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

Two-year findings from a real-world Japanese patient cohort indicate deucravacitinib provides durable disease control in 

, although responses differ over time based on age and body mass index (BMI) of patients.

These findings were authored by such researchers as Teppei Hagino, MD, PhD, of Nippon Medical School Chiba Hokusoh Hospital. In the background of their analysis, Hagino and colleagues noted prior data suggesting those with a BMI of ≥ 25 kg/m

 had slightly diminished responses to this drug than patients with a BMI < 25 kg/m

Despite positive findings on deucravacitinib’s efficacy among those with psoriasis, the investigative team highlighted the lack of real-world data on its long-term use and the prior lack of awareness about BMI and/or age’s impact on such results.

“The aim of this study was to evaluate the 104 week…effectiveness of deucravacitinib 6 mg daily in patients with psoriasis, stratified by BMI (< 25 versus ≥ 25 kg/m2) or age (< 65 versus ≥ 65 years),” Hagino and coauthors wrote.

In the period between December 2022 - August 2025, the investigators carried out their prospective, single-center investigation in Japan. They involved patients in the age range of 15 years or older who also lived with moderate-to-severe psoriasis. All participants given once-per-day, oral deucravacitinib therapy at a dose of 6 mg for a maximum duration of 104 weeks. Some of the team’s subjects had previously been given apremilast or biologics prior to their using deucravacitinib.

After detailed consultations took place their treating clinicians, those involved in the analysis elected to begin deucravacitinib from among the available options for systemic agents. Hagino et al noted a portion of the data from this 104-week cohort, drawn from Weeks 16 - 52, had been published previously under the same study protocol. Additional participants were newly and prospectively involved for this more recent analysis.

Those included as participants were patients with moderate-to-severe psoriasis, psoriatic arthritis (PsA), or erythrodermic psoriasis. Individuals shifting directly from other systemic agents to deucravacitinib did so without a required washout period. For these patients, their PASI and sPGA scores recorded at the time of treatment switch were defined as baseline values at Week 0. At the time of their entry, the participants’ demographic and clinical variables were documented by the investigative team.

These would include BMI, age, sex, duration of disease, and the existence or absence of arthritis. Comorbid condition information, with conditions including smoking status, diabetes, heart disease, and prior exposure to systemic drugs including apremilast or biologics, was gathered by the team. At baseline, they looked at disease severity via patients’ Psoriasis Area and Severity Index (PASI) and static Physician’s Global Assessment (sPGA) scores.

There were 127 total participants with psoriasis who were provided  dail oral deucravacitinib 6 mg. Across the entire cohort, Hagino and colleagues noted their PASI scores indicated sustained disease improvements over the full 104-week treatment period. When stratified by age or by BMI, there was no statistically significant distinction observed in participants’ mean percentage PASI reduction between the cohorts at any time point.

The team highlighted data showing, between the 16 and 68-week marks, PASI score reductions and the proportions of subjects attaining PASI 75, PASI 90, or an absolute PASI score of 2 or below showed a tendency to be slightly greater in those with a BMI below 25.

 This was compared with subjects showing a BMI of 25 or higher, though Hagino and coauthors noted the reversal of this pattern reversed at later points in their analysis.

Throughout the 104-week follow-up, the investigators noted higher rates of complete or near-complete clearance, defined as PASI 100 or an absolute PASI score of 1 or less, consistently seen among those with BMI below 25.

 By the 104-week mark, PASI 100 and absolute PASI ≤1 were attained by 16.7% and 54.2% of individuals showing a BMI of <25, respectively. This was compared to rates of 0% and 40.0% among individuals with a BMI of ≥25.

In an analysis which was age-based, Hagino et al found the percentages of PASI reductions and the PASI 75 and PASI 90 rates were slightly higher in those aged 65 years or older versus younger subjects, after which this trend would reverse.

 By the 104-week mark, they found PASI 100 and absolute PASI ≤1 were seen among 28.6% and 57.1% of individuals below 65 years, respectively. Conversely, rates noted in participants aged 65 years or older were 0% and 46.7%, respectively.

“In conclusion, once daily deucravacitinib 6 mg showed sustained effectiveness for Japanese patients with psoriasis throughout 104 weeks in real-world analyses stratified by BMI or age,” the team concluded.

 “Early differences between age groups should be interpreted with caution because older patients had lower baseline PASI and the subgroup analyses were not adjusted for baseline severity.”

Okabe Y, Hagino T, Kanda N. Two-Year Real-World Effectiveness of Deucravacitinib 6 mg in Psoriasis: A Single-Center Analysis Stratified by Body Mass Index or Age in a Japanese Cohort. J Dermatol. 2026 Jan 5. 

Hagino T, Onda M, Kanda N, et al. Real-world 52-week effectiveness of deucravacitinib in psoriasis: A stratified analysis by age and body mass index. J Dermatol. 2025 Apr;52(4):663-671. 

Articles

Deucravacitinib demonstrates durable disease control in moderate-to-severe psoriasis over 104 weeks, with varying responses based on age and BMI. A Japanese cohort study involving 127 patients revealed sustained PASI score improvements, with no significant differences in mean percentage PASI reduction when stratified by age or BMI. However, patients with a BMI below 25 showed higher rates of complete or near-complete clearance. Age-based analysis indicated slightly higher PASI reductions in those aged 65 or older initially, but this trend reversed over time. The study emphasizes cautious interpretation of early differences due to baseline severity.

This study highlights the efficacy and safety of deucravacitinib 6 mg in psoriasis, with results stratified by body mass index and age in a Japanese patient cohort.

Plaque Psoriasis

The HCPLive plaque psoriasis page is a resource for medical news and expert insights on psoriasis. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for psoriatic disease, and more.

News

news page, resources on the topics of disease- and specialty-specific medical news and expert insight can be found. Content includes articles, interviews, videos, podcasts, and breaking news on health care research, treatment, and drug development.

Clinical

clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

Deucravacitinib 6 mg Effective in Patients with Psoriasis Over 2 Years

Alex Hillenbrand is an assistant editor for 

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

According to new research, among patients with acute kidney injury (AKI) on 

, moderate-stable, moderate-high stable, and high-decreasing serum creatinine trajectories were associated with an increased risk of 28-day mortality.

“The serum creatinine trajectory can serve as an important indicator for assessing the short-term and long-term mortality risks of patients (especially critically ill or post-operative patients), and has significant reference value for clinical prognosis judgment,” wrote study investigator Jian Huag, MD, research director from the Zhejiang University School of Medicine, and colleagues.

Serum creatinine, as a biomarker reflecting glomerular filtration function, has been widely used to assess renal function and diagnose kidney-related diseases. The latest evidence had suggested serum creatinine fluctuations were closely associated with the risk of death in CKD, but systematic trajectory typing research required further exploration.

In a retrospective study, investigators aimed to explore the association between serum creatinine trajectories and 28-mortality in AKI on CKD patients through group-based trajectory modeling. They leveraged data from the Medical Information Mart for Intensive Care-IV (MIMIC) database, containing de-identified health-related information of Intensive Care Unit (ICU) patients from Beth Israel Deaconess Medical Center.

Investigators measured and recorded serum creatinine > 3 times during the first 96 hours after admission to the ICU, and calculated the mean.

The study included 7852 patients with CKD who developed AKI during hospitalization, defined as an increase in serum creatinine of ≥ 0.3 mg/dL within 48 hours, or an increase in serum creatinine of ≥ 50% from baseline within 7 days.

Upon Group-Based Trajectory Modeling, investigators identified 5 trajectories:

Serum creatinine low-stable (Group G1): with levels maintained at approximately 1 and showing a stable trend

Serum Creatinine High-Decreasing (Group G2): with baseline levels > 8 and showing a decreasing trend

Serum Creatinine Moderate-Low Stable (Group G3) with levels maintained at approximately 1.3–1.5 and showing a stable trend

Serum Creatinine Moderate-Stable (Group G4) with levels maintained at approximately 2, and showing a stable trend

Serum Creatinine Moderate-High Stable (Group G5) with levels maintained at approximately 4 and showing a stable trend

In terms of comorbidities, group G5 had a significantly increased prevalence of diabetes and sepsis, G4 of chronic pulmonary disease and congestive heart failure, and G1 of cerebrovascular diseases. Regarding prognostic scores, group G1 had decreased Simplified Acute Physiology Score II and Sequential Organ Failure Assessment scores, while group G2 had a decreased Charlson Comorbidity Index Score.

Investigators saw significant differences among the 5 groups in white blood cells, blood urea nitrogen, anion gap, total calcium, glucose, potassium, sodium, bicarbonate, and chloride levels. Group G2 had the highest serum creatinine baseline levels and estimated glomerular filtration rate (eGFR) percentage change.

In fully adjusted analyses, compared with the low-stable trajectory group (G1), 28-day mortality risk was significantly increased in the high-decreasing group (G2) (Hazard Ratio [HR], 1.82; 95% Confidence Interval [CI], 1.18-2.82; 

 = .007), the moderate-stable group (G4) (HR, 1.45; 95% CI, 1.14-1.86; 

 = .003), and the moderate–high stable group (G5) (HR, 1.86; 95% CI, 1.36-2.54; 

Investigators identified a significant interaction between baseline serum creatinine and trajectory group. The association between moderate-stable (G4) and moderate–high stable (G5) trajectories and 28-day mortality was only observed among patients with baseline serum creatinine ≤ 1.8 mg/dL, which investigators suggested may reflect preserved baseline renal filtration, making subsequent trajectory abnormalities more prognostically meaningful.

“This finding provides a reference for clinical practice in formulating individualized prognostic assessment protocols for patients with different baseline serum creatinine levels,” concluded investigators.

Ying J, Zhou H, Zhang Y, Zhu S, Zhang G, Huang J. Association of different serum creatinine trajectories with 28-day mortality in patients with acute kidney injury on chronic kidney disease: based on the MIMIC-IV database. 

. Published online Autumn 2025:10.1186/s40001-02503632-x. doi:

https://doi.org/10.1186/s40001-025-03632-x

Horne KL, Packington R, Monaghan J, Reilly T, Selby NM. Three-year outcomes after acute kidney injury: results of a prospective parallel group cohort study. 

https://doi.org/10.1136/bmjopen-2016-015316

New research highlights the association between serum creatinine trajectories and 28-day mortality in patients with acute kidney injury on chronic kidney disease. The study identified five distinct serum creatinine trajectory groups, with moderate-stable, moderate-high stable, and high-decreasing trajectories linked to increased mortality risk. The findings underscore the prognostic value of serum creatinine trajectories, particularly in patients with preserved baseline renal filtration. This research provides a foundation for developing individualized prognostic assessment protocols based on baseline serum creatinine levels, enhancing clinical decision-making for critically ill patients.

Retrospective data suggest serum creatinine trajectories might predict 28-day mortality in acute kidney injury on chronic kidney disease. 


Nephrology

The HCPLive nephrology page is a resource for medical news and expert insights on kidney disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in nephrology, and more.

Chronic Kidney Disease

Serum Creatinine Trajectories May Predict 28-Day Mortality in CKD

Chelsie Derman is an associate editor for 

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

A new study found that changing therapists or therapy approach does not offer additional benefit for adults with 

 who do not respond to initial psychotherapy.

 Further psychotherapy after initial non-response produces modest reductions in depressive symptoms.

Only about 40% of people experience a significant response to psychotherapy. One solution may be to switch therapists altogether. The Associated Clinic of Psychology (ACP) lists 11 signs that it may be time to switch therapists: feeling a lack of progress, being unable to speak openly, feeling unheard or misunderstood, mismatched therapeutic styles, unresolved issues, a personality clash, discomfort during sessions, changing goals or focus, frequent scheduling problems, lack of engagement, and a gut feeling.

 Changing therapists may provide other benefits, such as accelerating recovery when a patient requires a different therapeutic approach, or shortening the duration of depression, which may help limit feelings of hopelessness.

However, whether changing therapists actually improves depressive symptoms remains an open question. Emerging data suggest the benefit may be limited.

In this randomized controlled study, Maartje Miggiels, PhD candidate, from the Dimence Group and the department of psychiatry at Amsterdam UMC in the Netherlands, and colleagues, investigated whether continuing cognitive behavioral therapy (CBT) or short-term psychodynamic supportive therapy (SPSP) with the same therapist differs in effectiveness from 2 alternative strategies: switching therapists or switching both the therapist and the therapeutic approach.

 The primary outcome was depressive symptom severity, assessed via the Inventory of Depression Symptomatology-Self Report (IDS-SR).

This was the second phase of a randomized study published in 2021, which compared CBT with SPSP for MDD during the initial 16-session treatment phase. Participants were outpatients of 1 of 4 locations of Dimence, a specialized mental health care institution in the Netherlands.

The first phase showed favorability of SPSP over CBT, with an estimated mean post-treatment difference of 2.54 (95% CI, -0.63 to 5.72). SPSP also showed favorable remission rates over CBT (9.0% vs 20.5%; 

 =.01). Response rates did not differ significantly between SPSP vs CBT (23.6% vs 20.7%; 

This second phase randomized 163 non-responders 1:1:1 to either continue treatment with the same therapist, switch to a different therapist, or switch both therapist and treatment method.

 Participants were offered an additional 16 sessions over 8 weeks.

The study showed a modest but statistically significant reduction in depressive symptoms after continuing psychotherapy (mean change, -5.23; 95% CI, -7.27 to -3.12). However, investigators observed no significant differences in symptom reduction, response, or remission rates between the 3 treatment strategies.

“Switching therapist or both therapist and method does not appear to offer additional benefit, but also does not hinder outcomes,” investigators concluded.

 “These findings suggest that there is no one-size-fits-all switching strategy that is suitable for all non-responders.”

 hosted a peer exchange with Andrew J. Cutler, MD, Sagar V. Parikh, MD, FRCPC, and Gregory Mattingly, MD, on switching treatment vs augmenting strategies in MDD.

They discussed what point psychiatrists should start to think about switching or starting a new treatment and at what point you would augment.

“It’s one of the mysteries of what we do in clinical practice, and I don’t think there’s a right or a wrong answer,” Mattingly said.

 “If you’d asked me 20 years ago, I would’ve quite often started something new. I’ve become a fan of augmentation strategies more and more over the course of my practice.”

He described different augmentation strategies, such as adding a medicine or augmenting with psychotherapy or exercise.

“It’s important to know when you can augment and when you can start a new treatment option,” Mattingly continued.

 “If we see zero benefit, obviously we’re going to start something new. I think if we see an intolerable adverse effect, we’re going to start something new. It’s that group in the middle, they’re partially better, but not all the way better. And quite often I like that option of being able to augment something on top.”

Miggiels M, Ten Klooster P, Beekman A, et al. A randomized controlled trial testing the effects of sequential psychotherapy in depression: Changing therapist, or both therapist and method?. 

Switching Therapists: 11 Signs It’s Time To Go. Associated Clinic of Psychology. Published on February 21, 2024. Accessed January 6, 2026. 

https://acp-mn.com/about-acp/blog/switching-therapists/ 

Miggiels M, Ten Klooster P, Beekman A, et al. The D*Phase-study: Comparing short-term psychodynamic psychotherapy and cognitive behavioural therapy for major depressive disorder in a randomised controlled non-inferiority trial. 

Cutler A, Mattingly G, and Parikh S. Switching Treatment vs Augmenting Strategies in MDD. 

 Published on January 27, 2023. Accessed January 6, 2026. 

https://www.hcplive.com/view/switching-treatment-vs-augmenting-strategies-in-mdd

A recent study explored the effectiveness of changing therapists or therapy approaches for adults with major depressive disorder (MDD) who do not initially respond to psychotherapy. The study found that continuing therapy, regardless of switching therapists or methods, resulted in modest symptom reduction, with no significant differences between strategies. This suggests that switching therapists or approaches may not offer additional benefits. The study highlights the complexity of treatment decisions in MDD, emphasizing the need for personalized strategies, including potential augmentation with medication or other therapies.

A study found no differences in depressive symptom reduction when nonresponders continued therapy, switched therapists, or changed both therapist and treatment approach.

Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

Major Depressive Disorder

Major Depressive Disorder condition center page, resources on the topics of medical news and expert insight into depression can be found. Content includes articles, interviews, videos, podcasts, and breaking news on MDD research, treatment, and drug development.

Switching Therapists for Psychotherapy Offers No Advantage in MDD

Abigail Brooks is an assistant managing editor for 

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

December 2025 brought a diverse set of clinically relevant insights across gastroenterology, highlighting evolving risks, emerging perioperative strategies, and innovation in both adult and pediatric care.

New real-world and observational data sharpened understanding of corticosteroid exposure patterns in inflammatory bowel disease (IBD), while early evidence from a randomized feasibility trial suggested that intentional, intensive weight loss before colorectal cancer surgery is both safe and well tolerated.

Across functional, pediatric, and autoimmune gastrointestinal disease, December’s updates emphasized personalization of care. Real-world evidence supported a novel, device-based approach to chronic idiopathic constipation, while pediatric-focused research explored predictors of response to teduglutide in short bowel syndrome–associated intestinal failure. Rounding out the month, expert discussion at the 

2025 North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN)

 meeting highlighted the growing importance of recognizing autoimmune overlap in celiac disease, particularly with type 1 diabetes, and the role of early screening in improving long-term outcomes.

Check out this December 2025 gastroenterology month in review for a recap of 

’s coverage of the top GI news and research from the past few weeks:

Young Women With Ulcerative Colitis Face Higher Corticosteroid Exposure Risk

A recent 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. Findings highlight key groups at higher risk of exposure and help identify opportunities for reducing unnecessary exposure.

Intensive Weight Loss Before Colorectal Cancer Surgery Safe, Feasible

Emerging research is shedding light on the feasibility and safety of intentional weight loss with a low-energy total diet replacement before colorectal cancer surgery in patients with colorectal cancer and excess weight. Findings from the multicenter, external, feasibility, parallel, individually randomized CARE trial show a low-energy total diet replacement before colorectal cancer resection is feasible and well tolerated, lacks safety concerns, and is likely cost-effective, necessitating further research about the potential utility of this approach.

Real-World Data Highlight a New Approach to Chronic Constipation, With Darren Brenner, MD

Darren Brenner, MD, a professor of medicine and surgery in the division of gastroenterology at Northwestern University and serves as director of the Neurogastromotility and Interdisciplinary Bowel Dysfunction programs, describes shortcomings of pharmacologic chronic idiopathic constipation options and reviews real-world data on the Vibrant System’s benefits in this context.

The novel, device-based therapeutic approach is designed to enhance colonic motility without pharmacologic action, with new real-world evidence showing patients using the device for 3 and 6 months experienced improvements across multiple clinically relevant endpoints, including increased complete spontaneous bowel movements, reduced straining, and greater frequency of complete evacuation.

Predicting Teduglutide Treatment Response for Pediatric SBS-IF, With Valeria Cohran, MD

Recent research presented at the 2025 NASPGHAN Annual Meeting sheds light on the characteristics of children with short bowel syndrome-associated intestinal failure (SBS-IF) by response to teduglutide, including attainment of consistent response and sustained enteral autonomy. In this interview, Valeria Cohran, MD, a professor of pediatrics and the medical director of intestinal rehabilitation and transplant at Ann and Robert H Lurie Children's Hospital of Chicago, describes key findings from this study, a post hoc analysis pooled data from pediatric patients who took part in 1 of 2 open-label, multicenter, phase 3, long-term extension studies over 96 weeks and their respective parent studies, and emphasizes the need for additional studies of this agent in this patient population to further inform treatment decisions.

Navigating Autoimmune Overlap in Celiac Disease, With Daniel Mallon, MD

The overlap between celiac disease and other autoimmune disorders, especially type 1 diabetes, is an increasingly important area of clinical focus, with experts working to refine screening strategies and improve care for patients who may develop multiple autoimmune conditions.

In an interview with HCPLive at the 2025 NASPGHAN Annual Meeting, Daniel Mallon, MD, a pediatric gastroenterologist at Cincinnati Children’s Hospital, explained that about 5-10% of patients with type 1 diabetes will also develop celiac disease, while a smaller proportion of patients with celiac disease later develop type 1 diabetes. Beyond the shared risks linking celiac disease and type 1 diabetes, he also goes on to emphasize why early screening improves outcomes.

December 2025 offered significant advancements in gastroenterology, focusing on personalized care and innovative strategies. Observational data highlighted corticosteroid exposure risks in young women with ulcerative colitis. A feasibility trial demonstrated the safety and potential cost-effectiveness of intensive weight loss before colorectal cancer surgery. Real-world evidence supported a novel device-based approach for chronic idiopathic constipation. Pediatric research identified predictors of teduglutide response in short bowel syndrome-associated intestinal failure. Additionally, expert discussions emphasized the importance of early screening for autoimmune overlap in celiac disease and type 1 diabetes to improve outcomes.

Catch up on IBD steroid exposure risk, intensive weight loss before colorectal cancer surgery, a new chronic idiopathic constipation treatment option, and more.

Gastroenterology

Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for 

, IBS and IBD, Crohn's disease, and more.

Inflammatory Bowel Disease

On the HCPLive inflammatory bowel disease page, resources on the topics of medical news and expert insight into IBD can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBD and more.

Strategic Alliance Partnership

5 Gastroenterology Headlines You Missed in December 2025

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

Nipocalimab reduced disease activity in adults with 

 (SLE), meeting the primary end point of Systemic Lupus Erythematosus Responder Index [SRI-4] composite response in the phase 2b JASMINE (NCT04882878) study. The positive data have prompted Johnson & Johnson’s plans to initiate a phase 3 study to continue investigations.

“… SLE is a serious autoantibody-driven disease that can impact multiple organ systems, significantly reducing health-related quality of life for millions of people,” Leonard L. Dragone, MD, PhD, Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson Innovative Medicine, said in a statement.

 “Many people living with SLE also face complications associated with long-term steroid use, underscoring the limitations of current treatment approaches and the critical need for immunoselective therapies that are safe, tolerable, and capable of reducing disease activity, while preserving immune function.”

JASMINE is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study in 228 adults participants spanning 52 weeks. Its primary endpoint is SRI-4 composite response at Week 24 compared to placebo, and key secondary and exploratory endpoints include effects on steroid sparing. Investigators found that nipocalimab’s safety and tolerability profile was consistent with previous Phase 2 studies, and there were no new safety signals identified. Further data from JASMINE will be presented at a future medical conference.

Nipocalimab is a monoclonal antibody designed to block FcRn with high affinity and reduce levels of circulating immunoglobulin G (IgG) antibodies without affecting other adaptive and innate immune functions. It targets autoantibodies and alloantibodies involved in multiple conditions in the autoantibody space, including Rare Autoantibody diseases, maternal fetal diseases mediated by maternal alloantibodies, and autoantibody-driven rheumatic diseases.

Nipocalimab was approved in 2025, under the name Imaavy, to treat generalized myasthenia gravis (gMG) in adults and children (> 12 years) who are anti-acetylcholine receptor (AChR) or anti-muscular-specific kinase (MuSK) antibody positive.The therapy was approved in a 300 mg/ 1.62 mL formulation and a 1200 mg/6.5 mL (185 mg/mL) formulation of single-dose vials per carton for intravenous injection.

"The clinical results we've seen with IMAAVY represent a significant milestone in the treatment of gMG," said Nicholas J. Silvestri, MD, professor of neurology at the University of Buffalo, in a statement at that time.

 "Patients experienced substantial symptom relief and lasting disease control that translated into better daily function and did not fade over 24 weeks in the pivotal Vivacity-MG3 study. Having a treatment that delivers this level of durable symptom stability is a meaningful step forward for managing a complex and unpredictable disease like gMG, and to have it in both AChR+ and MuSK+ adults and pediatric patients 12 years and older brings an additional FcRn treatment to a broader range of patients."

The FDA’s decision was supported by findings from the ongoing 24-week, double-blind, placebo-controlled phase 3 VIVACITY-MG3 trial.³ The study enrolled 199 adult patients with antibody-positive or antibody-negative generalized myasthenia gravis (gMG) who had shown an inadequate response to standard-of-care therapy. Participants were randomized 1:1 to receive either nipocalimab in combination with standard of care (a 30 mg/kg intravenous loading dose followed by 15 mg/kg every 2 weeks) or placebo plus standard of care.

Results demonstrated that patients treated with nipocalimab achieved a 4.70-point improvement in the Myasthenia Gravis–Activities of Daily Living (MG-ADL) score, compared with a 3.35-point improvement in the placebo group over weeks 22, 23, and 24 (

 = .002). Treatment with nipocalimab was also associated with significantly greater improvements in the Quantitative Myasthenia Gravis score versus placebo through weeks 22 and 24 (

Johnson & Johnson unveils new data showing nipocalimab is the first and only investigational FcRn blocker with potential to reduce systemic lupus erythematosus (SLE) activity in a Phase 2 study. News release. Johnson & Johnson. January 6, 2026. 

https://www.jnj.com/media-center/press-releases/johnson-johnson-unveils-new-data-showing-nipocalimab-is-the-first-and-only-investigational-fcrn-blocker-with-potential-to-reduce-systemic-lupus-erythematosus-sle-activity-in-a-phase-2-study

Derman C. FDA Approves Nipocalimab Generalized Myasthenia Gravis for Adults, Children. Article. HCPLive. April 30, 2025. 

https://www.hcplive.com/view/fda-approves-nipocalimab-generalized-myasthenia-gravis-for-adults-children

Nipocalimab pivotal Phase 3 trial demonstrates longest sustained disease control in FcRn class. Johnson & Johnson. June 28, 2024. https://www.jnj.com/media-center/press-releases/nipocalimab-pivotal-phase-3-trial-demonstrates-longest-sustained-disease-control-in-fcrn-class.

Nipocalimab has shown promise in reducing disease activity in systemic lupus erythematosus (SLE) patients, achieving the primary endpoint in the phase 2b JASMINE study. This success has led to plans for a phase 3 study. Nipocalimab, a monoclonal antibody, targets FcRn to lower IgG antibody levels without compromising immune function. It has been approved for generalized myasthenia gravis (gMG) and demonstrated significant symptom relief in the VIVACITY-MG3 trial. The therapy offers a new treatment avenue for autoantibody-driven diseases, addressing limitations of current therapies.

Johnson & Johnson plans to initiate a phase 3 study based off the positive data.

Lupus

Rheumatology

Rheumatology condition center page is a comprehensive resource for clinical news and insights on rheumatologic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for arthritis, gout, nr-AxSpA, and more.

Nipocalimab Reduces SLE Disease Activity, Meeting JASMINE Study End Point

Amer Zeidan, MD, is a professor of medicine and the chief of the Division of Hematologic Malignancies at Yale University.

Videos

Zeidan discusses the interim results from the ongoing phase 1/2 trial, highlighting bexmarilimab’s efficacy in combination with azacitidine SoC.

Hematology

Bexmarilimab Safe and Efficacious in Treating Myelodysplastic Syndromes, With Amer Zeidan, MD

A cross-sectional study in CKD suggests patients undergoing hemodialysis have increased social frailty and depression compared to transplant recipients. 


Chronic Kidney Disease Paired With Social Frailty May Increase Depression Risk  

Two phase 3 trials met their primary and secondary endpoints in patients with moderate-to-severe plaque psoriasis on envudeucitinib.

ONWARD Studies: Oral Envudeucitinib Treatment Effective, Safe for Psoriasis

Crohn’s & Colitis Foundation survey findings show 18% of young adults with IBD work extra hours to afford care and > 1 in 3 are not confident navigating insurance.

Young Adults With IBD Face Greater Healthcare Access Challenges, Financial Burdens

Alixorexton receives FDA Breakthrough Therapy Designation, promising significant advancements in treating narcolepsy type 1.

FDA News

Sleep

On the HCPLive sleep page, resources on the topics of medical news and expert insight into sleep medicine can be found. Content includes articles, interviews, videos, podcasts, and breaking news on sleep apnea, insomnia, narcolepsy, and more.

FDA Grants Breakthrough Therapy Designation to Alixorexton for Narcolepsy Type 1

Sonalika Khachikian, MD, is an endocrinologist at Monument Health.

Timely referral and accurate assessment of disease activity and severity are critical determinants of outcomes in thyroid eye disease (TED) management.

Video Series

Referral Timing and Treatment Decisions in Thyroid Eye Disease

This quarterly recap highlights some of the most notable news and developments in the dermatology space from Q4 in 2025.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

Q4 2025 Recap: Dermatology News and Updates

Q4 2025 brought key FDA approvals and phase 3 advances in HAE, peanut allergy, multi-allergen immunotherapy, and allergic fungal rhinosinusitis.

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Anaphylaxis

The HCPLive anaphylaxis page is a comprehensive resource for clinical news and insights on acute allergic reactions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for preventing anaphylaxis, and more.

Food Allergy

Q4 2025 Recap: Allergy News and Updates

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

Catch up with major FDA decisions, critical conference news, and more.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Heart Failure

The HCPLive heart failure page is a resource for medical news and expert insights on HF. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for heart disease, reduced and preserved ejection fraction, and more.

Cardiomyopathy

Dyslipidemia

7 Cardiology Headlines You Missed in December 2025

Data from the ongoing phase 4 PETITE-T1D study, highlighting the substantially reduced progression to stage 3 T1D, headline the application.

Endocrinology

The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

Latest News

Deucravacitinib 6 mg Effective in Patients with Psoriasis Over 2 Years

Serum Creatinine Trajectories May Predict 28-Day Mortality in CKD

Switching Therapists for Psychotherapy Offers No Advantage in MDD

5 Gastroenterology Headlines You Missed in December 2025

Nipocalimab Reduces SLE Disease Activity, Meeting JASMINE Study End Point