Adrenal function recovery after durable oral corticosteroid sparing with benralizumab in the PONENTE study.

BACKGROUND: Oral corticosteroid (OCS) dependence among patients with severe eosinophilic asthma can cause adverse outcomes, including adrenal insufficiency. PONENTE's OCS reduction phase showed that, following benralizumab initiation, 91.5% of patients eliminated corticosteroids or achieved a final dosage ≤5 mg·day-1 (median (range) 0.0 (0.0-40.0) mg). METHODS: The maintenance phase assessed the durability of corticosteroid reduction and further adrenal function recovery. For ∼6 months, patients continued benralizumab 30 mg every 8 weeks without corticosteroids or with the final dosage achieved during the reduction phase. Investigators could prescribe corticosteroids for asthma exacerbations or increase daily dosages for asthma control deteriorations. Outcomes included changes in daily OCS dosage, Asthma Control Questionnaire (ACQ)-6 and St George's Respiratory Questionnaire (SGRQ), as well as adrenal status, asthma exacerbations and adverse events. RESULTS: 598 patients entered PONENTE; 563 (94.1%) completed the reduction phase and entered the maintenance phase. From the end of reduction to the end of maintenance, the median (range) OCS dosage was unchanged (0.0 (0.0-40.0) mg), 3.2% (n=18/563) of patients experienced daily dosage increases, the mean ACQ-6 score decreased from 1.26 to 1.18 and 84.5% (n=476/563) of patients were exacerbation free. The mean SGRQ improvement (-19.65 points) from baseline to the end of maintenance indicated substantial quality-of-life improvements. Of patients entering the maintenance phase with adrenal insufficiency, 32.4% (n=104/321) demonstrated an improvement in adrenal function. Adverse events were consistent with previous reports. CONCLUSIONS: Most patients successfully maintained maximal OCS reduction while achieving improved asthma control with few exacerbations and maintaining or recovering adrenal function.

Characterizing Real-World Use Of Tiotropium In Asthma In The USA.

BACKGROUND: Tiotropium bromide (TIO) is a long-acting muscarinic antagonist recommended as an add-on therapy option for patients with uncontrolled asthma on inhaled corticosteroids (ICS) and long-acting ß2-agonists (LABA). However, real-world data on TIO use in asthma remains limited. To identify unmet needs, this study explored the use of TIO in US patients with asthma. METHODS: This retrospective cohort study used IQVIATM Health Plan Claims Data (October 1, 2014─December 31, 2016). Patients with asthma diagnoses initiating TIO 1.25 or 2.5 mcg after September 16, 2015 (first dispensing on index date) with ≥6 and ≥3 months continuous enrollment pre- and post-index, respectively, were identified. Patients with COPD diagnoses were excluded. Baseline characteristics, healthcare resource utilization and costs, and treatment patterns before and following TIO initiation were described for TIO cohorts and subgroups classified by concomitant medications received during the 30-day period after initiation. RESULTS: The study included 766 TIO 1.25 mcg and 1055 TIO 2.5 mcg users. In the TIO 1.25 mcg cohort, 16% (126/766) used TIO monotherapy while 61% (465/766) used TIO+ICS/LABA± leukotriene receptor antagonists (triple therapy). In TIO 1.25 mcg monotherapy and triple therapy subgroups, 39% and 49% were treated by allergists/pulmonologists, 27% and 48% experienced a moderate/severe asthma exacerbation, and 50% and 68% used rescue oral corticosteroids during the baseline period, respectively. Following triple therapy initiation, 44% of patients discontinued ICS within 6 months. The TIO 2.5 mcg cohort demonstrated similar trends. CONCLUSION: This study provided insights into real-world US use of TIO in asthma. Overall, 16-19% of patients received TIO monotherapy and had high baseline exacerbation rates, suggesting that additional ICS-containing medication may be beneficial. Patients initiating triple therapy were among the most severe, with high baseline exacerbation rates and rescue medication use, and had high post-treatment ICS discontinuation rates, suggesting unmet needs in this population.