Need for Head-to-Head Adjunctive MDD Data, With Leslie Citrome, MD

A network meta-analysis presented as a late-breaking session at the 2026 Neuroscience Education Institute (NEI) Spring Congress in Kissimmee, Florida, suggested lumateperone (CAPLYTA) demonstrated favorable efficacy outcomes and limited weight gain and akathisia risk compared with other FDA-approved adjunctive atypical antipsychotics for 

, investigator Leslie Citrome, MD, MPH, a clinical professor of psychiatry and behavioral sciences at New York Medical College, said direct comparative data remain needed to clarify differences between therapies in clinical practice. He said that clinicians should interpret the findings within the context of indirect evidence and the broader limitations of registrational clinical trial populations.

“The limitation that’s really key is that not all studies that were done were included—only those that led to approval by the FDA and that are mentioned in product labeling,” Citrome said.

The analysis indirectly compared lumateperone with aripiprazole, brexpiprazole, cariprazine, and quetiapine XR using placebo plus antidepressant therapy as a common comparator across 10 randomized placebo-controlled registrational trials. Citrome and colleagues reported lumateperone showed the greatest effect size across 4 efficacy outcomes, including Montgomery-Åsberg Depression Rating Scale (MADRS) change from baseline (mean difference, -4.71; 95% credible interval [CrI], -5.78 to -3.63), MADRS response (odds ratio [OR], 2.33; 95% CrI, 1.77 to 3.05), MADRS remission (OR, 2.22; 95% CrI, 1.57 to 3.07), and Clinical Global Impression-Severity (CGI-S) (-0.60; 95% CrI, -0.74 to -0.46) improvements.

According to Citrome, another important limitation involves the characteristics of patients enrolled in randomized controlled trials, which may differ from those of patients routinely seen in practice. Clinical trial participants must provide informed consent, attend scheduled visits, and often receive compensation for participation, creating what he described as a “quasi-artificial environment.”

Patients with suicidal ideation or elevated suicide risk are also commonly excluded from adjunctive MDD trials, potentially limiting generalizability to more complex real-world populations.

“The patients that are in the study may differ somewhat from the patients in practice, but in general, we would expect the same treatment effects overall,” Citrome said.

The findings were not unexpected to Citrome, who noted he has previously evaluated lumateperone using measures such as number needed to treat and number needed to harm. However, he suggested many practicing clinicians may still find the comparative differences among adjunctive atypical antipsychotics notable.

“The average clinician who’s not aware of this research may be a little bit surprised that these drugs are not all the same, and they’re not interchangeable,” Citrome said.

The network meta-analysis found lumateperone demonstrated no statistically significant weight gain relative to placebo plus antidepressant therapy and was the only treatment evaluated with akathisia risk comparable to placebo. Somnolence risk remained greater than placebo, consistent with the broader adjunctive atypical antipsychotic class.

Citrome emphasized that treatment selection in MDD remains individualized and should account for patient preferences and prior adverse event experiences, particularly related to weight gain, akathisia, sedation, and somnolence.

“If you’re looking for a particular drug for a particular person, you must take into account the person’s own values and preferences,” he said.

Editor’s note: Relevant disclosures for Citrome include H. Lundbeck A/S, Axsome Therapeutics, Alkermes, Otsuka America Pharmaceutical, E.R. Squibb & Sons, Neurocrine Biosciences, Teva Pharmaceutical, and others.

Lumateperone Ranked Favorably Among Adjunctive MDD Therapies, With Leslie Citrome, MD

CAPLYTA® (lumateperone) showed greatest improvement across key efficacy outcomes among adjunctive MDD treatments in new network meta-analysis. JNJ.com. Published May 4, 2026. Accessed May 12, 2026. 

https://www.jnj.com/media-center/press-releases/caplyta-lumateperone-showed-greatest-improvement-across-key-efficacy-outcomes-among-adjunctive-mdd-treatments-in-new-network-meta-analysis

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Citrome discussed the limitations of indirect comparisons and the need for head-to-head trials evaluating adjunctive atypical antipsychotics for MDD, including lumateperone.

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Katalin Susztak, MD, PhD, is a Professor of Medicine and Genetics at the University of PennsylvaniaKatalin Susztak, MD, PhD, is a Professor of Medicine and Genetics at the University of Pennsylvania

9-Protein Plasma Score Predicts Kidney Failure Risk in APOL1 High-Risk Individuals Before Visible CKD

A plasma proteomic risk score built from 9 circulating proteins can identify individuals with high-risk APOL1 genotypes who are most likely to progress to kidney failure, years before standard clinical markers such as estimated glomerular filtration rate (eGFR) or albuminuria become abnormal.

The findings, derived from the Penn Medicine BioBank (PMBB) and validated in 2 independent cohorts, offer a potential precision medicine framework to address predicting which APOL1 carriers will actually develop kidney disease, one of the most persistent gaps in nephrology.

Score: APOL1 Proteomic Risk Score (APRS), 9 proteins

Population: APOL1 high-risk, eGFR ≥60, African ancestry

Status: Research tool; prospective validation needed

"APOL1 variants are common — present in about one third of African Americans — and while they confer substantial risk, only a minority of individuals develop kidney disease. So the challenge is not identifying risk, but distinguishing who will get sick from who will remain healthy," said Katalin Susztak, MD, PhD, Professor of Medicine in the Renal-Electrolyte and Hypertension Division at the University of Pennsylvania Perelman School of Medicine.

What the APOL1 Proteomic Risk Score Study Found

Researchers profiled plasma proteomes using the SomaScan platform, quantifying approximately 7549 proteoforms, in 851 PMBB participants of African ancestry who carried high-risk APOL1 genotypes (G1/G1, G2/G2, or G1/G2) and had preserved kidney function, defined as ≥ eGFR of 60 ml/min/1.73m2. Using elastic net Cox regression adjusted for age, sex, eGFR, and urine albumin-creatinine ratio (UACR), the team derived a 9-protein APOL1 Proteomic Risk Score (APRS) comprising SPON1, SUMO2, EPHA10, REG3A, WFDC2, LYZ, MMP7, NPPB, and CILP2.

The composite primary outcome of a ≥ 40% eGFR decline, kidney failure, or death occurred in 18.0% of participants, with preserved eGFR in 10 years of follow-up, underscoring the event burden in this population even before CKD is clinically apparent. APRS achieved a time-dependent area under the receiver operating characteristic curve (tAUC) of 86.5% for the composite outcome, substantially outperforming the Kidney Failure Risk Equation (KFRE; tAUC 66.1%) and polygenic risk scores (tAUC 58.5%) in this group. Risk stratification by quintile showed 10-year cumulative event rates of 62.5% in the highest APRS quintile versus 3.3% in the lowest (

 = 4.73 × 10−23). At 5 years, APRS demonstrated a sensitivity of 76.3% and specificity of 86.7%.

How APRS Performs Compared to Existing Kidney Failure Prediction Tools

The KFRE, the most widely validated clinical equation for kidney outcomes, is known to perform poorly when eGFR is preserved, precisely the population where early intervention would have the greatest benefit. Polygenic risk scores, which aggregate inherited susceptibility variants across the genome, similarly showed limited discrimination in the APOL1 high-risk group, consistent with prior observations that static genetic measures provide modest predictive value in diverse populations.

The APRS was also benchmarked against the Chronic Renal Insufficiency Cohort (CRIC) proteomic score, a 65-protein model developed in patients with established CKD. Although the CRIC score was derived from a more advanced disease population, APRS outperformed it in the preserved-eGFR group (tAUC 86.5% versus 79.0%) while performing comparably in participants with eGFR below 60 ml/min/1.73 m

Decision curve analysis confirmed greater net clinical benefit from APRS than either a treat-all or treat-none strategy across a range of decision thresholds. Assuming a treatment that reduces composite endpoint risk by 27%, the reduction reported for the investigational APOL1 inhibitor inaxaplin in prior trials, APRS at or above the 95th percentile, yielded a number needed to treat of 4.9, compared with 8.4 for KFRE and 23.9 for a CKD polygenic risk score.

External Validation of the 9-Protein Score Across Independent Cohorts

To assess generalizability, APRS was validated in 2 external population-based cohorts. In the Atherosclerosis Risk in Communities (ARIC) study, 314 APOL1 high-risk African American participants with preserved kidney function at baseline (mean eGFR 96.2 ml/min/1.73 m

) were evaluated; APRS achieved a tAUC of 82.2% over 10 years. In the UK Biobank, 204 APOL1 high-risk participants of African ancestry (mean eGFR 87.1 ml per minute per 1.73 m

) showed similarly strong discrimination, with a tAUC of 84.7%. Despite differences in recruitment era, geographic setting, and healthcare systems, performance remained consistent across both cohorts, supporting reproducibility beyond the academic medical center setting where the score was developed. 

Among the 9 component proteins, 4 were significantly associated with interstitial fibrosis in independent human kidney tissue samples at both the mRNA and protein levels, suggesting biological plausibility. Susztak noted that some proteins are linked to fibrosis and tissue injury, others to inflammatory pathways, and some to endothelial dysfunction. MMP7 has been reported as a marker of tubular injury and fibrosis; WFDC2 correlates with interstitial fibrosis and rapid eGFR decline; and LYZ is associated with fibroblast proliferation and tubular cell senescence.

The investigators acknowledge that these associations are correlative and that whether these proteins actively drive disease progression or reflect altered renal clearance remains to be established through experimental validation.

"APRS is currently a research tool," Susztak said. "While we have validated it in independent cohorts, including studies in the United Kingdom and NIH-funded populations, clinical implementation requires further work. The challenge is demonstrating that acting on this information improves outcomes, particularly in populations that have historically experienced a disproportionate burden of disease."

The investigators outline several translational steps, including independent prospective validation, assay standardization across platforms, and incorporation of APRS into clinical trials of APOL1-targeted therapies to determine whether score-guided enrollment and treatment decisions improve patient outcomes. As APOL1-directed agents such as inaxaplin advance through development, APRS may also serve as a pharmacodynamic readout of treatment effect and a subject enrichment tool to improve trial efficiency.

Editor’s Note: Susztak reports relevant disclosures with Ilead, Novo Nordisk, Novartis, and others. 

Susztak K, et al. Plasma proteomic risk score predicts kidney failure in APOL1 high-risk individuals. Nature Medicine. 2025.

Inker LA, Tangri N, Greene T, et al. Kidney Failure Risk Equation performance across eGFR strata. J Am Soc Nephrol. 2019;30(9):1731-1742.

Olabisi OA, Zhang JY, VerPlank L, et al. APOL1 nephropathy risk variants induce cytotoxicity by disrupting cellular electrolyte homeostasis. Proc Natl Acad Sci USA. 2016;113(4):830-837.

Gharavi AG, Ahmad T, Roberts JD, et al. Genome-wide association analysis improves polygenic risk prediction for CKD. J Am Soc Nephrol. 2023. [Note: Verify full citation details; PRS reference sourced from study methods.]

Susztak, MD, PhD, offers insight into a new score that predicts which APOL1 carriers will actually develop 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.

How to Educate Dermatology Patients on Colorism Issues, With Seemal Desai, MD, and Pearl Grimes, MD

 in partnership with the Skin of Color Society (SOCS), dermatologists Seemal R. Desai, MD, and Pearl Grimes, MD, expanded their discussion on colorism and pigmentary disorders by focusing on patient education, dangerous skin-lightening practices, and the broader advocacy efforts needed to address the global harms associated with skin bleaching.

Desai emphasized that open and detailed communication with patients is critical when evaluating pigmentary concerns in clinical practice. He explained that dermatologists must go beyond simply asking whether patients are using treatments for pigmentation and instead ask specifically about moisturizers, serums, brightening creams, and products purchased online or abroad. According to Desai, many harmful products marketed as beauty or fairness creams may contain potent topical steroids, high-dose hydroquinone, arsenic, or mercury without patients fully understanding the risks involved.

He noted that unsafe skin-lightening practices remain widespread in several parts of the world, particularly in Southeast Asia and West Africa. Desai referenced reports of severe systemic toxicity and even deaths related to chronic exposure to mercury- and arsenic-containing bleaching products, highlighting recent research he coauthored in the Journal of the American Academy of Dermatology examining these concerns.

Grimes agreed that careful product review has become an essential part of patient care. She described routinely asking patients to bring products into the office or pull ingredient lists up on their phones during visits to better understand what they are using. According to Grimes, this level of investigation is often necessary because many patients may unknowingly apply harmful agents as part of daily skin care routines influenced by societal pressures surrounding skin tone.

The discussion also turned to the growing popularity of glutathione-based skin-lightening therapies, particularly intravenous glutathione infusions marketed by clinics in the US and abroad. Grimes warned that these treatments are far from benign, citing reports in the medical literature linking IV glutathione “cocktails” to severe adverse events including anaphylaxis and Stevens-Johnson syndrome. She additionally described a recent patient case in which prolonged use of high-dose oral glutathione was suspected of contributing to severe, widespread vitiligo.

Both physicians stressed that combating colorism requires coordinated advocacy efforts involving clinicians, regulatory agencies, and professional organizations. Desai pointed to collaborations involving groups such as the American Academy of Dermatology, the Global Vitiligo Foundation, and the International League of Dermatological Societies aimed at increasing awareness of the medical and psychological harms tied to skin bleaching practices.

Grimes concluded by emphasizing the importance of helping patients appreciate their natural skin tone and identity while working to dismantle the longstanding societal stigmas that continue to fuel colorism worldwide.

Editor’s note: This description was summarized with the help of AI tools.

Desai S, Grimes P. Skin of Color Savvy: Tackling Colorism in Dermatology, With Seemal Desai, MD, and Pearl Grimes, MD. HCPLive. March 24, 2026. Accessed May 13, 2026. 

https://www.hcplive.com/view/skin-of-color-savvy-tackling-colorism-dermatology-seemal-desai-md-pearl-grimes-md

This segment of a recent Skin of Color Savvy podcast highlights the experts' views on education related to colorism and skin pigment-related concerns.

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.

Linda Stein Gold, MD, is a dermatologist at Henry Ford Health. 

Eingun James Song, MD, is the director of clinical research for Frontier Dermatology. 

Implementing Remission Goals in Psoriasis Practice

In the final episode, ‘Implementing Remission Goals in Psoriasis Practice,’ the panelists focus on the practical application of remission-focused strategies in psoriasis management, emphasizing how clinicians can translate evolving treatment goals into everyday practice. The expert faculty highlight that while formal definitions of on-treatment remission provide valuable guidance, implementation does not require rigid protocols. Instead, simply recognizing remission as an achievable goal can shift the clinical mindset and elevate standards of care in psoriasis.

They discuss the importance of setting clear expectations with patients, particularly the goal of achieving and maintaining complete skin clearance. The faculty emphasize that patients typically seek the most effective therapy available and expect sustained results, reinforcing the need to align treatment strategies with these expectations. They also highlighted practical tools, such as routine assessment of body surface area (BSA) and Investigator’s Global Assessment (IGA), are efficient ways to monitor progress and prompt treatment reassessment when targets are not met. These measures can also streamline clinical workflows and support performance metrics. The panelists conclude by encouraging clinicians to become familiar with a core set of biologic therapies and to confidently communicate their benefits to patients with psoriasis.

Thank you for watching this peer exchange series on on-treatment remission in psoriasis. Please subscribe to our newsletter for information on upcoming video series.

Experts explain managing psoriasis biologic failures: reassess response, use topicals, and switch smarter to reach near‑clear skin.

Video Series

Patient-Level Treatment Drivers — Route of Administration, Psoriatic Arthritis, and Comorbidity Considerations 

Strober examines how patient preference for oral versus injectable therapy and the presence and pattern of psoriatic arthritis.

Effective psoriasis management increasingly depends on a treatment selection framework that extends beyond skin severity scores to encompass the full clinical and contextual profile of the individual patient. Route of administration is among the most practically influential of these factors. Many patients express an instinctive preference for oral medications, but that preference is rarely absolute and often shifts when the clinical conversation addresses the full picture of treatment burden — including how often injections actually occur at maintenance and how that compares with the commitment of daily oral dosing. For patients who prioritize the fewest possible interactions with a therapy once disease is controlled, the every-12-weeks maintenance schedule of an IL-23 biologic may ultimately be more acceptable than a once-daily oral pill. The clinician's role is to surface these preferences explicitly rather than assume them, and to provide the comparative context patients need to make an informed choice.

Psoriatic arthritis (PsA) — its presence, severity, and anatomical pattern — is among the most consequential determinants of mechanism selection in patients with psoriatic disease. IL-17 inhibitors carry the most robust data across the full spectrum of PsA domains, including peripheral joint disease, distal interphalangeal involvement, dactylitis, enthesitis, and axial disease, and have demonstrated inhibition of radiographic progression across these domains. For patients with prominent axial psoriatic arthritis in particular, IL-17 blockade remains the preferred mechanism, supported by an evidence base that IL-23 inhibitors have not yet matched for this specific manifestation. That said, guselkumab has recently demonstrated radiographic benefit in psoriatic arthritis, and the differentiation between IL-17 and IL-23 agents in this domain continues to evolve. Conversely, IL-17 inhibitors carry meaningful contraindications in patients with inflammatory bowel disease — a comorbidity that is not uncommon in patients with psoriasis — whereas IL-23 inhibitors can be used across a far broader comorbidity range.

In this segment of the video discussion on psoriasis treatment selection, Bruce Strober, MD, PhD, Clinical Professor of Dermatology at Yale University School of Medicine, describes the practical algorithm he applies at the point of prescribing. IL-23 inhibitors occupy a favored default position in his treatment approach for most patients with skin-predominant disease: they offer infrequent maintenance dosing, an essentially unrestricted comorbidity profile outside of active infection, and long-term durability data that compare favorably with other biologic classes. IL-17 inhibitors are reserved primarily for patients with significant psoriatic arthritis — particularly those with axial involvement — where the evidence for superior joint outcomes justifies accepting the more restrictive contraindication profile. Icotrokinra and other oral agents are positioned for patients who prioritize the oral route and can accept a somewhat lower efficacy ceiling than the most potent injectable biologics. This mechanism-first framework, calibrated by comorbidity and arthritis pattern before patient preference is layered on top, reflects the current complexity of psoriasis care and the degree to which therapeutic selection has evolved from a simple stepwise escalation into a nuanced, multidimensional clinical decision.

Oral therapies offer convenience, but biologics deliver faster, stronger results; experts weigh psoriatic arthritis, dosing schedules, safety profiles, and IL-17 vs IL-23 choices.

Managing Treatment Failure in Psoriasis

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.

Articles

Catch up on 5 notable studies and trial updates from DDW 2026!

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 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

DDW 2026 Recap: 5 Trials to Know

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.

This large real-world analysis of patients with vitiligo suggests many individuals remain untreated after diagnosis.

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Key Characteristics, Treatment Patterns Identified in Patients with Vitiligo

Mehdi Shishehbor, DO, PhD, is the president of the Harrington Heart & Vascular Institute at University Hospitals.

Mehdi Shishehbor, DO, PhD, discusses the 6-month results from his recent study, confirming the efficacy of the LimFlow System in patients with CLTI.

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PROMISE III: Substantial Amputation-Free Survival With LimFlow TADV in CLTI

Practicing critical care pulmonologist, Managing Director of Health Innovation at Manatt, medical analyst for NBC News and MSNBC, affiliate faculty at the University of Washington's Institute for Health Metrics and Evaluation, commissioned officer (Major) in the United States Air Force Medical Reserve Corps, and board member of the American Lung Association

Gupta discusses clinical responsibility in response to the ALA's State of the Air 2026 report.

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Strategic Alliance Partnership

Eyes on Chronic Air Pollution, With Vin Gupta, MD, MPA

Erin Ferranti, PhD, MPH, is an associate professor at the Nell Hodgson Woodruff School of Nursing at Emory University and the director of the Farmworker Family Health Program.

Erin Ferranti, PhD, MPH, discusses the new guidelines and their implications for continued enhancement of both access to and outcomes of postpartum care.

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Atherosclerotic Cardiovascular Disease

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New AHA Recommendations Encourage Improving Postpartum Cardiovascular Care

Abigail Brooks is a strategic content lead overseeing 

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.

After roughly 14 months leading the agency and recent reports of the Trump administration planning his removal, FDA Commissioner Marty Makary, MD, MPH, has resigned.

FDA News

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FDA Commissioner Marty Makary Resigns, Kyle Diamantas Steps In as Acting Head

A study suggested lumateperone demonstrated favorable efficacy outcomes and limited weight gain and akathisia risk compared with other adjunctive antipsychotics for MDD.

Seemal R. Desai, MD, and Pearl E. Grimes, MD, discuss the complexities of colorism and its impact on pigmentary disorders.

Discussing Colorism and Pigmentary Disorders, With Seemal Desai, MD, and Pearl Grimes, MD

Christopher Brooks, MD, an allergy and immunology physician at The Ohio State University.

In this Q&A, Christopher Brooks, MD, discusses advancing research on intralymphatic immunotherapy for environmental and, more recently, food allergies.

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Latest News

Need for Head-to-Head Adjunctive MDD Data, With Leslie Citrome, MD

9-Protein Plasma Score Predicts Kidney Failure Risk in APOL1 High-Risk Individuals Before Visible CKD

How to Educate Dermatology Patients on Colorism Issues, With Seemal Desai, MD, and Pearl Grimes, MD

Implementing Remission Goals in Psoriasis Practice

Patient-Level Treatment Drivers — Route of Administration, Psoriatic Arthritis, and Comorbidity Considerations