Omalizumab and remibrutinib demonstrated similar early disease activity improvements in chronic spontaneous urticaria during an indirect analysis presented on Thursday at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting in Phoenix, Arizona.
At week 1, 6% of patients receiving omalizumab achieved a response, defined as a weekly urticaria activity score of 6 or less, versus 2% receiving placebo, HCPLive reported. No patients in either group achieved a complete response with a score of zero. By week 2, response rates climbed to 39% with omalizumab compared with 6% for placebo, while complete response rates reached 13% versus 3%.
To evaluate these timelines against emerging options, investigators utilized published data from the pooled phase 3 REMIX-1 and REMIX-2 trials of remibrutinib, which included 613 active-treatment participants and 312 placebo controls. They compared placebo-adjusted differences in mean daily urticaria activity scores between the two agents using unmatched comparisons and two-sample t tests.
Baseline characteristics remained broadly balanced across the evaluated trials. The mean weekly urticaria activity score measured 30.4 in the omalizumab arm, compared with 30.6 and 30.2 in the respective remibrutinib arms of the REMIX trials. Meanwhile, mean Dermatology Life Quality Index scores ranged between 12.9 and 14.2 across all study arms.
Demographic distribution showed some variance, as female patients accounted for 76.9% of the omalizumab cohort. In contrast, female representation stood at 67.7% and 65.7% across the remibrutinib trial arms.
Placebo-adjusted improvements in mean daily scores showed no statistically significant divergence between omalizumab and remibrutinib. Researchers recorded p-values of .52 at day 2, .39 at day 7, and .15 at day 14.
“By post hoc indirect comparison, improvements in disease activity appeared to be similar for omalizumab vs remibrutinib during the first 14 days post treatment initiation, highlighting that omalizumab remains an effective treatment option for patients with CSU,” Joshi and colleagues wrote, according to HCPLive.
| Treatment Arm | Sample Size (N) | Baseline Activity Score | Week 2 Response Rate (Score ≤ 6) | Week 2 Complete Response (Score = 0) |
|---|---|---|---|---|
| Omalizumab (300 mg) | Not Reported | 30.4 | 39% | 13% |
| Placebo (Omalizumab Trials) | Not Reported | Not Reported | 6% | 3% |
| Remibrutinib (REMIX-1 / REMIX-2) | 613 | 30.2 – 30.6 | Not Reported | Not Reported |
| Placebo (REMIX Trials) | 312 | Not Reported | Not Reported | Not Reported |
The analysis relied on post hoc, unadjusted cross-trial comparisons that drew on clinical trials conducted approximately a decade apart. Investigators did not perform statistical adjustments to account for subtle population differences between the historical omalizumab cohorts and the modern remibrutinib study populations. Safety profiles for both drug programs were published previously and were omitted from this reanalysis.
Funding for the study came from Genentech, the corporate entity that markets omalizumab. Three of the six study authors are employees of Genentech, a factor that introduces industry ties into the evaluation of comparative efficacy.
No head-to-head clinical trial has directly compared omalizumab and remibrutinib in real time.
- Joshi S, Burg C, Iqbal A, et al. Early improvement in disease activity with omalizumab vs remibrutinib in patients with chronic spontaneous urticaria. Poster 8059. Presented at: American College of Allergy, Asthma & Immunology 2026 Annual Scientific Meeting; November 12-16, 2026; Phoenix, AZ.
- Metz M, Giménez-Arnau A, Hide M, et al. Remibrutinib in chronic spontaneous urticaria. N Engl J Med. 2025;392:984-994.
- Maurer M, Rosén K, Hsieh HJ, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med. 2013;368:924-935.
- Kaplan A, Ferrer M, Bernstein JA, et al. Timing and duration of omalizumab response in patients with chronic idiopathic/spontaneous urticaria. J Allergy Clin Immunol. 2016;137:474-481.
Disclaimer: This article is intended for informational and educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult a qualified physician regarding any questions about a medical condition or therapeutic regimen.
