https://orcid.org/0000-0001-7855-129X
Abstract
Purpose
Associations between systemic glucocorticoid (SGC) exposure and risk for adverse outcomes have spurred a move toward steroid-sparing treatment strategies. Real-world changes in SGC exposure over time, after the introduction of steroid-sparing treatment strategies, reveal areas of successful risk mitigation as well as unmet needs.
Patients and Methods
A population-based ecological study was performed from the Optimum Patient Care Research Database to describe SGC prescribing trends of steroid-sparing treatment strategies in primary care practices before and after licensure of biologics in the United Kingdom from 1990 to 2019. Each analysis year included patients aged ≥5 years who were registered for ≥1 year with a participating primary care practice. The primary analysis was SGC exposure, defined as total cumulative SGC dose per patient per year, for asthma, severe asthma, chronic obstructive pulmonary disease (COPD), nasal polyps, Crohn’s disease, rheumatoid arthritis, ulcerative colitis, and systemic lupus erythematosus. Secondary outcomes were percentages of patients prescribed SGCs and number of SGC prescriptions per patient per year.
Results
The number of patients who met study inclusion criteria ranged from 219,862 (1990) to 1,261,550 (2019). At the population level, patients with asthma or COPD accounted for 67.7% to 73.2% of patients per year with an SGC prescription. Over three decades, decreases in SGC total yearly dose ≥1000 mg have been achieved in multiple conditions. Patients with COPD prescribed SGCs increased from 5.8% (1990) to 34.8% (2017). SGC prescribing trends for severe asthma, Crohn’s disease, and ulcerative colitis show decreased prescribing trends after the introduction of biologics.
Conclusion
Decreases in total yearly SGC doses have been shown in multiple conditions; however, for conditions such as severe asthma and COPD, an unmet need remains for increased awareness of SGC burden and the adoption or development of SGC-sparing alternatives to reduce overuse.
Acknowledgments
The authors thank the members of the Forum for reducing Oral Corticosteroid Use in Severe asthma (FOCUS) for their involvement in the conception of the study (Table S5). Medical writing support, including preparation of the draft manuscript under the direction and guidance of the authors, incorporating author feedback, and manuscript submission, was provided by Lea Anne Gardner, PhD, RN (Citrus Health Group), in accordance with Good Publication Practice 2022 (GPP 2022) guidelines. This support was funded by AstraZeneca (Cambridge, UK). Data from OPCRD were obtained under license from Optimum Patient Care Limited. The interpretation and conclusions contained in this report are those of the authors alone.
Author Contributions
All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agreed to be accountable for all aspects of the work.
Disclosure
All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare support from AstraZeneca for the submitted work.
AMG is an employee of AstraZeneca and has attended advisory boards for AstraZeneca, GlaxoSmithKline, Novartis, Sanofi, and Teva; received speaker fees from AstraZeneca, Novartis, Sanofi, and Teva; participated in research with AstraZeneca for which his institution has been remunerated; and had consultancy agreements with AstraZeneca and Sanofi.
TNT, JC, and BE are employees of AstraZeneca.
BS and VC report no conflict of interest.
JSS has received research grants for his institution from AbbVie, AstraZeneca, Lilly, Novartis, and Roche; and honoraria for consultancies and/or speaking engagements from AbbVie, Amgen, AstraZeneca, Astro, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Gilead, ILTOO, Janssen, Lilly, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, R-Pharm, Roche, Samsung, Sanofi, and UCB.
AB has received personal fees and a grant from Boehringer Ingelheim; personal fees from AstraZeneca, Chiesi, GSK, Novartis, and Sanofi-Regeneron; and is an investigator in clinical trials from Acceleron, Actelion, Galapagos, MSD, Nuvaira, Pulmonx, United Therapeutic, and Vertex.
JMF has attended advisory boards for AstraZeneca, GSK, Novartis, Sanofi Regeneron, and Theravance; received speaker fees/honoraria from AstraZeneca, GSK, Sanofi-Regeneron, and TEVA; received research funding from AllerGen National Centre for Excellence, AstraZeneca, Canadian Institute for Health Research, GSK, National Institutes of Health, Novartis, Sanofi-Regeneron, and TEVA, all paid directly to his institution; and has been a member of the steering committee for the International Severe Asthma Registry, principal investigator for Canadian Severe Asthma Registry, and a member of the GINA Science and Executive Committees.
TR has received research/educational grants and/or speaker/consultation fees from AbbVie, Arena, AstraZeneca, BMS, Celgene, Ferring, Galapagos, Gilead, GSK, LabGenius, Janssen, MSD, Mylan, Novartis, Pfizer, Sandoz, Takeda, and UCB.
DJJ has attended advisory boards and has received speaker fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, and Sanofi.
DBP has board membership with AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, and Thermofisher; consultancy agreements with Airway Vista Secretariat, AstraZeneca, Boehringer Ingelheim, Chiesi, EPG Communication Holdings Ltd, FIECON Ltd, Fieldwork International, GlaxoSmithKline, Mundipharma, Mylan, Novartis, OM Pharma SA, PeerVoice, Phadia AB, Spirosure Inc., Strategic North Limited, Synapse Research Management Partners SL, Talos Health Solutions, Theravance, and WebMD Global LLC; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Theravance, and the UK National Health Service; received payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals, and Sanofi Genzyme; received payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, and Thermofisher; stock/stock options from AKL Research and Development Ltd, which produces phytopharmaceuticals; ownership of 74% of the social enterprise Optimum Patient Care Ltd (Australia, UK) and 92.61% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp, which develops adherence monitoring technology; a peer reviewer role for grant committees of the UK Efficacy and Mechanism Evaluation program and the Health Technology Assessment; and served as an expert witness for GlaxoSmithKline.