ARRIVAL: a phase 3b study to assess potential for tezepelumab to reduce maintenance inhaled therapy and induce remission in patients with severe asthma

<bold>Background:</bold> Biologic therapy may allow patients with severe asthma to reduce or stop maintenance inhaled asthma therapies without loss of asthma control. <bold>Objective:</bold> ARRIVAL will assess the potential for patients receiving tezepelumab to reduce maintenance inhaled asthma therapy while maintaining asthma control and achieve remission. <bold>Methods:</bold> Approximately 300 patients with severe, uncontrolled asthma will receive tezepelumab 210 mg every 4 weeks for 72 weeks. At week 24, patients with no exacerbations, who achieve asthma control (Asthma Control Questionnaire [ACQ]-5 score <1.5) and/or low biomarkers with an ACQ-5 score ≤2, will be randomized 2:1 to either step-down or not step-down maintenance inhaled corticosteroids (ICS) until week 56 (<bold>Figure</bold>). All patients will maintain their ICS dose for weeks 56–72. <bold>Results:</bold> The primary endpoint is the proportion of patients randomized to step-down ICS who reduce their ICS dose while maintaining asthma control at week 56. Secondary endpoints include the proportions of patients who achieve asthma control and clinical remission at weeks 52 and 72 among those who demonstrated asthma control and characteristics of clinical remission at week 24. <bold>Conclusion:</bold> ARRIVAL will assess the potential of tezepelumab to enable withdrawal of maintenance ICS while maintaining asthma control in patients with severe, uncontrolled asthma. <fig><object-id>erj;64/suppl_68/PA3564/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig>