Step-DAWN: an Italian algorithm proposed for the management of inhaled corticosteroids in severe asthma

Purpose of research: Biologics have transformed the management of severe asthma, establishing clinical remission as a realistic treatment objective. Moreover, they offer the potential to reduce background treatment with inhaled corticosteroids (ICS). Although guidelines recommend ICS dose reduction in patients achieving disease control, they provide limited guidance on how to implement tapering. In this context, we developed Step-DAWN (De-escalation of ICS in Asthma With a Novel algorithm), a consensus-based protocol that guides ICS tapering in adults with severe asthma receiving biologic therapy. Methods: Step-DAWN was ideated through a modified Delphi process; a Steering Committee consisting of two Italian specialists and two pharmaceutical Medical Affairs professionals drafted 30 statements, which were voted by an Expert Panel comprising 12 specialists. Results: Consensus was reached on 21 of 30 statements in the first round; three other statements reached consensus in the second round; six statements did not reach consensus. The Step-DAWN protocol was designed based on 24 statements that achieved consensus. Patients eligible to Step-DAWN should have maintained the four criteria of complete clinical remission (cCR) for at least 6 months. ICS dose should be reduced gradually, with follow-up assessments not exceeding 6 months. In case of loss of eligibility criteria, potential causes should be addressed before reattempting tapering. Fractional exhaled nitric oxide (FeNO) and blood eosinophil count (BEC) were identified as key biomarkers for monitoring airway inflammation. Conclusion: Step-DAWN is the first consensus-based protocol designed by Italian specialists to provide guidance for ICS tapering in patients with severe asthma treated with biologics.