Dose-Response Relationship Between Long-Term Systemic Corticosteroid Use and Related Complications in Patients with Severe Asthma

Abstract

Funding for this study was provided by GlaxoSmithKline, Study number H0-15-15930, to Analysis Group for the conduct of this study. Lefebvre, Duh, and Gozalo are employees of Analysis Group, a contract research organization that has received research grants from GlaxoSmithKline. Robitaille was employed by Analysis Group at the time of this study. Yancey, Forshag, Lin, and Albers are employees of GlaxoSmithKline and own company stock. Dalal and Ortega were employed by GlaxoSmithKline at the time of this study. Lefebvre had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Additionally, all listed authors meet the criteria for authorship set forth by the International Committee for Medical Journal Editors. Study concept and design were contributed by Dalal, Duh, Albers, Yancey, Ortega, Forshag, and Lefebvre. Data acquisition was by Dalal, Gozalo, Robitaille, Forshag, and Lefebvre and was analyzed and interpreted by Dalal, Gozalo, Robitaille, Albers, Yancey, Ortega, Forshag, and Lefebvre. The manuscript was drafted and approved by Dalal, Duh, Gozalo, Robitaille, Albers, Yancey, Ortega, Forshag, Lin, and Lefebvre.

Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study

“…We followed patients from the time of SCS initiation until the time they experienced an event or were otherwise censored. The use of large UK databases containing longitudinal medical record data allowed us to examine a median of almost 10 years before the first SCS prescription to exclude prior SCS use, with subsequent follow-up of a median of 7 years, much longer than prior studies in asthma with reported mean and median follow-up periods of 1–5 years 7–9,15,25. Moreover, earlier studies examined effects of ongoing (rather than initiating) SCS exposure7,8,25–27 or ruled out previous exposure for only ≤12 months before the index prescription 9,15…”

“…Most prior studies included limited patient populations, ie, those classified as having severe asthma7–9,25 or those prescribed SCS for prespecified lengths of time 26,27. Studies from the USA included low-income7,8 or employed15,25–28 populations, selective populations with limited or better-than-average access to care, respectively.…”

“…Studies from the USA included low-income7,8 or employed15,25–28 populations, selective populations with limited or better-than-average access to care, respectively. Instead, the majority of people in the UK are registered with GPs, who administer primary care and serve as the gate-keeper for secondary care; thus, the CPRD and OPCRD include data from a broad, representative patient population, supporting the generalizability of our findings.…”

Healthcare resource utilization and costs associated with incremental systemic corticosteroid exposure in asthma

“…This was driven by asthma‐associated oral corticosteroid (OCS) use. In addition, the increased risk of adverse effects is dependent on corticosteroid dosage . Dalal et al found that long‐term corticosteroid users (≥6 months) with low‐ (<5 mg/day), medium‐ (≥5‐10 mg/day), and high‐dosage (>10 mg/day) exposure had, respectively, a 2.5‐, 2.95‐, and 3.32‐fold greater adjusted relative risk of developing any steroid‐related complication compared with steroid nonusers.…”

Sputum cell counts to manage prednisone-dependent asthma: effects on FEV1 and eosinophilic exacerbations

“…These patients, although fortunately infrequent, consume the largest health care resources for asthma care [7]. They often have significant adverse effects from their doses of corticosteroids [8] and these are the patients who may benefit most with the advent of biologics that target the Th2 cytokine pathways [9]. …”