| 1. |
- Burn, E., et al.
(författare)
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Deep phenotyping of 34,128 adult patients hospitalised with COVID-19 in an international network study
- 2020
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Ingår i: Nature Communications. - : Springer Science and Business Media LLC. - 2041-1723. ; 11:1
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Tidskriftsartikel (refereegranskat)abstract
- Comorbid conditions appear to be common among individuals hospitalised with coronavirus disease 2019 (COVID-19) but estimates of prevalence vary and little is known about the prior medication use of patients. Here, we describe the characteristics of adults hospitalised with COVID-19 and compare them with influenza patients. We include 34,128 (US: 8362, South Korea: 7341, Spain: 18,425) COVID-19 patients, summarising between 4811 and 11,643 unique aggregate characteristics. COVID-19 patients have been majority male in the US and Spain, but predominantly female in South Korea. Age profiles vary across data sources. Compared to 84,585 individuals hospitalised with influenza in 2014-19, COVID-19 patients have more typically been male, younger, and with fewer comorbidities and lower medication use. While protecting groups vulnerable to influenza is likely a useful starting point in the response to COVID-19, strategies will likely need to be broadened to reflect the particular characteristics of individuals being hospitalised with COVID-19. Detailed knowledge of the characteristics of COVID-19 patients helps with public health planning. Here, the authors use routinely-collected data from seven databases in three countries to describe the characteristics of >30,000 patients admitted with COVID-19 and compare them with those admitted for influenza in previous years.
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| 2. |
- Lane, J. C. E., et al.
(författare)
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Risk of hydroxychloroquine alone and in combination with azithromycin in the treatment of rheumatoid arthritis: a multinational, retrospective study
- 2020
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Ingår i: Lancet Rheumatology. - : Elsevier BV. - 2665-9913. ; 2:11
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Tidskriftsartikel (refereegranskat)abstract
- Background Hydroxychloroquine, a drug commonly used in the treatment of rheumatoid arthritis, has received much negative publicity for adverse events associated with its authorisation for emergency use to treat patients with COVID-19 pneumonia. We studied the safety of hydroxychloroquine, alone and in combination with azithromycin, to determine the risk associated with its use in routine care in patients with rheumatoid arthritis. Methods In this multinational, retrospective study, new user cohort studies in patients with rheumatoid arthritis aged 18 years or older and initiating hydroxychloroquine were compared with those initiating sulfasalazine and followed up over 30 days, with 16 severe adverse events studied. Self-controlled case series were done to further establish safety in wider populations, and included all users of hydroxychloroquine regardless of rheumatoid arthritis status or indication. Separately, severe adverse events associated with hydroxychloroquine plus azithromycin (compared with hydroxychloroquine plus amoxicillin) were studied. Data comprised 14 sources of claims data or electronic medical records from Germany, Japan, the Netherlands, Spain, the UK, and the USA. Propensity score stratification and calibration using negative control outcomes were used to address confounding. Cox models were fitted to estimate calibrated hazard ratios (HRs) according to drug use. Estimates were pooled where the I-2 value was less than 0.4. Findings The study included 956 374 users of hydroxychloroquine, 310 350 users of sulfasalazine, 323 122 users of hydroxychloroquine plus azithromycin, and 351 956 users of hydroxychloroquine plus amoxicillin. No excess risk of severe adverse events was identified when 30-day hydroxychloroquine and sulfasalazine use were compared. Selfcontrolled case series confirmed these findings. However, long-term use of hydroxychloroquine appeared to be associated with increased cardiovascular mortality (calibrated HR 1.65 [95% CI 1.12-2.44]). Addition of azithromycin appeared to be associated with an increased risk of 30-day cardiovascular mortality (calibrated HR 2.19 [95% CI 1.22-3.95]), chest pain or angina (1.15 [1.05-1.26]), and heart failure (1.22 [1.02-1.45]). Interpretation Hydroxychloroquine treatment appears to have no increased risk in the short term among patients with rheumatoid arthritis, but in the long term it appears to be associated with excess cardiovascular mortality. The addition of azithromycin increases the risk of heart failure and cardiovascular mortality even in the short term. We call for careful consideration of the benefit-risk trade-off when counselling those on hydroxychloroquine treatment. Copyright (c) 2020 The Author(s). Published by Elsevier Ltd.
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| 3. |
- Kanis, J. A., et al.
(författare)
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Algorithm for the management of patients at low, high and very high risk of osteoporotic fractures
- 2020
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Ingår i: Osteoporosis International. - : Springer Science and Business Media LLC. - 0937-941X .- 1433-2965. ; 31, s. 1-12
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Tidskriftsartikel (refereegranskat)abstract
- Guidance is provided in an international setting on the assessment and specific treatment of postmenopausal women at low, high and very high risk of fragility fractures. Introduction The International Osteoporosis Foundation and European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis published guidance for the diagnosis and management of osteoporosis in 2019. This manuscript seeks to apply this in an international setting, taking additional account of further categorisation of increased risk of fracture, which may inform choice of therapeutic approach. Methods Clinical perspective and updated literature search. Results The following areas are reviewed: categorisation of fracture risk and general pharmacological management of osteoporosis. Conclusions A platform is provided on which specific guidelines can be developed for national use to characterise fracture risk and direct interventions.
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| 4. |
- Sena, AG, et al.
(författare)
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FIRST LINE TREATMENT WITH CONVENTIONAL SYNTHETIC DISEASE MODIFYING ANTIRHEUMATIC DRUGS IN RHEUMATOID ARTHRITIS: A MULTINATIONAL POPULATION-BASED COHORT FROM 14 REAL WORLD HEALTHCARE DATABASES AND 9 COUNTRIES - REALITY VERSUS GUIDELINES
- 2020
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Ingår i: ANNALS OF THE RHEUMATIC DISEASES. - : BMJ. - 0003-4967 .- 1468-2060. ; 79, s. 327-327
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Treatment guidelines recommend early initiation of csDMARDs following diagnosis of rheumatoid arthritis (RA), with methotrexate (MTX) as first-line therapy. Scarce evidence exists on adherence to this guidanceObjectives:To characterize first-line csDMARD treatment during the first year following an RA diagnosis.Methods:14 real world databases (3 Primary care, 6 primary/secondary care records, 5 claims) from 9 countries were included, all mapped to the OMOP common data model.Patients were included on the earliest event of: 1st diagnosis of RA or 1st DMARD prescription with an RA diagnosis within 30 days. Patients were >18 years-old, required 1+ year pre-index data, and at least 1-year follow-up. Study period covered 2000-2018. Previous users of DMARDs or non-RA inflammatory arthritis history were excluded. Only MTX, Hydroxychloroquine (HCQ), Sulfasalazine (SSZ) and Leflunomide (LEF) were available in all databases.Results:We identified 323,547 eligible participants. Large variation was observed internationally (Figure 1). MTX as first-line monotherapy ranged from 33.3% to 74.5%, and in combination with HCQ from 2.1% to 6.7%. Three additional csDMARDs were used as first-line: HCQ in 10.1% to 30.2%, SSZ in 0.9% to 28.7%, and LEF in 1.8% to 15.2%.Figure 1.First line csDMARD treatment during 1yr from first observed RA diagnosisConclusion:We report wide heterogeneity of first-line csDMARDs regimens internationally. Despite recommendations for MTX to be first line therapy, data suggest that a large proportion of patients receive alternative csDMARD.Disclosure of Interests: :Anthony G Sena Shareholder of: J&J shares, Grant/research support from: Full-time employment salary from Janssen, Consultant of: Full-time employment salary from Janssen, Employee of: Janssen employee, Paid instructor for: Janssen employee, Speakers bureau: Janssen employee, Denis Granados: None declared, Nigel Hughes Shareholder of: J&J shares, Grant/research support from: Full-time employment salary from Janssen, Consultant of: Janssen employee, Employee of: Janssen employee, Paid instructor for: Janssen employee, Speakers bureau: Janssen employee, WALID FAKHOURI Shareholder of: E Lilly Shares, Employee of: Eli Lilly and Company, Antje Hottgenroth Shareholder of: Eli Lilly shares, Employee of: Lilly Deutschland GmbH, Raivo Kolde: None declared, Sulev Reisberg: None declared, Carmen Olga Torre: None declared, Talita Duarte-Salles: None declared, Yesika Díaz: None declared, Jose Felipe Golib-Dzib Grant/research support from: Full-time employment salary from Janssen, Employee of: Yes, Janssen employee, Paid instructor for: Janssen Employee, Speakers bureau: Janssen Employee, Emily S. Brouwer Shareholder of: J&J shares, Takeda shares, Grant/research support from: Full-time employment salary from Janssen, Consultant of: Janssen employee, Employee of: Janssen employee, Paid instructor for: Janssen Employee, Speakers bureau: Janssen Employee, Edward Burn: None declared, Jennifer Lane: None declared, David Vizcaya Employee of: Bayer, Sara Bruce Wirta Employee of: Janssen-Cilag Sweden AB, Marcel de Wilde: None declared, Katia Verhamme: None declared, Peter Rijnbeek: None declared, Elke Theander Employee of: Janssen-Cilag Sweden AB, Katerina Chatzidionysiou Consultant of: AbbVie, Pfizer, Lilly., Daniel Prieto-Alhambra Grant/research support from: Professor Prieto-Alhambra has received research Grants from AMGEN, UCB Biopharma and Les Laboratoires Servier, Consultant of: DPA’s department has received fees for consultancy services from UCB Biopharma, Speakers bureau: DPA’s department has received fees for speaker and advisory board membership services from Amgen, Patrick Ryan: None declared
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| 5. |
- Duarte-Salles, T, et al.
(författare)
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COMPARATIVE RISK OF CANCER ASSOCIATED WITH FIRST-LINE DMARDS USE IN RHEUMATOID ARTHRITIS: REAL WORLD EVIDENCE FROM THE OHDSI NETWORK
- 2020
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Ingår i: ANNALS OF THE RHEUMATIC DISEASES. - : BMJ. - 0003-4967 .- 1468-2060. ; 79, s. 1000-1000
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) are recommended as first line treatment for rheumatoid arthritis (RA) patients, but limited information exists on the comparative risk of cancer associated with their use.Objectives:To compare the risk of incident overall (excluding non-melanoma skin) and site-specific cancers (colorectal, lung, lymphoma, leukaemia) associated with first-line use of csDMARDs in patients with RA.Methods:We conducted a multinational cohort study informed by data from 7 healthcare databases including claims and electronic medical records from 4 countries (SIDIAP-Spain, MDCR-US Optum-US, CCAE-US, IQVIA AMBEMR-US, IQVIA-Germany, THIN-UK) part of the Observational Health Data Sciences and Informatics (OHDSI) network. All patients aged ≥18 years who initiated methotrexate (MTX), hydroxychloroquine (HCQ), sulphasalazine (SSZ), or leflunomide (LEF) as first-line monotherapy after a diagnosis of RA between 2005 to 2018 were eligible. Individuals with a prior diagnosis of another inflammatory arthropathy or cancer, or <1 year of follow-up were excluded. Patients were followed from 1-year after treatment initiation to the earliest of incident cancer, loss to follow-up, or 5-years. Cox proportional-hazard models for MTX against each other csDMARD were performed after propensity score stratification. A large set of negative control outcomes were analysed to calibrate hazard ratios (cHRs). Estimates were pooled where homogeneity across sources was adequate (I2<0.4).Results:Across the databases, 127,547 RA patients initiating csDMARD therapy were included in the analyses (MTX: 73,996, HCL: 36,381 SSZ: 9,383 LEF: 7,787). The pooled incidence rate of overall cancer for MTX was 22.8 per 1,000 person years. The pooled summary and source-specific estimated cHRs for overall cancer are shown below in Figure 1. While little difference was seen for HCQ and SSZ compared to MTX, LEF was consistently associated with a reduced cancer risk: pooled cHR (95% CI) 0.67 (0.59 to 0.76) and cHRs ranged from 0.53 (0.36 to 0.80) in CCAE-US to 0.84 (0.58 to 1.22) in SIDIAP-Spain. There were insufficient cases to look site-specific cancers within data sources, although pooled results suggest little risk difference in leukemia, lymphoma, colorectal, or lung cancers.Figure 1.Calibrated hazard ratios (cHRs) of overall cancer risk with their respective confidence intervals (95%CI) by study database. Database estimates not reported where adequate covariate balance not attained. Meta-analysis results not reported where I2>0.4.Conclusion:Compared to MTX users, patients treated with LEF had a lower risk of overall cancer. Risk of four specific cancers did not differ by first line csDMARD exposure.Disclosure of Interests: :Talita Duarte-Salles: None declared, Martina Recalde: None declared, James Weaver Shareholder of: J&J Shares, Grant/research support from: Full-time employment salary from Janssen, Consultant of: Janssen employee, Employee of: Janssen, Paid instructor for: Janssen employee, have instructed at conferences, Speakers bureau: Janssen employee, have spoken at conferences, Edward Burn: None declared, Karine Marinier Employee of: Servier, Yesika Díaz: None declared, Ben Illingens: None declared, David Vizcaya Employee of: Bayer, Katerina Chatzidionysiou Consultant of: AbbVie, Pfizer, Lilly., Patrick Ryan: None declared, Daniel Prieto-Alhambra Grant/research support from: Professor Prieto-Alhambra has received research Grants from AMGEN, UCB Biopharma and Les Laboratoires Servier, Consultant of: DPA’s department has received fees for consultancy services from UCB Biopharma, Speakers bureau: DPA’s department has received fees for speaker and advisory board membership services from Amgen
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| 6. |
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| 7. |
- Thorlund, J. B., et al.
(författare)
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Inappropriate opioid dispensing in patients with knee and hip osteoarthritis : a population-based cohort study
- 2020
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Ingår i: Osteoarthritis and Cartilage. - : Elsevier BV. - 1063-4584. ; 28:2, s. 146-153
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To estimate inappropriate opioid dispensing in patients with knee or hip osteoarthritis (OA) defined as (1) dispensing of opioids within the first year of diagnosis or (2) long-term opioid use. Design: Data from Skåne Healthcare Register was linked with the Swedish Prescribed Drug Register. Incidence proportion of dispensed opioids within first year of incident knee or hip OA diagnosis was determined in knee (n = 399,670) and hip (413,216) OA cohorts without a history of OA. The 1-year period prevalence of long-term opioid dispensing was determined in a prevalence cohort (n = 48,574 with knee and/or hip OA and n = 457,587 without OA). The proportion of OA patients with excess opioid dispensing attributable to OA was estimated using inverse probability weighted regression adjustment. Results: In the incident cohorts, 5866 and 2359 developed knee and hip OA, respectively. Within the first year after OA diagnosis 14.7% patients with knee OA and 20.7% with hip OA had an opioid dispensed. The estimated inappropriate dispensing attributable to OA was 7.4% (95% CI 6.5–8.4) for knee OA and 12.8% (95% CI 11.1–14.4) for hip OA. Among persons with prevalent knee, hip or knee and hip OA inappropriate, long-term opioid use attributable to OA was 1.3%, 2.0% and 2.4% of, respectively. Conclusions: More than half the incident opioid dispensations to patients within their first year after knee or hip OA diagnosis are inappropriate according to current treatment guidelines. Furthermore, 2% of patients with prevalent knee or hip OA have inappropriate long-term dispensing of opioids.
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| 8. |
- Yang, C, et al.
(författare)
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DEVELOPMENT AND VALIDATION OF PATIENT-LEVEL PREDICTION MODELS FOR ADVERSE HEALTH OUTCOMES AMONGST ADULT RA PATIENTS INITIATING FIRST-LINE TREATMENT OF METHOTREXATE MONOTHERAPY: A MULTINATIONAL REAL-WORLD COHORT ANALYSIS INCLUDING 164,735 SUBJECTS
- 2020
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Ingår i: ANNALS OF THE RHEUMATIC DISEASES. - : BMJ. - 0003-4967 .- 1468-2060. ; 79, s. 134-134
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- EULAR guidelines recommend the early initiation of methotrexate (MTX) monotherapy as soon as possible after the diagnosis of rheumatoid arthritis (RA). Evaluating patient-level risks for adverse outcomes after MTX initiation would allow clinicians to provide more personalised care.Objectives:To develop and validate patient-level prediction models for adverse health outcomes including leukopenia, pancytopenia, infection (serious, opportunistic, all), cardiovascular disease (CVD) (myocardial infarction (MI), stroke), and cancer (breast, colorectal, uterus) in adult RA patients initiating first-line treatment of MTX monotherapyMethods:Health data from claims and electronic health records were used including patients from 7 European countries (Spain, Estonia, Netherlands, Belgium, Germany, France, and the UK), the United States of America, Australia, and Japan. All RA patients initiating first-line treatment of MTX monotherapy with at least one year of prior observation were included. Prediction models for the outcomes were developed for a time at risk of 3 months (infections, leukopenia, pancytopenia), 2 years (MI and stroke), and 5 years (cancers) on the Optum© De-Identified Clinformatics® Data Mart Database. Models were developed using LASSO logistic regression and were evaluated using the area under the receiver operator characteristic curve (AUROC) for discrimination and graphically assessed for calibration. The models were externally validated on all other databases.Results:A total of 21,307 subjects were used for training and validated against 143,427 patients from 14 sites. MI (AUROC internal 0.77, AUROC external ranging from 0.49 to 0.78), stroke (AUROC internal 0.78, AUROC external ranging from 0.68 to 0.79) and serious infection (AUROC internal 0.75, AUROC external ranging from 0.63 to 0.79) had good predictive validity [Table 1]. Discrimination for all other outcomes was lower, with all AUC<0.7 in internal validation. For detailed results see:https://data.ohdsi.org/ehdenRaPrediction/Table 1.Internal (Optum) and external validation results: AUC ROC for discriminationDatabaseAcute MI within 2yStroke within 2ySerious Infection within 3mOptum (internal)0.770.780.75PanTher0.760.780.74IQVIA_AMBEMR0.760.72CCAE0.730.730.66IQVIA_GERMANY0.640.70IQVIA_THIN0.620.65MDCR0.680.680.67IQVIA_HOSPITAL0.670.630.61MDCD0.720.790.63JMDC0.490.750.71IQVIA_LPDFRANCE0.69Estonia0.670.770.82IQVIA_AUS0.58IPCI0.68SIDIAP0.650.75Conclusion:Clinical tools were developed that successfully identify subjects at risk of MI, stroke and serious infection at the initiation of first-line MTX therapy. The developed algorithms had good transportability and generally, the models with high AUROC had adequate internal calibration although some external validations show they could benefit from recalibration. For short-term opportunistic and all infections, as well as 5-year cancer models, we were unable to achieve a high enough AUROC to warrant validating externally.Disclosure of Interests:Cynthia Yang: None declared, Ross Williams: None declared, Joel Swerdel Shareholder of: J&J shares, Grant/research support from: Full-time employment salary from Janssen, Consultant of: Janssen employee, Employee of: Janssen, Paid instructor for: Janssen employee, have instructed at conferences, Speakers bureau: Janssen employee, have spoken at conferences, Meghna Jani Speakers bureau: Grifols, Talita Duarte-Salles: None declared, Katerina Chatzidionysiou Consultant of: AbbVie, Pfizer, Lilly., Daniel Prieto-Alhambra Grant/research support from: Professor Prieto-Alhambra has received research Grants from AMGEN, UCB Biopharma and Les Laboratoires Servier, Consultant of: DPA’s department has received fees for consultancy services from UCB Biopharma, Speakers bureau: DPA’s department has received fees for speaker and advisory board membership services from Amgen, Patrick Ryan: None declared, Peter Rijnbeek: None declared
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