Rationale: Three patient-reported outcomes (PRO) instruments were compared to assess if they are equally informative in assessing symptoms and health-related quality of life (HRQoL) in CSU/CIU: UAS7 (measuring weekly pruritus scores and number of hives), DLQI (dermatologic HRQoL), and CU-Q2oL (urticaria-specific HRQoL).
Methods: Data were obtained from 3 phase III clinical trials investigating the effects of omalizumab for patients with refractory CSU/CIU. PRO data were collected at baseline, Weeks 4, 12, 24, and 40 (ASTERIA I and GLACIAL), and baseline, Weeks 4, 12, and 28 (ASTERIA II). Data were analyzed using latent growth models (LGMs), irrespective of treatment. For each trial, correlations between changes in UAS7 and the other PROs were examined to investigate how closely changes in symptoms are associated with changes in HRQoL.
Results: In all the 3 trials, mean baseline UAS7 score was 30 out of 42, corresponding to a large effect on patient’s dermatologic HRQoL (DLQI mean score=12 out of 30) and above-median urticaria-specific HRQoL (CU-Q2oL median score=43 out of 100). Over the course of each trial, changes in symptom and HRQoL scores were 4–15 scale points, depending on PRO. LGMs found that changes in symptoms and HRQoL were highly correlated: 0.88, 0.85 and 0.88 (for each trial, respectively) between DLQI and UAS7; 0.94, 0.93 and 0.90 (for each trial, respectively) between CU-Q2oL and UAS7.
Conclusion: Collecting HRQoL information in-clinic can provide indication of symptom scores evolution. Results suggest that clinicians have a choice of PRO instruments for assessing patient burden and response to treatment.
