Shyam Joshi, MD 

Anticipated Role of New Therapies in CSU Guidelines, Management

With the imminent update to chronic spontaneous urticaria (CSU) management guidelines, multiple newly approved therapies are anticipated to be positioned alongside existing options for patients with antihistamine-refractory disease. Shyam Joshi, MD, assistant professor of medicine in the Section of Allergy and Clinical Immunology at Oregon Health & Science University (OHSU) School of Medicine, discusses how previous guidelines, could give way to an evidence-based framework embraces shared decision-making based on patient preference, presentation, and comorbidities. Recent meta-analyses and clinical trial data indicate that both omalizumab and remibrutinib demonstrate the most favorable balance of efficacy and safety among the available agents.

The introduction of these new agents is expected to significantly enhance individualized care. With options spanning multiple mechanisms and modes of administration, clinicians will be able to tailor therapy based on patient-specific factors and clinical context. Remibrutinib, in particular, stands out for its oral route, rapid onset of action, and robust efficacy, supporting its use as either an early post-antihistamine option or as an alternative for patients for whom injectable biologics are contraindicated or unacceptable.

Joshi anticipates that the evolving treatment landscape will reshape CSU management over the next several years, mirroring advances observed in other atopic and inflammatory conditions. The ability to offer multiple safe and effective therapies will better address the diverse needs and preferences of CSU patients, foster more productive patient-provider discussions, and improve overall disease outcomes as future guidelines are adopted.

Videos

Shyam Joshi explores the expected incorporation of new therapies within updated CSU guidelines and their anticipated impact on clinical management strategies.


Updates in Remibrutinib from ACAAI 2025

Recent presentations at the American College of Allergy, Asthma & Immunology (ACAAI) 2025 and European Academy of Dermatology and Venereology provided additional insights into the clinical and immunologic effects of remibrutinib in chronic spontaneous urticaria (CSU). In this video Shyam Joshi, MD, assistant professor of medicine in the Section of Allergy and Clinical Immunology at Oregon Health & Science University (OHSU) School of Medicine, breaks down Data demonstrating remibrutinib’s efficacy and safety across both major CSU subtypes—autoallergic (type I) and autoimmune (type IIb).

Analysis of the REMIX trials and additional substudies highlighted remibrutinib’s robust efficacy in patients previously unresponsive to omalizumab, the first FDA-approved biologic for CSU. Even among those who were refractory to this established treatment, remibrutinib achieved high response rates, supporting its utility as a second-line or rescue therapy in difficult-to-treat populations. This finding is of particular clinical significance, given the historical reliance on immunosuppressive agents for patients who failed standard therapies.

The breadth and quality of evidence presented at ACAAI 2025 solidify remibrutinib’s standing as a versatile agent within the CSU therapeutic armamentarium, with its oral administration, rapid onset of action, effective disease modification, and broad applicability positioning it as an integral component of individualized, guideline-driven CSU management. Ongoing updates to clinical practice recommendations are anticipated to further define remibrutinib’s role in routine care.

Shyam Joshi, MD, reviews clinical and mechanistic data on remibrutinib in chronic spontaneous urticaria, as presented at ACAAI 2025 and EADV 2025.


Potential Advantages of Oral BTKi in CSU Management

The oral administration of Bruton tyrosine kinase inhibitors (BTKi) such as remibrutinib confers several advantages over injectable therapies in the treatment of chronic spontaneous urticaria (CSU). For many patients, oral therapy aligns with preferences for convenience, ease of use, and avoidance of injection-site complications. Remibrutinib's efficacy, established in phase 3 trials, offers a non-invasive alternative without compromising clinical effectiveness or safety.

Patient autonomy in selecting therapy is increasingly recognized as central to shared decision-making in chronic disease management. Shyam Joshi, MD, assistant professor of medicine in the Section of Allergy and Clinical Immunology at Oregon Health & Science University (OHSU) School of Medicine, emphasizes that many individuals with CSU prioritize not only therapeutic benefit and safety but also the practical considerations of daily administration. When clinical efficacy and safety profiles are comparable, the oral route may improve adherence and facilitate rapid symptom control, contributing to improved patient satisfaction.

Importantly, the expansion of approved therapies for CSU—from a single injectable agent to multiple options, including oral BTK inhibitors—enhances clinicians' ability to tailor management strategies to individual patient circumstances. This broadened therapeutic landscape allows for more nuanced discussions addressing each patient’s unique treatment goals, comorbidities, and lifestyle requirements, optimizing outcomes in CSU care.

Shyam Joshi, MD, highlights the practical and patient-centered advantages of oral BTK inhibitors in the management of chronic spontaneous urticaria.


Remibrutinib Onset of Action and Safety Profile

New data on remibrutinib demonstrates the agent’s rapid onset of action in patients with chronic spontaneous urticaria (CSU). Shyam Joshi, MD, assistant professor of medicine in the Section of Allergy and Clinical Immunology at Oregon Health & Science University (OHSU) School of Medicine, discussesdiscusses data from phase 3 REMIX trials revealed that significant improvements in symptom control were observed as early as one to two weeks following initiation of therapy. This early efficacy distinguishes remibrutinib from established biologic therapies, such as omalizumab and dupilumab, which typically require longer durations to achieve comparable clinical endpoints.

The rapid mitigation of pruritus and hive activity provides clinically meaningful relief for patients who often experience prolonged morbidity prior to effective management. Early symptom resolution can improve sleep quality, daily functioning, and overall quality of life for individuals with CSU. For clinicians, the potential to offer immediate improvement is a significant advancement, particularly for those patients suffering with delayed diagnosis and limited success on previous therapies.

The most notable side effect in clinical trials was the occurrence of mild petechiae, which generally resolved without intervention and did not necessitate discontinuation of therapy. Importantly, incidence rates for infection, changes in immunoglobulin levels, and alterations in B cell function were comparable between remibrutinib and placebo groups. These data provide clinicians with confidence in prescribing remibrutinib as a safe and efficacious option within the CSU treatment landscape.

Shyam Joshi, MD, discusses the rapid onset of action and favorable safety profile of remibrutinib, distinguishing it among therapies for CSU.

Shyam Joshi, MD

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