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We are pleased to announce that a review article entitled ‘Defining severe obstructive lung disease in the biologic era: an endotype-based approach’ has been published in the European Respiratory Journal.1
This article, authored by members of the NOVELTY Scientific Committee, reviews the evolving clinical definitions of severe asthma, severe COPD and “asthma–COPD overlap” (i.e. patients with features of both diseases).
The findings of this review support the rationale for initiating the NOVELTY study, by highlighting that existing clinical definitions of asthma and COPD do not reflect the known heterogeneity within these diagnoses, nor the potential for overlap between them. The authors discuss how these clinical definitions have influenced (and are influenced by) the design of randomised clinical trials that often have highly restrictive eligibility criteria, which limits their generalisability to patients in real-world clinical practice.
Currently, the mainstay therapy for severe stages of both asthma and COPD are oral corticosteroids, which have well-documented irreversible dose- and duration-dependent adverse effects. The review highlights evidence suggesting that molecularly targeted biologic therapies improve outcomes in subsets of patients with severe obstructive lung disease.
The authors call for investigators, companies and regulators to collaborate in a phenotype- and endotype-based approach to defining severe obstructive lung disease, in order to improve access to targeted medicines, including biologics, for patients who are most likely to benefit. As a large, observational study with very few enrolment restrictions, NOVELTY is an important step towards achieving these goals and providing real-world perspective on the characteristics and outcomes of patients with severe obstructive lung disease.