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Stone is professor of medicine at Harvard Medical School and the Edward A Fox Chair in Medicine at the Massachusetts General Hospital. He has treated IgG4-related disease (IgG4-RD) since its emergence in recent years and is passionate about educating patients and fellow healthcare providers (HCPs) about the indolent and systemic nature of this disease.

Achieving GC-Free IgG4-Related Disease Remission With Rilzabrutinib, with John Stone, MD, MPH

Rilzabrutinib demonstrated high rates of remission in people with IgG4-related disease despite a short glucocorticoid (GC) tapering period, in new data from a phase 2 study.

European Alliance of Associations for Rheumatology (EULAR) Congress 2025 

in Barcelona, Spain, taking place June 11-14, 2025, by investigator John Stone, MD, MPH, professor of medicine at Harvard Medical School and Edward A. Fox Chair in Medicine at the Massachusetts General Hospital.

spoke with Stone to learn more about rilzabrutinib and its potential advantages for treating IgG4-related disease, including the fact that it is an oral drug, which offers access and safety benefits compared to intravenous infusions. He emphasized the high, 70% rate of remission seen in study participants at week 52 without any additional treatments like GCs or immunosuppressants. Furthermore, he highlighted the very short steroid taper period, with participants discontinuing their steroids after only 1 month of rilzabrutinib treatment.

“Remember that when we use B-cell depletion strategies, whether rituximab as in the past sometimes or inebilizumab now, patients receive 100 milligrams of methylprednisolone with each of their infusions. So that contributes also to the efficacy of that approach. With the rose Ibrutinib trial, there was very little steroid at the beginning, and it was tapered off completely at 1 month,” Stone said.

Participants also experienced clinically meaningful improvements in disease activity were observed at week 52 as assessed by ≥2 point reductions in IgG4-RD responder index, with improvements evident as early as week 12 and sustained at week 52. The safety profile of rilzabrutinib was consistent with that in previous studies, with no new safety signals observed. Diarrhea, COVID-19, dizziness, dry mouth and nausea were among treatment-emergent adverse events reported by over 10% of patients.

Media Update: EULAR: rilzabrutinib data in IgG4-related disease show reduction in flares and key disease markers; earns Fast Track designation in the US. News release. Sanofi. June 12, 2025. https://www.sanofi.com/en/media-room/press-releases/2025/2025-06-12-08-30-00-3098093

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Rilzabrutinib shows promising remission rates in IgG4-related disease with minimal glucocorticoid use, offering a safer oral treatment option.

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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.

On July 8, 2025, Johnson & Johnson announced that the company submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for lumateperone (CAPLYTA) to prevent 

The sNDA submission was based on long-term phase 3 data showing that lumateperone led to a 63% reduction in the risk of relapse in adults with schizophrenia compared to placebo. Lumateperone 42 mg, an oral, once-daily atypical antipsychotic, is characterized by high serotonin 5-HT2A receptor occupancy and lower amounts of dopamine D2 receptor occupancy at therapeutic doses.

“For people living with schizophrenia, relapses can be devastating as they disrupt lives, undo hard-earned treatment progress toward patients’ goals, and increase the risk of hospitalization with each episode,” said Christoph U. Correll, MD, clinical professor of psychiatry at the Zucker School of Medicine at Hofstra/Northwell, New York, in a statement. “CAPLYTA® substantially lowers the chance of relapse for patients compared to placebo, which is often a major source of anxiety and suffering for them and their families.”

Lumateperone is FDA-approved to treat schizophrenia as a monotherapy or an adjunctive therapy with lithium or valproate. The drug is also already approved for bipolar disorder (I and II) and depression as an adjunctive and monotherapy. An NDA for lumateperone as an adjunctive major depressive disorder (MDD) is currently under FDA review.

Lumateperone may already be approved to treat schizophrenia, but the data support the drug’s safety and efficacy in preventing schizophrenia relapse.

The phase 3, double-blind, multicenter, placebo-controlled, randomized withdrawal 47-week trial included an 18-week open-label and 26-week double-blind phase. During the open-label phase, patients with schizophrenia were treated with lumateperone 42 mg per day. Patients who met the stabilization criteria during the open-label period entered the double-blind phase, where they were randomized to either continue lumateperone 42 mg (n = 114) or switch to placebo (n = 114) for 26 weeks or until relapse.

The phase 3, double-blind, multicenter, placebo-controlled, randomized withdrawal trial showed that time to relapse during the 26-week double-blind treatment phase was significantly longer in patients on lumateperone vs placebo (P = .0002). Additionally, compared with placebo, lumateperone was linked to a 63% reduction in the risk of relapse (hazard ratio [HR], 0.37; 95% confidence interval [CI], 0.22 – 0.65).

The study also showed significantly delayed time to all-cause discontinuation among patients on lumateperone vs placebo during the double-blind phase (P = .0007). Lumateperone had a consistent safety profile in earlier clinical trials, with similar rates of weight change, metabolic effects, and extrapyramidal symptoms; no new safety concerns were identified. Common adverse events included a headache, somnolence/sedation, dizziness, nausea, and dry mouth.

“Relapse prevention is a critical goal for the long-term care and management of this debilitating disorder,” said Bill Martin, PhD, Global Therapeutic Area Head, Neuroscience, at Johnson & Johnson Innovative Medicine, in a statement. “These phase 3 results provide compelling evidence of meaningful relapse prevention, which is critical in preserving long-term patient stability, breaking the cycle of hospitalization, and helping to control symptom progression.”

Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo. Johnson & Johnson. July 8, 2025. 

https://www.jnj.com/media-center/press-releases/supplemental-new-drug-application-submitted-to-u-s-fda-for-caplyta-lumateperone-with-data-demonstrating-significant-schizophrenia-relapse-prevention-compared-to-placebo

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Johnson & Johnson has submitted a supplemental New Drug Application to the FDA for lumateperone (CAPLYTA) to prevent schizophrenia relapse. The application is supported by phase 3 trial data showing a 63% reduction in relapse risk compared to placebo. Lumateperone, an atypical antipsychotic, is already approved for schizophrenia, bipolar disorder, and depression. The trial demonstrated significantly longer time to relapse and delayed all-cause discontinuation for patients on lumateperone. The drug maintained a consistent safety profile, with common adverse events including headache, somnolence, and dizziness.

Johnson & Johnson seeks FDA approval for lumateperone (CAPLYTA) to significantly reduce schizophrenia relapse risk. Company submits an sNDA.

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J&J Submits sNDA to FDA for Lumateperone (CAPLYTA) to Prevent Schizophrenia Relapse

Walt Whitley, OD, MBA | Image Credit: Virginia Eye Consultants

2025 American Optometric Association Conference

 in Minneapolis, MN, Walt Whitley, OD, MBA, optometrist at Virginia Eye Consultants, presented his lecture on the role biologic therapies play in 

Over the last two decades, a wide variety of biologic therapies have been investigated and approved for several different ocular diseases, including 

, scleritis, and orbital inflammation. Medications such as corticosteroids and cytokines have revolutionized the treatment landscape for these diseases, and further drugs in the pipeline currently promise even further advancement.

Whitley named what he believes are some of the most critical biologic treatments currently on the market, primarily for the neurotrophic keratitis.

“The most common thing that we’re going to see is neurotrophic keratitis, and there’s several different treatments that are available,” Whitley told 

 “We talked about both cryopreserved and dry amniotic membrane. We talked about topical biologic therapies such as cenegermine, which is 1 drop every 2 hours 6 times a day for 8 weeks, which shows the effect of rehabilitating those nerves, regenerating those corneal nerves to help that surface heal to improve our patients’ conditions.”

Whitley also spoke to the confusion and uncertainty inherent in such a wide range of possible treatments. Individual clinicians can often wind up overwhelmed by the sheer volume of choices, according to Whitley.

“The real-world barrier when it comes to incorporating biologics within eye care is often what is available, so there’s confusion because there’s so many different things that are out there,” Whitley said. “Every single time you turn on the TV, there’s a commercial about some type of biologic, so it can get confusing.”

Delving further into this, Whitley described the frustrations born of too many choices, chief among them the conflicting guidelines and regulations.

“The confusion is, where do I prescribe it? What are the steps? How are my patients going to get it? How long are they going to take the medication? So, it’s going to require education for us, the providers, but also for the patients themselves,” Whitley said.

Looking ahead, Whitley expressed interest in a slew of advancements on the horizon, highlighting everything from neuropathic corneal pain to ocular surface disease.

“I’m looking for things that are going to help our patients,” Whitley said. “In my cornea practice, we have many patients that are suffering from neuropathic corneal pain. We know that their corneal nerves are firing abnormally, and so in those cases these patients are in pain and they’re looking for some kind of treatment. If we can find a way to address this for our patients, it is only going to benefit them.”

Additionally, given the status of several biologics as frontline therapies for various ocular diseases, Whitley instead turned his attention to improving both testing and care for various diseases.

“I was part of a neurotrophic keratitis study group, and one of the callouts we had was anytime patients had ≥2 staining or higher, that’s where we needed to check for corneal sensitivity. Is it present? Is it reduced or is it absent? If it’s reduced or absent, then we need to do one of our therapies, whether it’s the membranes, the drops, et cetera, to help our patients.”

Whitley W. The Role of Biologics in Eye Care. Presented at the 2025 American Optometric Association Conference in Minneapolis, MN, June 25-28, 2025.

Lim L, Suhler EB, Smith JR. Biologic therapies for inflammatory eye disease. Clin Exp Ophthalmol. 2006;34(4):365-374. doi:10.1111/j.1442-9071.2006.01225.x

Whitley speaks to the plethora of available biologics, the choice paralysis that can accompany the wide range of options, and the future of the industry.

Ophthalmology

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The Role of Biologic Therapies in Optometry with Walt Whitley, OD, MBA

Professor of Rheumatology and Deputy Head of the Department of Rheumatology and Clinical Immunology, Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin

Cutting Down on Glucocorticoids in Giant Cell Arteritis With Upadacitinib, with Frank Buttgereit, MD

New data continue to support upadacitinib15 mg’s benefit for people with giant cell arteritis (GCA) with a shorter glucocorticoid (GC) tapering over placebo with a longer taper, with low rates of serious infection.

These findings, from the pivotal SELECT-GCA trial, were presented at the 

in Barcelona, Spain, taking place June 11-14, 2025, by Frank Buttgereit, MD, Professor of Rheumatology and Deputy Head of the Department of Rheumatology and Clinical Immunology, Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin.

Rates of serious infections through week 52 were numerically lower with both upadacitinib 15 mg (7.9 events/100 patient-years [E/100 PY]; 95% CI, 4.3–13.2) and 7.5 mg (7.9 E/100 PY; 95% CI, 3.2–16.3) compared to placebo (12.7 E/100 PY; 95% CI, 6.6–22.2). In contrast, herpes zoster rates were higher with upadacitinib 15 mg (7.3 E/100 PY; 95% CI, 3.9–12.5) but comparable between upadacitinib 7.5 mg (4.5 E/100 PY; 95% CI, 1.2–11.6) and placebo (4.2 E/100 PY; 95% CI, 1.2–10.9).

Opportunistic infections were rare across all groups. No cases were reported with the 7.5 mg dose, while four were seen with 15 mg, including one serious case of Pneumocystis jiroveci pneumonia that led to treatment discontinuation. The others were mild to moderate and did not result in discontinuation.

In the post-glucocorticoid (GC) taper period, serious infection rates remained lower with upadacitinib 7.5 mg (3.4 E/100 PY; 95% CI, 0.7–9.9) and 15 mg (3.9 E/100 PY; 95% CI, 1.6–8.1) compared to placebo (8.5 E/100 PY; 95% CI, 3.7–16.7). Herpes zoster rates during and after the GC taper were similar between upadacitinib 15 mg and placebo. Of the four opportunistic infections in the 15 mg group, three occurred during the taper and one after, in a patient on GC escape therapy. Baseline GC dose did not appear to influence serious infection risk.

spoke with Buttgereit to learn more about the SELECT-GCA trial, what it aimed to assess, and how its trial design compared the different treatment regimens and glucocorticoid tapering strategies.

Upadacitinib 15 mg once daily was previously approved for the treatment of adults with GCA, under the name Rinvoq, in April 2025.

Buttgereit F, Winthrop KL, Calabrese LH, et al. Impact of Glucocorticoid Tapering in Giant Cell Arteritis: Analysis From the SELECT-GCA Trial. Presented at: EULAR Congress 2025; Barcelona, Spain; June 11-14. Presentation #OP0057

RINVOQ® (upadacitinib) Receives U.S. FDA Approval for Giant Cell Arteritis (GCA). News release. AbbVie. April 29, 2025. https://news.abbvie.com/2025-04-29-RINVOQ-R-upadacitinib-Receives-U-S-FDA-Approval-for-Giant-Cell-Arteritis-GCA

New findings highlight upadacitinib's effectiveness in treating giant cell arteritis, showcasing lower infection rates and improved glucocorticoid tapering strategies.

Artificial Intelligence in Cataract Surgery and Optometry at Large with Harvey Richman, OD, and Rebecca Wartman, OD

 in Minneapolis, MN, Harvey Richman, OD, Shore Family Eyecare, and Rebecca Wartman, OD, optometrist chair of AOA Coding and Reimbursement Committee, presented their lecture on the implementation of artificial intelligence (AI) devices in cataract surgery and 

AI has been implemented in a variety of ophthalmology fields already, from analyzing and interpreting ocular imaging to determining the presence of diseases or disorders of the retina or macula. Recent studies have tested AI algorithms in analyzing fundus fluorescein angiography, finding the programs extremely effective at enhancing clinical efficiency.

However, there are concerns as to the efficacy and reliability of AI programs, given their propensity for hallucination and misinterpretation. To that end, Drs. Richman and Wartman presented a study highlighting the present and future possibilities of AI in cataract surgery, extrapolating its usability to optometry as a whole.

Richman spoke to the importance of research in navigating the learning curve of AI technology. With the rapid advancements and breakneck pace of implementation, Richman points out the relative ease with which an individual can fall behind on the latest developments and technologies available to them.

“The problem is that the technology is advancing much quicker than the people are able to adapt to it,” Richman told 

. “There’s been research done on AI for years and years; unfortunately, the implementation just hasn’t been as effective.”

Wartman warned against the potential for AI to take too much control in a clinical setting. She cautioned that clinicians should be wary of letting algorithms make all of the treatment decisions, as well as having a method of undoing those decisions.

“I think they need to be very well aware of what algorithms the AI is using to get to its interpretations and be a little cautious when the AI does all of the decision making,” Wartman said. “Make sure you know how to override that decision making.”

Richman went on to discuss the 3 major levels of AI: assistive technology, augmented technology, and autonomous intelligence.

“Some of those are just bringing out data, some of them bring data and make recommendations for treatment protocol, and the third one can actually make the diagnosis and treatment protocol and implement it without a physician even involved,” Richman said. “In fact, the first artificial intelligence code that was approved by CPT had to do with diabetic retina screening, and it is autonomous. There is no physician work involved in that.”

 that a significant amount of surgical technology is already using artificial intelligence, mainly in the form of pattern recognition software and predictive devices.

“A lot of our equipment is already using some form of artificial intelligence, or at least algorithms to give you patterns and tell you whether it’s inside or outside the norm,” Wartman said.

Richman H, Wartman R. A.I. in Cataract Surgery. Presented at the 2025 American Optometric Association in Minneapolis, MN, June 25-28, 2025.

Shao A, Liu X, Shen W, et al. Generative artificial intelligence for fundus fluorescein angiography interpretation and human expert evaluation. NPJ Digit Med. 2025;8(1):396. Published 2025 Jul 2. doi:10.1038/s41746-025-01759-z

Drs. Richman and Wartman discuss the benefits of using predictive and diagnostic AI, while cautioning about the implicit risks of overreliance on early, imperfect technology.

Tim Smith joined the MJH Life Sciences team as an assistant editor for HCPLive in August 2022. He graduated from UC Berkeley with a degree in political science, working in multimedia journalism as a staff writer prior to joining MJH. In his spare time, he enjoys reading, watching TV, listening to podcasts, and rock climbing. You can contact him at 

These ADHAND trial data highlight the results of tralokinumab in those with atopic dermatitis on the hands who are candidates for systemic therapy.

Atopic Dermatitis

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Positive 16-Week Findings Highlighted on Tralokinumab for Atopic Dermatitis on the Hands

Findings highlight the ongoing burden of generalized pustular psoriasis and suggest patients may benefit from targeted biologic therapies like the FDA-approved spesolimab.

Plaque Psoriasis

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Most Patients With GPP Failed to Achieve Clear Skin on Small-Molecule Therapy

Abigail Brooks is an assistant 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.

The first half of 2025 recap for nephrology spotlights renal FDA action, ERA 2025 Congress coverage, and updates in xenotransplantation.

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Nephrology First Half Recap: 2025

In ARRECTOR, patients reported symptom relief and improved quality of life as early as week 2, with strong tolerability and safety through week 8.

Roflumilast Foam 0.3% Effective for Scalp, Body Psoriasis in Phase 3 Trial

Rebecca Vasquez, MD, is an associate professor of dermatology at UT Southwestern.

This clinical episode of Skin of Color Savvy features a discussion on UV safety and photo protection in patients with skin of color.

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

Hosted by Skin of Color Society and produced by HCPLive, 

 delves into the latest research, clinical insights, and culturally intelligent care practices in dermatology with leading experts. 

Whether it’s groundbreaking research, practice-changing insights, or highlights from the SOCS community, this twice-monthly program provides dermatologists and care providers with expert perspectives on treating patients with skin of color.

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Skin of Color Savvy: UV Safety in Skin of Color, with Rebecca Vasquez, MD and Adewole Adamson, MD, MPP

Panelists discuss how standard ACE therapy leaves multiple pathways unblocked in resistant hypertension, with spironolactone being the most evidence-based fourth-line therapy despite limitations, while emerging therapies target sympathetic nervous system overactivity, aldosterone excess, and endothelin-mediated vasoconstriction.

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Efficacy of Current Standard-of-Care Treatments for Resistant Hypertension

Panelists discuss how lifestyle modifications, particularly sodium restriction and plant-based diets, form the foundation of resistant hypertension management, with innovative approaches like teaching kitchens and food-as-medicine programs being more effective than traditional diet counseling.

Lifestyle vs Medical Treatment

Alberto Augsten, PharmD, is an adjunct professor at Nova Southeastern University and a medical expert witness known for tackling treatment-resistant depression.

Long-acting injectables improve outcomes in schizophrenia, yet remain underutilized, highlighting the need for earlier, proactive conversations in care.

Why Long-Acting Injectables Deserve Our Attention in Schizophrenia Care

The first half of 2025 recap for gastroenterology spotlights GI FDA approvals, clinical trial data, and new guidance on bowel preparation for colonoscopy.

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

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Gastroenterology First Half Recap: 2025

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.

Based on reduced FOXP3+ expression in patients, investigators have drawn a strong correlation between MetS due to psoriasis and immune dysregulation.

Latest News

Achieving GC-Free IgG4-Related Disease Remission With Rilzabrutinib, with John Stone, MD, MPH

J&J Submits sNDA to FDA for Lumateperone (CAPLYTA) to Prevent Schizophrenia Relapse

The Role of Biologic Therapies in Optometry with Walt Whitley, OD, MBA

Cutting Down on Glucocorticoids in Giant Cell Arteritis With Upadacitinib, with Frank Buttgereit, MD

Artificial Intelligence in Cataract Surgery and Optometry at Large with Harvey Richman, OD, and Rebecca Wartman, OD