Rachel Gafni, MD, is a senior research physician at the National Institutes of Health.

CALIBRATE: Encaleret Achieves Mineral Homeostasis in Patients With ADH1, With Rachel Gafni, MD

Encaleret, an investigational oral calcilytic in development by Calcilytix Therapeutics, has displayed potential as a disease-specific therapy for 

autosomal dominant hypocalcemia type 1 (ADH1)

Endocrine Society (ENDO) Annual Meeting 2026

 in Chicago, Illinois, by Rachel Gafni, MD, a senior research physician at the National Institutes of Health, this trial presents a possible alternative to the historically limited treatment options for patients with ADH1.

ADH1 generally manifests as low parathyroid hormone (PTH), hypercalciuria, hyperphosphatemia, hypocalcemia, and hypomagnesemia, due in large part to gain-of-function variants in the calcium-sensing receptor gene (CaSR). Standard of care treatment, which includes calcium and active vitamin D (SoC) worsens hypercalciuria, potentially causing chronic kidney disease.

“Conventional therapy or standard of care with calcium and activated vitamin D doesn’t really correct the abnormal physiology in patients with ADH1 – you’re just sort of filling the leaky bucket,” Gafni told 

 in an exclusive interview. “You give them calcium and they urinate it out, but that can damage the kidney. So, a more precision medicine that actually targets the pathogenesis of ADH1, in this case the activated calcium sensing receptor, is the dream.”

To this end, Gafni and colleagues conducted the global, phase 3, randomized, controlled, open-label CALIBRATE trial across 25 locations worldwide. The team included patients with a documented pathogenic or likely pathogenic activating variant of the CaSR gene and a documented history of symptoms or signs of ADH1. Additionally, patients receiving thiazide diuretics, phosphate binders, magnesium or potassium supplements, or potassium-sparing diuretics were required to discontinue their treatment prior to the first dose of encaleret.

Patients with a history of hypocalcemic seizure within the 3 months prior to screening, as well as thyroid or parathyroid surgery, renal transplantation, or treatment with parathyroid hormone 1-84 or 1-34, among other criteria, were excluded. The study’s primary endpoint was the number of responders achieving both albumin-corrected blood calcium (cCa) and 24-hour urinary calcium (UCa) within the target range, defined as 8.3-10.7 mg/dL and 300 mg/day for men or 250 mg/day for women, respectively. Secondary outcomes included the number of patients with intact parathyroid hormone (PTH) within or above the reference range, the number of participants with blood magnesium within the reference range, and change from baseline in blood vitamin D, among others.

All screened participants entered the first study period, a 4-week SoC maintenance period; after this, 67 patients were randomly assigned in a 2:1 ratio to receive encaleret or SoC for 20 weeks during the second dose titration period. Following this, both treatment groups entered a 4-week dose maintenance period that lasted until week 24.

Gafni and colleagues found that 75.6% of participants treated with encaleret achieved both target cCa and UCa by week 24, compared to 4.4% at week 4 (

 <.0001). Encaleret also increased mean cCa by day 3 of part 2 and decreased mean UCa by week 3 of part 2. These improvements were maintained through week 24.

Additionally, within the encaleret group, 91.1% had PTH ≥15 pg/mL at week 24, versus only 6.7% at week 4 of part 1 (

 <.0001), and 91.1% achieved normal serum phosphate compared to 55.6% at week 4 of part 1 (

 = .0002). Further analyses showed that more participants randomized to encaleret had cCa and UCa within target ranges versus those assigned to SoC at week 24 (75.6% vs 19%; 

The team ultimately concluded that encaleret, based on these data, is a potential disease-specific therapy for ADH1, given its clinically meaningful safety, tolerability, and efficacy. Gafni also discusses her aspirations for once encaleret becomes available to patients with this difficult-to-treat disease.

“My hope is that, ultimately, if this drug becomes available to younger and younger patients, they will never develop the renal complications that are associated with conventional treatment in ADH, one that 80% of the patients in CALIBRATE already had,” Gafni said. “Whether or not starting the drug in adulthood will help reverse that or improve renal function, we don’t know at this point – continued research is really important to assess these potential complications associated with the underlying disease and conventional treatment.”

Editors’ Note: Gafni reports no relevant disclosures.

Gafni R, Ing S, Giustina A, et al. Encaleret Restores Mineral Homeostasis in Autosomal Dominant Hypocalcemia Type 1 (ADH1): Primary Results from the Phase 3 CALIBRATE Trial. Abstract presented at the Endocrine Society (ENDO) Annual Meeting 2026, Chicago, IL. June 13-15, 2026.

Calcilytix Therapeutics, Inc. Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1 (CALIBRATE). ClinicalTrials.gov Identifier: NCT05680818. Updated June 11, 2026. Accessed June 18, 2026. 

https://clinicaltrials.gov/study/NCT05680818

Videos

Gafni discusses the primary results of the phase 3 CALIBRATE trial, testing the investigational oral calcilytic in this difficult-to-treat disease state.

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Conference

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

Revolutionizing Atopic Dermatitis (RAD) 2026 Conference

, 4 studies document the substantial burden of 

 in the United States, spanning workers' compensation (WC) costs, health-related quality of life (HRQoL), patient-perceived triggers, and treatment preferences in patients with moderate-to-severe disease.

The analyses draw from real-world WC claims, the CHECK-US cross-sectional survey, and a discrete choice experiment (DCE) among 300 US adults with moderate-to-severe CHE. Together, they paint a picture of a condition carrying major occupational, psychosocial, and functional consequences.

"Chronic hand eczema imposes substantial physical and psychosocial burden, especially among individuals with moderate to severe disease, despite treatment with topical corticosteroids," the CHECK-US investigators concluded. "These results highlight the need to optimize treatment strategies to alleviate the overall individual burden of CHE in the United States."

Workers' compensation claims and occupational burden of CHE

A retrospective analysis of the Workpartners Research Reference Database identified 226 employees with closed WC claims involving the hands, wrists, or fingers and ICD-coded diagnoses consistent with hand eczema. The overall incidence was 6.06 CHE-related WC claims per 100,000 eligible person-years.

The highest claim incidences were in manufacturing (11.20 per 100,000 person-years), retail trade (10.49), and health care and social assistance (8.70).

The mean WC claim cost was $10,197 (SD=$45,172), with median $477. In manufacturing, mean costs reached $29,587 per claim. Finger-location claims carried the highest mean cost at $37,792.

 Of the 11.5% of claims involving lost work time, the average absence was 277 days (median 121 days). Healthcare and social assistance claims averaged 1,443 days of work absence per claim.

HRQoL, triggers, and treatment preferences in CHE

In the CHECK-US survey, which contained data from 982 patients, those with moderate-to-severe CHE receiving topical corticosteroids (TCS) reported significantly lower HRQoL than those receiving systemics or phototherapy (DLQI 7.6 vs 15.9; 

<.01), indicating the systemics-treated group carried greater disease burden requiring escalation.

 Among moderate-to-severe patients, 65.1% rated disease severity as moderate-to-severe by patient global assessment. Only 19.1% were currently untreated.

In the same CHECK-US cohort, 69.4% of participants identified environmental factors as a CHE trigger, most commonly frequent hand washing or water exposure, chemical irritant exposure, and contact allergen exposure.

 Biological triggers (47.4%), psychological triggers including stress (34.1%), and lifestyle factors (26.0%) were also frequently cited.

Females were significantly more likely to report environmental (73.4% vs 66.1%; 

= .02) and psychological triggers (47.5% vs 22.8%; 

In the DCE study among 300 patients with moderate-to-severe CHE, itch improvement, skin appearance improvement, and risk of adverse events (cancer, serious infections, major cardiac events) were the most heavily weighted treatment attributes. Patients were willing to trade 28 percentage points of itch improvement to avoid a 1 percentage point increase in cancer risk.

The investigators noted the DCE findings could inform shared decision-making discussions with patients, including weighing treatment trade-offs likely to improve adherence and clinical outcomes.

Brook RA, Bin Sawad A, Beren IA, et al. Hand eczema workers' compensation claims: real-world data analysis in the United States. Presented at: Revolutionizing Atopic Dermatitis; Nashville, TN; June 17-19, 2026.

Chovatiya R, Balu S, Bin Sawad A, et al. Health-related quality of life in people with chronic hand eczema: results from the CHECK study in the United States. Presented at: Revolutionizing Atopic Dermatitis; Nashville, TN; June 17-19, 2026.

Simpson E, Balu S, Bin Sawad A, et al. Patient-perceived factors associated with chronic hand eczema: results from the CHECK study in the United States. Presented at: Revolutionizing Atopic Dermatitis; Nashville, TN; June 17-19, 2026.

Armstrong AW, Bin Sawad A, Hazra NC, et al. Patient preference study of medication attributes in moderate to severe chronic hand eczema using a discrete choice experiment. Presented at: Revolutionizing Atopic Dermatitis; Nashville, TN; June 17-19, 2026.

Articles

Chronic hand eczema in the US is associated with meaningful occupational and patient-level burden, particularly in moderate-to-severe disease. Workers’ compensation analyses show higher claim incidence in manufacturing, retail, and healthcare, with wide cost dispersion and substantial absenteeism among time-loss claims. Patient-reported outcomes indicate impaired HRQoL and frequent trigger attribution to environmental exposures, with sex differences in reported triggers. Preference elicitation underscores strong valuation of itch and appearance improvement, tempered by marked risk aversion to rare but serious adverse events, informing shared decision-making.

RAD 2026 analyses reveal the impact of CHE on patients' lives, including its financial effects and influence on treatment decision-making. 

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.

Atopic Dermatitis

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.

CHE Imposes Heavy Occupational, Quality-of-Life, and Economic Burden on US Patients

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.

April Armstrong, MD, MPH
Credit: UCLA Health

Twelve months of tralokinumab (Adbry) treatment improved clinician- and patient-reported outcomes across multiple difficult-to-treat 

 subpopulations, according to final real-world data from the international TRACE study presented at the 

“Tralokinumab demonstrated robust real-world effectiveness in US adults with AD, with improvements in both disease severity and itch observed by Month 3 and sustained up to Month 12, regardless of prior dupilumab history,” wrote April Armstrong, MD, MPH, and colleagues in their conclusion of the 12-month TRACE data. “The majority of both dupilumab-naïve  and dupilumab-experienced patients achieved the composite response or ≥2-point improvement in IGA score.”

Tralokinumab effectiveness in TRACE subpopulations at 12 months

Tralokinumab is a high-affinity monoclonal antibody specifically targeting interleukin-13 (IL-13), approved for moderate-to-severe disease. Real-world evidence in high-burden anatomic regions and in skin of color has been limited, leaving gaps the TRACE final analyses and a parallel US registry readout aimed to address.

TRACE was a prospective, non-interventional, international, single-cohort study of 824 adults (full analysis set) with atopic dermatitis prescribed tralokinumab per the approved label and followed for up to 12 months.

 Effectiveness was tracked using a composite response defined as IGA 0/1, EASI ≤7, or SCORAD <10.

Among 654 participants with head and neck involvement, IGA 0/1 rose from 1.4% (9/619) at baseline to 64.7% (205/371) at month 12, and EASI ≤7 reached 89.3% (259/290).

 Improvements held regardless of prior dupilumab use.

In the 495 patients with hand and foot involvement, 57.4% had no atopic dermatitis on hands or feet by month 12, with gains in IGA, EASI, and SCORAD consistent with the overall cohort.

Among 131 patients with skin of color (Fitzpatrick IV-VI), composite response climbed to 86% by month 12, and SCORAD ≤24 increased from 15.9% at baseline to 81.8%.

Minimal disease activity, US outcomes, and tralokinumab safety

A separate TRACE analysis applied the AHEAD minimal disease activity (MDA) targets to the full cohort.

 After 12 months, 91% of patients met at least one moderate target and 78% met at least one optimal target, corresponding to MDA.

 The most commonly met moderate targets were EASI ≤7 (88%) and IGA ≤2 plus 50% BSA improvement (84%), while EASI ≤3 (74%) and Sleep NRS ≤1 (57%) were the most frequent optimal targets.

In the US cohort (N = 137), composite response increased from 5.2% (7/135) at baseline to 61.5% (24/39) at month 12.

 Response was seen in both dupilumab-naive and dupilumab-experienced patients, at 64.0% and 57.1%, respectively, by month 12.

Tralokinumab was well tolerated in the US cohort.

 Adverse events occurred in 13 patients (9.5%) and were primarily mild or moderate, and two serious adverse events (1.5%) were reported, none considered treatment related.

 Investigators identified no new safety signals.

Tralokinumab in the PPD CorEvitas AD Registry

US real-world findings from the PPD CorEvitas AD Registry, presented earlier in 2026, complemented the TRACE data. Among 119 patients persistent on tralokinumab at 12 months, clear or almost clear skin (vIGA-AD ≤1) rose from 6.7% (8/119) at baseline to 63.9% (76/119), and EASI ≤7 increased from 36.1% (43/119) to 85.7% (102/119).

Among patients with moderate-to-severe disease at baseline (EASI ≥7.1), 78.9% achieved EASI-75 at 12 months.

 Of the registry cohort, 36.1% were advanced systemic therapy (AST) experienced, and 93.0% of those patients had prior dupilumab.

Improvements extended to quality of life and itch.

 Among patients with baseline DLQI ≥4, 74.7% achieved a four-point or greater improvement, and 66.7% of those with weekly mean pruritus NRS ≥3 achieved a three-point or greater improvement.

 Mean WPAI activity impairment fell by 17.1%, with benefits observed regardless of prior AST use.

LEO Pharma markets tralokinumab as Adbry in the US and Adtralza in other regions for moderate-to-severe atopic dermatitis.

 The TRACE subpopulation analyses and the CorEvitas registry add real-world durability and tolerability evidence in patients with high-burden involvement and prior advanced systemic therapy exposure.

Pink AE, Pezzolo E, Jarell A, et al. Minimal disease activity with 12 months of tralokinumab treatment in adults with atopic dermatitis: real-world data from the TRACE study. Presented at: 8th Annual Revolutionizing Atopic Dermatitis (RAD) Conference; June 17-19, 2026.

Armstrong AW, Rubin C, Jarell A, et al. Effectiveness and safety of 12-month tralokinumab treatment in US adults with atopic dermatitis in the TRACE study. Presented at: 8th Annual Revolutionizing Atopic Dermatitis (RAD) Conference; June 17-19, 2026.

Silverberg JI, Balu S, Choi CJ, et al. Real-world effectiveness of 12-month persistent tralokinumab use: data from the PPD CorEvitas Atopic Dermatitis Registry. Presented at: 4th Annual Winter Clinical Dermatology Conference; February 21-March 1, 2026; Miami, FL.

ADBRY (tralokinumab-ldrm). Prescribing information. LEO Pharma Inc.; 2024.

Real-world 12‑month tralokinumab data from TRACE (N=824) showed durable improvements in atopic dermatitis severity and pruritus, including in difficult anatomic sites and skin of color, and in patients with prior dupilumab exposure. At month 12, head/neck disease achieved IGA 0/1 in 64.7% and EASI ≤7 in 89.3%; 57.4% with hand/foot involvement were clear. Fitzpatrick IV–VI patients reached 86% composite response. AHEAD minimal disease activity targets were frequently met. US and CorEvitas registry cohorts confirmed effectiveness, quality-of-life gains, and tolerability without new safety signals.

Real-world data from the international TRACE study show 12 months of tralokinumab improved skin and quality-of-life outcomes.

Tralokinumab Improves Atopic Dermatitis Across Subgroups in TRACE study

Improving Quality of Life with Biologic Therapy in IBD

In this episode, “Improving Quality of Life with Biologic Therapy in IBD,” the panelists explore the long-term patient experience with biologic therapy and the impact of treatment on remission, confidence, and quality of life in inflammatory bowel disease (IBD). The patient panelist reflects on adapting to life with Crohn’s disease, discussing how biologic therapy became part of a manageable routine and helped restore a sense of normalcy and peace of mind. The panel also highlights the importance of treatment adherence, ongoing monitoring, and maintaining open communication with the healthcare team throughout the disease journey.

Throughout the discussion, expert faculty address common patient fears surrounding biologic therapies, including concerns related to side effects and long-term safety. The panel reviews the importance of patient education and shared decision-making, emphasizing that the risks associated with uncontrolled IBD may outweigh the potential risks of advanced therapies. Expert faculty also discuss how clinicians counsel patients on common adverse events, monitoring expectations, and when patients should contact their care team regarding new or worsening symptoms.

In addition, the conversation reinforces the importance of early diagnosis and early treatment intervention to reduce complications and improve long-term outcomes in IBD. The patient panelist shares how achieving remission improved the ability to travel, participate in family activities, and regain confidence in daily life without constant concern about symptoms or disease flares. The panel concludes by emphasizing that modern IBD therapies can help patients achieve meaningful symptom control, remission, and an improved quality of life through proactive, individualized care.

The next episode in this series, “Open Communication Between Patients and Providers in IBD,” features the panelists discussing the importance of early symptom recognition, honest communication with healthcare providers, and timely evaluation for inflammatory bowel disease. The panel will also highlight how biologic therapies, patient engagement, and early intervention can improve remission and quality of life in patients living with IBD.

Learn why controlling IBD matters more than feared side effects, and how biologics, monitoring, and whole-person care restore normal life.

Video Series

Chronicity, Symptom Variability, and Treatment Expectations in Pediatric Functional Constipation and IBS-C

An expert underscores the importance of early expectation setting around chronicity, symptom variability, and realistic treatment goals for children with functional constipation or IBS-C.

Successful long-term management of pediatric functional constipation and IBS-C requires more than selecting a specific therapy; it depends heavily on how clinicians frame the conditions and set expectations with families. Julie Khlevner, MD, recommends presenting these disorders early as chronic, often relapsing conditions with fluctuating symptom intensity rather than problems that will respond to a rapid or linear cure. She finds that normalizing symptom variability from the outset can help reduce anxiety when symptoms recur, mitigate repeated urgent reassessments, and decrease reliance on unnecessary investigations.

In functional constipation, Khlevner observes that many families expect laxatives to “fix” the problem within weeks, whereas underlying drivers—such as withholding behaviors, altered anorectal sensation, rectal dilation, and dysfunctional toileting patterns—frequently require months to improve. She emphasizes that maintenance therapy often must continue even after stool frequency normalizes, with careful tapering only when appropriate. Without explicit counseling, families may stop treatments prematurely or use medications inconsistently, leading to relapse and a loss of confidence in the care plan.

For IBS-C, Khlevner highlights that outcomes are typically judged by reductions in symptom burden and improvements in daily functioning, not complete symptom resolution. She deliberately distinguishes symptom improvement, functional improvement, and full symptom eradication, and she aligns therapeutic goals through shared decision-making. She also notes that a subset of children will continue to experience symptoms into adulthood, underscoring the importance of planned transition-of-care strategies. Clear, early communication about chronicity, timelines, and realistic targets can preserve adherence and sustain therapeutic alliances over the course of a child’s development.

Learn how realistic expectations, long-term laxative plans, and shared goals improve pediatric constipation and IBS outcomes, reducing relapse anxiety

Learn how IBD patients get fast access to Tremfya, navigate insurance, and stay in remission with ongoing tests and doctor teamwork.

Addressing Safety Concerns with Biologic Therapies in IBD

Erika Lundgrin, MD, is an adult and pediatric endocrinologist at University Hospitals Cleveland Medical Center and Rainbow Babies and Children’s Hospital.

Erika Lundgrin, MD, discusses her recent work comparing the various components of financial toxicity, determining what has the greatest effect on negative outcomes.

Type 1 Diabetes

Health Insurance Largely Controls Financial Toxicity in Patients With T1D

Shipra Patel, MD, MS, is the senior medical director, global head of pediatrics, and global section head of endocrinology and metabolism at Parexel.

Shipra Patel, MD, MS, discusses her recent study highlighting best practices for phase 1 and 2 obesity trials to avoid attrition and loss of data.

Obesity Management

Obesity Management condition center page, resources on the topics of medical news and expert insight into clinical weight management can be found. Content includes articles, interviews, videos, podcasts, and breaking news on obesity research, treatment, and drug development.

Structuring Obesity Trials to Optimize Patient Retention and Data Integrity

Victoria Johnson joined MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and is now an assistant managing editor for HCPLive and RheumatologyLive. She doesn’t have enough time for her numerous hobbies. You can reach her at vjohnson@mjhlifesciences.com.

An expert clinical forum explores recent updates in the field and incorporating sotatercept treatment.

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.

Sotatercept, De-escalation, and Systemic Barriers: A PAH Expert Forum

Aleena Banerji, MD, professor at Harvard Medical School and director of clinical care at the Center for Drug and Vaccine Allergy at Massachusetts General Hospital.

Aleena Banerji, MD, reviews HAELO secondary data: 91% reduction in moderate/severe attacks, 17-point QoL gain, and zero non-responders for lonvo-z.

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.

HAELO Phase 3: Lonvo-z Secondary Endpoints, QoL Data Detailed at EAACI

Bharat Saboo, MS, is the director of Prayas Diabetes Center.

Bharat Saboo, MS, discusses his recent study investigating the LLM device in improving both physical and psychological issues associated with T1D.

Mitraa-T1D: AI-Driven Converastional Tool Improves T1D Diabetes Distress, Self-Care Behaviors

Samuel Shangwu Wu, PhD, is a professor and deputy director of the Health Informatics Institute at the University of South Florida.

Samuel Shangwu Wu, PhD, discusses his recent work evaluating TMRCP as an effective endpoint for future T1D trials.

Time to Minimum Residual C-Peptide As a Predictor of Treatment Efficacy in T1D

DiRuggiero on PsO-LD, a heating pad for molluscum, and why psoriasis counseling must now include pulmonary risk.

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.

Psoriasis-Associated Lung Disease and Clinical Pearls for Dermatologist 

Harrison Nguyen, MD, MBA, MPH, is a double board-certified dermatologist/Mohs micrographic surgeon and clinical researcher in Houston, Texas.

This video feature highlights the views of dermatologists on prior authorization, step therapy, and issues related to these processes.

The Cost of Delay: How Prior Authorization Is Impacting Dermatology

Dermatologists write up to 10% of US antibiotics. At SDPA 2026, Douglas DiRuggiero, PA-C, explains why that must change and what to use instead.

Latest News

CALIBRATE: Encaleret Achieves Mineral Homeostasis in Patients With ADH1, With Rachel Gafni, MD

CHE Imposes Heavy Occupational, Quality-of-Life, and Economic Burden on US Patients

Tralokinumab Improves Atopic Dermatitis Across Subgroups in TRACE study

Improving Quality of Life with Biologic Therapy in IBD

Chronicity, Symptom Variability, and Treatment Expectations in Pediatric Functional Constipation and IBS-C