Severe Asthma Biologic Selection

Use the ERS/ATS severe-asthma construct: asthma requiring high-dose inhaled corticosteroid (ICS) plus a second controller and/or systemic corticosteroids to prevent loss of control, or asthma remaining uncontrolled despite that treatment. Confirm the asthma diagnosis before applying this label, and reassess relevant comorbidities before escalating to a biologic. BMJ+1BMJCharacterisation of patients with severe asthma in the UK Severe Asthma Registry in the biologic eraPubMedInternational ERS/ATS guidelines on definition, evaluation and treatment of severe asthma - PubMed

Document current controller dispensing and observed inhaler technique before referral or authorization. In a U.S. claims analysis of patients escalated to biologics, 63% had suboptimal maintenance-medication adherence, defined as proportion of days covered below 80%; a biologic should not substitute for correcting avoidable underexposure to ICS-based therapy. ScienceDirectScienceDirectAssessment of Real-World Escalation to Biologics in US Patients With Asthma - ScienceDirect

Use a structured difficult-asthma assessment when control remains poor. Specialist review that includes diagnostic reassessment, treatment optimization, adherence and inhaler-technique intervention, and self-management education has been associated with improved control, lung function, exacerbation outcomes, and reduced oral corticosteroid burden. ScienceDirectScienceDirectSystematic Assessment for Difficult and Severe Asthma Improves Outcomes and Halves Oral Corticosteroid Burden Independent of Monoclonal Biologic Use - ScienceDirect

For a patient with confirmed severe asthma and persistent exacerbations despite optimized inhaled therapy, obtain blood eosinophils, FeNO, total serum IgE, and aeroallergen sensitization by skin-prick testing or allergen-specific IgE. Blood eosinophils, FeNO, and total IgE are the principal biomarkers used in clinical phenotyping for type 2-high and type 2-low asthma. Wolters Kluwer+1Wolters KluwerEligibility of C-BIOPRED severe asthma cohort for... : Chinese Medical JournalScienceDirectPhenotyping of Severe Asthma in the Era of Broad-Acting Anti ...

Interpret blood eosinophils and FeNO in the context of ongoing corticosteroid treatment. Blood eosinophils of at least 150 cells/μL and FeNO of at least 20 ppb despite treatment indicate residual type 2 inflammation; higher eosinophils and FeNO predict greater expected response to dupilumab. Wolters Kluwer+1Wolters KluwerCharacteristics, phenotypes, mechanisms and... : Chinese Medical JournalScienceDirectGuidance for type 2 inflammatory biomarkers - ScienceDirect.com

If eosinophilic and allergic signals coexist, do not infer that one class is universally superior. Patients may meet eligibility criteria for both anti-IgE and anti-IL-5/IL-5R treatment, while direct comparative evidence is limited and an indirect comparison found no difference in comparative effectiveness or tolerability between anti-IL-5 and anti-IgE therapy in overlapping eligible populations. catalogues ema europa eucatalogues ema europa eu[PDF] The comparative effectiveness across severe asthma biologic ...

Choose anti-IgE therapy when allergic sensitization is unequivocal and the patient's total IgE and body weight fit the dosing framework. Omalizumab is the established anti-IgE option; its selection depends on allergic phenotype rather than blood eosinophil count alone. Wolters Kluwer+1Wolters KluwerEligibility of C-BIOPRED severe asthma cohort for... : Chinese Medical JournalPubMedTable 4, Summary of Drug Plan Input and Clinical Expert Response - Tezepelumab (Tezspire) - NCBI Bookshelf

Choose an IL-5-pathway strategy when recurrent exacerbations occur in eosinophilic asthma. Mepolizumab and benralizumab are identified for severe eosinophilic asthma, and reslizumab is another anti-IL-5 option. A blood eosinophil count meeting the applicable threshold supports this branch, but the decision should remain anchored to prior exacerbations despite optimized standard therapy. Wolters Kluwer+2Wolters KluwerCharacteristics, phenotypes, mechanisms and... : Chinese Medical JournalWolters KluwerEligibility of C-BIOPRED severe asthma cohort for... : Chinese Medical JournalPubMedTable 4, Summary of Drug Plan Input and Clinical Expert Response - Tezepelumab (Tezspire) - NCBI Bookshelf

Choose dupilumab when type 2 biology is signaled by eosinophils of at least 150 cells/μL or FeNO of at least 25 ppb in a patient with prior-year exacerbations, or when maintenance oral corticosteroid dependence is the dominant problem. Elevated eosinophils and FeNO are associated with greater expected response, whereas ERS/ATS guidance permits use in corticosteroid-dependent severe asthma regardless of eosinophil count. Wolters Kluwer+1Wolters KluwerCharacteristics, phenotypes, mechanisms and... : Chinese Medical JournalWolters KluwerEligibility of C-BIOPRED severe asthma cohort for... : Chinese Medical Journal

For patients eligible for several agents, select the therapy most likely to address the dominant asthma trait and relevant type 2 comorbidities, while incorporating dosing burden, prior response, and patient preference. There are no robust head-to-head comparative trials sufficient to establish a universal rank order among biologics. Wolters Kluwer+1Wolters KluwerBiologic Management in Severe Asthma for Adults : Chestcatalogues ema europa eu[PDF] The comparative effectiveness across severe asthma biologic ...

At each follow-up, quantify exacerbations requiring systemic corticosteroids, emergency or hospital care, maintenance oral corticosteroid exposure, symptom control using ACT or ACQ, lung function, and treatment adherence. These outcomes align with the goals of biologic treatment: fewer exacerbations and hospitalizations, improved disease control, and lower corticosteroid burden. catalogues ema europa eu+2catalogues ema europa eu[PDF] PROTOCOL CHECKLIST - HMA-EMA CataloguesPubMedEfficacy of azithromycin in severe asthma from the AMAZES randomised trial - PMCPubMedSwitching to twice-yearly depemokimab from mepolizumab/benralizumab in severe asthma: a multicenter, randomized, double-blind, phase 3A clinical trial (NIMBLE)

If maintenance oral corticosteroids are being used, make reduction of systemic corticosteroid burden an explicit outcome. Biologics are commonly initiated in severe uncontrolled asthma to replace or reduce oral corticosteroids, but withdrawal should be guided by sustained asthma control and monitored for deterioration. PubMedPubMedSafety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database

If the selected biologic does not produce meaningful improvement in the patient's dominant baseline problem, repeat the systematic assessment before changing class: verify asthma diagnosis, adherence, inhaler technique, exacerbation attribution, and current biomarker pattern. If persistent severe asthma is confirmed, switch to a different biologic monotherapy rather than empirically adding a second asthma biologic. ScienceDirect+2ScienceDirectSystematic Assessment for Difficult and Severe Asthma Improves Outcomes and Halves Oral Corticosteroid Burden Independent of Monoclonal Biologic Use - ScienceDirectPubMedTable 4, Summary of Drug Plan Input and Clinical Expert Response - Tezepelumab (Tezspire) - NCBI BookshelfPubMedCombination of Biological Therapy in Severe Asthma: Where We Are?