Quality of Life: The Pending Outcome in Idiopathic Pulmonary Fibrosis

ABSTRACT

Recent real-world evidence on idiopathic pulmonary fibrosis (IPF) has provided important insights into survival and disease progression; however, critical patient-centered outcomes remain insufficiently addressed. The article “Real-World Data on the Course of Idiopathic Pulmonary Fibrosis,” published in an October 2024 supplement to The American Journal of Managed Care, highlights this limitation by focusing predominantly on objective clinical parameters while lacking systematic evaluation of health-related quality of life (HRQOL). This gap is particularly relevant given limited evidence on how antifibrotic therapies affect symptoms, pulmonary function, and psychosocial well-being beyond radiologic progression.

QOL is especially relevant in resource-limited settings, where demonstrating benefits in symptom control and functional status may influence therapeutic decisions, coverage policies, and resource allocation. Although international clinical practice guidelines, including those of the American Thoracic Society and the European Respiratory Society, recognize QOL as a key domain in IPF management, they also acknowledge the paucity of evidence addressing psychosocial and functional outcomes. Notably, major clinical trials such as INPULSIS and ASCEND, while demonstrating efficacy in slowing forced vital capacity decline, did not incorporate HRQOL as a primary outcome.

Recent guideline updates propose a conceptual framework integrating validated measures of symptoms, pulmonary function, and psychosocial impact. However, these dimensions have not yet been systematically embedded in clinical research. Reanalysis of existing data and future studies using this framework are warranted. A comprehensive evaluation of quality of life is therefore a clinical and ethical imperative for advancing patient-centered and holistic care in IPF.

Am J Manag Care. 2026;32(2):In Press

Takeaway Points

Evaluating quality of life (QOL) in patients with idiopathic pulmonary fibrosis (IPF) goes beyond lung function numbers. It also shows how treatments affect daily well-being and guides funding, coverage, and care policies.

• Demonstrating symptom relief and improved daily functioning supports reimbursement decisions for costly antifibrotic drugs.
• Health-related QOL metrics inform resource allocation and health care budgeting in constrained settings.
• Aligning trials with patient-reported outcomes enhances the relevance of clinical guidelines for corporate benefit managers.
• Combining physiological and QOL end points drives more holistic IPF care strategies.

The article “Real-World Data on the Course of Idiopathic Pulmonary Fibrosis,” published in an October 2024 supplement to The American Journal of Managed Care, provides valuable information on the clinical course of idiopathic pulmonary fibrosis (IPF) in real-world practice, focusing predominantly on survival parameters and disease progression.¹ However, its analysis reveals a critical gap in knowledge: The systematic evaluation of health-related quality of life (HRQOL) is lacking. This issue is particularly significant because there is a notable lack of evidence on how antifibrotic therapies influence clinically relevant patient-centered dimensions—such as symptom control, lung function, and psychosocial well-being—beyond the radiological progression of the disease.

QOL assumes special relevance in resource-limited settings, where evidence that antifibrotic therapies not only alter objective progression parameters but also directly impact pulmonary function and patient symptom control could be crucial in supporting therapeutic and coverage decisions in health care policy, practice, and decision-making.

Worldwide, clinical practice guidelines such as those of the American Thoracic Society (ATS) recognize QOL as an important directive, which requires more current evidence on the impact of antifibrotic therapies on psychosocial and functional outcomes, highlighting a critical evidence gap.²

However, although most IPF clinical trials, including INPULSIS (NCT01335464 and NCT01335477) and ASCEND (NCT01366209), demonstrated agents’ efficacy in slowing the decline in forced vital capacity, they did not include specific instruments to measure the impact on HRQOL as a primary outcome.^2-4 This omission is particularly relevant given that current guidelines explicitly recognize QOL as a fundamental domain in IPF management requiring further research.²

The recent ATS/European Respiratory Society guideline update provides a conceptual framework to address this gap by suggesting the integration of validated measures of symptoms, pulmonary function, and psychosocial impact.² These dimensions, although mentioned in the guidelines, have not yet been systematically incorporated into clinical research designs, as shown by the reviewed studies.^1-4 It would be valuable to reanalyze existing trial data to gather information on QOL outcomes where available and to use the guidelines framework to design future studies that include these aspects as primary end points. This approach is particularly important in resource-limited settings, where evaluating outcomes that combine physiological and functional measures may be especially relevant for guiding resource allocation and patient care.

In conclusion, a comprehensive evaluation of QOL in patients with IPF is a clinical and ethical imperative that transcends the mere measurement of physiological parameters. Existing studies, although valuable in characterizing disease progression, have left unexplored fundamental dimensions of the patient experience that could redefine our therapeutic approach. The guidelines themselves recognize this need, emphasizing the urgency of incorporating validated measures that capture the real impact of the disease on patients’ daily lives. This patient-centered approach, rather than one focused solely on pathology, represents the next necessary step in our understanding and management of this complex condition, allowing us to offer truly holistic care that considers both the quantity and quality of life of those with IPF.

Author Affiliation: Faculty of Human Medicine, Ricardo Palma University, Lima, Peru.

Source of Funding: None.

Author Disclosures: The author reports no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

Authorship Information: Concept and design; acquisition of data; and drafting of the manuscript.

Address Correspondence to: Franco Nicolae Grados Rodriguez, Faculty of Human Medicine, Ricardo Palma University, Jr Marañón 425, Villa María del Triunfo, Lima, Peru. Email: franco.grados.97@gmail.com.

REFERENCES

1. Nathan SD, Lee JS. Real-world data on the course of idiopathic pulmonary fibrosis. Am J Manag Care. 2024;30(suppl 7):S107-S113. doi:10.37765/ajmc.2024.89632

2. Raghu G, Remy-Jardin M, Richeldi L, et al. Idiopathic pulmonary fibrosis (an update) and progressive pulmonary fibrosis in adults: an official ATS/ERS/JRS/ALAT clinical practice guideline. Am J Respir Crit Care Med. 2022;205(9):e18-e47. doi:10.1164/rccm.202202-0399ST

3. Richeldi L, du Bois RM, Raghu G, et al; INPULSIS Trial Investigators. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014;370(22):2071-2082. doi:10.1056/NEJMoa1402584

4. King TE Jr, Bradford WZ, Castro-Bernardini S, et al; ASCEND Study Group. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med. 2014;370(22):2083-2092. doi:10.1056/NEJMoa1402582