The US Food and Drug Administration (FDA) has approved GSK’s depemokimab-ulaa (Exdensur

 as an add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients ≥ 12 years of age.

As described in a December 16, 2025, release from the Company, the decision was based on data from the phase 3 SWIFT-1 and SWIFT-2 trials showing sustained exacerbation reduction with 2 doses per year versus placebo, both plus standard of care.

“Current biologic treatments for asthma are often underutilised and frequent injections can be inconvenient for many patients and lead to inconsistent use. There is clearly an opportunity to provide a longer duration of protection from exacerbations between injections for severe asthma patients that reduces the frequency of doses and may improve overall health care utilisation,” Geoffrey Chupp, MD, Professor of Medicine, Pulmonary, Critical Care and Sleep Medicine, Yale University, said in a statement.

could empower physicians and patients to potentially achieve their treatment goals with fewer injections.”

Depemokimab-ulaa is the first ultra-long-acting biologic being evaluated for certain respiratory diseases with underlying type 2 inflammation, such as severe asthma. It has been developed with an extended half-life to enable twice-yearly dosing.

SWIFT-1 and SWIFT-2 assessed the efficacy and safety of depemokimab adjunctive therapy in 382 and 380 participants with severe asthma who were randomly assigned to receive depemokimab or a placebo respectively, in addition to their standard of care treatment with medium to high-dose inhaled corticosteroids plus ≥ 1 additional controller.

The full analysis set in SWIFT-1 included 250 patients in the depemokimab plus standard of care arm and 132 in the placebo plus standard of care arm; in SWIFT-2, 252 patients were included in the depemokimab plus standard of care arm and 128 in the placebo plus standard of care arm.

Results showed treatment with depemokimab resulted in a significant 58% and 48% reduction in the rate of annualised asthma exacerbations (asthma attacks) over 52 weeks from SWIFT-1 and SWIFT-2, respectively (SWIFT-1: Rate ratio, 0.42; 95% CI, 0.30-0.59; 

<.001 and SWIFT-2: Rate ratio, 0.52; 95% CI, 0.36-0.73; 

<.001; AER depemokimab vs placebo: SWIFT-1 0.46 vs 1.11 and SWIFT-2 0.56 vs 1.08 exacerbations per year).

In a secondary endpoint from SWIFT-1 and SWIFT-2, patients treated with depemokimab experienced numerically fewer exacerbations requiring hospitalization and/or emergency department visits (1% and 4%) compared with placebo (8% and 10%), respectively. A pre-specified pooled analysis of the trials showed a 72% reduction in the annualized rate of clinically significant exacerbations requiring hospitalisation and/or ED visits over 52 weeks for depemokimab compared with placebo (rate ratio, 0.28; 95% CI, 0.13-0.61; nominal 

= .002; AER depemokimab 0.02 vs placebo 0.09).

Across these trials, depemokimab was well-tolerated, with patients experiencing a similar rate and severity of side effects as those receiving placebo.

“The struggle for people living with severe asthma is immense, with many silently enduring continued symptom recurrence and exacerbations. An innovative treatment option like Exdensur that offers the long-acting protection from exacerbations that severe asthma patients with an eosinophilic phenotype deserve, with the benefit of fewer doses, is truly welcome,” Tonya Winders, President and CEO, Global Allergy & Airways Patient Platform, said.

GSK. Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma. December 16, 2025. Accessed December 16, 2025. 

https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-by-us-fda-for-the-treatment-of-severe-asthma/

Smith T. Positive Phase 3 Findings Identified for Depemokimab Treatment of Severe Asthma. September 9, 2024. Accessed December 16, 2025. 

https://www.hcplive.com/view/positive-phase-3-findings-identified-depemokimab-treatment-severe-asthma

Articles

The FDA has approved GSK's depemokimab-ulaa (Exdensur) for severe asthma with an eosinophilic phenotype in patients aged 12 and older. This approval is based on phase 3 SWIFT-1 and SWIFT-2 trials, which demonstrated significant reductions in asthma exacerbations with twice-yearly dosing. Depemokimab-ulaa, an ultra-long-acting biologic, showed a 58% and 48% reduction in exacerbation rates in SWIFT-1 and SWIFT-2, respectively. The treatment was well-tolerated, with fewer exacerbations requiring hospitalization or emergency visits compared to placebo, offering a promising option for severe asthma management.

Depemokimab-ulaa is the first and only ultra-long-acting biologic with twice-yearly dosing for patients with severe asthma with an eosinophilic phenotype.

FDA Approves Depemokimab-ulaa (Exdensur) for Severe Asthma

Credit: Norwegian University of Science and Technology

A study found that participants with moderate or severe 

had a significantly reduced ability to relax their muscles compared with those reporting minimal or no chronic pain.

“The results of this study may have value for clinical practice by increasing the attention, awareness, and evidence of the ability to relax muscles and highlight that clinical bodily findings among individuals with chronic pain should guide the choice of treatment,” wrote investigator Live Førland Havstad, PhD Candidate, from Norwegian University of Science and Technology, and colleagues.

Clinicians commonly assess muscle tension by evaluating a patient’s ability to relax through flexibility testing and passive range-of-motion maneuvers. Clinicians may measure muscle displacement, force, and stiffness.

Empirical evidence characterizing muscle tension in patients with chronic pain remains limited. Thus, investigators compared the ability to relax muscles in individuals with and without chronic pain, as well as in those with fibromyalgia and chronic tension-type headache, versus other chronic pain conditions.

The team analyzed data from the HUNT Pain Examination Study, which included 551 individuals from the general Norwegian population. Based on clinical assessments by physicians and physiotherapists, 399 participants had chronic pain of at least moderate severity, while 152 had no chronic pain. Among those with chronic pain, 57 had fibromyalgia, and 23 had chronic tension-type headache.

Investigators evaluated muscle relaxation using the Global Physiotherapy Examination (GPE), which assesses flexibility and passive movement. Investigators performed multiple linear regression analyses to examine associations between chronic pain status and the ability to relax muscles.

Results showed that participants with moderate to severe chronic pain had significantly poorer muscle relaxation, reflected by reduced flexibility (

 < .001) and impaired passive movements (

< .001), compared with those with minimal or no chronic pain. Gender, age, and chronic pain status accounted for 23% of the variance in flexibility and 15% of the variance in passive movements. Women demonstrated a greater ability to relax their muscles than men. Further analyses demonstrated reductions in flexibility and passive movements among participants with fibromyalgia (

 <.001) and chronic tension-type headache (

=.027) compared with those with other chronic pain conditions.

The team noted the absence of a clear definition for what constitutes a normal ability to relax muscles. In prior research, GPE testing in healthy individuals who struggled with muscle relaxation helped distinguish deviations from an “ideal” ability versus a normal range. The investigators emphasized the need to establish normative ranges and clinically meaningful thresholds, which could inform decisions about whether improving muscle relaxation should serve as a treatment target.

Investigators acknowledged several limitations, including the use of the broad term of flexibility. In this study, flexibility represented the participant’s ability to relax muscles, but the term also captures joint mobility and may relate to limitations in connective tissue elasticity involving joint capsules, tendons, and ligaments. Age-related changes in joint mobility further complicate interpretation, making it difficult to determine whether reduced flexibility stemmed from biomechanical joint constraints, impaired muscle relaxation, or both.

Additional limitations included an older sample (mean age, 63 years) and potential bias from subjective assessments conducted by multiple examiners, without intra-examiner reliability testing. The findings were also influenced by the HUNT study’s 52% participation rate. Participants were drawn from HUNT-3, which included lower proportions of men, younger individuals, and those with lower socioeconomic status, along with higher rates of musculoskeletal pain and headache.

“The findings reveal a significant reduction in the ability to relax muscles during clinical testing in these patient groups,” investigators concluded. “This contribution from the general population provides insights into an area often studied within patient populations, underlining the importance of relaxation techniques as a component in the management of chronic pain.”

Havstad LF, Glette M, Landmark T, Butler S, Woodhouse A. The Ability to Relax Muscles in Chronic Pain Conditions in the General Population: A Cross-Sectional Study (The HUNT Pain Examination Study). 

. 2026;31(1):e70131. doi:10.1002/pri.70131

Davidson MJ, Nielsen PMF, Taberner AJ, Kruger JA. Is it time to rethink using digital palpation for assessment of muscle stiffness?. 

. 2020;39(1):279-285. doi:10.1002/nau.24192

A study involving 551 participants from the Norwegian population revealed that individuals with moderate to severe chronic pain exhibit significantly reduced muscle relaxation capabilities compared to those with minimal or no pain. The research utilized the Global Physiotherapy Examination to assess flexibility and passive movement, finding notable impairments in those with fibromyalgia and chronic tension-type headache. The study highlights the need for establishing normative ranges for muscle relaxation and suggests that improving muscle relaxation could be a treatment target. Limitations include potential biases and the broad definition of flexibility.

New data links chronic pain to impaired muscle relaxation, with the greatest limitations observed in fibromyalgia and chronic tension-type headache.

Chronic Pain Associated With Significantly Reduced Ability to Relax Muscles

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

Welcome to Skin of Color Savvy: The Art and Science of Treating Patients of Color!

In this 'Savvy Conversations' episode of 

, hosted by Skin of Color Society leaders and produced by 

, Heather Woolery-Lloyd, MD, an internationally recognized expert in skin of color, board-certified dermatologist at Miami Design District Dermatology and Aesthetics, and director of Ethnic Skin Care at the University of Miami Department of Dermatology and Cutaneous Surgery, sits down with Aderonke Obayomi, MD, MPH, a board-certified dermatologist at Mount Sinai Health System, for an in-depth discussion on 

 and seasonal dermatologic challenges affecting patients of color.

Drawing from their experiences practicing in very different climates, Woolery-Lloyd and Obayomi explore how seasonal changes, particularly decreased humidity, can significantly impact skin health. Obayomi, who trained in Miami before relocating to New York, describes the stark contrast in patient presentations, noting increased severity of xerosis, eczema flares, and pruritus in colder environments where indoor heating further dries the air. The conversation highlights how environmental factors such as forced indoor heat, limited control over apartment temperatures, and prolonged cold exposure can exacerbate inflammatory skin conditions.

The episode offers practical, evidence-based guidance for clinicians counseling patients during winter months. Obayomi emphasizes foundational skincare strategies, including the use of humidifiers, transitioning from lotions to thicker creams or ointments, avoiding prolonged hot showers, and moisturizing immediately after bathing. Both dermatologists stress the importance of barrier repair and frequent reapplication, reinforcing that during winter months, aggressive moisturization is often necessary to maintain skin integrity.

Woolery-Lloyd expands the discussion to include how winter affects chronic dermatologic conditions such as eczema, psoriasis, and acne. They review clinical observations and data suggesting that while some patients experience minimal seasonal variation, others see meaningful worsening during colder months, likely driven by barrier dysfunction, reduced humidity, and lifestyle factors including stress and holiday-related dietary changes. The conversation underscores the importance of individualized patient counseling and anticipatory guidance.

A key focus of the episode is how winter skin conditions may present differently in patients of color. Obayomi explains that erythema can be subtler or present as violaceous, gray, or ashy tones, and that follicular eczema is more commonly observed. Both dermatologists emphasize that post-inflammatory hyperpigmentation is a frequent and often distressing sequela of inflammation in skin of color, reinforcing the importance of early intervention and control of the underlying condition.

The conversation also addresses common misconceptions around skincare practices, including reliance on natural oils, essential oils, and homemade remedies, which may worsen irritation or provoke allergic reactions. Woolery-Lloyd and Obayomi stress the importance of gentle, fragrance-free formulations and caution against assuming that “natural” products are inherently safe.

Finally, the episode reinforces the year-round importance of sunscreen use, particularly tinted mineral sunscreens containing iron oxides, to protect against UVA and visible light, both of which contribute to pigmentary disorders in skin of color. Together, Woolery-Lloyd and Obayomi deliver a clinically grounded, culturally informed discussion that equips clinicians with practical strategies to better care for patients of color throughout the winter season.

To learn more about SOCS’s mentorship programs and initiatives, visit 

Editor’s note: This summary was edited with the help of artificial intelligence tools.

The discussion between dermatologists Heather Woolery-Lloyd and Aderonke Obayomi focuses on the unique dermatologic challenges faced by patients of color during winter. They explore how decreased humidity and environmental factors exacerbate conditions like xerosis, eczema, and pruritus. Practical skincare strategies, such as using humidifiers and thicker creams, are emphasized. The conversation highlights the importance of individualized patient counseling, especially regarding post-inflammatory hyperpigmentation and the subtler presentation of erythema in skin of color. The episode also addresses misconceptions about natural skincare products and underscores the importance of sunscreen use.

This December 16 episode features a discussion of winter skin concerns and seasonal dermatologic challenges impacting patients with skin of color.

Skin of Color Savvy: Winter Skin Care for Patients of Color, With Heather Woolery-Lloyd, MD, and Aderonke Obayomi, MD, MPH

Efanesoctocog Alfa Improves Bleeding Regardless of Age in Hemophilia A, With Lynn Malec, MD, MSc

Once-weekly efanesoctocog alfa is both well tolerated and efficacious in providing bleed protection to adult, adolescent, and child patients with 

, according to results from the XTEND-ed study.

 67th American Society of Hematology (ASH) Annual Meeting and Exposition

 by Lynn Malec, MD, MSc, an associate professor in the division of hematology and oncology at the Medical College of Wisconsin.

Efanesoctocog alfa is a first-in-class high-sustained factor VIII (FVIII) replacement therapy that decouples recombinant FVIII from endogenous von Willebrand factor. The prior phase 3 XTEND-1 and XTEND-Kids studies saw once-weekly efanesoctocog alfa exhibit effective bleed protection and provide FVIII activity within the normal to near-normal (>40%) range for 4 and 3 days, respectively, at steady state.

“I think the exciting data, besides just the aspects of the inhibitors, is how well patients are protected from bleeding,” Malec told 

 in an exclusive interview. “We typically measure that by way of annualized bleed rates in patients, and what we saw in the study was that patients across the age span continue to have really great bleed protection while on the extension study.”

Participants who completed the XTEND-1 or XTEND-Kids study could continue once-weekly 50 IU/kg of efanesoctocog alfa prophylaxis in XTEND-ed, an ongoing multicenter, open-label, long-term study. The primary endpoint for this trial was incidence of FVIII inhibitor development, while secondary endpoints included annualized bleed rates (ABRs), efficacy for bleed treatment, and safety.

Ultimately, 146 adult and adolescent patients rolled over from the XTEND-1 to XTEND-ed baseline. The median age was 37 years (range, 13-74), and the median treatment duration in XTEND-ed was 166 weeks (range, 14.1-192.7), which comprised a median of 167 days (range, 14-200) exposure days (EDs).

During the trial, the mean ABR for day 1-month 12 (n = 146) was 0.7 (standard deviation [SD], 1.31), months 12-24 (n = 141) was 0.62 (1.23), and months 24-36 (n = 132) was 0.45 (1.24), with 96/146 (65.8%), 96/141 (68.1%), and 103/132 (78%) of participants with zero bleeds, respectively. The mean model-based ABR for the efficacy period was 0.6 (95% CI, 0.47-0.76) for overall treated bleeds, and 0.2 (95% CI, 0.15-0.28) and 0.29 (95% CI, 0.22-0.39) for spontaneous and traumatic bleeds, respectively. Additionally, of 252 treated bleeding episodes, 94% were resolved with 1 efanesoctocog alfa injection.

Among children, 71 patients rolled over from XTEND-kids to XTEND-ed; median treatment duration was 116.7 (range, 36.3-152.6) weeks, comprising a median of 116 (range, 11-153) EDs. The mean ABR evaluated for day 1-month 12 (n = 71) was 0.68 (SD, 1.13) and months 12-25 (n = 62) was 0.49 (0.82), with 46/71 (64.8%) and 41/62 (66.1%) of participants with zero bleeds, respectively. The mean model-based ABR was 0.64 (95% CI, 0.48-0.85) for overall treated bleeds, and 0.08 (95% CI, 0.04-0.15) and 0.44 (95% CI, 0.31-0.62) for spontaneous and traumatic bleeds, respectively. Of 89 episodes, 91% (81) were resolved with 1 efanesoctocog injection. No FVIII inhibitors were noted in either the adult/adolescent or child groups at any point during the study.

“I treat patients across the age spectrum – both pediatric and adult patients – and I think the aspect of zero bleeds really is the new benchmark,” Malec told HCPLive. “Are you on a therapy to be bleed-free or to have zero bleeds? I think that data is, in my mind, the gold standard.”

Editor's Note: Malec reports disclosures with Biomarin, Genentech, Novo Nordisk, Sanofi, Shire, and Takeda, among others.

Susen S, Chan A, Chowdary P, et al. Clinical outcomes up to 4 years of once-weekly efanesoctocog alfa prophylaxis in previously treated adults, adolescents, and children with severe hemophilia A: Interim analysis of the phase 3 XTEND-ed long-term extension study. Abstract presented at the 67th American Society of Hematology Annual Meeting. Orlando, Fl. December 6-9, 2025.

Bioverativ. A phase 3 open-label interventional study of intravenous recombinant coagulation factor VIII fc-von Willebrand factor-XTEN fusion protein, efanesoctocog alfa (BIVV001) in patients with severe hemophilia A (XTEND-1). ClinicalTrials.gov Identifier: NCT04161495. Updated September 17, 2025. Accessed December 16, 2025. 

https://clinicaltrials.gov/study/NCT04161495

Videos

Malec discusses the XTEND-ed trial, which proved the efficacy and tolerability of efanesoctocog alfa in adults and children with hemophilia A.

A recent analysis of global data suggest the reported prevalence of 

focal segmental glomerulosclerosis (FSGS)

 has increased over time in most countries.

With > 32 years of data, the findings provide clinicians with epidemiological information while establishing a foundation for future research to characterize geographic differences, temporal trends, and potential risk factors.

“This information is crucial for tailoring prevention strategies, refining diagnostic approaches, and guiding future research efforts aimed at addressing the global burden of FSGS,” wrote study investigator Venice Chávez-Valencia, from the Ambulatory Care Medical Unit 254 of the Mexican Social Security Institute, and colleagues.

Previous research has emphasized slowing disease progression as the primary therapeutic goal in FSGS, but beyond understanding the underlying pathologic mechanisms, improved characterization of geographic and population-level epidemiology may help inform disease recognition and management, particularly given the absence of an FDA-approved pharmacologic therapy for FSGS.

To address gaps in the literature, Chávez-Valencia and colleagues conducted a systematic review of studies published between 1992 and 2024 using the Medline, Embase, and ScienceDirect databases.

For inclusion, studies were required to be original research, published in English or Spanish, and to report epidemiological data on FSGS prevalence, incidence, or temporal trends. Exclusion criteria included duplicate publications, insufficient incidence or prevalence data, unavailable full text, incomplete datasets, reporting bias, review articles, transplant registries, conference abstracts, unpublished manuscripts, sample sizes <100 patients, and recurrent FSGS.

Investigators emphasized substantial heterogeneity across study designs regarding renal biopsy practices, which subsequently limited the comparability of this data.

After applying the eligibility criteria, investigators included 130 studies in the final analysis. Asia accounted for the largest number of reports (n = 67), followed by Europe (n = 33), the Americas (n = 22), and then Africa (n = 9).

Across regions, investigators observed substantial variability in reported prevalence, reflecting differences in study design, biopsy practices, and population characteristics rather than true population-level incidence. Together, South Asian and Middle Eastern cohorts had a mean prevalence of 19%, while there was 6.5% in East Asian cohorts.

In the Americas, several countries reported relatively increased estimates of FSGS rates. In the United States, investigators reported a mean estimate of approximately 20%. Comparisons between time periods, 1994–2003 and 2004–2013, suggested an increase in reported cases over time. In fact, 2 studies reported incidence estimates of approximately 1.6 cases per 100,000 individuals per year.

Investigators noted relatively similar prevalence rates between European countries, with an average of 10%. They also pointed out that several studies, particularly from Africa and parts of Asia, had an increased proportion of FSGS among pediatric patients, underscoring age-related differences in disease burden and diagnosis.

“It is important to note that data from many countries are based on limited samples, not numerically representative of the population, which means that actual prevalence rates of FSGS may differ from those reported,” concluded investigators. “Despite these limitations, this study provides valuable information on an estimate of the overall prevalence of FSGS in different countries and, in some cases, highlights trends and changes over time.”

Orizaga-de-la-Cruz C, Lagunas-Rangel FA, Gómez-García A, Chávez-Valencia V, et al. An approximation to the prevalence of focal segmental glomerulosclerosis: A systematic review of world literature over the past 32 years. 

https://doi.org/10.1016/j.nefroe.2025.501404

Abbate M, Zoja C, Remuzzi G. How Does Proteinuria Cause Progressive Renal Damage? Journal of the American Society of Nephrology. 2006;17(11):2974-2984. doi:

The prevalence of focal segmental glomerulosclerosis (FSGS) has reportedly increased globally over the past 32 years, with significant geographic variability. This data is crucial for developing prevention strategies, refining diagnostics, and guiding research. A systematic review of studies from 1992 to 2024 revealed substantial heterogeneity in study designs and biopsy practices, affecting data comparability. The analysis included 130 studies, with Asia contributing the most reports. Variability in prevalence was noted, with South Asian and Middle Eastern cohorts showing higher rates than East Asian cohorts. The study underscores the need for more representative data.

A review of 32 years of global data on FSGS highlights increased prevalence, with a limitation of biopsy variation and regional practices.


Global Data Suggest Increased Prevalence of Focal Segmental Glomerulosclerosis

Platelet Transfusion Raises Mortality Risk in Consumptive Thrombocytopenia, with Manas Pustake, MD

Platelet transfusion led to fewer thrombotic events but was associated with higher mortality in patients with consumptive thrombocytopenias, likely due to confounding by indication, based on a retrospective cohort study.

67th American Society of Hematology (ASH) Annual Meeting and Exposition

 by Manas Pustake, MD, a resident in internal medicine at Texas Tech University. The study specifically examined 

, thrombotic thrombocytopenia purpura (TTP), and heparin-induced thrombocytopenia (HIT). Platelet transfusion is still controversial in these conditions, largely due to concerns that exogenous platelets may cause microthrombosis or worsen the underlying condition.

“Platelet transfusion has been very controversial in platelet-consumptive disorders like heparin-induced thrombocytopenia, thrombotic thrombocytopenic purpura, or disseminated intravascular coagulation,” Pustake told 

 in an interview. “So, to answer our research question, we did the study with a National Inpatient Sample dataset to see how platelet transfusion affects thrombosis risk or in-hospital mortality risk.”

Previous studies have highlighted the efficacy of restrictive platelet transfusion strategies, as they have been shown to cause limited increases in mortality or bleeding relative to more liberal strategies. These recommendations reflect guidelines: for consumptive thrombocytopenia in neonates without major bleeding, platelet transfusion is recommended when platelets are <25x10^3/µL, while patients with consumptive thrombocytopenia due to Dengue without major bleeding should not receive platelet transfusions.

This retrospective cohort study included all admitted patients ≥18 years from 2018 to 2020 with primary or secondary diagnoses of platelet consumptive disorders - including ITP, TTP, HIT, and other primary thrombocytopenias – identified using validated ICD-10-CM codes. Records were sourced from the Healthcare Cost and Utilization Project all-payer inpatient healthcare database. Primary outcomes for the study included arterial/venous thrombotic events and in-hospital mortality. Key secondary outcomes included length of stay (LOS) and hospital costs.

Ultimately, Pustake and colleagues examined 41,678 hospitalizations with consumptive thrombocytopenia, of which 71.8% were ITP, 16.3% were HIT, 9.5% were TTP, and 2.8% were classified as “other.” Of these, 11.3% received platelet transfusion – this cohort had substantially higher baseline acuity (ventilation: 12% vs 8.7%, shock: 11.8% vs 9.4%, hematologic malignancy: 10.3% vs 6.5%; all 

Platelet transfusion was associated with lower adjusted odds of thrombosis (aOR, 0.764; 

 <.001) increased thrombosis risk, as well as being on mechanical ventilation (aOR, 1.593; 

 <.001). Higher in-hospital mortality was also linked to platelet transfusion (aOR, 1.411; 

 <.001). Mortality was high with TTP (aOR, 2.422; 

 <.001), and mechanical ventilation (aOR, 8.643; 

Regarding secondary outcomes, platelet transfusion was associated with longer mean LOS (10.04 vs 8.18 days; 

 <.001) and higher mean costs ($179,597 vs $120,825; 

 <.001). Thrombotic events substantially increased LOS (11.92 vs 7.53 days; 

 <.001). Additionally, platelet transfusion’s association with reduced thrombosis persisted when stratified by the presence or absence of hematologic malignancy (no malignancy: aOR, 0.777; 

Pustake and colleagues attribute the higher mortality rates noted during the study to confounding by indication, such as sicker patients receiving transfusions. The team determined that these findings confirm established guideline recommendations to avoid platelet transfusion in high-thrombosis-risk conditions such as TTP and HIT.

“Platelets are transfused to patients having significant bleeding, so the key takeaway from this study is that platelet transfusion should be more conservative and restrictive,” Pustake said. “But that judgement should be made by the clinician.”

Pustake M, Kattamuri L, Sharma K, Deoker A. Platelet transfusion is associated with reduced thrombosis yet elevated mortality in consumptive thrombocytopenias: A retrospective cohort study. Abstract presented at the 67th American Society of Hematology Annual Meeting. Orlando, FL. December 6-9, 2025.

Metcalf RA, Nahirniak S, Guyatt G, et al. Platelet Transfusion: 2025 AABB and ICTMG International Clinical Practice Guidelines. JAMA. 2025;334(7):606-617. 

Pustake highlights the reticence with which clinicians should approach providing platelet transfusion to patients.

New research is providing clinicians with an overview of the prevalence of steroid use in inflammatory bowel disease (IBD) care, highlighting key groups at higher risk of exposure and identifying opportunities for reducing unnecessary exposure.

The observational, retrospective analysis of Crohn's Colitis Care (CCCare) data suggest steroid exposure for IBD management is most common among younger individuals, females, and those with ulcerative colitis (UC), as well as individuals receiving combination immunomodulators and advanced therapies.

“To our knowledge, this is one of the largest, contemporaneous real-world cohorts to examine steroid use in people with IBD, providing valuable insights into steroid use patterns,” Rodger Wu, MD, an IBD research fellow at Crohn's Colitis Cure and Conjoint Associate Lecturer with the University of New South Wales, and colleagues wrote.

While steroids are commonly used in IBD management due to their high efficacy in rapid symptom reduction, adverse effects like nausea, weight gain, liver dysfunction, and increased risk of opportunistic infections limit their clinical utility. Additionally, existing research suggests use of steroids as maintenance therapy offers no benefit and instead serves as a risk factor for serious infection and death.

To describe real-world patterns of corticosteroid use among people with IBD receiving routine clinical care, investigators assessed deidentified data from CCCare, a cloud-based, IBD-specific electronic medical record used in several public and private centers in Australia and New Zealand.

Data for people with IBD under active care, defined as having had an assessment during the last 14 months, were included. For these individuals, data for the preceding 3 years were assessed.

Steroids captured included oral prednisone, prednisolone, and budesonide, as well as intravenous methylprednisolone and hydrocortisone. Other corticosteroids not used in IBD are not captured in the IBD medication section. Investigators categorized steroid exposure based on both duration and recency. Duration was defined as short (1–28 days), moderate (29–56 days), or prolonged (> 56 days). Recency was defined as recent (within 365 days), previous (365–1085 days), or no exposure.

Investigators assessed steroid use patterns by the number of steroid courses during the 3-year period (oral and intravenous), duration of exposure, and recency of exposure.

The eligible cohort comprised 5436 patients, including 3136 (57.6%) with CD, 2165 (39.7%) with UC, and 135 (2.5%) with IBD-unspecified (IBD-U). Investigators noted the cohort was nearly evenly distributed in terms of sex (50.2% female) with a median age of 42 years (IQR 32–56). During the study period, 71.6% of those with CD and 50.5% of those with UC received advanced therapies.

Overall, 994 (18.3%) people had been exposed to steroids over the preceding 3-year period, with 126 (2.3%) having prolonged and 370 (6.8%) having recent exposure, and a further 624 people (11.4%) being previously

Upon analysis, people with CD had a lower likelihood of prolonged exposure to steroids over the study period compared to people with UC (adjusted odds ratio [AOR], 0.72; 95% CI, 0.59–0.89; 

= .001). Additionally, females had a greater likelihood of both prolonged and recent exposure (AOR, 1.22; 

Investigators pointed out young adults aged 20–29 years had greater odds of prolonged and recent use than those > 70 years of age (AOR, 6.59 and 9.12, respectively; 

 <.001). Age at diagnosis was also found to have a modest effect size (AOR, 1.03; 

Of note, combination immunomodulator and advanced therapy use was associated with an increased likelihood of both prolonged and recent use compared to 5-aminosalicylic acid therapy alone (AOR, 4.01; 

“These findings identify key groups at higher risk of corticosteroid exposure, including younger individuals, females and those with stoma surgery or receiving combination immunomodulators and advanced therapies,” investigators concluded.

 “In clinical practice, recognition of these subgroups should prompt early review of treatment adequacy and timely escalation to steroid-sparing agents.”

Wu R, Rivas C, Su WK, et al. Patterns and Predictors of Steroid Use in a Real-World Inflammatory Bowel Disease Cohort. 

Feuerstein JD, Rubin DT, Aberra FN, et al. Appropriate Use and Complications of Corticosteroids in Inflammatory Bowel Disease: A Comprehensive Review. Clinical Gastroenterology and Hepatology. doi:

Research highlights the prevalence of steroid use in IBD management, identifying key groups at higher risk and opportunities to reduce unnecessary exposure. Steroid use is prevalent among younger individuals, females, and those with ulcerative colitis, especially when using combination immunomodulators and advanced therapies. Despite their efficacy in symptom reduction, steroids pose risks like infections and adverse effects, with no benefit as maintenance therapy. The study analyzed data from a large cohort, revealing patterns of steroid exposure and emphasizing the need for early treatment review and steroid-sparing strategies in high-risk groups.

Study findings highlight the prevalence of steroid use in IBD care and identify key subgroups at higher risk of exposure.

Young Women With Ulcerative Colitis Face Higher Corticosteroid Exposure Risk

Lerodalcibep’s FDA Approval For Hypercholesterolemia With Dean Kereiakes, MD

lerodalcibep (Lerochol) may address the unmet needs of adults with hypercholesterolemia by improving accessibility, quality of life, and affordability.

Recent discussion highlights the potential of the PCSK9 inhibitor to reduce low-density lipoprotein cholesterol (LDL-C) in this patient population, including those with 

heterozygous familial hypercholesterolemia (HeFH

), further expanding the treatment landscape.

“More options and more players in this space will mean better medicine for more patients, but it will also make these therapies more affordable,” said Dean Kereiakes, MD, chairman of The Christ Hospital Heart and Vascular Institute, in an interview with 

. “I’ve had too many patients who couldn’t afford the best treatment, and that era is coming to an end.”

For patients currently taking statins, common side effects include severe muscle cramping after exertion. Kereiakes noted he has seen >100 patients experience these cramps, which result from statin-induced depletion of muscle energy stores combined with physical activity.

PCSK9 inhibitors provide an effective and generally well-tolerated mechanism to reduce LDL-C, but widespread implementation has been limited by convenience and access barriers. Lerodalcibep, a novel, small protein-binding, third-generation PCSK9 inhibitor, was designed to bridge this therapeutic gap.

The FDA approved lerodalcibep for use as an adjunct to diet and exercise to reduce LDL-C based on results from the LIBerate program, a series of 5 global, placebo-controlled phase 3 registration studies. In these trials, lerodalcibep was administered once monthly for 52 weeks, followed by a 72-week open-label extension.

Overall, the LIBerate program enrolled > 2900 patients, including those with cardiovascular disease (CVD) and those without CVD but at very high or high risk. In the open-label extension, approximately 2400 patients continued treatment.

In clinical trials, lerodalcibep produced sustained LDL-C reductions of ≥60% in patients with, or at very high or high risk of, cardiovascular disease, and ≥50% in those with HeFH, who typically have more severe LDL-C elevations.

“That’s important, because some of the other medicines have more of a sawtooth effect where levels go down after the injection or infusion, then start to come back up before the next dose,” explained Kereiakes. “That’s less effective and provides less benefit than pushing LDL down and keeping it down. This has been a huge unmet need, and I think the success of this class of drugs reflects that need.”

Differing from other PCSK9 inhibitors, lerodalcibep can be self-administered once monthly, offering a convenient option for patients requiring lifelong cholesterol management. The drug can also be maintained at room temperature for up to three months.

The most frequent adverse reaction leading to treatment discontinuation in trials for primary hypercholesterolemia was injection-site reactions, occurring in 1% of lerodalcibep-treated patients compared with 0% of placebo-treated patients.

“I’ve actually told patients that I think PCKS9 inhibitors are the greatest thing to happen in cardiovascular medicine in over a decade. They’ve allowed us to stabilize high-risk patients who would have otherwise had more events,” concluded Kereiakes, “And I think we’ll have a rapid ramp-up of these therapies because it’s got advantages over those that are currently available.”

Editor’s Note: Kereiakes reports relevant disclosures with Ablative Solutions Inc., Shockwave, CeleCor, and others.

National Lipid Association. U.S. Food and Drug Administration Approves LIB Therapeutics’ LEROCHOLTM (lerodalcibep-liga) for Adults with Elevated LDL Cholesterol | National Lipid Association Online. Lipid.org. Published 2025. Accessed December 16, 2025. 

https://www.lipid.org/nla/us-food-and-drug-administration-approves-lib-therapeutics%E2%80%99-lerochol%E2%84%A2-lerodalcibep-liga-adults

Harvard Health Publishing. Managing statin muscle pain - Harvard Health. Harvard Health. Published August 9, 2019. 

https://www.health.harvard.edu/pain/managing-statin-muscle-pain

LIB Therapeutics. U.S. Food and Drug Administration Approves LIB Therapeutics’ LEROCHOL™ (lerodalcibep-liga) for Adults with Elevated LDL Cholesterol. News & Events. Libtherapeutics.com. Published 2025. Accessed December 16, 2025. 

https://libtherapeutics.com/news-and-events/us-food-and-drug-administration-approves-lib-therapeutics-lerochol-for-adults-with-elevated-ldl-cholesterol.html

Kereiakes discusses the potential of lerodalcibep for adults with hypercholesterolemia and high LDL-C, highlighting recent FDA approval. 

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

Diabetes Dialogue: Reacting to Retatrutide and TRIUMPH-4 Topline Data

 hosts 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, share early  impressions of topline phase 3 results from the TRIUMPH-4 trial of retatrutide, a once-weekly triple agonist targeting GIP, GLP-1, and glucagon receptors. Recorded from the ADCES Technology Conference, the conversation frames retatrutide as a potential next step beyond current GLP-1 and dual incretin options, while emphasizing that detailed trial data remain pending.

TRIUMPH-4 was a phase 3 study enrolling patients with obesity and osteoarthritis. Topline data suggests participants receiving retatrutide 12 mg achieved a mean weight loss of 28.7% at 68 weeks. Among this population, the trial also reported a 75.8% reduction in WOMAC pain scores from baseline, with approximately 1 in 8 participants reporting complete pain freedom at week 68. Isaacs highlights how striking these figures are in light of the already high bar set by semaglutide and tirzepatide, noting that confirmation in phase 3 heightens anticipation for full publications and future readouts.

The hosts connect these findings to evolving clinical priorities reflected in the American Diabetes Association’s expanding attention to obesity-related comorbidities, including osteoarthritis, MASLD/MASH, sleep apnea, and kidney disease. They note the broader retatrutide phase 3 program includes studies in type 2 diabetes, moderate-to-severe obstructive sleep apnea, chronic low back pain, MASLD/MASH, and planned cardiovascular and renal outcomes trials. Isaacs underscores the ongoing question of whether benefits across these conditions will be primarily molecule-specific or largely driven by the magnitude of weight loss, particularly given the inclusion of glucagon receptor activity.

Safety is discussed cautiously, given the limited nature of top-line disclosures. The hosts note that discontinuation due to adverse events appeared higher with retatrutide than placebo, and they emphasize the need for full reporting on gastrointestinal tolerability and other adverse events. Bellini also points to an intriguing subgroup signal suggesting lower discontinuation rates among participants with higher baseline BMI, while acknowledging this could reflect chance in a modestly sized trial population.

Overall, Isaacs and Bellini characterize retatrutide’s TRIUMPH-4 update as an important milestone, while stressing that interpretation should remain measured until complete efficacy and safety data are available.

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.

Eli Lilly and Company. Lilly's triple agonist, retatrutide, delivered weight loss of up to an average of 71.2 lbs along with substantial relief from osteoarthritis pain in first successful Phase 3 trial. December 11, 2025. Accessed December 11, 2025. 

https://investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-delivered-weight-loss-average

American Diabetes Association. The American Diabetes Association Launches a New Obesity Division | ADA. diabetes.org. Published June 21, 2024. Accessed December 16, 2025. 

https://diabetes.org/newsroom/press-releases/american-diabetes-association-launches-new-obesity-division

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Discover the latest advancements in diabetes treatment with retatrutide, a promising triple agonist showing significant weight loss and pain relief.

Phase 3 Data Bolster FDA Approval of Lumateperone as Adjunctive MDD Therapy, With Suresh Durgam, MD

New phase 3 data strengthen the clinical rationale behind the recent US Food & Drug Administration (FDA) approval of lumateperone (CAPLYTA) as an adjunctive treatment for 

), according to study investigator Suresh Durgam, MD, chief medical officer of Intra-Cellular Therapies, a Johnson & Johnson company.

 Durgam said the newly published Study 502 was designed to replicate and extend earlier findings by specifically evaluating lumateperone added to ongoing antidepressant therapy in patients with an inadequate response.

“In this particular study, both the primary endpoint and secondary endpoints were statistically significant and robust, which showed that the patients who had inadequate response were beneficial on adding lumateperone on top of antidepressants,” Durgam said.

The FDA approved lumateperone in November 2025 as an adjunctive therapy for adults with MDD, a population in which nearly two-thirds of patients fail to respond adequately to standard oral antidepressants. Study 502 provides confirmatory phase 3 evidence aimed at helping clinicians better understand where lumateperone fits within an increasingly crowded adjunctive treatment landscape.

The randomized, double-blind, placebo-controlled trial enrolled 480 adults with DSM-5–defined MDD who had achieved < 50% response to 1 or 2 antidepressants during their current depressive episode. Patients received lumateperone 42 mg (n = 242) or placebo (n = 238) once daily in the evening, added to their existing antidepressant, for 6 weeks.

Lumateperone met its primary endpoint, significantly improving Montgomery-Åsberg Depression Rating Scale (MADRS) total scores compared with placebo (least squares mean difference [LSMD], −4.5) by day 43. The trial also met its key secondary endpoint of Clinical Global Impressions–Severity (CGI-S; LSMD, −0.5).

Separation from placebo emerged as early as 2 weeks, setting this antidepressant apart from others. Often, antidepressants take 4 – 8 weeks to go into effect. With lumateperone, patients do not have to wait a long period to see if the medication works for them.

Safety findings were consistent with lumateperone’s established profile. Although treatment discontinuation due to adverse events was greater with lumateperone than placebo, Durgam stressed that more than 89% of patients completed the study and that most adverse events were mild or moderate and resolved within 2 to 3 weeks. Notably, cardiometabolic parameters, weight gain, extrapyramidal symptoms, and prolactin levels were comparable to placebo.

Durgam said that the data reinforce lumateperone’s potential role for patients with partial or inadequate antidepressant response, particularly for those concerned about weight gain or metabolic burden, while providing clinicians with clearer guidance on efficacy, tolerability, and expectations early in treatment. The approval of lumateperone addresses the unmet need in patients with inadequate antidepressant response as only a few treatments are available.

“Adding this to that armamentarium for the prescriber’s toolbox will help as another option because of the robust efficacy and also the [low] side effect burden,” Durgam said.

Durgam S, Earley WR, Kozauer SG, et al. Adjunctive Lumateperone in Patients With Major Depressive Disorder: Results From a Randomized, Double-Blind, Phase 3 Trial. 

. 2025;182(12):1072-1082. doi:10.1176/appi.ajp.20250292

New phase 3 data support the FDA approval of lumateperone, showing early efficacy and favorable tolerability as an adjunctive treatment for MDD.

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