Pulmonologist and interventional pulmonologist, Pinehurst Medical Clinic

Shape-sensing robotic-assisted bronchoscopy (ssRAB) achieved a consensus-defined diagnostic yield of 82.1% and a sensitivity for malignancy of 87.3% in the first 750 patients with 1-year follow-up from the prospective, multicenter Ion Registry.

 Michael Pritchett, DO, MPH, medical director of the Chest Center of the Carolinas and an advanced bronchoscopist with FirstHealth Pulmonology and Pinehurst Medical Clinic, discussed the findings with 

Pritchett presented the late-breaking analysis at the 

, held October 18-21, 2026, in Phoenix, Arizona. The registry enrolled patients undergoing ssRAB biopsy with no prespecified patient or nodule criteria, and this analysis included 750 of 1,301 enrolled patients across 11 sites and 22 proceduralists.

 The data join other CHEST 2026 findings on 

breath-hold technique during robotic bronchoscopy

Robotic Bronchoscopy Shows 87% Malignancy Sensitivity: Michael Pritchett, DO, MPH

"Sensitivity for malignancy is a much better indicator because it takes into account that longitudinal follow-up for 1 year. In this case, for the data we are presenting now, but ultimately for 2 years, and so we want to be able to tell a patient, hey, 87% of the time, if you have cancer, we are going to get you a result that is accurate," Pritchett said.

Median largest nodule diameter was 17 mm (interquartile range [IQR], 13–27), median distance to pleura was 4 mm (IQR, 0–14), and 42.6% of lesions lacked a CT bronchus sign.

 Cone-beam CT was used in 73.1% of cases, cryobiopsy in 48.7%, and concurrent lymph node staging in 71%. Pritchett said a bronchus sign no longer drives yield with robotic navigation, noting the smallest lesion biopsied measured 4 mm.

Diagnostic yield under the American Thoracic Society/American College of Chest Physicians (ATS/ACCP) consensus definition was 82.1% (95% CI, 79.2%–84.8%), intermediate yield was 86.3% (95% CI, 83.6%–88.7%), and sensitivity for malignancy was 87.3% (95% CI, 84.2%–90.0%).

 Pritchett cautioned early yield estimates near 90% can be inflated without adequate follow-up, noting 13 patients with a specific benign result of granulomatous inflammation were later diagnosed with cancer.

Pneumothorax requiring intervention occurred in 0.9% of patients (95% CI, 0.4%–1.9%) and Nashville grade 3 or higher bleeding in 0.1% (95% CI, 0.0%–0.7%).

 Pritchett said this safety profile allows bilateral biopsies and mediastinal staging in a single procedure, and noted the median proceduralist performed 8 cases per month. These preliminary registry data have not been peer reviewed.

Disclosures include Medtronic, Johnson & Johnson, AstraZeneca, Intuitive, BodyVision, Boston Scientific, Philips, and Biodesix.

Pritchett MA, Postigo Jasahui M, Abedi A, et al. Real-world outcomes for shape-sensing robotic-assisted bronchoscopy: diagnostic yield and sensitivity for malignancy from the prospective multicenter Ion Registry. Presented at: CHEST 2026 Annual Meeting; October 18-21, 2026; Phoenix, AZ.

Gonzalez AV, Silvestri GA, Korevaar DA, et al. Assessment of advanced diagnostic bronchoscopy outcomes for peripheral lung lesions: a Delphi consensus definition of diagnostic yield and recommendations for patient-centered study designs. An official American Thoracic Society/American College of Chest Physicians research statement. 

Videos

Michael Pritchett, DO, MPH, discusses real-world Ion Registry yield, sensitivity, and safety data for robotic bronchoscopy presented at CHEST 2026.

Pulmonology

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. 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.


ORKA-001 is an investigational monoclonal antibody against IL-23p19. It is engineered for an extended half-life, with the goal of maintaining psoriasis control on 1 or 2 doses per year.


At week 16, 61% of patients receiving 600 mg ORKA-001 achieved PASI 100, vs 0% with placebo, and 86% reached PASI 90 and IGA 0/1.


Oruka plans to start phase 3 trials of the 600 mg dose in the first half of 2027, pending discussions with regulators.

ORKA-001, an investigational half-life extended interleukin (IL)-23p19 monoclonal antibody, produced complete skin clearance in 61% of high-dose recipients with 

 at week 16 of the phase 2b EVERLAST-B trial, Oruka Therapeutics announced on October 26, 2026.¹

The readout builds on the phase 2a EVERLAST-A trial, in which 63.5% (40/63) of patients given 600 mg ORKA-001 reached PASI 100 at week 16, vs 1 of 21 placebo recipients.² Oruka is developing the antibody with the goal of sustaining disease control on a schedule as infrequent as 1 or 2 doses per year.¹

Joel Gelfand, MD, MSCE, lead investigator for EVERLAST-B and James J. Leyden Professor of Dermatology and Epidemiology at the University of Pennsylvania, said the data suggest ORKA-001 could be the most effective IL-23 targeted biologic studied to date. He noted nearly all of those involved in the trial could anticipate a strong response, with most seeing fully clear skin within 16 weeks.¹

How Did ORKA-001 Perform in the Phase 2b EVERLAST-B Trial?

EVERLAST-B is a randomized, double-blind, placebo-controlled study enrolling 187 adults at 36 sites in the US, Canada and Europe, fewer than 30% of which also took part in EVERLAST-A.¹ Participants were assigned 1:1:1:1 to placebo or 1 of 3 ORKA-001 regimens: 37.5 mg at week 0, 300 mg at weeks 0 and 4, or 600 mg at weeks 0 and 4.¹ PASI 100 at week 16 served as the primary end point.

Responses rose with dose. In the 600 mg group (n = 46), 61% of patients achieved PASI 100, compared with 0% of placebo recipients (n = 47; 

 < .0001).¹ Rates in the 300 mg and 37.5 mg groups reached 44% and 43%, respectively.¹

Among high-dose recipients, 86% achieved both PASI 90 and an Investigator’s Global Assessment (IGA) score of 0/1.¹ The mid-dose group posted 85% on each measure, while the low-dose group reached 70% for PASI 90 and 74% for IGA 0/1; no placebo recipient met either threshold.¹ According to Oruka, these results closely track those from EVERLAST-A.¹

What Is the Safety Profile of ORKA-001 in Plaque Psoriasis?

Through week 16, 49% (68/140) of all ORKA-001 recipients and 43% (20/47) of placebo recipients experienced at least 1 treatment-emergent adverse event (TEAE).¹ The rate in the high-dose group was 39% (18/46). Upper respiratory tract infection (14% [20/140]) and headache (6% [8/140]) were the only TEAEs reported in 5% or more of treated patients, occurring at frequencies Oruka described as comparable to approved IL-23 inhibitors.¹

The company reported no dose-dependent trend in adverse events and no serious TEAEs in the 600 mg group.¹ Serious TEAEs elsewhere, including the placebo arm, comprised kidney stones, miscarriage, psoriasis, substance-induced psychotic disorder, and syncope with jaw fracture following a blood draw; investigators considered none related to treatment.¹ Two ORKA-001 recipients (1%) discontinued because of a TEAE, and no injection-site reactions occurred in any patient receiving the antibody.¹

At week 28, ORKA-001 recipients who reached PASI 100 will be re-randomized 1:1 to 600 mg once yearly or placebo, while those without complete clearance will receive 300 mg every 6 months.¹ Follow-up continues through week 100 to evaluate durability, maintenance dosing, and long-term safety.

Pending regulatory discussions, Oruka plans to launch phase 3 trials of the 600 mg dose in the first half of 2027.¹ The company expects 52-week EVERLAST-A data in December 2026 and 52-week EVERLAST-B data in the second half of 2027.¹

Editor’s Note: This summary has been edited for grammar and clarity using artificial intelligence tools.

Oruka Therapeutics. Oruka Therapeutics announces positive week 16 results for ORKA-001 from the ongoing EVERLAST-B trial in moderate-to-severe psoriasis. Published October 26, 2026. Accessed October 27, 2026. 

https://ir.orukatx.com/news-releases/news-release-details/oruka-therapeutics-announces-positive-week-16-results-orka-001

Oruka Therapeutics. Oruka Therapeutics announces positive week 16 data for ORKA-001 from the ongoing EVERLAST-A phase 2a trial in moderate-to-severe plaque psoriasis. Published April 27, 2026. Accessed October 27, 2026. 

https://ir.orukatx.com/news-releases/news-release-details/oruka-therapeutics-announces-positive-week-16-data-orka-001

Articles

ORKA-001, a half-life extended IL-23p19 antibody, achieved PASI 100 in 61% of high-dose patients at week 16 in the phase 2b EVERLAST-B psoriasis trial.

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.

ORKA-001 Clears Skin in 61% of High-Dose Psoriasis Patients at Week 16

pediatric pulmonologist and sleep medicine physician at University Hospitals (UH) Rainbow Babies and Children’s Hospital.

Gene therapy has transformed respiratory outcomes in spinal muscular atrophy (SMA) type 1, but children still need ongoing 

 and sleep monitoring, according to Moshe Prero, MD, pediatric pulmonologist and sleep medicine physician at University Hospitals (UH) Rainbow Babies and Children’s Hospital.¹

 approved onasemnogene abeparvovec-xioi (Zolgensma) in May 2019 for children aged < 2 years with SMA.

The approval was based on motor milestone gains, including sitting without support, compared with natural history.² In December 2023, the agency approved exagamglogene autotemcel (Casgevy) and lovotibeglogene autotemcel (Lyfgenia) for patients aged ≥ 12 years with sickle cell disease (SCD) and recurrent vaso-occlusive events.³,

 in Phoenix, Prero presented the session, “Updates in Pediatric Pulmonology: Year in Review,” which addressed the pulmonary implications of these therapies alongside bronchopulmonary dysplasia and chronic mechanical ventilation.¹ 

“Gene therapy has revolutionized the disease process for these patients,” he said. “Now, I’m seeing patients who are walking around without any ventilatory needs.”

Respiratory Monitoring After Spinal Muscular Atrophy Gene Therapy

Respiratory Outcomes After Gene Therapy in SMA Type 1

Prero noted children with the most severe form of SMA, often labeled type 1 SMA, were historically described in the neurological literature as “non-sitters.” These patients never developed the motor strength to sit independently.

Before gene therapy, they typically required ventilatory support through a mask or a tracheostomy tube during the first year of life and nearly always by the second year. Prero now sees patients from this population who sit, walk around the exam room, and participate in society as ambulatory children.

“It’s changed the landscape entirely,” Prero said.

Long-term outcomes remain uncertain. According to Prero, the residual disease burden after gene therapy is not yet defined, nor is its effect on sleep and respiratory needs as these children age.

Some patients may eventually need nocturnal continuous positive airway pressure (CPAP), and others may develop swallowing dysfunction or scoliosis, each of which carries respiratory consequences. Prero said further research is needed to characterize these trajectories.

Monitoring Lung Function and Sleep-Disordered Breathing After Gene Therapy

How has gene therapy changed respiratory care in SMA type 1?


Children with SMA type 1 who once required mask or tracheostomy ventilation by age 2 are now, in some cases, walking without any ventilatory support after gene therapy, according to Prero.

What should pulmonologists monitor after SMA gene therapy?


Prero recommends pulmonary function testing once children are old enough, plus screening for sleep-disordered breathing. If a child screens positive for snoring along with daytime symptoms, a sleep study should follow.

Does disease-modifying therapy change acute chest syndrome management in SCD?


According to Prero, the standard of care for acute chest syndrome remains the same for patients who have received disease-modifying therapy.

Because individual responses to gene therapy vary, Prero recommended pulmonologists continue structured follow-up even when motor function improves. Spirometry and pulmonary function testing should begin once a child is old enough to complete them reliably.

Screening for sleep-disordered breathing is equally important, Prero added. He advised clinicians to ask about nighttime snoring and about subtle daytime clues, including morning headaches, mood or behavior changes, and changes in concentration.

“If the patient screens positive ... meaning they have snoring and they have those changes during the day, it’s important to get a sleep study,” Prero said.

For SCD, Prero said disease-modifying therapy does not yet change the approach to acute chest syndrome. In his view, patients who develop acute chest syndrome after receiving such therapy should be managed according to the existing standard of care.

Prero M. Updates in pediatric pulmonology: year in review. Presented at: CHEST 2026 Annual Meeting; October 21, 2026; Phoenix, AZ.

FDA approves innovative gene therapy to treat pediatric patients with spinal muscular atrophy, a rare disease and leading genetic cause of infant mortality. US Food and Drug Administration. Published May 24, 2019. Accessed October 27, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-approves-innovative-gene-therapy-treat-pediatric-patients-spinal-muscular-atrophy-rare-disease

FDA approves first gene therapies to treat patients with sickle cell disease. US Food and Drug Administration. Published December 8, 2023. Accessed October 27, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapies-treat-patients-sickle-cell-disease

Exagamglogene autotemcel: MedlinePlus Drug Information. Medlineplus.gov. 2024. Accessed October 27, 2026. 

https://medlineplus.gov/druginfo/meds/a624018.html

Lovotibeglogene autotemcel Injection: MedlinePlus Drug Information. Medlineplus.gov. 2024. Accessed October 27, 2026. 

https://medlineplus.gov/druginfo/meds/a624020.html

Moshe Prero, MD, says gene therapy has changed respiratory care in SMA type 1, but residual sleep, swallowing, and spinal issues still warrant monitoring.

Shannon C. Trotter, DO, is a dermatologist and podcast host from Springfield, Ohio.

In "Closing the Care Gap for Antihistamine-Refractory CIndU," the panel closes the program with a call to action for dermatology.

Closing the Care Gap for Antihistamine-Refractory CIndU

Dr. Cotter notes that trial enrollment was easy, yet many antihistamine-refractory patients remain untreated in the real world. He asks Dr. Finklea what drives that gap and how to close it.

She points to the roughly two-year diagnostic delay, often spanning up to six practitioners. Many patients cycle through antihistamines because the treatment algorithm stops there in some clinics. Dermatologists' hesitancy over perceived omalizumab safety risks shifted much of the burden to allergists, who are too few. With advanced therapies now supported by safety data, she urges dermatologists to get back in the game.

Dr. Trotter calls for education of the public, patients, and colleagues. Dermatology relinquished CSU and CIndU to allergy, but she argues these are dermatologic diseases squarely in the specialty's “whealhouse”. Referring clinicians in primary care, emergency departments, and urgent care should send patients to dermatology. Dermatologists uncomfortable prescribing should refer to colleagues who are. Dr. Cotter appreciates the “wheelhouse” pun.

He then asks each panelist for one practice change. Dr. Finklea urges colleagues to become confident and conversational, read the guidelines, and learn the advanced therapies. Dr. Trotter encourages clinicians to feel empowered and move beyond antihistamines alone. She asks them to aim for control or remission rather than improvement, using quality-of-life questions to judge progress.

Dr. Cotter adds that dermatologists have grown comfortable with CSU and should recognize that CIndU often coexists with it. Listening to patients usually reveals the trigger and the diagnosis. When avoidance is not possible, clinicians should reach for advanced systemic therapy. He notes that remibrutinib 25 mg twice daily is now approved for symptomatic dermographism, the most common CIndU subtype.

Thank you for watching this HCPLive Peer Exchange series on chronic inducible urticaria. Please subscribe to our eNewsletter for information on upcoming video series.

Diagnostic delay, antihistamine cycling, and hesitancy around advanced therapy leave many patients undertreated, and the panel calls on dermatologists to reclaim urticaria care and redefine control.

Video Series

In “Biomarkers and Early Intervention: Can Treatment Timing Change CIndU’s Course?” the panel looks past today’s therapies toward precision medicine and disease modification.

Biomarkers and Early Intervention: Can Treatment Timing Change CIndU’s Course?

Dr. Trotter asks Dr. Finklea where research stands on biomarkers that could predict treatment response in CSU and CIndU. She wonders whether the field is moving toward more precise, personalized care. Dr. Finklea explains that no verifiable biomarkers currently exist for CIndU. Research in CSU is further along, but several candidate markers remain impractical for routine use. Basophil activation tests, for example, are too costly for most patients.

She adds that some findings make biological sense. Low blood basophil counts, for instance, likely reflect basophils migrating into the skin. Other associations, such as elevated D-dimer, are less intuitive. She applauds researchers for pursuing these leads. She expects both the list of biomarkers and the field’s understanding of them to grow. For now, though, she knows of no verifiable biomarker for CIndU.

Dr. Cotter then poses a practical scenario: a patient seen tomorrow with a new diagnosis of CSU or CIndU. Leaving without treatment would hardly be empathetic, given the burden on quality of life and mental health. But does delaying treatment carry risk from a disease modification standpoint? Dr. Finklea agrees that clinicians should achieve control quickly. She notes that early intervention has shown disease-modifying potential in hidradenitis suppurativa, psoriasis, and the atopic march. Early treatment of urticaria might similarly help induce remission by dampening or retraining immune cells.

Dr. Trotter says she would delay care only if a patient were unwilling. She uses emerging data on early treatment to motivate hesitant patients. She describes treatment as a reboot that interrupts a self-perpetuating immune cycle. Dr. Cotter agrees. He tells patients the disease can become hardwired and ingrained when left untreated.

Our final episode, "Closing the Care Gap for Antihistamine-Refractory CIndU," turns to why refractory patients remain undertreated and what dermatologists can change tomorrow.

No verifiable biomarker yet exists to guide CIndU treatment. Still, evidence from other inflammatory diseases suggests early intervention may do more than relieve symptoms and could change the course of disease.

Comorbidities, age, reproductive plans, route of administration, and subtype-specific evidence all shape advanced therapy selection in CIndU, even as data for rarer subtypes remain limited.

Personalizing Advanced Therapy Selection for CIndU Subtypes

None of the three advanced therapies requires mandatory laboratory monitoring, but each carries specific clinical checkpoints that shape counseling, from anaphylaxis preparedness to bleeding risk and hepatic status.

Monitoring Advanced Therapies for CIndU in Clinical Practice

Updated international guidelines place three advanced therapies on equal footing after antihistamine failure, while mast cell depletion and MRGPRX2 antagonism point toward the next generation of CIndU care.

Updated Urticaria Guidelines and Emerging Mechanisms in CIndU

Trial endpoints are binary but clinical practice is not, so the panel describes validated patient-reported tools and practical questions that reveal whether CIndU is truly controlled and their best practices for switching treatment.

Defining Treatment Success and Switching Treatment in CIndU

Remibrutinib's safety profile in CIndU mirrors the CSU program, and the panel puts its bleeding warning, perioperative guidance, and immunoglobulin data in practical clinical context.

Remibrutinib Safety in CIndU: Bleeding, Surgery, and Immunoglobulins

A phase 3 trial with a binary complete-response endpoint and rigorous provocation testing set an exceptionally high bar, and oral BTK inhibition cleared it across three distinct CIndU subtypes.

RemIND Trial Results: BTK Inhibition Across Three CIndU Subtypes

Anti-IgE therapy has served as a long-standing off-label mainstay across CIndU subtypes, while anti-IL-4 receptor data remain mixed, underscoring the need to match therapy to each patient and comorbidity.

Off-Label Biologics in CIndU: Real-World Lessons and Mixed Evidence

With the first FDA approval for symptomatic dermographism, the panel reviews the historical off-label toolkit and maps current and investigational agents from extracellular targets to intracellular signaling.

Beyond Antihistamines: Mapping CIndU Therapies to the Mast Cell

Prabir Roy-Chaudhury, MD, PhD, FASN, co-director of the University of North Carolina (UNC) Kidney Center at the UNC at Chapel Hill School of Medicine

In interim V012 data, women on hemodialysis reached usable access months sooner with ATEV, said Prabir Roy-Chaudhury, MD, PhD.

Nephrology

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

Chronic Kidney Disease

Bioengineered Vessel Adds 91 Catheter-Free Days for Women on Dialysis

Prabir Roy-Chaudhury, MD, PhD, explains how the ATEV is made and the research questions he wants answered next.

Latest News

Robotic Bronchoscopy Shows 87% Malignancy Sensitivity: Michael Pritchett, DO, MPH

ORKA-001 Clears Skin in 61% of High-Dose Psoriasis Patients at Week 16

Respiratory Monitoring After Spinal Muscular Atrophy Gene Therapy

Closing the Care Gap for Antihistamine-Refractory CIndU

Biomarkers and Early Intervention: Can Treatment Timing Change CIndU’s Course?