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2. Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Development and Pilot of a Metadata List and Catalogue in Europe

Author

Infection & Immunity, Child Health, Data Science & Biostatistiek, Pajouheshnia, Romin, Gini, Rosa, Gutierrez, Lia, Swertz, Morris A, Hyde, Eleanor, Sturkenboom, Miriam, Arana, Alejandro, Franzoni, Carla, Ehrenstein, Vera, Roberto, Giuseppe, Gil, Miguel, Maciá, Miguel Angel, Schäfer, Wiebke, Haug, Ulrike, Thurin, Nicolas H, Lassalle, Régis, Droz-Perroteau, Cécile, Zaccagnino, Silvia, Busto, Maria Paula, Middelkoop, Bas, Gembert, Karin, Sanchez-Saez, Francisco, Rodriguez-Bernal, Clara, Sanfélix-Gimeno, Gabriel, Hurtado, Isabel, Acosta, Manuel Barreiro de, Poblador-Plou, Beatriz, Carmona-Pírez, Jonás, Gimeno-Miguel, Antonio, Prados-Torres, Alexandra, Schultze, Anna, Jansen, Ella, Herings, Ron, Kuiper, Josine, Locatelli, Igor, Jazbar, Janja, Žerovnik, Špela, Kos, Mitja, Smit, Steven, Lind, Sirje, Metspalu, Andres, Simou, Stefania, Hedenmalm, Karin, Cochino, Ana, Alcini, Paolo, Kurz, Xavier, Perez-Gutthann, Susana, Infection & Immunity, Child Health, Data Science & Biostatistiek, Pajouheshnia, Romin, Gini, Rosa, Gutierrez, Lia, Swertz, Morris A, Hyde, Eleanor, Sturkenboom, Miriam, Arana, Alejandro, Franzoni, Carla, Ehrenstein, Vera, Roberto, Giuseppe, Gil, Miguel, Maciá, Miguel Angel, Schäfer, Wiebke, Haug, Ulrike, Thurin, Nicolas H, Lassalle, Régis, Droz-Perroteau, Cécile, Zaccagnino, Silvia, Busto, Maria Paula, Middelkoop, Bas, Gembert, Karin, Sanchez-Saez, Francisco, Rodriguez-Bernal, Clara, Sanfélix-Gimeno, Gabriel, Hurtado, Isabel, Acosta, Manuel Barreiro de, Poblador-Plou, Beatriz, Carmona-Pírez, Jonás, Gimeno-Miguel, Antonio, Prados-Torres, Alexandra, Schultze, Anna, Jansen, Ella, Herings, Ron, Kuiper, Josine, Locatelli, Igor, Jazbar, Janja, Žerovnik, Špela, Kos, Mitja, Smit, Steven, Lind, Sirje, Metspalu, Andres, Simou, Stefania, Hedenmalm, Karin, Cochino, Ana, Alcini, Paolo, Kurz, Xavier, and Perez-Gutthann, Susana

Published
2024

3. Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Lessons Learnt From the MINERVA Project in Europe

Author

Data Science & Biostatistiek, Child Health, Infection & Immunity, Gini, Rosa, Pajouheshnia, Romin, Gutierrez, Lia, Swertz, Morris A, Hyde, Eleanor, Sturkenboom, Miriam, Arana, Alejandro, Franzoni, Carla, Ehrenstein, Vera, Roberto, Giuseppe, Gil, Miguel, Maciá, Miguel Angel, Schäfer, Wiebke, Haug, Ulrike, Thurin, Nicolas H, Lassalle, Régis, Droz-Perroteau, Cécile, Zaccagnino, Silvia, Busto, Maria Paula, Middelkoop, Bas, Gembert, Karin, Sanchez-Saez, Francisco, Rodriguez-Bernal, Clara, Sanfélix-Gimeno, Gabriel, Hurtado, Isabel, Acosta, Manuel Barreiro de, Poblador-Plou, Beatriz, Carmona-Pírez, Jonás, Gimeno-Miguel, Antonio, Prados-Torres, Alexandra, Schultze, Anna, Jansen, Ella, Herings, Ron, Kuiper, Josine, Locatelli, Igor, Jazbar, Janja, Žerovnik, Špela, Kos, Mitja, Smit, Steven, Lind, Sirje, Metspalu, Andres, Simou, Stefania, Hedenmalm, Karin, Cochino, Ana, Alcini, Paolo, Kurz, Xavier, Perez-Gutthann, Susana, Data Science & Biostatistiek, Child Health, Infection & Immunity, Gini, Rosa, Pajouheshnia, Romin, Gutierrez, Lia, Swertz, Morris A, Hyde, Eleanor, Sturkenboom, Miriam, Arana, Alejandro, Franzoni, Carla, Ehrenstein, Vera, Roberto, Giuseppe, Gil, Miguel, Maciá, Miguel Angel, Schäfer, Wiebke, Haug, Ulrike, Thurin, Nicolas H, Lassalle, Régis, Droz-Perroteau, Cécile, Zaccagnino, Silvia, Busto, Maria Paula, Middelkoop, Bas, Gembert, Karin, Sanchez-Saez, Francisco, Rodriguez-Bernal, Clara, Sanfélix-Gimeno, Gabriel, Hurtado, Isabel, Acosta, Manuel Barreiro de, Poblador-Plou, Beatriz, Carmona-Pírez, Jonás, Gimeno-Miguel, Antonio, Prados-Torres, Alexandra, Schultze, Anna, Jansen, Ella, Herings, Ron, Kuiper, Josine, Locatelli, Igor, Jazbar, Janja, Žerovnik, Špela, Kos, Mitja, Smit, Steven, Lind, Sirje, Metspalu, Andres, Simou, Stefania, Hedenmalm, Karin, Cochino, Ana, Alcini, Paolo, Kurz, Xavier, and Perez-Gutthann, Susana

Published
2024

4. Pregnancy and Infant Outcomes After Prenatal Exposure to Golimumab in Denmark, Finland, and Sweden 2006–2019.

Author

Karlsson, Pär, Gembert, Karin, Esslinger, Suzan, Geldhof, Anja, Gissler, Mika, Leinonen, Maarit K., Otero‐Lobato, Marijo, Pedersen, Lars, and Cesta, Carolyn E.

Abstract

Purpose: To present the main findings of a post‐authorization safety study assessing pregnancy and infant outcomes after prenatal golimumab exposure in a real‐world setting. Methods: This observational population‐based cohort study included data from pregnancies ending in 2006–2018 (Finland) or 2019 (Denmark, Sweden). Infants born to women with rheumatic diseases or ulcerative colitis diagnoses were identified. Based on prescription fills from 90 days prior to pregnancy until delivery, infants were assigned to one of the four drug‐exposure cohorts: golimumab, other anti‐TNF biologics, other biologics, and nonbiologic systemic therapy, and the general population. Prevalence of adverse pregnancy outcomes, mortality, diagnoses of major congenital anomalies (MCA), and inpatient infections in the infants' first year of life were assessed. Odds ratios and 95% CIs were calculated for MCA and infection. Results: Among 134 infants in the golimumab cohort, none were stillborn or died in the first year of life. MCA were diagnosed in 4.5% of the infants in the golimumab cohort, versus 6.8%, 10.9%, 5.5%, and 4.6% in the other anti‐TNF biologics, other biologics, nonbiologic systemic therapy and general population cohorts, respectively. Inpatient infections were diagnosed in 11% of golimumab‐exposed infants, compared with 9%–11% of infants in the other cohorts. Unadjusted and selected adjusted comparisons showed no association between prenatal golimumab exposure and MCA or infection compared with the other exposure cohorts or general population. Conclusions: The number of infants with prenatal golimumab exposure was low, but results are reassuringly consistent with the evidence available for other anti‐TNF biologics. Continued monitoring is needed. [ABSTRACT FROM AUTHOR]

Published
2024
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5. Methodology of the brodalumab assessment of hazards: a multicentre observational safety (BRAHMS) study

Author

Reilev, Mette, primary, Jensen, Peter Bjødstrup, additional, Ranch, Lise Skov, additional, Egeberg, Alexander, additional, Furu, Kari, additional, Gembert, Karin, additional, Hagg, David, additional, Haug, Ulrike, additional, Karlstad, Øystein, additional, Reutfors, Johan, additional, Schäfer, Wiebke, additional, Schwartz, Sarina, additional, Smits, Elisabeth, additional, Holthius, Emily, additional, Herings, Ron, additional, Trifirò, Gianluca, additional, Kirchmayer, Ursula, additional, Rosa, Alessandro Cesare, additional, Belleudi, Valeria, additional, Gini, Rosa, additional, Støvring, Henrik, additional, and Hallas, Jesper, additional

Published
2023
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6. Long-Term Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus and Pimecrolimus: Final Results from the Extension of the Cohort Study Protopic Joint European Longitudinal Lymphoma and Skin Cancer Evaluation (JOELLE)

Author

Arana, Alejandro, primary, Pottegård, Anton, additional, Kuiper, Josephina G, additional, Booth, Helen, additional, Reutfors, Johan, additional, Calingaert, Brian, additional, Lund, Lars Christian, additional, Crellin, Elizabeth, additional, Schmitt-Egenolf, Marcus, additional, Kaye, James A, additional, Gembert, Karin, additional, Rothman, Kenneth J, additional, Kieler, Helle, additional, Dedman, Daniel, additional, Houben, Eline, additional, Gutiérrez, Lia, additional, Hallas, Jesper, additional, and Perez-Gutthann, Susana, additional

Published
2021
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7. Long-Term Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus and Pimecrolimus : Final Results from the Extension of the Cohort Study Protopic Joint European Longitudinal Lymphoma and Skin Cancer Evaluation (JOELLE)

Author

Arana, Alejandro, Pottegård, Anton, Kuiper, Josephina G., Booth, Helen, Reutfors, Johan, Calingaert, Brian, Lund, Lars Christian, Crellin, Elizabeth, Schmitt-Egenolf, Marcus, Kaye, James A., Gembert, Karin, Rothman, Kenneth J., Kieler, Helle, Dedman, Daniel, Houben, Eline, Gutiérrez, Lia, Hallas, Jesper, Perez-Gutthann, Susana, Arana, Alejandro, Pottegård, Anton, Kuiper, Josephina G., Booth, Helen, Reutfors, Johan, Calingaert, Brian, Lund, Lars Christian, Crellin, Elizabeth, Schmitt-Egenolf, Marcus, Kaye, James A., Gembert, Karin, Rothman, Kenneth J., Kieler, Helle, Dedman, Daniel, Houben, Eline, Gutiérrez, Lia, Hallas, Jesper, and Perez-Gutthann, Susana

Abstract

Purpose: Evidence is insufficient to infer whether topical calcineurin inhibitors (TCIs; tacrolimus and pimecrolimus) cause malignancy. The study objective was to estimate the long-term risk of skin cancer and lymphoma associated with topical TCI use in adults and children, separately. Patients and Methods: A cohort study in Denmark, Sweden, UK, and the Netherlands was conducted. Adjusted incidence rate ratios (IRRs) and 95% confidence intervals (CIs) were calculated for nonmelanoma skin cancer (NMSC), melanoma, cutaneous T-cell lymphoma (CTCL), non-Hodgkin lymphoma (NHL) excluding CTCL, and Hodgkin lymphoma (HL) in new users of TCIs versus users of moderate/high-potency topical corticosteroids. Results: The study included 126,908/61,841 adults and 32,605/27,961 children initiating treatment with tacrolimus/pimecrolimus, respectively. Follow-up was ≥10 years for 19% of adults and 32% of children. Incidence rate ratios and (95% confidence intervals) for tacrolimus versus corticosteroid users in adults were <1 for melanoma, non-Hodgkin lymphoma, and Hodgkin lymphoma; and 1.80 (1.25-2.58) for cutaneous T-cell lymphoma. For pimecrolimus, IRRs in adults were <1 for non-Hodgkin lymphoma, cutaneous T-cell lymphoma, and Hodgkin's lymphoma; and 1.21 (1.03-1.41) for melanoma; and 1.28 (1.20-1.35) for nonmelanoma skin cancer. In children, results were inconclusive due to few events. In adults, incidence rate ratios ≥5 years after first topical calcineurin inhibitor exposure were not higher than in overall analyses. Conclusion: Overall, we found little evidence associating use of topical calcineurin inhibitors with skin cancer and lymphoma; confounding by indication, surveillance bias, and reverse causation may have influenced these results. Even if causal, the public health impact of these excess risks would be low and confined to the first years of exposure.

Published
2021
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8. Long-Term Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus and Pimecrolimus: Final Results from the Extension of the Cohort Study Protopic Joint European Longitudinal Lymphoma and Skin Cancer Evaluation (JOELLE)

Author

Arana,Alejandro, Pottegård,Anton, Kuiper,Josephina G, Booth,Helen, Reutfors,Johan, Calingaert,Brian, Lund,Lars Christian, Crellin,Elizabeth, Schmitt-Egenolf,Marcus, Kaye,James A, Gembert,Karin, Rothman,Kenneth J, Kieler,Helle, Dedman,Daniel, Houben,Eline, Gutiérrez,Lia, Hallas,Jesper, Perez-Gutthann,Susana, Arana,Alejandro, Pottegård,Anton, Kuiper,Josephina G, Booth,Helen, Reutfors,Johan, Calingaert,Brian, Lund,Lars Christian, Crellin,Elizabeth, Schmitt-Egenolf,Marcus, Kaye,James A, Gembert,Karin, Rothman,Kenneth J, Kieler,Helle, Dedman,Daniel, Houben,Eline, Gutiérrez,Lia, Hallas,Jesper, and Perez-Gutthann,Susana

Abstract

Alejandro Arana,1 Anton Pottegård,2 Josephina G Kuiper,3 Helen Booth,4 Johan Reutfors,5 Brian Calingaert,6 Lars Christian Lund,2 Elizabeth Crellin,4 Marcus Schmitt-Egenolf,5,7 James A Kaye,8 Karin Gembert,5 Kenneth J Rothman,8 Helle Kieler,5 Daniel Dedman,4 Eline Houben,3 Lia Gutiérrez,1 Jesper Hallas,2 Susana Perez-Gutthann1 1Department of Epidemiology, RTI Health Solutions, Barcelona, 08028, Spain; 2Clinical Pharmacology, Pharmacy and Environmental Medicine, Institute of Public Health, University of Southern Denmark, Odense C, 5000, Denmark; 3The PHARMO Institute, Utrecht, 3528 AE, the Netherlands; 4Clinical Practice Research Datalink (CPRD), The Medicines and Healthcare Products Regulatory Agency, London, E14 4PU, UK; 5Centre for Pharmacoepidemiology, Karolinska Institutet, Solna, 171 76, Stockholm, Sweden; 6Department of Epidemiology, RTI Health Solutions, Research Triangle Park, NC, 27709-2194, USA; 7Department of Public Health and Clinical Medicine, Umeå University, Umeå, 901 87, Sweden; 8Department of Epidemiology, RTI Health Solutions, Waltham, MA, 02451-1623, USACorrespondence: Alejandro AranaDepartment of Epidemiology, RTI Health Solutions, Av. Diagonal 605, 9-1, Barcelona, 08028, SpainTel +34 93 362 2805Fax +34 93 414 2610Email aarana@rti.orgPurpose: Evidence is insufficient to infer whether topical calcineurin inhibitors (TCIs; tacrolimus and pimecrolimus) cause malignancy. The study objective was to estimate the long-term risk of skin cancer and lymphoma associated with topical TCI use in adults and children, separately.Patients and Methods: A cohort study in Denmark, Sweden, UK, and the Netherlands was conducted. Adjusted incidence rate ratios (IRRs) and 95% confidence intervals (CIs) were calculated for nonmelanoma skin cancer (NMSC), melanoma, cutaneous T-cell lymphoma (CTCL), non-Hodgkin lymphoma (NHL) excluding CTCL, and Hodgkin lymphoma (HL) in new users of TCIs versus users of moderate/high-potency topical corticosteroids.Results: The study i

Published
2021

9. To what extent are topical tacrolimus or pimecrolimus associated with increased risk of skin cancer and lymphoma? : Longterm results from Joelle study

Author

Arana, Alejandro, Pottegard, Anton, Kuiper, Josephina G., Crellin, Elizabeth, Reutfors, Johan, Schmitt-Egenolf, Marcus, Lund, Lars Christian, Houben, Eline, Booth, Helen, Calingaert, Brian, Kaye, James A., Gembert, Karin, Rothman, Kenneth J., Dedman, Daniel, Kieler, Helle, Gutierrez, Lia, Hallas, Jesper, Perez-Gutthann, Susana, Arana, Alejandro, Pottegard, Anton, Kuiper, Josephina G., Crellin, Elizabeth, Reutfors, Johan, Schmitt-Egenolf, Marcus, Lund, Lars Christian, Houben, Eline, Booth, Helen, Calingaert, Brian, Kaye, James A., Gembert, Karin, Rothman, Kenneth J., Dedman, Daniel, Kieler, Helle, Gutierrez, Lia, Hallas, Jesper, and Perez-Gutthann, Susana

Abstract

Special Issue nr. 3

Published
2020
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10. Minerva: Metadata for data discoverability and study replicability in observational studies

Author

Gutierrez, Lia, Gini, Rosa, Pajouheshnia, Romin, Hyde, Eleanor, Swertz, Morris A., Sturkenboom, Miriam, Margulis, Andrea, Franzoni, Carla, Arana, Alejandro, Ehrenstein, Vera, Gembert, Karin, Jansen, Ella, Herings, Ron, Thurin, Nicolas H., Locatelli, Igor, Jazbar, Janja, Zerovnik, Spela, Kos, Mitja, Smit, Steven, Lind, Sirje, Metspalu, Andres, Zaccagnino, Silvia, Busto, Maria Paula, Middelkoop, Bas, Barreiro-De Acosta, Manuel, Sanchez-Saez, Francisco, Rodriguez-Bernal, Clara, Gabriel Sanfélix-Gimeno, Poblador-Plou, Beatriz, Carmona-Pirez, Jonas, Gimeno-Miguel, Antonio, Gil, Miguel, Schaefer, Wiebke, Haug, Ulrike, Simou, Stefania, Quinten, Chantal, Cochino, Ana, Alcini, Paolo, Kurz, Xavier, and Perez-Gutthann, Susana

11. Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Lessons Learnt From the MINERVA Project in Europe.

Author

Gini R, Pajouheshnia R, Gutierrez L, Swertz MA, Hyde E, Sturkenboom M, Arana A, Franzoni C, Ehrenstein V, Roberto G, Gil M, Maciá MA, Schäfer W, Haug U, Thurin NH, Lassalle R, Droz-Perroteau C, Zaccagnino S, Busto MP, Middelkoop B, Gembert K, Sanchez-Saez F, Rodriguez-Bernal C, Sanfélix-Gimeno G, Hurtado I, Acosta MB, Poblador-Plou B, Carmona-Pírez J, Gimeno-Miguel A, Prados-Torres A, Schultze A, Jansen E, Herings R, Kuiper J, Locatelli I, Jazbar J, Žerovnik Š, Kos M, Smit S, Lind S, Metspalu A, Simou S, Hedenmalm K, Cochino A, Alcini P, Kurz X, and Perez-Gutthann S

Subjects
Europe, Humans, Reproducibility of Results, Data Mining methods, Pharmacoepidemiology methods, Databases, Factual, Observational Studies as Topic methods, Metadata
Published
2024
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12. Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Development and Pilot of a Metadata List and Catalogue in Europe.

Author

Pajouheshnia R, Gini R, Gutierrez L, Swertz MA, Hyde E, Sturkenboom M, Arana A, Franzoni C, Ehrenstein V, Roberto G, Gil M, Maciá MA, Schäfer W, Haug U, Thurin NH, Lassalle R, Droz-Perroteau C, Zaccagnino S, Busto MP, Middelkoop B, Gembert K, Sanchez-Saez F, Rodriguez-Bernal C, Sanfélix-Gimeno G, Hurtado I, Acosta MB, Poblador-Plou B, Carmona-Pírez J, Gimeno-Miguel A, Prados-Torres A, Schultze A, Jansen E, Herings R, Kuiper J, Locatelli I, Jazbar J, Žerovnik Š, Kos M, Smit S, Lind S, Metspalu A, Simou S, Hedenmalm K, Cochino A, Alcini P, Kurz X, and Perez-Gutthann S

Subjects
Europe, Humans, Pilot Projects, Reproducibility of Results, Data Collection methods, Data Collection standards, Databases, Factual statistics & numerical data, Software, Pharmacoepidemiology methods, Metadata, Observational Studies as Topic methods
Abstract

Purpose: Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies (MINERVA), a European Medicines Agency-funded project (EUPAS39322), defined a set of metadata to describe real-world data sources (RWDSs) and piloted metadata collection in a prototype catalogue to assist investigators from data source discoverability through study conduct., Methods: A list of metadata was created from a review of existing metadata catalogues and recommendations, structured interviews, a stakeholder survey, and a technical workshop. The prototype was designed to comply with the FAIR principles (findable, accessible, interoperable, reusable), using MOLGENIS software. Metadata collection was piloted by 15 data access partners (DAPs) from across Europe., Results: A total of 442 metadata variables were defined in six domains: institutions (organizations connected to a data source); data banks (data collections sustained by an organization); data sources (collections of linkable data banks covering a common underlying population); studies; networks (of institutions); and common data models (CDMs). A total of 26 institutions were recorded in the prototype. Each DAP populated the metadata of one data source and its selected data banks. The number of data banks varied by data source; the most common data banks were hospital administrative records and pharmacy dispensation records (10 data sources each). Quantitative metadata were successfully extracted from three data sources conforming to different CDMs and entered into the prototype., Conclusions: A metadata list was finalized, a prototype was successfully populated, and a good practice guide was developed. Setting up and maintaining a metadata catalogue on RWDSs will require substantial effort to support discoverability of data sources and reproducibility of studies in Europe., (© 2024 The Author(s). Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.)

Published
2024
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