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.

A supplemental New Drug Application (sNDA) has been submitted to the US Food and Drug Administration (FDA) for the broadening of roflumilast cream 0.05% (Zoryve) to treat mild to moderate atopic dermatitis in infants down to the age of 3 months.

The sNDA submission, announced on April 27 by Arcutis Biotherapeutics, was backed by data from a pair of open-label studies assessing once-daily roflumilast cream 0.05% in infants aged 3 to less than 24 months with mild to moderate atopic dermatitis. The disease itself is the most prevalent form of eczema in the US, impacting an estimated 9.6 million children and 16.5 million adults.

“Atopic dermatitis often begins within the first year of life, yet treatment options for infants are extremely limited,” Mercedes E. Gonzalez, MD, medical director of Pediatric Skin Research, LLC and INTEGUMENT-INFANT clinical trial investigator, said in a statement.

Parents and caregivers are often faced with difficult decisions around managing these symptoms, including concerns about the long-term use of topical steroids. Because their immune system and skin barrier are still developing, infants are particularly vulnerable to the burdensome symptoms of atopic dermatitis, including visible disease and intense itch that can disrupt sleep and significantly impact both infants and their caregivers.”

The disease often manifests during infancy, imposing considerable burden on both patients and their caregivers. The disease presents unique treatment considerations among infants, including a higher body surface area-to-body mass ratio heightening systemic exposure risk from topical medications.

The data leading to this sNDA first included a phase 1 pharmacokinetic study in 19 infants demonstrating a safety, efficacy, and pharmacokinetic profile over 4 weeks. These findings aligned with data from prior research in older pediatric populations. In the larger phase 2 INTEGUMENT-INFANT trial, 101 infants were recruited and roflumilast cream’s safety, tolerability, and efficacy were evaluated across 4 weeks of treatment.

The medication was shown by Gonzalez and colleagues to be well tolerated, with patients’ most commonly reported adverse events (AEs) being nasopharyngitis, diarrhea, upper respiratory tract infection, and vomiting.

 These AEs were described as consistent with the broader INTEGUMENT program experience.

In the infants completing the full 4-week treatment course (n=96), investigators found 34.4% attained success in their Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score, defined as a ‘clear’ or ‘almost clear’ score with at least a 2-grade improvement from baseline.

 The team further noted 49% succeeded in achieving a vIGA-AD score at the 4-week mark.

Improvements were observed by Gonzalez et al as early as Week 1. Among infants showing scalp involvement at baseline, 67.5% saw vIGA-scalp success at the 4-week mark, and 58.3% attained an EASI-75 score at Week 4.

 The team further noted notable caregiver-reported itch outcomes, including that 72.7% of infants met the threshold for Worst Scratch Itch Numeric Rating Scale success at Week 4. Rapid onset was observed in these infants, as suggested by a 46.6% response rate on the Dynamic Pruritus Scale by 10 minutes post-application.

Roflumilast cream 0.05% is already FDA-approved for mild to moderate AD in patients aged 2 to 5 years.

 This new move could expand its indication if it receives approval by FDA officials for this newer age range.

“Safe and effective long-term therapies suitable for use anywhere on the body, including sensitive regions such as the face and skin folds, remain an important unmet need for infants with atopic dermatitis,” Gonzalez said in her statement.

 “If approved, [roflumilast] cream 0.05% could offer a much-needed, non-steroidal treatment option developed specifically for very young children, including infants.”

Arcutis Submits Supplemental New Drug Application to the FDA for ZORYVE® (roflumilast) Cream 0.05% to Expand Indication for Treatment of Atopic Dermatitis to Infants Down to 3 Months. Arcutis Biotherapeutics, Inc. April 27, 2026. 

https://investors.arcutis.com/news-releases/news-release-details/arcutis-submits-supplemental-new-drug-application-fda-zoryver

Smith T. FDA Approves Roflumilast (Zoryve) Cream 0.05% for Atopic Dermatitis in Children Aged 2-5 Years. HCPLive. October 6, 2025. Accessed April 27, 2026. 

https://www.hcplive.com/view/fda-approves-roflumilast-zoryve-cream-0-05-for-atopic-dermatitis-in-children-aged-2-5-years

Articles

Arcutis submitted an sNDA to expand roflumilast cream 0.05% for mild-to-moderate atopic dermatitis to infants aged ≥3 months. The filing is supported by open-label phase 1 PK (n=19) and phase 2 INTEGUMENT-INFANT (n=101) data over 4 weeks, addressing infant-specific exposure concerns. Treatment was well tolerated, with AEs including nasopharyngitis, diarrhea, URTI, and vomiting. Efficacy signals included vIGA-AD success in 34.4% (n=96), early improvement by Week 1, EASI-75 in 58.3%, and rapid caregiver-reported itch relief.

This supplemental New Drug Application for roflumilast cream (Zoryve) to the FDA was supported by the INTEGUMENT-INFANT open-label study.

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Atopic Dermatitis condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatitis research, treatment, and drug development.

Roflumilast Cream 0.05% sNDA Submitted to FDA for Infants Down to 3 Months with Atopic Dermatitis

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.

The US Food and Drug Administration (FDA) has approved anifrolumab-fnia (Saphnelo) for subcutaneous self-administration via a once-weekly 120 mg autoinjector, the Saphnelo Pen, for adult patients with moderate to severe systemic lupus erythematosus (SLE) receiving standard therapy.¹ 

According to AstraZeneca, the approval was based on results from the phase III TULIP-SC trial, published in 

 in January 2026.² Anifrolumab had previously been available only as an intravenous infusion administered in clinical settings since its initial US approval in 2021.

What is anifrolumab (Saphnelo) approved for? 

Anifrolumab is approved for adult patients with moderate to severe SLE receiving standard therapy, now available as both an IV infusion and a once-weekly 120 mg subcutaneous autoinjector (Saphnelo Pen).

Anifrolumab is a fully human monoclonal antibody binding subunit 1 of the type I interferon receptor, blocking the activity of type I interferons such as IFN-alpha, IFN-beta, and IFN-kappa implicated in SLE pathogenesis.

The phase 3 TULIP-SC trial demonstrated a statistically significant and clinically meaningful reduction in SLE disease activity at week 52 on the BICLA response endpoint with subcutaneous anifrolumab versus placebo, with 29.0% of anifrolumab-treated patients achieving DORIS remission.

"The approval of anifrolumab as a self-administered autoinjector is exciting news as it makes this important medicine more convenient and accessible for many more patients,” Susan Manzi, MD, MPH, chair of the Allegheny Health Network Medicine Institute, director of the Lupus Center of Excellence at the AHN Autoimmunity Institute, and principal investigator of TULIP-SC, said in a statement. “With its proven ability to significantly reduce disease activity and the risk of organ damage, anifrolumab has been a much-needed innovation in lupus."

The subcutaneous formulation addresses a practical barrier for patients requiring every-four-week IV infusions in clinic and aligns with recent ACR and EULAR guideline updates emphasizing treat-to-target strategies and corticosteroid minimization in SLE.¹ 

Anifrolumab remains the only approved type I interferon receptor antagonist in SLE, and AstraZeneca reports > 40,000 patients globally have received the drug to date.¹ Subcutaneous administration of anifrolumab has already been approved in the EU and Japan.¹

TULIP-SC Trial Design and Primary Efficacy Results

The TULIP-SC trial was a phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating subcutaneous anifrolumab versus placebo in adults aged 18 to 70 years with moderate to severe SLE on standard therapy, including oral corticosteroids, antimalarials, and/or immunosuppressants.¹ A total of 367 participants were randomly assigned in a 1:1 to receive anifrolumab 120 mg or placebo weekly via a pre-filled, single-use syringe.¹

The primary endpoint was British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response at week 52, which requires improvement in all organ domains with active disease at baseline and no new flares.¹ According to AstraZeneca, subcutaneous anifrolumab achieved a statistically significant and clinically meaningful reduction in disease activity compared with placebo on this endpoint.¹ A planned interim analysis was conducted when the first 220 participants reached week 52 or withdrew from the study.¹

The press release did not disclose exact BICLA response rates, effect sizes, or p-values for the primary endpoint. Full trial data were published by Manzi et al in Arthritis & Rheumatology.²

Anifrolumab Subcutaneous Safety Profile and Secondary Endpoints in TULIP-SC

Across pre-specified secondary and exploratory endpoints, anifrolumab demonstrated clinically meaningful effects on multiple outcome measures, according to AstraZeneca.¹ The drug reduced SLE disease activity while enabling corticosteroid tapering to low doses (≤7.5 mg/day prednisone equivalent), and more patients receiving anifrolumab achieved BICLA response sooner compared with placebo.¹ Time to first flare was numerically delayed in the anifrolumab arm.¹

Among patients receiving anifrolumab, 29.0% achieved DORIS remission and 40.1% attained low-level disease activity as measured by the Lupus Low Disease Activity State (LLDAS) score on pre-specified secondary and exploratory endpoints.¹ The DORIS remission criteria include a clinical SLEDAI-2K score of 0, physician global assessment below 0.5, and prednisone-equivalent dose of 5 mg/day or less on stable immunosuppressant doses.¹

The safety profile observed with subcutaneous anifrolumab was consistent with the known clinical profile of the IV formulation, per the company.¹ The most common adverse reactions (≥5% incidence) with anifrolumab include nasopharyngitis, upper respiratory tract infections, bronchitis, infusion-related reactions, herpes zoster, and cough.¹ Serious infections, hypersensitivity reactions including anaphylaxis, and herpes zoster remain adverse events of special interest; the label notes increased malignancy risk with immunosuppressants and recommends avoiding live vaccines.¹

Anifrolumab continues to be evaluated in phase 3 trials across 4 additional type I interferon-driven indications, including cutaneous lupus erythematosus (LAVENDER), idiopathic inflammatory myopathies (JASMINE), systemic sclerosis (DAISY), and lupus nephritis (IRIS).¹ The IV formulation remains the first biologic with 4-year placebo-controlled remission data in SLE from the TULIP-LTE trial.¹

AstraZeneca. SAPHNELO approved in the US for subcutaneous self-administration as a new autoinjector for the treatment of systemic lupus erythematosus. Published April 27, 2026. Accessed April 27, 2026. 

https://www.businesswire.com/news/home/20260427513110/en/SAPHNELO-approved-in-the-US-for-subcutaneous-self-administration-as-a-new-autoinjector-for-the-treatment-of-systemic-lupus-erythematosus

Manzi S, Furie R, et al. Efficacy and safety of subcutaneous anifrolumab in systemic lupus erythematosus: the randomized, phase 3, TULIP-SC study. Arthritis Rheumatol. 2025. doi:10.1002/art.70041

Morand E, Furie R, Tanaka Y, et al. Trial of anifrolumab in active systemic lupus erythematosus. N Engl J Med. 2020;382(3):211-221.

FDA authorized once-weekly 120 mg subcutaneous anifrolumab autoinjector self-administration for adults with moderate-to-severe SLE on standard therapy, expanding access beyond q4-week IV infusions. Approval was supported by phase III TULIP-SC (n=367), a randomized, double-blind, placebo-controlled study meeting its week-52 BICLA primary endpoint. Secondary analyses showed corticosteroid tapering to ≤7.5 mg/day, earlier responses, numerically delayed flares, 29% DORIS remission, and 40.1% LLDAS. Safety mirrored IV labeling, with infection, hypersensitivity, and herpes zoster risks. It remains the only approved type I interferon receptor antagonist, with phase III studies in other interferon-driven diseases.

The FDA approved anifrolumab via a once-weekly subcutaneous autoinjector for moderate to severe SLE based on phase 3 TULIP-SC trial results.

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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.

Anifrolumab (Saphnelo) Wins FDA Approval for Subcutaneous Self-Administration in SLE

Patrick Campbell is the editorial director of HCPLive. Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter and/or multimedia specialist with the Pocono Record, Star News Group, and NJ Advance Media. He is the executive producer for multiple HCPLive podcasts, including Diabetes Dialogue, Don't Miss a Beat, Kidney Compass, Medical Ethics Unpacked, The Medical Sisterhood, and Skin of Color Savvy. 


Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

 has approved a supplemental New Drug Application (sNDA) for lumateperone (Caplyta) based on long-term data supporting the prevention of relapse in adults with 

Johnson & Johnson announced the lumateperone FDA approval on April 26, 2026. The approval stems from a phase 3 randomized withdrawal trial demonstrating a 63% reduction in relapse risk versus placebo over a 26-week double-blind treatment period.¹

"This label update, backed by long-term Phase 3 data demonstrating a significant delay in time to relapse, reinforces our commitment to advancing evidence-based therapies to support each patient's individual needs including a proven therapy supporting stability over time," said Celine Goldberger, MD, PhD, Vice President of Global Medical Affairs, Neuroscience, Innovative Medicine at Johnson & Johnson.

Lumateperone is already approved in adults for schizophrenia, as adjunctive therapy with antidepressants for major depressive disorder, and for depressive episodes associated with bipolar I or II disorder. The sNDA expands the label by incorporating long-term efficacy and tolerability data reinforcing its role in sustained disease management, an area of particular clinical interest given the frequency of relapse events in this population.

Lumateperone (Caplyta) is FDA-approved in adults for schizophrenia, as adjunctive therapy with antidepressants for major depressive disorder, and for depressive episodes associated with bipolar I or II disorder as monotherapy or adjunctive therapy with lithium or valproate. The updated label now includes long-term data supporting relapse prevention in schizophrenia.

Lumateperone is characterized by antagonist activity at central serotonin 5-HT2A receptors and partial agonist activity at central dopamine D2 receptors, with high 5-HT2A occupancy and moderate D2 occupancy at therapeutic doses.

In a phase 3 randomized withdrawal trial, lumateperone 42 mg significantly extended time to relapse versus placebo over 26 weeks (

=.0002), reducing relapse risk by 63% (HR, 0.37), with 84% of patients remaining relapse-free at six months.

Lumateperone efficacy in the Study 304 randomized withdrawal trial

Study 304 was a multicenter, multinational, double-blind, placebo-controlled, randomized withdrawal study enrolling adults with schizophrenia.¹ The trial included an 18-week open-label phase during which patients received lumateperone 42 mg once daily. Patients meeting predefined stabilization criteria were randomized to continue lumateperone 42 mg (N=110) or switch to placebo (N=114) for up to 26 weeks.¹

On the primary endpoint, lumateperone significantly extended time to first symptom relapse compared with placebo during the double-blind phase (P = .0002).¹ Patients receiving lumateperone had a 63% lower risk of relapse versus placebo (hazard ratio, 0.37), and 84% of lumateperone-treated patients remained relapse-free over 6 months.¹ The key secondary endpoint, time to all-cause treatment discontinuation including relapse, also favored lumateperone, with a significant delay compared with placebo.¹

"These Phase 3 results, showing significantly longer time to relapse with 84% remaining relapse free over 6 months, provide clinicians with another tool offering long-term stability for people living with schizophrenia," said Christoph U. Correll, MD, clinical professor of psychiatry at the Zucker School of Medicine at Hofstra/Northwell, New York.

Lumateperone safety profile and metabolic outcomes in long-term use

The safety profile of lumateperone in Study 304 remained consistent with the existing body of clinical data, and no new safety concerns were identified, according to Johnson & Johnson.¹ The most common treatment-related adverse event was headache, occurring in at least 5% of patients and at least twice the rate observed with placebo.¹ No clinically relevant increases in prolactin or cardiometabolic parameters emerged at the end of the double-blind treatment period.¹

Data from a separate 12-month open-label extension study in schizophrenia further supported long-term tolerability. Patients treated with lumateperone experienced a mean weight change of −2.05 kg (−4.52 lbs) over one year, with sustained improvements or stability in metabolic parameters.¹ In prior short-term clinical studies, lumateperone was similar to placebo in weight change, metabolic effects, and extrapyramidal symptoms.¹

Lumateperone is also being evaluated in clinical studies for other neuropsychiatric and neurological conditions beyond its current FDA-approved indications, according to the company.¹

Johnson & Johnson. FDA approves CAPLYTA (lumateperone) sNDA with robust new data supporting reduced risk of relapse in schizophrenia. Published April 26, 2026. Accessed April 26, 2026. 

https://www.prnewswire.com/news-releases/fda-approves-caplyta-lumateperone-snda-with-robust-new-data-supporting-reduced-risk-of-relapse-in-schizophrenia-302753851.html

Intra-Cellular Therapies. Announces positive topline results in phase 3 trial evaluating CAPLYTA for the prevention of relapse in patients with schizophrenia. Published November 5, 2024. Accessed April 26, 2026. 

https://www.globenewswire.com/news-release/2024/11/05/2974784/30597/en/Intra-Cellular-Therapies-Announces-Positive-Topline-Results-in-Phase-3-Trial-Evaluating-CAPLYTA-for-the-Prevention-of-Relapse-in-Patients-with-Schizophrenia.html

FDA clearance of a lumateperone sNDA adds phase 3 long-term evidence for relapse prevention in adult schizophrenia. In the multinational Study 304 randomized-withdrawal design, stabilized patients continuing lumateperone 42 mg daily showed significantly prolonged time to symptom relapse versus placebo (HR 0.37; P=.0002), with 84% remaining relapse-free through 26 weeks. Treatment also delayed all-cause discontinuation. Safety remained consistent with prior experience, without clinically meaningful prolactin or cardiometabolic changes, and 12-month open-label data showed modest mean weight reduction with metabolic stability.

The FDA approved a lumateperone sNDA adding relapse prevention data in schizophrenia based on a 63% reduction in relapse risk versus placebo.

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Lumateperone sNDA Approved with Relapse Prevention Data in Schizophrenia

AbbVie has submitted a regulatory application to the US Food and Drug Administration (FDA) seeking approval for risankizumab-rzaa (Skyrizi) subcutaneous (SC) induction for adults with moderately to severely active 

The supplemental application, announced on April 27, 2026, is supported by positive data from the phase 3 AFFIRM study.¹ If approved, risankizumab SC induction would offer an alternative to the currently approved intravenous (IV) induction regimen.

"Crohn's disease is a chronic inflammatory condition that affects an estimated 1 million Americans, and its impact often reaches beyond the gut as its unpredictability can impact daily life and emotional health for patients," Kori Wallace, MD, PhD, vice president, global head of immunology clinical development, AbbVie, said in a statement. "AbbVie continues to invest in research and innovative solutions to help elevate the standard of care for patients so that they may live a life unburdened by their Crohn's disease."

Risankizumab became the first interleukin-23 (IL-23) inhibitor approved by the FDA for moderately to severely active CD in 2022.¹ The current label requires IV induction followed by SC maintenance dosing every 8 weeks. An SC induction option would eliminate the need for infusion-center visits during the induction phase, a meaningful logistical consideration for patients and practices alike.

What is the new risankizumab FDA submission for? 

AbbVie is seeking approval for subcutaneous induction dosing of risankizumab in adults with moderately to severely active Crohn's disease. The drug is already approved with IV induction followed by SC maintenance.

Risankizumab is a monoclonal antibody selectively blocking IL-23 by binding its p19 subunit, inhibiting a key cytokine involved in chronic immune-mediated inflammation.

AFFIRM is a phase 3, randomized, placebo-controlled study of 289 patients assessing risankizumab SC induction, with co-primary endpoints of CDAI clinical remission and endoscopic response at week 12. AbbVie reported positive topline results in March 2026.

AFFIRM trial design and co-primary endpoints for risankizumab SC induction

According to AbbVie, the AFFIRM study is a global, phase 3, randomized, double-blind, placebo-controlled trial evaluating risankizumab SC induction in adult patients with moderately to severely active CD. A total of 289 patients were randomized in a 2:1 ratio to risankizumab SC or placebo.¹ 

The enrolled population included both advanced-therapy-naive patients and those with prior advanced therapy failure; 65% of participants had previously failed advanced therapies for CD.¹

The study defined 2 coprimary endpoints: 

Achievement of CDAI clinical remission (CDAI < 150)

Achievement of endoscopic response, both assessed at week 12

AbbVie reported positive topline results on both co-primary endpoints in March 2026, though the company has not yet disclosed specific effect sizes, response rates, or p-values in the public domain.¹ 

AFFIRM includes 3 treatment periods. Period A (baseline to week 12) serves as the placebo-controlled induction evaluation. Period B (week 12 to 24) assigns patients to blinded or open-label treatment based on their clinical response at week 12. Period C is a 52-week open-label extension in which all patients receive the approved risankizumab maintenance regimen.¹

Risankizumab safety profile and Crohn's disease dosing flexibility

AbbVie has not released detailed safety data from the AFFIRM study in this announcement. The known safety profile of risankizumab in CD and ulcerative colitis, as described in the current prescribing information, includes upper respiratory infections, headache, joint pain, abdominal pain, injection site reactions, anemia, fever, back pain, urinary tract infection, and rash.² Liver enzyme elevations have been reported during IV induction; a hepatic event with rash leading to hospitalization occurred in a patient with CD receiving IV risankizumab.²

If approved, the SC induction pathway would allow clinicians to offer patients a fully subcutaneous treatment course from induction through maintenance. Patients would choose between SC injection and IV infusion for their induction period, then continue SC maintenance dosing every eight weeks regardless of induction route.¹ AbbVie anticipates FDA approval for the new dosing regimen later in 2026.¹

AbbVie. AbbVie submits regulatory application to FDA for Skyrizi (risankizumab-rzaa) subcutaneous induction for adults with moderately to severely active Crohn's disease. Published April 27, 2026. Accessed April 27, 2026. 

https://www.prnewswire.com/news-releases/abbvie-submits-regulatory-application-to-fda-for-skyrizi-risankizumab-rzaa-subcutaneous-induction-for-adults-with-moderately-to-severely-active-crohns-disease-302753553.html

Brooks A. AFFIRM: Risankizumab (Skyrizi) Subcutaneous Induction Achieves Primary Endpoints in Crohn’s Disease. HCPLive. March 2, 2026. Accessed April 27, 2026. 

https://www.hcplive.com/view/affirm-risankizumab-skyrizi-subcutaneous-induction-achieves-primary-endpoints-in-crohn-s-disease

AbbVie has filed a supplemental FDA application for risankizumab-rzaa subcutaneous induction in adults with moderately to severely active Crohn’s disease, supported by phase 3 AFFIRM topline results. Risankizumab, the first FDA-approved IL-23p19 inhibitor for Crohn’s disease (2022), currently requires IV induction followed by SC maintenance every eight weeks. AFFIRM randomized 289 patients (2:1), including a high proportion with prior advanced-therapy failure, and met co-primary endpoints of CDAI remission and endoscopic response at week 12, with detailed efficacy and safety pending.

AbbVie submitted an FDA application for risankizumab subcutaneous induction in Crohn's disease based on phase 3 AFFIRM data.

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.

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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.

Risankizumab (Skyrizi) SC Induction Application Submitted to FDA for Crohn's disease

Andrea Cipriani, MD, PhD, from the University of Oxford.

PETRUSHKA Tool Improves Antidepressant Continuation, With Andrea Cipriani, MD, PhD

A digital decision-support tool that integrates predictive modeling with patient preference data improved antidepressant continuation and longer-term symptom outcomes in adults with 

, according to findings from a recent multicenter randomized clinical trial.

“The bottom line is that we can personalize treatment, and this means better adherence and clinical improvement for patients,” Andrea Cipriani, MD, PhD, from the University of Oxford, said in an interview with 

In the trial, 520 adults with MDD were randomized across 47 sites in Brazil, Canada, and the United Kingdom to receive either usual care or antidepressant selection guided by the PETRUSHKA (Personalizing Antidepressant Treatment for Unipolar Depression Combining Individual Choices, Risks and Big Data) tool. The system uses clinical and demographic variables alongside patient-reported preferences regarding adverse effects to generate individualized antidepressant rankings intended to support shared decision-making.

The PETRUSHKA algorithm produces a ranked list of antidepressants based on predicted efficacy and tolerability using variables such as symptom severity, prior treatment history, comorbid conditions, and demographic factors. This ranking is then modified based on patient preferences related to adverse effects, including sedation, gastrointestinal symptoms, and sexual dysfunction, to support individualized treatment selection during the clinical encounter.

At 8 weeks, all-cause antidepressant discontinuation was significantly lower in the PETRUSHKA group compared with usual care (17% vs 27%; adjusted relative risk [RR], 0.62; 95% CI, 0.44 – 0.88; 

 =.007). Discontinuation due to adverse events was also reduced (9% vs 16%; RR, 0.59; 95% CI, 0.36 – 0.97; 

Cipriani noted that this outcome reflects a pragmatic measure of treatment success. Staying on treatment for at least two months is a meaningful indicator that the medication is both tolerated and potentially effective, he said.

No significant differences in depressive or anxiety symptom scores were observed at 8 weeks. However, at 24 weeks, patients in the PETRUSHKA arm demonstrated greater improvement in depressive symptoms measured by the PHQ-9 compared with usual care (mean 7.1 vs 9.2; adjusted mean difference, −1.92; 95% CI, −3.06 to −0.78; 

 <.001). Anxiety symptoms measured by the GAD-7 were also lower at 24 weeks (mean 4.6 vs 5.8; adjusted mean difference, −1.39; 95% CI, −2.26 to −0.52; 

Antidepressant selection patterns differed between groups. While PETRUSHKA more frequently recommended mirtazapine, escitalopram, and vortioxetine, usual care more often involved sertraline and citalopram.

The findings suggest potential utility for decision-support tools in primary care and other nonpsychiatric settings where most depression is treated. Cipriani noted that structured systems may help clinicians navigate antidepressant selection more consistently.

An unresolved question is whether improved outcomes are driven primarily by better pharmacologic matching or by enhanced engagement through shared decision-making. Cipriani acknowledged that the study design cannot distinguish between these mechanisms because the trial was open-label.

“We would need a much larger sample size, a different design, like a factorial trial,” he said. “We did not focus on this as the main question for our study, but in the next study that we are currently designing, we will use a double blind design so we will be able to understand whether [shared decision-making] is the active ingredient of the personalization: the asking, eliciting preferences from patients, or a combination of the two.”

Cipriani has no relevant reported disclosures.

Cipriani A, Fernandes KBP, Mulsant BH, et al. A Decision-Support System to Personalize Antidepressant Treatment in Major Depressive Disorder: A Randomized Clinical Trial. 

Videos

In a randomized trial, PETRUSHKA improved antidepressant continuation and 24-week symptom outcomes by integrating clinical data with patient preferences.

Armstrong spoke in an interview regarding several different sessions presented at the 2026 AAD meeting.

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Q&A: IL-23, Oral Therapies, and Inflammatory Disease Management, With April W. Armstrong, MD, MPH

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

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OX40 for Atopic Dermatitis: A Target at a Crossroads

David Kass, MD, is the Abraham and Virginia Weiss Professor of Cardiology at the Johns Hopkins University School of Medicine.

Kass explains 2 distinct biological subgroups discovered in HFpEF and how they relate to a paradigm shift. 

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Severe Obesity Linked to Distinct Myocardial Dysfunction in HFpEF

Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

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Elizabeth Bauer, MD, joins the show to discuss her AACE 2026 presentation on key updates in obesity management and nutrition.

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Diabetes Dialogue: Nutrition, Medication, and Treatment in Obesity With Elizabeth Bauer, MD

Auchus discusses the 2-year results from CAHtalyst Adult, highlighting the substantial retention rates over the open-label extension period.

Crinecerfont Reduces Glucocorticoid Doses in CAH, With Richard Auchus, MD, PhD

Jagbir Gill, MD, MPH, is an Associate Professor of Medicine in the Division of Nephrology at the University of British Columbia and Medical Director of the Kidney Transplant Program at St. Paul’s Hospital in Vancouver. He also serves as Medical Director of Data and Quality for BC Transplant, President of the Canadian Organ Replacement Register Board of Directors, and as Treasurer for the Canadian Society of Transplantation.

Gill describes how storytelling and patient representation can build trust and education in Indigenous populations regarding transplantation. 


Chronic Kidney Disease

Transplant Care Strategies to Target Mistrust, Close Gaps in Indigenous Communities

Scott Isaacs, MD, is an Adjunct Assistant Professor of Medicine at Emory University. He currently serves as Immediate Past President of the American Association of Clinical Endocrinology (AACE).

Isaacs explains how prediabetes care is shifting toward early intervention, risk stratification, and prevention of cardiometabolic disease, not just progression to diabetes.

Breaking the ‘Watch and Wait’ Model in Prediabetes Care, With Scott Isaacs, MD

Oksana Hamidi, DO, is an associate professor in the division of endocrinology and metabolism at the University of Texas Southwestern Medical Center.

Hamidi reviews 2-year CAHtalyst data showing crinecerfont enabled sustained glucocorticoid reductions to physiologic range in adults with classic congenital adrenal hyperplasia.

CAHtalyst Adult: Sustained GC Reduction With Crinecerfont in CAH, With Oksana Hamidi, DO

Chelsie Derman is an associate editor for 

who covers allergy and  psychiatry. 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.

Twin phase 3 trials show triple therapy with budesonide–glycopyrronium–formoterol improves FEV1 and lowers severe exacerbation rates in patients with uncontrolled asthma on ICS–LABA


Pulmonology

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

Asthma

The HCPLive asthma page is a comprehensive resource for clinical news and insights on asthmatic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for allergic and severe asthma, and more.

BGF Triple Therapy Improves Lung Function in Phase 3 Uncontrolled Asthma Controls

Christopher G. Bunick, MD, PhD, is an associate professor of dermatology at Yale University School of Medicine.

Christopher Bunick, MD, PhD, and colleagues conducted a review bispecific and trispecific antibodies in atopic dermatitis.

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