In the REMIX-1 and REMIX-2 trials, RHAPSIDO significantly improved hives, itch, disease activity and angioedema vs placebo in patients with CSU who remained symptomatic on antihistamines. The co-primary end points were absolute change from baseline in HSS7 and ISS7 at week 12.¹

Fast relief from hives¹

Significant reduction in HSS7 vs placebo at week 12: LS mean CFB -10.47 with RHAPSIDO vs -6.00 with placebo (P<.001) in REMIX-2. Similar results were observed in REMIX-1.^1–3,*

Results were observed as early as week 1 in a post hoc analysis and at week 52 in an exploratory analysis.^2,3,†

*Multiple imputation techniques were implemented for missing data.^1
†LIMITATIONS: No conclusions or comparisons can be drawn since post hoc or prespecified exploratory analyses were performed at week 1 and weeks 12 and 24, respectively. These analyses were not adjusted for multiplicity. Data after week 24 should be interpreted with caution due to the open-label design and absence of a control group. Week 52 data is a prespecified exploratory analysis and no statistical tests were done.^2,4

Improvements in HSS7 at week 12 were consistent regardless of patients' baseline total IgE level.¹

Fast relief from itch¹

Significant reduction in ISS7 vs placebo at week 12: LS mean CFB -8.95 with RHAPSIDO vs -5.72 with placebo (P<.001) in REMIX-2. Similar results were seen in REMIX-1.^1–3,*

Results were observed as early as week 1 in a post hoc analysis and at week 52 in an exploratory analysis.^2,3,†

*Multiple imputation techniques were implemented for missing data.^1
†LIMITATIONS: No conclusions or comparisons can be drawn since post hoc or prespecified exploratory analyses were performed at week 1 and weeks 12 and 24, respectively. These analyses were not adjusted for multiplicity. Data after week 24 should be interpreted with caution due to the open-label design and absence of a control group. Week 52 data is a prespecified exploratory analysis and no statistical tests were done.^2,4

Improvements in ISS7 at week 12 were consistent regardless of patients' baseline total IgE level.¹

RHAPSIDO is proven to deliver well-controlled CSU^1,4

Well-controlled CSU (UAS7 ≤6) at weeks 2 and 12 (secondary end points)^1,*

*Multiple imputation techniques were implemented for missing data.¹

Complete absence of hives and itch (UAS7=0)

At week 12 (secondary end point)^1,*

*Multiple imputation techniques were implemented for missing data.¹

Exploratory analysis at week 52 (observed data) in REMIX-2^2,†

^†LIMITATIONS: No conclusions or comparisons can be drawn. Data after week 24 should be interpreted with caution due to the open-label design and absence of a control group. Week 52 data is a prespecified exploratory analysis and no statistical tests were done.²

Disease activity results (UAS7)

Key secondary end point: significant reduction in UAS7 vs placebo at week 12 (LS mean CFB in REMIX-2: -19.41 with RHAPSIDO vs -11.73 with placebo; P<.001). Similar results were observed in REMIX-1.^1–3,*

*Multiple imputation techniques were implemented for missing data.^1
†LIMITATIONS: No conclusions or comparisons can be drawn since post-hoc or prespecified exploratory analyses were performed at week 1 and weeks 12 and 24, respectively. These analyses were not adjusted for multiplicity. Data after week 24 should be interpreted with caution due to the open-label design and absence of a control group. Week 52 data is a prespecified exploratory analysis and no statistical tests were done.^2,4

Cumulative number of angioedema-free weeks (AAS7=0) with RHAPSIDO²

In REMIX-2 at baseline:

Secondary end point LS mean: Cumulative, nonconsecutive, angioedema-free (AAS7=0) weeks vs placebo between baseline and week 12. Similar results were observed in REMIX-1.^2,3,*