Quality of Life Improvements with Biologic Initiation Among Subspecialist-Treated US Patients with Severe Asthma

Abstract

Purpose

Patients living with severe asthma (SA) experience multiple health-related quality of life (HRQoL) impairments. This study examined HRQoL changes after biologic treatment initiation among a large, real-world cohort of patients with SA.

Patients and methods

CHRONICLE is an ongoing observational study of subspecialist-treated adults with SA who receive biologics or maintenance systemic corticosteroids or are uncontrolled on high-dosage inhaled corticosteroids with additional controllers. Patients enrolled February 2018–February 2023 were asked to complete the St. George’s Respiratory Questionnaire (SGRQ) every 6 months (total score range of 0–100 [0=best possible health], meaningful change threshold is a 4-unit reduction in the total score). Changes in SGRQ responses from 6 months before initiation to 12 to 18 months after initiation were summarized.

Results

A total of 76 patients completed the SGRQ 0 to 6 months before and 12 to 18 months after biologic initiation. The mean (SD) SGRQ total score decreased from 52.2 (20.6) to 41.9 (23.8), with improvement across the symptoms (−14.5), activity (−11.0), and impacts (−8.3) components. For specific impairments reported by ≥50% of patients before biologic initiation, fewer reported each impairment after biologic initiation; the largest reductions were for “Questions about what activities usually make you feel short of breath these days [Walking outside on level ground]” (67% to 43%), “Questions about other effects that your respiratory problems may have on you these days [I feel that I am not in control of my respiratory problems]” (55% to 34%), and “Questions about your cough and shortness of breath these days [My coughing or breathing disturbs my sleep]” (63% to 45%).

Conclusion

In this real-world cohort of adults with SA, biologic initiation was associated with meaningful improvements in asthma-related HRQoL. These data provide further insight into the burden SA places on patients and the benefits of biologic treatment.

Keywords:

• observational
• real-world
• health-related quality of life
• St. George’s Respiratory Questionnaire

Abbreviations

HRQoL, health-related quality of life; ICS, inhaled corticosteroids; LABA, long-acting beta agonists; MCT, meaningful change threshold; mSCS, maintenance systemic corticosteroids; OCS, oral corticosteroids; SA, severe asthma; SD, standard deviation; SGRQ, St. George’s Respiratory Questionnaire.

Data Sharing Statement

CHRONICLE is an ongoing study; individual de-identified participant data cannot be shared until the study concludes. The full study protocol is available upon request of the corresponding author. Individuals who were or were not involved in the study may submit publication proposals to the study’s Publication Steering Committee by contacting the corresponding author.

Ethics Approval and Informed Consent

The CHRONICLE study protocol received central institutional review board (Advarra, Columbia, MD) approval on November 3, 2017, and was registered on ClinicalTrials.gov on December 14, 2017 (NCT03373045). A signed informed consent form is obtained at enrollment for study participation and to acquire medical records from other providers, including pharmacy records.

Acknowledgments

Medical writing support was provided by Anne Kangethe, PhD, and Holden Young, PharmD, MBA, of Oxford PharmaGenesis, Inc. (Newtown, PA, USA), which was in accordance with Good Publication Practice (GPP 2022) and was funded by AstraZeneca, Wilmington, DE, United States.

Disclosure

WS: Consultant – Amgen, AstraZeneca, Genentech, Regeneron, Sanofi, Novartis, Teva; speaker – Amgen, AstraZeneca, GSK, Regeneron, Sanofi; research – Amgen, AstraZeneca, Genentech, GSK, Incyte, Konseka, Pfizer, AbbVie, Upstream-Bio, Regeneron, Sanofi, Novartis. BEC: Advisory boards, consultant, and speaker – AstraZeneca, Boehringer Ingelheim, Genentech, GSK, Novartis, Regeneron, Sanofi Genzyme. WC: Speaker – AbbVie, Alladapt Immunotherapeutics, Blueprint Medicines, Bryn Pharma, Hikma Pharmaceuticals, Merck Sharp & Dohme LLC, Merz Pharmaceuticals, AstraZeneca, Teva, Boehringer Ingelheim, Regeneron, and Sanofi and Genzyme US Companies; consultant – AstraZeneca, Teva, Boehringer Ingelheim, Regeneron, Sanofi, Circassia, CSL Behring, Genentech, GlaxoSmithKline, Horizon Pharma, Kaleo, Mylan, Pfizer, Shire, Meda, Baxalta, Novartis, Greer Laboratories, Alcon Laboratories, Valeant Pharmaceuticals, Grifols, Optinose, Aerocrine. JT: Consultant and advisory boards – AstraZeneca. AP, NC: Employees and shareholders at the time this work was completed – AstraZeneca. DC, and CSA: Employees and shareholders – AstraZeneca.

Additional information

Funding

This work was supported by AstraZeneca, and the CHRONICLE study is funded by the same.