scholarly journals Disease severity, flares and treatment patterns in adults with systemic lupus erythematosus in the UK: a real-world observational retrospective cohort analysis

2021 ◽  
Vol 5 (3) ◽  
Author(s):  
Julia Langham ◽  
Volkan Barut ◽  
Mihail Samnaliev ◽  
Sue Langham ◽  
Sharada Weir ◽  
...  
Keyword(s):  
Disease Severity ◽  
Median Time ◽  
Service Use ◽  
Cohort Analysis ◽  
Clinical Manifestations ◽  
Treatment Patterns ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
The Mean ◽  
The Uk

Abstract Objectives The aim was to characterize disease severity, clinical manifestations, treatment patterns and flares in a longitudinal cohort of adults with SLE in the UK. Methods Adults with SLE were identified in the Clinical Practice Research Datalink–Hospital Episode Statistics database (1 January 2005–31 December 2017). Patients were required to have ≥12 months of data before and after the index date (earliest SLE diagnosis date available). SLE disease severity and flares were classified using adapted claims-based algorithms, which are based on SLE-related conditions, medications and health-service use. Results Of 802 patients, 369 had mild, 345 moderate and 88 severe SLE at baseline. A total of 692 initiated treatment in the first year after diagnosis. Five hundred and fifty-seven received antimalarials, 203 immunosuppressants and 416 oral CSs. Information on biologic use in hospitals was unavailable. The mean (S.d.) time to initiating any medication was 177 (385.3) days. The median time to first flare was 63 days (95% CI: 57, 71). At least one flare was experienced by 750 of 802 patients during follow-up; the first flare was mild for 549 of 750, moderate for 116 of 750 and severe for 85 of 750. The mean (S.d.) annual overall flare rate (year 1) was 3.5 (2.5). A shorter median time to first flare was significantly associated with moderate/severe disease (P < 0.001) and clinical manifestations (P < 0.001). Conclusion Our findings suggest some delay in the initiation of SLE treatment. Most patients experience a flare within 2 months of diagnosis. Early treatment might delay or reduce the severity of the first SLE flare and might translate to slower disease progression, lower accrual of organ damage and better outcomes.

scholarly journals Healthcare utilization and costs in adults with SLE in the United Kingdom: a real-world observational retrospective cohort analysis

2021 ◽  
Author(s):  
Mihail Samnaliev ◽  
Volkan Barut ◽  
Sharada Weir ◽  
Julia Langham ◽  
Sue Langham ◽  
...  
Keyword(s):  
Disease Severity ◽  
Healthcare Costs ◽  
Severe Disease ◽  
Cohort Analysis ◽  
Practice Research ◽  
Future Research ◽  
First Year ◽  
Clinical Practice Research Datalink ◽  
Comorbid Conditions ◽  
The Uk

Abstract Objectives To describe direct healthcare costs for adults with systemic lupus erythematosus (SLE) in the UK over time and by disease severity and encounter type. Methods Patients aged ≥18 years with SLE were identified using the linked Clinical Practice Research Datalink—Hospital Episode Statistics database from January 2005 to December 2017. Patients were classified as having mild, moderate, or severe disease using an adapted claims-based algorithm based on prescriptions and comorbid conditions. We estimated all-cause healthcare costs and incremental costs associated with each year of follow-up compared with a baseline year adjusting for age, sex, disease severity, and comorbid conditions (2017 UK pounds). Results We identified 802 patients; 369 (46.0%) with mild, 345 (43.0%) moderate, and 88 (11.0%) severe disease. The mean all-cause cost increased in the 3 years before diagnosis, peaked in the first year after diagnosis and remained high. Adjusted total mean annual increase in costs per patient was £4476 (95% confidence interval £3809–5143) greater in the year of diagnosis compared with the baseline year (p < 0.0001). The increase in costs per year were 4.7-fold and 1.6-fold higher among patients with severe SLE compared with those with mild and moderate SLE respectively. Primary care utilisation was the leading component of costs during the first year of diagnosis. Conclusion The healthcare costs for patients with SLE in the UK are substantial, remain high after diagnosis and increase with increasing severity. Future research should assess whether earlier diagnosis and treatment may reduce disease severity and associated high healthcare costs.

scholarly journals Prevalence and patterns of antidepressant switching amongst primary care patients in the UK

2017 ◽  
Vol 31 (5) ◽  
pp. 553-560 ◽  
Author(s):  
Becky Mars ◽  
Jon Heron ◽  
David Gunnell ◽  
Richard M Martin ◽  
Kyla H Thomas ◽  
...  
Keyword(s):  
Primary Care ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Antidepressant Treatment ◽  
Cohort Analysis ◽  
Antidepressant Therapy ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Line Treatment ◽  
Second Line ◽  
The Uk

Objective: Non-response to antidepressant treatment is a substantial problem in primary care, and many patients with depression require additional second-line treatments. This study aimed to examine the prevalence and patterns of antidepressant switching in the UK, and identify associated demographic and clinical factors. Method: Cohort analysis of antidepressant prescribing data from the Clinical Practice Research Datalink, a large, anonymised UK primary care database. The sample included 262,844 patients who initiated antidepressant therapy between 1 January 2005 and 31 June 2011. Results: 9.3% of patients switched to a different antidepressant product, with most switches (60%) occurring within 8 weeks of the index date. The proportion switching was similar for selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants and other antidepressants (9.3%, 9.8% and 9.2%, respectively). Most switches were to an SSRI (64.5%), and this was the preferred option regardless of initial antidepressant class. Factors predictive of switching included male gender, age, and history of self-harm and psychiatric illness. Conclusion: Over one in every 11 patients who initiates antidepressant therapy will switch medication, suggesting that initial antidepressant treatment has been unsatisfactory. Evidence to guide choice of second-line treatment for individual patients is currently limited. Additional research comparing different pharmacological and psychological second-line treatment strategies is required in order to inform guidelines and improve patient outcomes.

scholarly journals Treatment patterns in patients with Familial hypercholesterolemia: evidence from real-world studies in Germany and the UK

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
I Gouni-Berthold ◽  
D Seshagiri ◽  
R Studer ◽  
A Durand ◽  
S Klebs ◽  
...  
Keyword(s):  
Familial Hypercholesterolemia ◽  
Real World ◽  
Treatment Patterns ◽  
Lipid Lowering ◽  
Clinical Practice Research Datalink ◽  
Private Company ◽  
Statin Monotherapy ◽  
The Mean ◽  
The Uk

Abstract Background Familial hypercholesterolemia (FH) includes a spectrum of disease as per the number and effect of mutations in specific proteins involved in low-density lipoprotein cholesterol (LDL-C) metabolism, together with other genetic factors. Elevated LDL-C levels have been strongly associated with risk of cardiovascular and coronary heart disease, with up to 10-fold risk in patients (pts) with FH than without FH. The aim of lipid-lowering treatments (LLTs) is to reduce the LDL-C levels, although there is limited research describing treatment patterns and LDL-C outcomes in FH pts in routine care. Purpose To characterize the treatment patterns and LDL-C outcomes of FH pts in the real-world setting in Germany (GER) and the UK. Methods We conducted two descriptive, non-interventional and retrospective cohort studies. Pts in GER were identified from General Physician (GP) and Cardiology practices available in electronic medical records database Disease Analyzer (January 1992-June 2020). Pts in the UK were identified from the Clinical Practice Research Datalink linked to the Hospital Episode Statistics admitted pts care and Office of National Statistics datasets. Pts were included if they had diagnosis of FH (index date [ID]) and data available within 6-month before and 3-month after the ID. The first diagnosis of FH in the identification period (GER, 1/07/2015–30/06/2019; UK, 01/01/2010–31/05/2018) was considered the ID. Persistence and adherence to the recorded LLT at ID was analyzed for pts with at least 12 months and 24 months of follow-up. Persistence was measured as the duration (in days) with allowed gap of 60 days and adherence as proportion of days covered (PDC). Results Analysis included 2,105 FH pts from GER and 9,846 from the UK. Data are presented as GER/UK. The mean (SD) age of pts was 60 (15)/52 (14) years, and 60%/61% were females. Hypertension (53%/27%) and depression (31%/38%) were the common comorbidities. At ID, statin monotherapy (29%/68%) was the most commonly prescribed LLT. The use of ezetimibe, fibrates and PCSK9 inhibitors was very low in both countries (Table 1). Of note, LDL-C measurements at ID (−6m/+3m) were available for 31%/73% of pts. In pts with uncontrolled LDL-C (≥55 mg/dL), 34%/64% were receiving statin monotherapy, whereas there was no use of LLT in 62%/29% of pts. During the 24 months follow-up, the mean (SD) persistence and PDC to statins monotherapy was 471 (264)/489 (289) days and 0.65 (0.36)/0.69 (0.46), respectively, with 50%/70% of pts being adherent (PDC ≥0.80). Conclusions In our study, in GER, the rate of LDL-C measurements was low. In both GER and UK, almost all measured patients had LDL-C ≥55mg/dL at ID. Findings indicate low prescriptions of LLTs in GP setting, particularly non-statin LLTs in both countries. The mean adherence (PDC) in GER and the UK was 65% and 69%, respectively within 24 months after ID. Improved LDL-C monitoring and new therapies with potential to lower LDL-C are warranted. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Novartis Pharma AG, Basel, Switzerland

scholarly journals The incidence and healthcare costs of persistent postoperative pain following lumbar spine surgery in the UK: a cohort study using the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES)

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e017585 ◽  
Author(s):  
Sharada Weir ◽  
Mihail Samnaliev ◽  
Tzu-Chun Kuo ◽  
Caitriona Ni Choitir ◽  
Travis S Tierney ◽  
...  
Keyword(s):  
Spine Surgery ◽  
Healthcare Costs ◽  
Population Based ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Lumbar Surgery ◽  
Persistent Postoperative Pain ◽  
The Mean ◽  
The Uk ◽  
Mean Cost

ObjectiveTo characterise incidence and healthcare costs associated with persistent postoperative pain (PPP) following lumbar surgery.DesignRetrospective, population-based cohort study.SettingClinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) databases.ParticipantsPopulation-based cohort of 10 216 adults who underwent lumbar surgery in England from 1997/1998 through 2011/2012 and had at least 1 year of presurgery data and 2 years of postoperative follow-up data in the linked CPRD–HES.Primary and secondary outcomes measuresIncidence and total healthcare costs over 2, 5 and 10 years attributable to persistent PPP following initial lumbar surgery.ResultsThe rate of individuals undergoing lumbar surgery in the CPRD–HES linked data doubled over the 15-year study period, fiscal years 1997/1998 to 2011/2012, from 2.5 to 4.9 per 10 000 adults. Over the most recent 5-year period (2007/2008 to 2011/2012), on average 20.8% (95% CI 19.7% to 21.9%) of lumbar surgery patients met criteria for PPP. Rates of healthcare usage were significantly higher for patients with PPP across all types of care. Over 2 years following initial spine surgery, the mean cost difference between patients with and without PPP was £5383 (95% CI £4872 to £5916). Over 5 and 10 years following initial spine surgery, the mean cost difference between patients with and without PPP increased to £10 195 (95% CI £8726 to £11 669) and £14 318 (95% CI £8386 to £19 771), respectively. Extrapolated to the UK population, we estimate that nearly 5000 adults experience PPP after spine surgery annually, with each new cohort costing the UK National Health Service in excess of £70 million over the first 10 years alone.ConclusionsPersistent pain affects more than one-in-five lumbar surgery patients and accounts for substantial long-term healthcare costs. There is a need for formal, evidence-based guidelines for a coherent, coordinated management strategy for patients with continuing pain after lumbar surgery.

scholarly journals SAT0216 DISEASE SEVERITY, COMORBID CONDITIONS, TREATMENT PATTERNS, AND FLARES IN ADULTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS IN THE UNITED KINGDOM: A REAL-WORLD OBSERVATIONAL RETROSPECTIVE COHORT ANALYSIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1050.3-1051
Author(s):  
J. Langham ◽  
V. Barut ◽  
M. Samnaliev ◽  
S. Langham ◽  
S. Weir ◽  
...  
Keyword(s):  
Disease Severity ◽  
Lupus Erythematosus ◽  
Index Date ◽  
Treatment Patterns ◽  
First Year ◽  
Comorbid Conditions ◽  
Systemic Lupus ◽  
The United Kingdom ◽  
The Mean ◽  
The Uk

Background:There is limited real-world evidence describing the presentation and treatment patterns of systemic lupus erythematosus (SLE) in the United Kingdom (UK).Objectives:To characterize disease severity, comorbid conditions, treatment patterns, and flares in a longitudinal cohort of adults with SLE in the UK.Methods:Patients aged ≥18 years with SLE were identified in the Clinical Practice Research Datalink – Hospital Episode Statistics database from January 1, 2005, to December 31, 2017. Patients were required to have ≥12 months of data before and after index date (date of earliest SLE diagnosis available). SLE disease severity and flares were classified as mild, moderate, or severe using adapted claims-based algorithms1,2that use SLE-related conditions (eg, end-stage renal disease), medications (eg, antimalarials, immunosuppressants, and corticosteroids), and health service use (eg, hospitalizations and emergency department visits).Results:Of 802 patients with SLE, 369 (46.0%) had mild, 345 (43.0%) had moderate, and 88 (11.0%) had severe SLE at baseline. In total, 692 (86.3%) patients were treated with SLE medications in the first year after SLE diagnosis. Among the total population (802), 557 (69.5%) patients received antimalarials, 203 (25.3%) received immunosuppressants, and 416 (51.9%) received corticosteroids (prednisolone); patients may have received ≥1 type of drug. Information on biologic use in hospitals is unavailable in these data. The mean (standard deviation [SD]) time to initiating any medication from index date was 177 (385.3) days (Figure 1A). The median time to first flare from index date was 63 days (95% confidence interval 57–71) (Figure 1B). A majority of patients (750/802, 93.5%) experienced ≥1 flare during follow-up; the first flare was mild for 73.2% of patients (549/750), moderate for 15.5% (116/750), and severe for 11.3% (85/750). The mean (SD) annual overall flare rate in the first year after index date was 3.5 (2.5) (mild flares: 2.6 [2.5]; moderate flares: 0.7 [1.5]; severe flares: 0.2 [0.6]) (Figure 2). A shorter median time to first flare was significantly associated with moderate or severe disease (P<0.001) and the presence of comorbid conditions (P<0.001).Conclusion:Our findings suggest some delay in SLE treatment initiation in the UK. Most patients with SLE experience flares within 2 months from diagnosis. Early treatment may delay or reduce the severity of the first SLE flare after diagnosis and may translate to slower disease progression, lower organ damage accrual, and better outcomes.References:[1]Garris C, et al.J Med Econ. 2013;16:667–77.[2]Nightingale AL, et al.Lupus Sci Med. 2017;4:e000172.Disclosure of Interests:Julia Langham Consultant of: AstraZeneca, Volkan Barut Employee of: AstraZeneca, Mihail Samnaliev Consultant of: AstraZeneca, Sue Langham Consultant of: AstraZeneca, Sharada Weir Consultant of: AstraZeneca, Xia Wang Employee of: AstraZeneca, Barnabas Desta Employee of: AstraZeneca, Edward R. Hammond Employee of: AstraZeneca

scholarly journals OP0074 MULTIMORBIDITY CLUSTERS, DETERMINANTS AND TRAJECTORIES IN OSTEOARTHRITIS IN THE UK: FINDINGS FROM THE CLINICAL PRACTICE RESEARCH DATALINK

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 49.1-50
Author(s):  
S. Swain ◽  
C. Coupland ◽  
V. Strauss ◽  
C. Mallen ◽  
C. F. Kuo ◽  
...  
Keyword(s):  
Chronic Conditions ◽  
Index Date ◽  
Latent Class ◽  
Rapid Onset ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Research Support ◽  
Gradual Onset ◽  
The Uk ◽  
Slow Onset

Background:Multimorbidity (≥2 chronic conditions) escalates the risk of adverse health outcomes. However, its burden in people with osteoarthritis (OA) remains largely unknown.Objectives:To identify the clusters of patients with multimorbidity and associated factors in OA and non-OA populations and to estimate the risk of developing multimorbidity clusters after the index date (after diagnosis).Methods:The study used the Clinical Practice Research Datalink – a primary care database from the UK. Firstly, age, sex and practice matched OA and non-OA people aged 20+ were identified to explore patterns and associations of clusters of multimorbidity within each group. Non-OA controls were assigned with same index date as that of matched OA cases. Secondly, multimorbidity trajectories for 20 years after the index date were examined in people without any comorbidities at baseline in both OA and non-OA groups. Latent class analysis was used to identify clusters and latent class growth modelling was used for cluster trajectories. The associations between clusters and age, sex, body mass index (BMI), alcohol use, smoking habits at baseline were quantified through multinomial logistic regression.Results:In total, 47 long-term conditions were studied in 443,822 people (OA- 221922; non-OA- 221900), with a mean age of 62 years (standard deviation ± 13 years), and 58% being women. The prevalence of multimorbidity was 76.6% and 68.9% in the OA and non-OA groups, respectively. In the OA group five clusters were identified including relatively healthy (18%), ‘cardiovascular (CVD) and musculoskeletal (MSK)’ (12.3%), metabolic syndrome (28.2%), ‘pain and psychological (9.1%), and ‘musculoskeletal’ (32.4%). The non-OA group had similar patterns except that the ‘pain+ psychological’ cluster was replaced by ‘thyroid and psychological’. (Figure 1) Among people with OA, ‘CVD+MSK’ and metabolic syndrome clusters were strongly associated with obesity with a relative risk ratio (RRR) of 2.04 (95% CI 1.95-2.13) and 2.10 (95% CI 2.03-2.17), respectively. Women had four times higher risk of being in the ‘pain+ psychological’ cluster than men when compared to the gender ratio in the healthy cluster, (RRR 4.28; 95% CI 4.09-4.48). In the non-OA group, obesity was significantly associated with all the clusters.Figure 1: Posterior probability distribution of chronic conditions across the clusters in Osteoarthritis (OA, n=221922) and Non-Osteoarthritis (Non-OA, n=221900) group. COPD- Chronic Obstructive Pulmonary Disease; CVD- Cardiovascular; MSK- MusculoskeletalOA (n=24139) and non-OA (n=24144) groups had five and four multimorbidity trajectory clusters, respectively. Among the OA population, 2.7% had rapid onset of multimorbidity, 9.5% had gradual onset and 11.6% had slow onset, whereas among the non-OA population, there was no rapid onset cluster, 4.6% had gradual onset and 14.3% had slow onset of multimorbidity. (Figure 2)Figure 2: Clusters of multimorbidity trajectories after index date in OA (n=24139) and Non-OA (n=24144)Conclusion:Distinct identified groups in OA and non-OA suggests further research for possible biological linkage within each cluster. The rapid onset of multimorbidity in OA should be considered for chronic disease management.Supported by:Acknowledgments:We would like to thank the University of Nottingham, UK, Beijing Joint Care Foundation, China and Foundation for Research in Rheumatology (FOREUM) for supporting the study.Disclosure of Interests:Subhashisa Swain: None declared, Carol Coupland: None declared, Victoria Strauss: None declared, Christian Mallen Grant/research support from: My department has received financial grants from BMS for a cardiology trial., Chang-Fu Kuo: None declared, Aliya Sarmanova: None declared, Michael Doherty Grant/research support from: AstraZeneca funded the Nottingham Sons of Gout study, Consultant of: Advisory borads on gout for Grunenthal and Mallinckrodt, Weiya Zhang Consultant of: Grunenthal for advice on gout management, Speakers bureau: Bioiberica as an invited speaker for EULAR 2016 satellite symposium

scholarly journals AB0576 BONE EROSION IN PSORIATIC ARTHRITIS ASSOCIATED WITH PSORIASIS DURATION, SKIN, NAIL AND JOINT DISEASE SEVERITY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1325.2-1326
Author(s):  
M. Chamurlieva ◽  
E. Loginova ◽  
T. Korotaeva ◽  
Y. Korsakova ◽  
E. Gubar ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Psoriatic Arthritis ◽  
Disease Severity ◽  
Bone Erosion ◽  
Joint Disease ◽  
Practice Research ◽  
Forest Plot ◽  
Clinical Practice Research Datalink ◽  
Increased Risk ◽  
Nail Disease

Background:Psoriatic arthritis (PsA) is heterogeneous in its clinical presentation and disease course, but many patients (pts) develop a destructive form of arthritis. Psoriasis (PsO) precedes arthritis by an average of 7 years. [1]. Theory of transition from PsO to PsA has been proposed recently [2]. But association between skin disease severity and joint disease are still unclear.Objectives:to evaluate association between bone erosion, PsO duration, skin and nail disease severity in PsA pts based on data from clinical practice (RU-PsART cohort).Methods:737 (M/F=350/387) PsA pts fulfilling the CASPAR criteria were included. Mean age 47.4±12.7 years (yrs), PsA duration 55[17;120] mos., PsO duration 165[74.5;292] mos., mean DAPSA 23.3[14;36.9] mos., HAQ-DI - 0.98 [0.5;1.38], CRP - 7.4 [2.1;18] mg/l. All pts underwent standard clinical examination (tender joins count (TJC)/68, swelling joints count (SJC)/66, CRP (mg/l), DAPSA, dactylitis, enthesitis by LEI + Plantar Facia (PF), HAQ-DI. Mild disease was defined as body surface area (BSA)≤10%, moderate to severe as BSA>10%. The presence/absent of nail PsO was evaluated. X-ray of feet and hand were done in 622 out of 737 pts. The one-factor model of logistic regression was used to identify a group of features that are associated with achievement MDA. M±SD, Me [Q25; Q75], Min-Max, %, t-test, Pierson-χ2, Manna-Whitney tests, ORs with 95% CI were performed. All p<0.05 were considered to indicate statistical significance.Results:PsO precedes of PsA by an average of 9.2 years. BSA≤10% was found in 615 out of 672 pts (91.5%), BSA>10% - in 57 out of 672 pts (8.5%). Nail PsO were seen in 230 out of 737 (31.2%). Bone erosion was found in 237 out of 622 of pts (38.1%). Among these pts nail PsO were seen in 67 out of 237 pts (28.3%). Enthesitis found in 236 out of 737 pts (42.1%), dactylitis – in 197 out 731 pts (27%), axial PsA – in 315 out of 731 pts (43.1%). Bone erosion significantly associated with PsO duration more than 5 yrs., skin and nail PsO severity, high PsA activity by DAPSA, axial manifestation and duration of PsA > 36 mos. (Figure 1).Figure 1Forest plot of factors associated with bone erosion in PsA pts.Conclusion:In our cohort the majority of PsA pts had mild PsO preceded PsA on average of 9.2 yrs. Bone erosion was found in 30% of PsA pts which associated with PsO duration, skin and nail disease severity as well as with PsA activity. Early diagnosis and therapeutic intervention within a “window of opportunity” are very important for improving outcomes and prevent structural damage in PsA.References:[1]Tillett W, et al. Interval between onset of psoriasis and psoriatic arthritis comparing the UK Clinical Practice Research Datalink with a hospital-based cohort. Rheumatol. 2017; 56, 2109–2113[2]Scher JU, et al. Preventing psoriatic arthritis: focusing on patients with psoriasis at increased risk of transition. Nat Rev Rheumatol. 2019;15(3):153-166. doi: 10.1038/s41584-019-0175-0. PMID: 30742092.Disclosure of Interests:None declared.

scholarly journals Paediatric rotavirus vaccination, coeliac disease and type 1 diabetes in children: a population-based cohort study

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Thomas Inns ◽  
Kate M. Fleming ◽  
Miren Iturriza-Gomara ◽  
Daniel Hungerford
Keyword(s):  
Type 1 Diabetes ◽  
Cohort Study ◽  
Coeliac Disease ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Rotavirus Vaccine ◽  
Rotavirus Vaccination ◽  
Increased Risk ◽  
The Uk

Abstract Background Rotavirus infection has been proposed as a risk factor for coeliac disease (CD) and type 1 diabetes (T1D). The UK introduced infant rotavirus vaccination in 2013. We have previously shown that rotavirus vaccination can have beneficial off-target effects on syndromes, such as hospitalised seizures. We therefore investigated whether rotavirus vaccination prevents CD and T1D in the UK. Methods A cohort study of children born between 2010 and 2015 was conducted using primary care records from the Clinical Practice Research Datalink. Children were followed up from 6 months to 7 years old, with censoring for outcome, death or leaving the practice. CD was defined as diagnosis of CD or the prescription of gluten-free goods. T1D was defined as a T1D diagnosis. The exposure was rotavirus vaccination, defined as one or more doses. Mixed-effects Cox regression was used to estimate hazard ratios (HR) and 95% confidence intervals (CIs). Models were adjusted for potential confounders and included random intercepts for general practices. Results There were 880,629 children in the cohort (48.8% female). A total of 343,113 (39.0%) participants received rotavirus vaccine; among those born after the introduction of rotavirus vaccination, 93.4% were vaccinated. Study participants contributed 4,388,355 person-years, with median follow-up 5.66 person-years. There were 1657 CD cases, an incidence of 38.0 cases per 100,000 person-years. Compared with unvaccinated children, the adjusted HR for a CD was 1.05 (95% CI 0.86–1.28) for vaccinated children. Females had a 40% higher hazard than males. T1D was recorded for 733 participants, an incidence of 17.1 cases per 100,000 person-years. In adjusted analysis, rotavirus vaccination was not associated with risk of T1D (HR = 0.89, 95% CI 0.68–1.19). Conclusions Rotavirus vaccination has reduced diarrhoeal disease morbidity and mortality substantial since licencing in 2006. Our finding from this large cohort study did not provide evidence that rotavirus vaccination prevents CD or T1D, nor is it associated with increased risk, delivering further evidence of rotavirus vaccine safety.

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