The journal of allergy and clinical immunology. Global · 2026
Matching-adjusted indirect comparison analysis of omalizumab versus dupilumab in patients with chronic spontaneous urticaria.
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Mosnaim Giselle, Seetasith Arpamas, Holden Michael, Trzaskoma Benjamin L, Saini Sarbjit S
Аннотация
BACKGROUND: 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.
OBJECTIVE: To overcome this limitation, we used matching-adjusted indirect comparison to assess the efficacy of omalizumab versus dupilumab in primary phase 3 trials.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: Despite limitations, our matching-adjusted indirect comparison analysis highlights that omalizumab is an effective treatment option for appropriate patients with chronic spontaneous urticaria.
OBJECTIVE: To overcome this limitation, we used matching-adjusted indirect comparison to assess the efficacy of omalizumab versus dupilumab in primary phase 3 trials.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: Despite limitations, our matching-adjusted indirect comparison analysis highlights that omalizumab is an effective treatment option for appropriate patients with chronic spontaneous urticaria.