the United States Food and Drug Administration (FDA) Drug Database were also used by the team, and any primary literature cited by these databases was further examined when accessible. Terms included the medication names and classes assessed by this review, as well as “lactation” and “breastfeeding.” Searches were done from November 2024 - December 2024.

The investigators noted the increasing systemic and topical medication use in alopecia treatment. The hair regrowth medication minoxidil is generally classified as low-risk during lactation, with oral being documented in breastfeeding mothers without complications. Nevertheless, because of possible transmission through skin contact or milk, cautious utilization of minoxidil is still being advised, especially in premature infants or neonates.

Needle and coauthors highlighted that Janus kinase inhibitors (JAKi), which reduce inflammation by targeting T-cell signaling pathways, are among some of the most effective. Approved JAKis for alopecia areata include baricitinib, deuruxolitinib, and ritlecitinib. As a result of their small molecular size, JAK inhibitors can pass into breast milk, contributing to concerns about infant exposure.

Tofacitinib appears in human breast milk within hours of ingestion, leading to current guidelines to avoid breastfeeding while implementing it. For other JAKis, such as baricitinib and ritlecitinib, lactation safety data are limited, though pharmacokinetic modeling suggests drug levels fall below clinical significance within several half-lives. Given uncertainty, those using such drugs are typically advised to pause breastfeeding during active JAKi use.

Needle and colleagues pointed to a variety of other research, noting different recommendations based on the drugs available for alopecia. Methotrexate, for example, only enters breast milk in small amounts but its active metabolite can linger in neonatal tissues as a result of immature infant kidney function. Even low levels of exposure is linked to potential developmental toxicity, so methotrexate is contraindicated during breastfeeding.

Other data highlighted by the investigative team included diphencyprone (DPCP), a topical option often used in alopecia areata that also acts as a contact allergen, triggering localized immune responses to encourage hair regrowth. Despite noted minimal systemic absorbtion, rare reports of DPCP entering circulation do exist. The lack of robust data, the team suggest, suggests a need for caution until further research is available.

The investigators further highlighted azathioprine that is now applied in autoimmune dermatologic conditions, noting that most experts recommend waiting a few hours after dosing before breastfeeding to allow peak concentrations of the medication to subside. They further pointed to cyclosporine, adding that variable transmission into breast milk has been observed with the drug and largely depends on the formulation. Generally, cyclosporine is considered compatible with breastfeeding, though infants should be monitored for potential adverse effects.

The Excimer laser, a narrow-band ultraviolet B (NB-UVB) therapy used to manage autoimmune scalp conditions, was noted as effective and generally safe, though folate supplementation was highlighted as necessary for consideration in postpartum mothers given this treatment. Needle et al pointed to data suggesting poor absorbtion of topical vitamin D analogues like calcipotriene during lactation, but noted that oral vitamin D is safe up to 10,000 IU daily, and supplementation in the mother may benefit infants given low levels of breast milk vitamin D.

A recent review examines the safety of alopecia treatments for breastfeeding mothers, focusing on drug transfer to breast milk, infant serum levels, and potential neonatal adverse events. The review highlights the need for clinicians to make informed decisions about alopecia therapies during lactation, considering the limited research available. Various treatments, including minoxidil, JAK inhibitors, methotrexate, and others, are discussed in terms of their safety profiles and recommendations for breastfeeding mothers. The review emphasizes the importance of understanding systemic absorption risks to provide safe treatment options for lactating patients.

This review provides guidance to clinicians in choosing effective and safe alopecia therapies during breastfeeding periods.

All News