Long-term omalizumab outcomes in chronic idiopathic urticaria: a real-world study.

Background: Although clinical trials documented omalizumab's efficacy in U.S. patients with chronic idiopathic urticaria (CIU), the real-world evidence on its long-term effectiveness is lacking. Objective: To assess omalizumab use and the long-term response in a large sample of U.S. real-world patients. Methods: Patients with CIU and ≥ 12 years old who were initiated on omalizumab (index date) and with ≥ 6 months of postindex data were identified in an electronic medical record system (2007-2018). Omalizumab use was described. Provider assessments of disease control and course, and patient-reported symptoms were compared at 6-month intervals postindex versus baseline in the patients with values available at both time points. Results: A total of 1096 patients (mean age, 44.1 years; 74.7% women) were followed up for a mean of 19 months postindex. Patients, predominantly initiated on a 300-mg dose, received a mean of 15 omalizumab administrations and were treated continuously for a mean of 14.2 months. At 6 months postindex versus baseline, the patients (n = 708) were more likely to be well controlled (odds ratio [OR] 31.68 [95% confidence interval {CI}, 17.20-58.36]) with an improved disease course (OR 15.73 [95% CI, 11.33-21.85]). Moreover, the patients (n = 373) were less likely to report itching (OR 0.39 [95% CI, 0.21-0.76]), rash (OR 0.59 [95% CI, 0.45-0.78]), and swelling (OR 0.46 [95% CI, 0.36-0.59]). Benefits associated with omalizumab treatment were sustained through month 24 and beyond. Conclusion: This real-world study showed that the patients who received a mean of 15 omalizumab administrations over a mean of 14.2 months experienced, starting at 6 and through 24 months after omalizumab initiation and beyond, improved CIU control, course, and symptoms.

The economic burden of psoriasis with high comorbidity among privately insured patients in the United States.

OBJECTIVE: To evaluate the impact of comorbidities on healthcare resource use (HRU), and direct and indirect work-loss-related costs in psoriasis patients. METHODS: Adults with psoriasis (≥2 diagnoses, the first designated as the index date) and non-psoriasis controls (no psoriasis diagnoses, randomly generated index date) were identified in a US healthcare claims database of privately-insured patients (data between January 2010 and March 2017 were used). Psoriasis patients were stratified based on the number of psoriasis-related comorbidities (0, 1-2, or ≥3) developed during the 12 months post-index. All outcomes were evaluated during the follow-up period, spanning the index date until the end of continuous health plan eligibility or data cut-off. HRU and costs per-patient-per-year (PPPY) were compared in psoriasis and non-psoriasis patients with ≥12 months of follow-up. RESULTS: A total of 9,078 psoriasis (mean age = 44 years, 51% female) and 48,704 non-psoriasis (mean age = 41 years, 50% female) patients were selected. During the 12 months post-index, among psoriasis vs non-psoriasis patients, 71.0% vs 83.0% developed no psoriasis-related comorbidities, 26.3% vs 16.0% developed 1-2, and 2.6% vs 1.0% developed ≥3 psoriasis-related comorbidities. Compared to non-psoriasis patients, psoriasis patients had more HRU including outpatient visits (incidence rate ratios [IRRs] = 1.52, 2.03, and 2.66 for 0, 1-2, and ≥3 comorbidities, respectively [all p < 0.01]) and emergency room visits (IRRs = 1.12, 1.59, and 2.45 for 0, 1-2, and ≥3 comorbidities, respectively [all p < 0.01]) during the follow-up period. Psoriasis patients incurred greater total healthcare costs (mean cost differences [MCDs] = $1,590, $5,870, and $18,427, in patients with 0, 1-2, and ≥3 comorbidities, respectively [all p < 0.01]), and work-loss-related costs (MCDs = $335, $655, and $1,695, in patients with 0, 1-2, and ≥3 comorbidities, respectively [all p < 0.01]). CONCLUSIONS: HRU and cost burden of psoriasis are substantial, and increase with the development of psoriasis-related comorbidities.