open access publication

Article, 2024

Background incidence rates of health outcomes in populations at risk for Lyme disease using US administrative claims data

Vaccine, ISSN 0264-410X, 1873-2518, Volume 42, 5, Pages 1094-1107, 10.1016/j.vaccine.2024.01.037

Contributors

Dreyfus, Jill (Corresponding author) [1] Munnangi, Swapna [2] Bengtsson, Camilla [3] Correia, Bárbara Pinto 0000-0002-9161-5937 [4] Figueiredo, Rejane [5] Stark, James H 0000-0002-0728-876X [6] Zawora, Michele [1] Riddle, Mark S 0000-0002-0607-7880 [1] Maguire, Jason D [1] Jiang, Qin [1] Ianos, Claudia Ana 0000-0002-8719-5490 [7] Naredo Turrado, Juan [8] Svanström, Henrik [9] Bailey, Steven [1] Dekoven, Mitchell P [2]

Affiliations

  1. [1] Pfizer (United States)
    2. [NORA names: United States; America, North; OECD];
  2. [2] IQVIA (United States)
    3. [NORA names: United States; America, North; OECD];
  3. [3] IQVIA, Solna, Sweden.
    4. [NORA names: Sweden; Europe, EU; Nordic; OECD];
  4. [4] IQVIA, Oeiras, Portugal.
    5. [NORA names: Portugal; Europe, EU; OECD];
  5. [5] IQVIA, Espoo, Finland.
    6. [NORA names: Finland; Europe, EU; Nordic; OECD];

Abstract

BACKGROUND: Background incidence rates (IRs) of health outcomes in Lyme disease endemic regions are useful to contextualize events reported during Lyme disease vaccine clinical trials or post-marketing. The objective of this study was to estimate and compare IRs of health outcomes in Lyme disease endemic versus non-endemic regions in the US during pre-COVID and COVID era timeframes. METHODS: IQVIA PharMetrics® Plus commercial claims database was used to estimate IRs of 64 outcomes relevant to vaccine safety monitoring in the US during January 1, 2017-December 31, 2019 and January 1, 2020-December 31, 2021. Analyses included all individuals aged ≥ 2 years with ≥ 1 year of continuous enrollment. Outcomes were defined by International Classification of Diseases Clinical Modification, 10th Revision (ICD-10-CM) diagnosis codes. IRs and 95 % confidence intervals (CIs) were calculated for each outcome and compared between endemic vs. non-endemic regions, and pre-COVID vs. COVID era using IR ratios (IRR). RESULTS: The study population included 8.7 million (M) in endemic and 27.8 M in non-endemic regions. Mean age and sex were similar in endemic and non-endemic regions. In both study periods, the IRs were statistically higher in endemic regions for anaphylaxis, meningoencephalitis, myocarditis/pericarditis, and rash (including erythema migrans) as compared with non-endemic regions. Conversely, significantly lower IRs were observed in endemic regions for acute kidney injury, disseminated intravascular coagulation, heart failure, myelitis, myopathies, and systemic lupus erythematosus in both study periods. Most outcomes were statistically less frequent during the COVID-era. CONCLUSION: This study identified potential differences between Lyme endemic and non-endemic regions of the US in background IRs of health conditions during pre-COVID and COVID era timeframes to inform Lyme disease vaccine safety monitoring. These regional and temporal differences in background IRs should be considered when contextualizing possible safety signals in clinical trials and post-marketing of a vaccine targeted at Lyme disease prevention.

Keywords

COVID era, Clinical Modification, IQVIA, IR ratio, International, International Classification, International Classification of Diseases Clinical Modification, Lyme, Lyme disease, Lyme disease prevention, US, US administrative claims data, acute kidney injury, administrative claims data, age, analysis, anaphylaxis, background, background incidence rates, claims data, claims database, clinical trials, coagulation, code, commercial claims database, comparing IR, conditions, confidence, confidence intervals, continuous enrollment, data, database, diagnosis, diagnosis codes, differences, disease, disease endemic regions, disease prevention, disseminated intravascular coagulation, endemic regions, enrollment, era, erythematosus, estimated incidence rate, events, failure, health, health conditions, health outcomes, heart, heart failure, incidence, incidence rate, individuals, injury, interval, intravascular coagulation, kidney injury, lupus erythematosus, meningoencephalitis, modification, monitoring, myelitis, myocarditis/pericarditis, myopathy, non-endemic regions, objective, outcomes, period, population, post-marketing, pre-COVID, prevention, rash, rate, ratio, region, risk, safety monitoring, safety signals, sex, signal, study, study period, study population, systemic lupus erythematosus, temporal differences, timeframe, trials, vaccine, vaccine clinical trials, vaccine safety monitoring, years, years of continuous enrollment

Funders

  • Pfizer (United States)

Data Provider: Digital Science

LINKS
-

Matching Records in NORA

SUBJECTS
+

METRICS
+