Jason Hawkes, MD, MS

Identifying the Optimal CSU Patient Population for Remibrutinib

Jason Hawkes, MD, MS, a board-certified dermatologist and associate professor of Dermatology at the University of California Davis, notes that, unlike omalizumab, for which IgE levels may predict response, remibrutinib and dupilumab demonstrate efficacy irrespective of baseline IgE concentrations. This widens their applicability to both IgE-dependent and IgE-independent CSU populations, as well as those who have failed other therapies.

Despite these advances, Hawkes emphasizes the current lack of robust biomarkers or clinical predictors for individual response to BTK inhibitors and other novel agents in CSU. He stresses the ongoing need for further research to address this knowledge gap and optimize precision medicine approaches within the field.

Until more definitive markers are established, Hawkes encourages clinicians to focus primarily on reducing patient disease burden and improving quality of life, using available therapies judiciously and empirically while remaining alert for future evidence that could refine patient selection.

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Jason Hawkes, MD, MS, discusses emerging biomarkers and clinical characteristics that may help identify patients most likely to benefit from remibrutinib in CSU.



Role of Remibrutinib in Current Guideline-Based Care for CSU

Jason Hawkes, MD, MS, a board-certified dermatologist and associate professor of Dermatology at the University of California Davis, clarifies that recent and forthcoming CSU management guidelines now position remibrutinib alongside omalizumab and dupilumab as a reasonable next step for patients who do not respond to antihistamines, both at standard and escalated doses. This represents a move away from the historical paradigm in which omalizumab was the sole third-line agent.

He outlines that, while omalizumab has the most long-term safety and efficacy data, practical considerations—such as ease of use, patient preference, and specialist comfort—are shaping real-world utilization patterns. Dermatologists, in particular, may prefer newer targeted options that lack black box warnings and offer more flexibility compared to traditional immunosuppressants like methotrexate or cyclosporine.

The evolving guidelines thus provide clinicians with additional advanced therapy options and empower them to tailor treatments with an evidence-based but pragmatic approach, ultimately enhancing care and outcomes for patients with CSU.

Jason Hawkes, MD, MS, explains how updated treatment guidelines are incorporating remibrutinib as a key option for CSU after antihistamine failure.



Benefits of Oral BTKi Administration in CSU

Jason Hawkes, MD, MS, a board-certified dermatologist and associate professor of Dermatology at the University of California Davis outlines the mechanistic rationale for using oral BTK inhibitors, such as remibrutinib, in CSU. He notes remibrutinib’s selective inhibition of Bruton tyrosine kinase—central to mast cell activation—and its rapid, robust effect on both superficial and deep urticarial manifestations, including angioedema.

According to Hawkes, remibrutinib offers particular benefit to patients who have failed, are intolerant of, or are not candidates for antihistamines, omalizumab, or dupilumab. Its oral route confers convenience, making it well-suited for individuals already managing multiple medications or those averse to injectable therapies. Clinical improvements appear to be independent of baseline IgE levels, broadening its applicability across varied patient phenotypes.

Hawkes advises that the choice of remibrutinib can also be informed by unique patient characteristics, such as previous intolerance to other therapies, lifestyle considerations, and preference for oral versus injectable medications. He emphasizes that its rapid onset, broad efficacy, and safety profile support its integration into the therapeutic armamentarium for CSU.

Jason Hawkes, MD, MS details the clinical advantages and patient populations best suited for oral BTK inhibitor therapy, such as remibrutinib, in CSU.


Impact of Adherence on CSU Management

In this segment, Jason Hawkes, MD, MS, a board-certified dermatologist and associate professor of Dermatology at the University of California Davis, emphasizes that access to and affordability of therapies remain primary drivers in determining which treatments are initiated for CSU. If a prescribed therapy is not available or affordable, clinicians must pivot to accessible alternatives, sometimes relying on sample medications as a short-term bridge.

Hawkes addresses the nuances of adherence, noting that injectable therapies administered monthly may foster better compliance for some, while oral medications may be more easily integrated for patients with comorbidities or complex medication regimens. For CSU patients, the chronic nature of the disease means that stopping therapies often results in disease recurrence, underscoring the importance of sustainable long-term management strategies.

He further highlights the need for personalized treatment adaptation based on side effect profiles, tolerance, and patient efficacy experiences. The sequencing of therapies, including moving between classes, is thus a pragmatic response to the realities of patient experience and the healthcare system.

Jason Hawkes, MD, MS examines how adherence, patient expectations, and access barriers influence management and treatment sequencing in CSU.


Jason Hawkes, MD, MS

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