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.

IBI311 Efficacious and Safe in Reducing Proptosis in Thyroid Eye Disease | Image Credit: Pexels

IBI311, an insulin-like growth factor 1 receptor (IGF-1R) inhibitor, has successfully improved proptosis and disease activity in patients with moderate-to-severe 

 who responded poorly to glucocorticoid therapy.

American Association of Clinical Endocrinology (AACE) Annual Meeting 2026

 in Las Vegas, Nevada, by Xiuying Zhang, PhD, department of endocrinology and metabolism, Peking University People’s Hospital, followed up the phase 3 RESTORE-1 study in China, which saw IBI311 (teprotumumab N01) demonstrate promising results in TED.

The present study was a randomized, double-masked, placebo-controlled clinical trial, enrolling patients between 18 and 80 years and with a weight between 45 and 100 kg (99 and 220.5 lb). Additionally, patients were required to have a clinical diagnosis of Graves’ disease associated with active TED, with a Clinical Activity Score (CAS) ≥3 for ≥1 eye at screening and baseline, as well as moderate-severe active TED. Patients with optimal corrected vision loss due to optic neuropathy, corneal ulcers, or baseline CAS decreased by >2 points versus screening, among other criteria, were excluded.

Following enrollment, patients were stratified by baseline activity and randomly assigned in a 2:1 ratio to receive either IBI311 or placebo. Both treatments were given every 3 weeks for 4 infusions of 10mg/kg at day 1 and 20 mg/kg at weeks 3, 6, and 9. Patients were then evaluated at week 12, after which both arms were given another 4 infusions of IBI311 from week 12 to 21.

The study’s primary outcome was proptosis responder rate of the study eye, which was defined as the percentage of patients with a ≥2 mm reduction from baseline in proptosis without deterioration proptosis in the non-study eye. Secondary outcomes included the overall responder rate in the study eye, the percentage of subjects with a CAS value of 0 or 1 in the study eye, and the mean change from baseline in proptosis measurement, among others.

A total of 53 patients were included in the study, of whom 36 received IBI311 and 17 received placebo. Baseline characteristics were relatively balanced across both arms. By week 12, proptosis response was substantially higher with IBI311 than with placebo (58.3% vs 29.4%; 

 = .034). The IBI311 group also demonstrated greater mean reductions in proptosis (-2.28 vs -0.77 mm; 

Patients with active TED in the IBI311 arm achieved a superior overall response rate (46.2% vs 16.7%; 

 = .043), and a higher proportion of patients reached a CAS of 0 or 1 in the IBI311 arm. Diplopia response was numerically higher in the IBI311 arm. After transitioning from placebo to IBI311, patients in both arms saw sustained and further improved therapeutic benefits through week 24.

“In participants with moderate-to-severe TED with poor response to glucocorticoid therapy, IBI311 demonstrated significant efficacy in improving proptosis and disease activity and was well tolerated,” Zhang and colleagues wrote. “These findings support IGF-1R inhibitors as a promising treatment option for this population with unmet clinical need.”

Zhang XY, Zhao W, Li TY, et al. Efficacy and Safety of IBI311 in Thyroid Eye Disease (TED) Poorly Responsive to Glucocorticoids: A Randomized, Double-Masked, Placebo-Controlled Trial. Abstract presented at the American Association of Clinical Endocrinology Annual Meeting 2026, Las Vegas, NV. April 22-24, 2026.

Innovent Biologics (Suzhou) Co. Ltd. A Study of IBI311 in Subjects With Active Thyroid Eye Disease. ClinicalTrials.gov Identifier: NCT05795621. Updated February 8, 2024. Accessed April 22, 2026. 

https://clinicaltrials.gov/study/NCT05795621

Articles

IBI311, an IGF-1R inhibitor (teprotumumab N01), showed clinically meaningful improvements in moderate-to-severe active thyroid eye disease refractory to glucocorticoids. In a randomized, double-masked, placebo-controlled trial (n=53; 2:1 allocation), IBI311 produced higher week-12 proptosis responder rates and greater reductions in proptosis and Clinical Activity Score than placebo. Additional benefits were observed in overall response and attainment of low disease activity (CAS 0–1), with numerically improved diplopia. After crossover to active therapy, responses were sustained through week 24 with acceptable tolerability.

A recent study presented at AACE 2026 has displayed the IGF-1R’s capacity for improving proptosis and disease activity in patients with poorly-controlled TED.

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IBI311 Efficacious and Safe in Reducing Proptosis in Thyroid Eye Disease

Addressing Diagnostic Challenges in Wilson Disease

In 'Addressing Diagnostic Challenges in Wilson Disease,' our panel delves into the complexities of clinical recognition and the high stakes of early intervention. Dr. Peter Hedera identifies Wilson disease as a "great masquerader" due to its nonspecific and protean presentations, such as isolated tremors or parkinsonism, which can lead to significant diagnostic delays. The panel emphasizes that maintaining a high index of suspicion is vital, particularly in patients under age 40, though atypical presentations in older adults must not be entirely ignored.

A primary focus of this episode is the protocol for sibling screening. Given the one-in-four risk for siblings of a diagnosed patient, the experts describe it as a physician's duty to facilitate testing for these family members. The discussion compares the utility of 24-hour urine copper assays and ceruloplasmin levels against the increasing accessibility of genetic testing. While biochemical proof of copper overload remains the "gold standard" for adult patients, Dr. Fawaz notes that in children, 24-hour urine collections may be less reliable or harder to obtain, making targeted genetic testing for the ATP7B mutation even more valuable.

The panelists also address the practical hurdles of modern diagnosis, specifically insurance coverage for genetic testing and the challenge of interpreting variants of unknown significance. They highlight the importance of the Leipzig score, where a definitive genetic diagnosis can provide the necessary points for clinical confirmation. The episode concludes with a call for better advocacy toward insurance providers, reinforcing that early genetic and biochemical screening can save lives by identifying the disease in a pre-symptomatic state.

Our next episode, 'Impact of Early Diagnosis on Disease Progression and Quality of Life in Wilson Disease,' further explores Wilson disease, highlighting the critical window of opportunity for intervention to prevent irreversible organ damage. The experts discuss the transformative potential of newborn screening and the profound impact that early diagnosis has on long-term patient outcomes and daily functioning.

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Learn how Leipzig scoring and genetic testing, plus labs and eye exams, help diagnose pediatric Wilson disease when symptoms are subtle.

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Mark G. Lebwohl, MD, the dean for Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai,

Integrating TYK2 Inhibitors into the Psoriasis Treatment Algorithm

In ‘Integrating TYK2 Inhibitors into the Psoriasis Treatment Algorithm,’ our panel explores how the emergence of TYK2 inhibitors has reshaped the traditional hierarchy of psoriasis care. Dr. Mark Lebwohl explains that while he rarely utilizes older TNF blockers due to their boxed warnings for cancer and infection, he views newer IL-17 and IL-23 blockers as highly effective standards of care. He notes that the choice between a TYK2 inhibitor and a biologic often centers on patient preference for a daily oral pill versus an injection every few months. Dr. Lebwohl acknowledges that while some biologics may peak faster than oral agents, TYK2 inhibitors offer a remarkably safe profile that avoids the yeast infection risks associated with IL-17 inhibitors.

The experts also delve into advanced management strategies, including the off-label use of deucravacitinib in combination with biologics. Dr. Lebwohl references published data showing that patients who failed to reach "treat to target" goals on a single agent experienced significant improvement when a TYK2 inhibitor was added. Dr. Tina Bhutani-Jacques agrees, noting that she often employs combination therapy for complex cases involving both skin and psoriatic arthritis where monotherapy proves insufficient. Furthermore, the discussion touches on the expanding pipeline of oral therapies, including envudeucitinib, which recently reported phase 3 results. The panelists emphasize that having a variety of available TYK2 inhibitors is essential for clinical practice, likening the need for multiple options to having a diverse range of antibiotics to ensure every patient can find a successful long-term treatment.

Our next episode, ‘Potential Therapeutic Opportunities of TYK2 Therapy Beyond Psoriasis and Identifying the Ideal Patient,’ features the panelists discussing the long-term systemic benefits of reducing inflammation and the promising future of TYK2 inhibitors for comorbidities. Dr. Bhutani-Jacques and Dr. Lebwohl also identify key patient profiles, such as those with needle phobia or active lifestyles, who benefit most from oral treatment options.

Experts explain how deucravacitinib eases psoriasis itch fast, boosts quality of life, and why TB testing and boxed warnings matter.

Navigating the Differential: When EPI Looks Like Something Else

With diagnosis in sight, this episode addresses the important challenge of differential diagnosis and the conditions that can masquerade as or coexist with EPI. The panelists approach this from two angles: conditions that may be concomitant with EPI, and conditions that may be the true primary diagnosis in a patient with EPI-like symptoms.

Jennifer Geremia distinguishes between new patients presenting with postprandial symptoms—where the differential is broad and may require blood testing, stool testing, and endoscopy—and patients with known EPI-associated conditions (e.g., well-controlled celiac disease still symptomatic, IBD, post-gastric bypass) where EPI is one of several conditions potentially at play. Sarah Enslin highlights irritable bowel syndrome (diarrhea-predominant), small bowel Crohn's disease, and any condition involving abdominal bloating and diarrhea as key mimickers that require careful differentiation.

The panel recommends a personalized, stepwise diagnostic strategy. For patients with alarm features or family history warranting endoscopic evaluation, appropriate endoscopy should be prioritized. However, unnecessary testing should be avoided—if symptoms are not postprandial or clearly linked to meals, ordering a fecal elastase in a patient with likely IBS may yield low utility. The key is tailoring the diagnostic sequence to the individual presentation.

A particularly important clinical pearl is raised about prior testing: in referral center practice, patients often arrive having already undergone multiple scopes, CT scans, and bloodwork. Systematically reviewing prior testing avoids unnecessary duplication, saves costs, and ensures meaningful incremental workup rather than repeated baseline evaluation. This 'chronology first' approach is presented as a practical strategy for experienced clinicians and trainees alike.

Putting PROs to Work: The PEIQ and Symptom Scores in EPI Management

," the discussion examines how validated patient-reported outcome tools like the PEIQ can be integrated into clinical practice to guide diagnosis, treatment adjustment, and monitoring.

Learn a stepwise approach to evaluating EPI-like diarrhea—history, alarm features, fecal elastase and imaging—to rule out IBS, celiac, IBD.

Joseph Leventhal, MD, PhD, is a Professor of Surgery and Director of the Kidney and Pancreas Transplant Programs within the Comprehensive Transplant Center of the Northwestern University Feinberg School of Medicine.

Long-term limitations imposed by current immunosuppression options after kidney transplantation have led investigators to evaluate the potential of cellular therapies in early-phase clinical trials.

While consistent immunosuppression is essential to prevent graft rejection, the long-term efficacy, pill burden, and graft survival remain crucial issues that clinicians have yet to tackle with this patient population.

“With current drug-based immunosuppression, the best we can do—with a living donor transplant—is around 20 years,” said Joseph Leventhal, MD, PhD, a Professor of Surgery and Director of the Kidney and Pancreas Transplant Programs within the Comprehensive Transplant Center of the Northwestern University Feinberg School of Medicine, in an interview with 

“If you're someone in your 20s or 30s, that means you're going to need at least 2, maybe 3 transplants during your lifetime.”

Against this backdrop, investigators are exploring immune tolerance strategies designed to retrain the immune system to accept transplanted organs without recognizing them as foreign, while preserving normal immune function.

“That’s why tolerance induction is so important—whether it's getting someone entirely off of immunosuppression, full tolerance, or reducing the need and minimizing the need for drug-based immunosuppression to a low dose of a single agent, what we call drug minimization,” said Leventhal. “We’re looking to develop strategies that can safely do this in the large majority of patients. Where drug-based approaches have failed to allow us to establish tolerance, we are increasingly looking at cellular therapies to do this.”

Several early-phase clinical trials are currently underway, including a phase 1b study evaluating hematopoietic stem cell transplantation combined with regulatory T-cell therapy in living donor kidney transplant recipients, as well as a randomized phase 2 trial assessing whether patients can be safely transitioned to single-agent immunosuppression. Additional investigational approaches are exploring novel induction strategies using modified donor immune cells.

Across these studies, investigators are closely monitoring immunologic markers to better understand how tolerance may be achieved in practice. This includes assessing donor-specific hyporesponsiveness over time and combining these findings with biomarkers of immune quiescence.

“We want to show evidence of immune regulation that supports reducing immunosuppression,” the investigator said. “More than 95% of patients require multiple drugs today, so achieving monotherapy would be a major advance.”

Reducing exposure to multi-drug regimens may also help mitigate long-term toxicity and potentially improve graft durability. For some investigators, the long-term goal is to move closer to a model in which a single transplant can last a patient’s lifetime.

Looking ahead, the adoption of cellular therapies could require a shift in how transplant care is delivered, with Leventhal describing the potential for a “paradigm shift” towards increasingly personalized approaches.

While these strategies remain investigational, they reflect ongoing efforts to address persistent limitations in transplant care and improve long-term outcomes for patients.

Editor’s Note: Leventhal has reported relevant disclosures with Talaris Therapeutics.

Kamila Szumilas, Wilk A, Piotr Wiśniewski, et al. Current Status Regarding Immunosuppressive Treatment in Patients after Renal Transplantation. 

International Journal of Molecular Sciences

. 2023;24(12):10301-10301. doi:https://doi.org/10.3390/ijms241210301

Clinicaltrials.gov. Published 2026. Accessed April 23, 2026. https://clinicaltrials.gov/study/NCT07083830?tab=researcher

Levanthal describes the limits of current immunosuppression and the rationale behind early-phase clinical trials evaluating cellular therapies.

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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.

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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.

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IBI311 Efficacious and Safe in Reducing Proptosis in Thyroid Eye Disease

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