# Matching-adjusted indirect comparison analysis of omalizumab versus dupilumab in patients with chronic spontaneous urticaria

## TL;DR

This study compares omalizumab and dupilumab for chronic urticaria using indirect analysis, finding omalizumab more effective in reducing symptoms.

## Contribution

The study introduces a matching-adjusted indirect comparison to evaluate efficacy between omalizumab and dupilumab in chronic spontaneous urticaria.

## Key findings

- Omalizumab showed statistically significant improvements in UAS7 and ISS7 compared to dupilumab.
- Omalizumab's change from baseline in UAS7 and ISS7 was greater than dupilumab's.
- The analysis supports omalizumab as an effective treatment for chronic spontaneous urticaria.

## Abstract

Omalizumab is a well-established treatment for patients with chronic spontaneous urticaria, and dupilumab is a newly approved treatment. However, the lack of head-to-head randomized trials makes it challenging to compare treatment outcomes between omalizumab and dupilumab.

To overcome this limitation, we used matching-adjusted indirect comparison to assess the efficacy of omalizumab versus dupilumab in primary phase 3 trials.

Pooled patient-level data from the omalizumab ASTERIA I/II trials (NCT01287117/01292473) were compared with published aggregate data from the dupilumab LIBERTY-CSU CUPID Study A trial (NCT04180488). Populations were matched using the distribution of baseline weekly urticaria activity score (UAS7) in LIBERTY. Efficacy outcomes (UAS7; itch severity score [ISS7]) were then recalculated for the ASTERIA I/II trials using the matched cohorts. Least squares mean differences between treatments were determined by 2-sample t test. ClinicalTrials.gov identifiers: NCT01287117, 01292473, 04180488.

Improvements in both disease activity and itch severity were statistically significantly greater for omalizumab versus dupilumab (least squares mean [95% confidence interval] difference: UAS7, −7.6 [−13.0, −2.2], P = .006; ISS7, −3.0 [−5.8, −0.3], P = .031). Change from baseline in UAS7 at week 12 for omalizumab versus placebo was −12.6 (−15.7, −9.5) and for dupilumab versus placebo was −5.0 (−9.3, −0.7). Change from baseline in ISS7 at week 12 for omalizumab versus placebo was −5.4 (−6.9, −4.0) and for dupilumab versus placebo was −2.4 (−4.6, −0.1)

Despite limitations, our matching-adjusted indirect comparison analysis highlights that omalizumab is an effective treatment option for appropriate patients with chronic spontaneous urticaria.