Bruton's Tyrosine Kinase Inhibitors for Chronic Spontaneous Urticaria: A Systematic Review and Meta-Analysis

Area of Science:

• Immunology
• Dermatology
• Pharmacology

Background:

• Second-generation H1 antihistamines are first-line for chronic spontaneous urticaria (CSU).
• A notable patient subset shows inadequate symptom control with current therapies.
• This underscores the need for novel, targeted treatments for refractory CSU.

Purpose of the Study:

• To systematically review and meta-analyze randomized controlled trials (RCTs).
• To compare the efficacy and safety of Bruton's tyrosine kinase (BTK) inhibitors versus placebo in CSU patients.
• To assess treatment outcomes at 4, 8, and 12 weeks.

Main Methods:

• Systematic review and meta-analysis of 5 RCTs.
• Searched PubMed, Embase, and CENTRAL databases up to April 2025.
• Assessed outcomes including Weekly Urticaria Activity Score (UAS7), complete symptom absence (UAS7=0), well-controlled CSU (UAS7≤6), and safety.

Main Results:

• BTK inhibitors significantly increased the likelihood of achieving UAS7=0 at weeks 4, 8, and 12 compared to placebo.
• Consistent significant improvements were observed for UAS7≤6 at weeks 4, 8, and 12.
• No significant differences in the incidence of adverse events or serious adverse events were found between BTK inhibitors and placebo.

Conclusions:

• BTK inhibitors represent a valuable treatment option for chronic spontaneous urticaria.
• They demonstrate significant efficacy, particularly for patients refractory to H1 antihistamines.
• The safety profile appears comparable to placebo, supporting their clinical utility.