Jason Hawkes, MD, MS, outlines key factors influencing the selection between biologics, oral small molecules, and traditional systemic therapies in CSU management.

Considerations for Treatment Selection in CSU

Jason Hawkes, MD, MS, a board-certified dermatologist and associate professor of Dermatology at the University of California Davis, highlights how access, affordability, and insurance coverage are primary determinants when selecting therapies for chronic spontaneous urticaria. He underscores that even the most clinically desirable medication can be rendered inaccessible by practical cost or availability constraints. This reality underscores the need for shared decision-making and for clinicians to work closely with patients and insurers to ensure access to appropriate therapies.

In discussing patient preference, Hawkes notes the significance of mode of administration—some patients prefer the convenience of oral medications, such as antihistamines or remibrutinib, while others may find sustained injections more acceptable. The emergence of biologic therapies, including dupilumab and omalizumab, provides alternatives that may be administered less frequently, offering additional flexibility and speed of action, which can influence patient adherence and satisfaction.

Hawkes also considers the benefits of multi-indication therapies, citing dupilumab’s use across several type 2 inflammatory conditions, which may be advantageous for CSU patients with comorbidities. Ultimately, treatment selection is a nuanced process that involves balancing efficacy, safety, patient preference, and real-world factors such as coverage and cost.

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Considerations for Treatment Selection in CSU, With Jason Hawkes, MD, MS

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

The Underlying Causes of GCA: Environmental and Genetic Factors 

This video covers the following questions:

What do we currently understand about the underlying causes (i.e., pathogenesis and the inflammatory pathways) of GCA?

What role do genetics or environmental exposures appear to play in developing this disease?

How might the presence of comorbidities (such as hypertension, osteoporosis, cataracts, etc.) impact the screening and diagnosis of GCA? What diagnostic pearls can you share on screening patients for GCA with comorbidities?

The Underlying Causes of GCA: Environmental and Genetic Factors

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.

Mike Sharma, MD | Image Credit: Canadian Stroke Prevention Intervention Network

Asundexian, an investigational, once-daily oral FXIa inhibitor, has met its primary efficacy and safety endpoints, including reduction in 

 risk without increasing International Society on Thrombosis and Hemostasis (ISTH) major bleeding rate in patients after an acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack, in the phase 3 OCEANIC-STROKE study.

Announced on November 23, 2025, by parent company Bayer, this news comes on the heels of Bristol Myers Squibb and Johnson & Johnson cancelling their own investigative program, Liberaxia, for FXIa inhibitor milvexian for acute coronary syndrome. The collaborative program was terminated on November 14, 2025, after an interim analysis determined the trial was unlikely to meet its primary efficacy endpoint.

Asundexian inhibits Factor XIa, a protein in the blood coagulation pathway that forms hemostatic plugs to seal leaks at sites of vessel injury. FXIa is also thought to contribute to the formation of pathological thrombus growth and vessel blockage. Asundexian has now proven its efficacy in reducing thrombus formation without a significant increase in major bleeding.

“As clinicians, we see every day how devastating a recurrent stroke can be for patients and their families,” Mike Sharma, MD, director of the stroke program at Hamilton Health Sciences, Michael G. DeGroote Chair in stroke prevention at McMaster University, and principal investigator in OCEANIC-STROKE, said in a statement. “Even with currently available therapies, the risk of another stroke remains high, and each recurrence can have profound consequences. The topline results from OCEANIC-STROKE indicate that asundexian may become a new treatment option to reduce this risk, representing a potential major step forward in secondary stroke prevention.”

The OCEANIC-STROKE trial was a multicenter, randomized, international, double-blind, parallel group, event-driven, placebo-controlled phase 3 study, conducted over 741 locations. Patients were eligible for inclusion if they were ≥18 years old, had acute non-cardioembolic stroke or high-risk TIA, and had systemic or cerebrovascular atherosclerosis or acute non-lacunar infarct. Patients who had experienced ischemic stroke ≤7 days before index, an index stroke following procedures or strokes due to other rare causes, or a history of atrial fibrillation/flutter, left ventricular thrombus, mechanic valve or other cardioembolic source of stroke requiring anticoagulation were excluded.

A total of 12,327 patients were included in the study, who were then randomly assigned to either asundexian 50 mg once daily or placebo. The primary efficacy endpoints were time to first occurrence of ischemic stroke and time to first occurrence of ISTH major bleeding, both measured up to 31 months. Secondary outcomes included time to first occurrence of all strokes, first occurrence of a composite of cardiovascular death, myocardial infarction (MI), or stroke, first occurrence of a composite of all-cause mortality, MI, or stroke, first occurrence of transient ischemic attack, and others.

Ultimately, investigators found a significant reduction in ischemic stroke risk with asundexian compared to placebo, both in combination with antiplatelet therapy. Additionally, participants had no increase in ISTH major bleeding risk. Detailed data from the trial will be presented at an upcoming scientific congress.

Notably, these results also come just over 2 years after Bayer cancelled their prior investigation of asundexian compared to apixaban, the OCEANIC-AF phase 3 study, in 2023. This trial was terminated on account of a lack of efficacy.

“We are excited by these positive topline findings, which highlight the potential of Factor Xia inhibition as a new way to help protect patients from a recurrent stroke,” Christian Rommel, PhD, head of research and development at Bayer’s Pharmaceuticals Division, said in a statement. “This marks an important milestone in Bayer’s longstanding commitment to advancing innovation in thrombosis prevention. We extend our sincere gratitude to the investigators, patients, and colleagues whose dedication made this milestone possible.”

Bayer. Bayer’s Asundexian Met Primary Efficacy and Safety Endpoints in Landmark Phase III OCEANIC-STROKE Study in Secondary Stroke Prevention. BusinessWire. November 23, 2025. Accessed November 24, 2025. 

https://www.businesswire.com/news/home/20251123638167/en/Bayers-Asundexian-Met-Primary-Efficacy-and-Safety-Endpoints-in-Landmark-Phase-III-OCEANIC-STROKE-Study-in-Secondary-Stroke-Prevention

Bristol Myers Squibb. Update on Phase 3 Librexia ACS Trial. November 14, 2025. Accessed November 24, 2025. 

https://news.bms.com/news/details/2025/Update-on-Phase-3-Librexia-ACS-Trial/default.aspx

Bayer. A Study to Test Asundexian for Preventing a Stroke Caused by a Clot in Participants After an Acute Ischemic Stroke or After a High-risk Transient Ischemic Attack, a So-called Mini Stroke (OCEANIC-STROKE). ClinicalTrials.gov Identifier: NCT05686070. Updated November 12, 2025. Accessed November 24, 2025. 

https://www.clinicaltrials.gov/study/NCT05686070

Bayer // Global. OCEANIC-AF study stopped early due to lack of efficacy. November 19, 2023. Accessed November 24, 2025. 

https://www.bayer.com/media/en-us/oceanic-af-study-stopped-early-due-to-lack-of-efficacy/

Articles

Asundexian, an investigational oral FXIa inhibitor, demonstrated efficacy in reducing ischemic stroke risk without increasing major bleeding in the phase 3 OCEANIC-STROKE study. Conducted across 741 locations, the trial included 12,327 patients with acute non-cardioembolic stroke or high-risk TIA. Asundexian showed significant risk reduction compared to placebo, marking a potential advancement in secondary stroke prevention. This success follows the termination of Bayer's previous OCEANIC-AF study due to lack of efficacy and the discontinuation of the Liberaxia program by Bristol Myers Squibb and Johnson & Johnson.

Bayer’s investigational FXIa inhibitor has proven its superiority to placebo in reducing ischemic stroke risk without increasing major bleeding rate.

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OCEANIC-STROKE: Asundexian Achieves Primary Efficacy Endpoint in Patients with Ischemic Stroke

Jason Hawkes, MD, MS, discusses recent advances in the management of chronic spontaneous urticaria, focusing on the transition to new targeted therapies.

Updates in Management of CSU

In this video series, Jason Hawkes, MD, MS, a board-certified dermatologist and associate professor of Dermatology at the University of California Davis, reviews significant therapeutic advancements in CSU management over the past five years. Hawkes describes a shift from initial discomfort with novel biologics, such as dupilumab and remibrutinib, toward greater comfort and routine use among dermatologists. He notes that the approval of remibrutinib and increased clinical trial activity have expanded treatment options, allowing dermatologists to offer targeted therapies that align with standard dermatological practice and mitigate earlier concerns, such as the anaphylaxis risk associated with omalizumab.

Hawkes details the recommended stepwise approach to antihistamine therapy, emphasizing that current guidelines support dose escalation up to fourfold as tolerated by the patient. He explains that, when patients exhibit nonresponsiveness at this level, clinicians should promptly consider biologics like omalizumab, dupilumab, or remibrutinib. About half of patients may not respond to maximal antihistamine doses, and further escalation beyond this, including combinations of antihistamines, is rarely effective. The "responsive versus nonresponsive" paradigm guides the decision to advance therapy.

Addressing the role of standardized disease activity metrics, Hawkes observes that tools such as ISS7, HSS7, UAS7, and the urticaria control test, while valuable in clinical trials, are not widely adopted in routine practice, particularly within dermatology. Instead, he recommends pragmatic patient-centered questions regarding the persistence of hives, itch, and the impact on daily activities, sleep, and quality of life. He underscores the importance of regular, direct assessments of symptom control to guide individualized treatment decisions for patients with CSU.

Updates in Management of CSU, With Jason Hawkes, MD, MS

 An Overview of Giant Cell Arteritis (GCA): Common Signs and Symptoms 

Can you provide a brief overview of giant cell arteritis (GCA), common presentations and symptoms?

How prevalent is GCA in the U.S. and globally, and what populations are commonly affected?

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Considerations for Treatment Selection in CSU, With Jason Hawkes, MD, MS

The Underlying Causes of GCA: Environmental and Genetic Factors

OCEANIC-STROKE: Asundexian Achieves Primary Efficacy Endpoint in Patients with Ischemic Stroke

Updates in Management of CSU, With Jason Hawkes, MD, MS

An Overview of Giant Cell Arteritis (GCA): Common Signs and Symptoms