Evidence map›Paper›PMID 40911497›Full record

SynthesisInternational archives of allergy and immunology2026

Safety and Efficacy of Remibrutinib for Chronic Spontaneous Urticaria: A Systematic Review and Meta-Analysis.

Muhammad Burhan, Saad Ashraf, Ahila Ali, Iqra Shahid, Jalib Ahmed, Muhammad Shahmeer Ullah Shah, Neha Bhagwan Das, Abdulqadir J Nashwan

Erratum issuedAbstract readSystematic ReviewMeta-Analysis
In one paragraph

Synthesis in International archives of allergy and immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Muhammad BurhanDepartment of Medicine, Dow University of Health Sciences, Karachi, Pakistan.
Saad AshrafDepartment of Medicine, Dow University of Health Sciences, Karachi, Pakistan.
Ahila AliDepartment of Medicine, Dow University of Health Sciences, Karachi, Pakistan.
Iqra ShahidDepartment of Medicine, King Edward Medical University, Lahore, Pakistan.
Jalib AhmedDepartment of Medicine, Dow University of Health Sciences, Karachi, Pakistan.
Muhammad Shahmeer Ullah ShahDepartment of Medicine, Dow University of Health Sciences, Karachi, Pakistan.
Neha Bhagwan DasDepartment of Medicine, Peoples University of Medical and Health Sciences for Women, Nawabshah, Pakistan.
Abdulqadir J NashwanNursing & Midwifery Research Department, Hamad Medical Corporation, Doha, Qatar, anashwan@hamad.qa.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionChronic spontaneous urticaria (CSU) is a burdensome condition marked by recurrent wheals and/or angioedema lasting over 6 weeks. Despite current treatments, many patients remain symptomatic. Remibrutinib, a selective Bruton's tyrosine kinase inhibitor, is a promising therapy targeting mast cell degranulation.

methodsA systematic review and meta-analysis following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines was conducted. PubMed, Cochrane CENTRAL, and Google Scholar were searched for randomized controlled trials (RCTs) comparing remibrutinib to placebo. The primary outcome was change in Urticaria Activity Score over 7 days (UAS7). Safety outcomes included adverse events (AEs) and serious adverse events (SAEs). Analyses were performed using Review Manager (RevMan 5.4).

resultsThree RCTs were included. Remibrutinib significantly reduced UAS7 scores compared to placebo (MD = -7.78, 95% confidence interval (CI): -10.24 to -5.32, p < 0.01) and improved disease control (RR = 2.16, 95% CI: 1.73-2.71, p < 0.00001) and absence of hives/itch (RR = 3.41, 95% CI: 2.32-5.03, p < 0.00001). No significant differences were found in overall AEs (RR = 1.05, p = 0.59) or SAEs (RR = 1.85, p = 0.37). However, infection risk was higher with remibrutinib, particularly for total infections (RR = 1.59, p < 0.00001) and upper respiratory infections (RR = 2.89, p = 0.009).

conclusionRemibrutinib significantly improves CSU symptoms and disease control. While generally safe, it may increase infection risk, notably upper respiratory tract infections. Further long-term studies are needed to confirm these findings.

Indexed as

Chronic UrticariaProtein Kinase InhibitorsPyrimidinesAgammaglobulinaemia Tyrosine KinaseChronic DiseaseHumansRandomized Controlled Trials as TopicTreatment OutcomeAgammaglobulinaemia Tyrosine KinaseProtein Kinase InhibitorsPyrimidinesremibrutinibBruton’s tyrosine kinase inhibitorChronic spontaneous urticariaMeta-analysisRemibrutinibUrticaria activity score

Identifiers

PMID40911497
PMCPMC13585416

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.