Patient-reported outcomes
Patient portrayal.
Observed sleep interference scores over 7 days
Exploratory end point: Reduction in SIS7 over time in REMIX-21,*
Similar results were seen in REMIX-1.
*No conclusions about sleep interference should be drawn as this is a prespecified exploratory analysis and no statistical tests were done. This analysis was 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. Patient-reported outcomes are subject to recall bias and do not account for the spontaneous nature of CSU.1,2
Observed activity interference scores over 7 days
Exploratory end point: Reduction in AIS7 over time in REMIX-21,*
Similar results were seen in REMIX-1.
*No conclusions about activity interference should be drawn as this is a prespecified exploratory analysis and no statistical tests were done. This analysis was 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. Patient-reported outcomes are subject to recall bias and do not account for the spontaneous nature of CSU.1,2