Serveur d'exploration COVID et hydrochloroquine

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Risk of depression, suicide and psychosis with hydroxychloroquine treatment for rheumatoid arthritis: a multinational network cohort study.

Identifieur interne : 000C78 ( Main/Exploration ); précédent : 000C77; suivant : 000C79

Risk of depression, suicide and psychosis with hydroxychloroquine treatment for rheumatoid arthritis: a multinational network cohort study.

Auteurs : Jennifer C E. Lane [Royaume-Uni] ; James Weaver [États-Unis] ; Kristin Kostka [États-Unis] ; Talita Duarte-Salles [Espagne] ; Maria Tereza F. Abrahao [Brésil] ; Heba Alghoul ; Osaid Alser [États-Unis] ; Thamir M. Alshammari [Arabie saoudite] ; Carlos Areia [Royaume-Uni] ; Patricia Biedermann [Suisse] ; Juan M. Banda [États-Unis] ; Edward Burn [Royaume-Uni, Espagne] ; Paula Casajust [Espagne] ; Kristina Fister [Croatie] ; Jill Hardin [États-Unis] ; Laura Hester [États-Unis] ; George Hripcsak [États-Unis] ; Benjamin Skov Kaas-Hansen [Danemark] ; Sajan Khosla [Royaume-Uni] ; Spyros Kolovos [Royaume-Uni] ; Kristine E. Lynch [États-Unis] ; Rupa Makadia [États-Unis] ; Paras P. Mehta [États-Unis] ; Daniel R. Morales [Royaume-Uni] ; Henry Morgan-Stewart [États-Unis] ; Mees Mosseveld [Pays-Bas] ; Danielle Newby [Royaume-Uni] ; Fredrik Nyberg [Suède] ; Anna Ostropolets [États-Unis] ; Rae Woong Park [Corée du Sud] ; Albert Prats-Uribe [Royaume-Uni] ; Gowtham A. Rao [États-Unis] ; Christian Reich [États-Unis] ; Peter Rijnbeek [Pays-Bas] ; Anthony G. Sena [États-Unis, Pays-Bas] ; Azza Shoaibi [États-Unis] ; Matthew Spotnitz [États-Unis] ; Subbian Vignesh [États-Unis] ; Marc A. Suchard [États-Unis] ; David Vizcaya [Espagne] ; Haini Wen [République populaire de Chine] ; Marcel De Wilde [Pays-Bas] ; Junqing Xie [Royaume-Uni] ; Seng Chan You [Corée du Sud] ; Lin Zhang [République populaire de Chine, Australie] ; Simon Lovestone [Royaume-Uni] ; Patrick Ryan [États-Unis] ; Daniel Prieto-Alhambra [Royaume-Uni]

Source :

RBID : pubmed:33367863

Abstract

OBJECTIVES

Concern has been raised in the rheumatology community regarding recent regulatory warnings that HCQ used in the coronavirus disease 2019 pandemic could cause acute psychiatric events. We aimed to study whether there is risk of incident depression, suicidal ideation or psychosis associated with HCQ as used for RA.

METHODS

We performed a new-user cohort study using claims and electronic medical records from 10 sources and 3 countries (Germany, UK and USA). RA patients ≥18 years of age and initiating HCQ were compared with those initiating SSZ (active comparator) and followed up in the short (30 days) and long term (on treatment). Study outcomes included depression, suicide/suicidal ideation and hospitalization for psychosis. Propensity score stratification and calibration using negative control outcomes were used to address confounding. Cox models were fitted to estimate database-specific calibrated hazard ratios (HRs), with estimates pooled where I2 <40%.

RESULTS

A total of 918 144 and 290 383 users of HCQ and SSZ, respectively, were included. No consistent risk of psychiatric events was observed with short-term HCQ (compared with SSZ) use, with meta-analytic HRs of 0.96 (95% CI 0.79, 1.16) for depression, 0.94 (95% CI 0.49, 1.77) for suicide/suicidal ideation and 1.03 (95% CI 0.66, 1.60) for psychosis. No consistent long-term risk was seen, with meta-analytic HRs of 0.94 (95% CI 0.71, 1.26) for depression, 0.77 (95% CI 0.56, 1.07) for suicide/suicidal ideation and 0.99 (95% CI 0.72, 1.35) for psychosis.

CONCLUSION

HCQ as used to treat RA does not appear to increase the risk of depression, suicide/suicidal ideation or psychosis compared with SSZ. No effects were seen in the short or long term. Use at a higher dose or for different indications needs further investigation.

TRIAL REGISTRATION

Registered with EU PAS (reference no. EUPAS34497; http://www.encepp.eu/encepp/viewResource.htm? id=34498). The full study protocol and analysis source code can be found at https://github.com/ohdsi-studies/Covid19EstimationHydroxychloroquine2.


DOI: 10.1093/rheumatology/keaa771
PubMed: 33367863
PubMed Central: PMC7798671


Affiliations:


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<nlm:affiliation>Department of Biomedical Informatics, Ajou University School of Medicine, Suwon-si, Gyeonggi-do, South Korea.</nlm:affiliation>
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<title xml:lang="en">Risk of depression, suicide and psychosis with hydroxychloroquine treatment for rheumatoid arthritis: a multinational network cohort study.</title>
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<region type="state">New Jersey</region>
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<name sortKey="Hripcsak, George" sort="Hripcsak, George" uniqKey="Hripcsak G" first="George" last="Hripcsak">George Hripcsak</name>
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</author>
<author>
<name sortKey="Kaas Hansen, Benjamin Skov" sort="Kaas Hansen, Benjamin Skov" uniqKey="Kaas Hansen B" first="Benjamin Skov" last="Kaas-Hansen">Benjamin Skov Kaas-Hansen</name>
<affiliation wicri:level="1">
<nlm:affiliation>Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Clinical Pharmacology Unit, Zealand University Hospital, Roskilde</wicri:regionArea>
<wicri:noRegion>Roskilde</wicri:noRegion>
</affiliation>
<affiliation wicri:level="3">
<nlm:affiliation>NNF Centre for Protein Research, University of Copenhagen, Copenhagen, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>NNF Centre for Protein Research, University of Copenhagen, Copenhagen</wicri:regionArea>
<placeName>
<settlement type="city">Copenhague</settlement>
<region type="région" nuts="2">Hovedstaden</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Khosla, Sajan" sort="Khosla, Sajan" uniqKey="Khosla S" first="Sajan" last="Khosla">Sajan Khosla</name>
<affiliation wicri:level="1">
<nlm:affiliation>Real World Science & Digital, AstraZeneca, Cambridge, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Real World Science & Digital, AstraZeneca, Cambridge</wicri:regionArea>
<wicri:noRegion>Cambridge</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Kolovos, Spyros" sort="Kolovos, Spyros" uniqKey="Kolovos S" first="Spyros" last="Kolovos">Spyros Kolovos</name>
<affiliation wicri:level="4">
<nlm:affiliation>Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford</wicri:regionArea>
<placeName>
<settlement type="city">Oxford</settlement>
<region type="country">Angleterre</region>
<region type="comté" nuts="2">Oxfordshire</region>
</placeName>
<orgName type="university">Université d'Oxford</orgName>
</affiliation>
</author>
<author>
<name sortKey="Lynch, Kristine E" sort="Lynch, Kristine E" uniqKey="Lynch K" first="Kristine E" last="Lynch">Kristine E. Lynch</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Veterans Affairs, Salt Lake City, UT, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Veterans Affairs, Salt Lake City, UT</wicri:regionArea>
<placeName>
<region type="state">Utah</region>
</placeName>
</affiliation>
<affiliation wicri:level="2">
<nlm:affiliation>University of Utah School of Medicine, Salt Lake City, UT, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Utah School of Medicine, Salt Lake City, UT</wicri:regionArea>
<placeName>
<region type="state">Utah</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Makadia, Rupa" sort="Makadia, Rupa" uniqKey="Makadia R" first="Rupa" last="Makadia">Rupa Makadia</name>
<affiliation wicri:level="2">
<nlm:affiliation>Janssen Research and Development, Titusville, NJ, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Janssen Research and Development, Titusville, NJ</wicri:regionArea>
<placeName>
<region type="state">New Jersey</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Mehta, Paras P" sort="Mehta, Paras P" uniqKey="Mehta P" first="Paras P" last="Mehta">Paras P. Mehta</name>
<affiliation wicri:level="2">
<nlm:affiliation>College of Medicine, University of Arizona, Tucson, AZ, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>College of Medicine, University of Arizona, Tucson, AZ</wicri:regionArea>
<placeName>
<region type="state">Arizona</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Morales, Daniel R" sort="Morales, Daniel R" uniqKey="Morales D" first="Daniel R" last="Morales">Daniel R. Morales</name>
<affiliation wicri:level="1">
<nlm:affiliation>Division of Population Health and Genomics, University of Dundee, Dundee, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Division of Population Health and Genomics, University of Dundee, Dundee</wicri:regionArea>
<wicri:noRegion>Dundee</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Morgan Stewart, Henry" sort="Morgan Stewart, Henry" uniqKey="Morgan Stewart H" first="Henry" last="Morgan-Stewart">Henry Morgan-Stewart</name>
<affiliation wicri:level="2">
<nlm:affiliation>Real World Solutions, IQVIA, Cambridge, MA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Real World Solutions, IQVIA, Cambridge, MA</wicri:regionArea>
<placeName>
<region type="state">Massachusetts</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Mosseveld, Mees" sort="Mosseveld, Mees" uniqKey="Mosseveld M" first="Mees" last="Mosseveld">Mees Mosseveld</name>
<affiliation wicri:level="3">
<nlm:affiliation>Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Department of Medical Informatics, Erasmus University Medical Center, Rotterdam</wicri:regionArea>
<placeName>
<settlement type="city">Rotterdam</settlement>
<region nuts="2" type="province">Hollande-Méridionale</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Newby, Danielle" sort="Newby, Danielle" uniqKey="Newby D" first="Danielle" last="Newby">Danielle Newby</name>
<affiliation wicri:level="4">
<nlm:affiliation>Department of Psychiatry, University of Oxford, Oxford, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Department of Psychiatry, University of Oxford, Oxford</wicri:regionArea>
<placeName>
<settlement type="city">Oxford</settlement>
<region type="country">Angleterre</region>
<region type="comté" nuts="2">Oxfordshire</region>
</placeName>
<orgName type="university">Université d'Oxford</orgName>
</affiliation>
</author>
<author>
<name sortKey="Nyberg, Fredrik" sort="Nyberg, Fredrik" uniqKey="Nyberg F" first="Fredrik" last="Nyberg">Fredrik Nyberg</name>
<affiliation wicri:level="1">
<nlm:affiliation>School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.</nlm:affiliation>
<country xml:lang="fr">Suède</country>
<wicri:regionArea>School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg</wicri:regionArea>
<wicri:noRegion>Gothenburg</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Ostropolets, Anna" sort="Ostropolets, Anna" uniqKey="Ostropolets A" first="Anna" last="Ostropolets">Anna Ostropolets</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Biomedical Informatics, Columbia University Irving Medical Center, New York, NY, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Biomedical Informatics, Columbia University Irving Medical Center, New York, NY</wicri:regionArea>
<placeName>
<region type="state">État de New York</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Woong Park, Rae" sort="Woong Park, Rae" uniqKey="Woong Park R" first="Rae" last="Woong Park">Rae Woong Park</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Biomedical Informatics, Ajou University School of Medicine, Suwon-si, Gyeonggi-do, South Korea.</nlm:affiliation>
<country xml:lang="fr">Corée du Sud</country>
<wicri:regionArea>Department of Biomedical Informatics, Ajou University School of Medicine, Suwon-si, Gyeonggi-do</wicri:regionArea>
<wicri:noRegion>Gyeonggi-do</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Prats Uribe, Albert" sort="Prats Uribe, Albert" uniqKey="Prats Uribe A" first="Albert" last="Prats-Uribe">Albert Prats-Uribe</name>
<affiliation wicri:level="4">
<nlm:affiliation>Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford</wicri:regionArea>
<placeName>
<settlement type="city">Oxford</settlement>
<region type="country">Angleterre</region>
<region type="comté" nuts="2">Oxfordshire</region>
</placeName>
<orgName type="university">Université d'Oxford</orgName>
</affiliation>
</author>
<author>
<name sortKey="Rao, Gowtham A" sort="Rao, Gowtham A" uniqKey="Rao G" first="Gowtham A" last="Rao">Gowtham A. Rao</name>
<affiliation wicri:level="2">
<nlm:affiliation>Janssen Research and Development, Titusville, NJ, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Janssen Research and Development, Titusville, NJ</wicri:regionArea>
<placeName>
<region type="state">New Jersey</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Reich, Christian" sort="Reich, Christian" uniqKey="Reich C" first="Christian" last="Reich">Christian Reich</name>
<affiliation wicri:level="2">
<nlm:affiliation>Real World Solutions, IQVIA, Cambridge, MA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Real World Solutions, IQVIA, Cambridge, MA</wicri:regionArea>
<placeName>
<region type="state">Massachusetts</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Rijnbeek, Peter" sort="Rijnbeek, Peter" uniqKey="Rijnbeek P" first="Peter" last="Rijnbeek">Peter Rijnbeek</name>
<affiliation wicri:level="3">
<nlm:affiliation>Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Department of Medical Informatics, Erasmus University Medical Center, Rotterdam</wicri:regionArea>
<placeName>
<settlement type="city">Rotterdam</settlement>
<region nuts="2" type="province">Hollande-Méridionale</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Sena, Anthony G" sort="Sena, Anthony G" uniqKey="Sena A" first="Anthony G" last="Sena">Anthony G. Sena</name>
<affiliation wicri:level="2">
<nlm:affiliation>Janssen Research and Development, Titusville, NJ, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Janssen Research and Development, Titusville, NJ</wicri:regionArea>
<placeName>
<region type="state">New Jersey</region>
</placeName>
</affiliation>
<affiliation wicri:level="3">
<nlm:affiliation>Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Department of Medical Informatics, Erasmus University Medical Center, Rotterdam</wicri:regionArea>
<placeName>
<settlement type="city">Rotterdam</settlement>
<region nuts="2" type="province">Hollande-Méridionale</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Shoaibi, Azza" sort="Shoaibi, Azza" uniqKey="Shoaibi A" first="Azza" last="Shoaibi">Azza Shoaibi</name>
<affiliation wicri:level="2">
<nlm:affiliation>Janssen Research and Development, Titusville, NJ, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Janssen Research and Development, Titusville, NJ</wicri:regionArea>
<placeName>
<region type="state">New Jersey</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Spotnitz, Matthew" sort="Spotnitz, Matthew" uniqKey="Spotnitz M" first="Matthew" last="Spotnitz">Matthew Spotnitz</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Biomedical Informatics, Columbia University Irving Medical Center, New York, NY, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Biomedical Informatics, Columbia University Irving Medical Center, New York, NY</wicri:regionArea>
<placeName>
<region type="state">État de New York</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Vignesh, Subbian" sort="Vignesh, Subbian" uniqKey="Vignesh S" first="Subbian" last="Vignesh">Subbian Vignesh</name>
<affiliation wicri:level="2">
<nlm:affiliation>College of Engineering, University of Arizona, Tucson, AZ, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>College of Engineering, University of Arizona, Tucson, AZ</wicri:regionArea>
<placeName>
<region type="state">Arizona</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Suchard, Marc A" sort="Suchard, Marc A" uniqKey="Suchard M" first="Marc A" last="Suchard">Marc A. Suchard</name>
<affiliation wicri:level="2">
<nlm:affiliation>Departments of Biomathematics and Human Genetics David Geffen School of Medicine at UCLA, and Department of Biostatistics, UCLA School of Public Health, South Los Angeles, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Departments of Biomathematics and Human Genetics David Geffen School of Medicine at UCLA, and Department of Biostatistics, UCLA School of Public Health, South Los Angeles, CA</wicri:regionArea>
<placeName>
<region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Vizcaya, David" sort="Vizcaya, David" uniqKey="Vizcaya D" first="David" last="Vizcaya">David Vizcaya</name>
<affiliation wicri:level="3">
<nlm:affiliation>Bayer Pharmaceuticals, Sant Joan Despi, Barcelona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Bayer Pharmaceuticals, Sant Joan Despi, Barcelona</wicri:regionArea>
<placeName>
<settlement type="city">Barcelone</settlement>
<region nuts="2" type="region">Catalogne</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Wen, Haini" sort="Wen, Haini" uniqKey="Wen H" first="Haini" last="Wen">Haini Wen</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Pharmacy, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, P.R. China.</nlm:affiliation>
<country xml:lang="fr" wicri:curation="lc">République populaire de Chine</country>
<wicri:regionArea>Department of Pharmacy, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai</wicri:regionArea>
<wicri:noRegion>Shanghai</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="De Wilde, Marcel" sort="De Wilde, Marcel" uniqKey="De Wilde M" first="Marcel" last="De Wilde">Marcel De Wilde</name>
<affiliation wicri:level="3">
<nlm:affiliation>Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Department of Medical Informatics, Erasmus University Medical Center, Rotterdam</wicri:regionArea>
<placeName>
<settlement type="city">Rotterdam</settlement>
<region nuts="2" type="province">Hollande-Méridionale</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Xie, Junqing" sort="Xie, Junqing" uniqKey="Xie J" first="Junqing" last="Xie">Junqing Xie</name>
<affiliation wicri:level="4">
<nlm:affiliation>Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford</wicri:regionArea>
<placeName>
<settlement type="city">Oxford</settlement>
<region type="country">Angleterre</region>
<region type="comté" nuts="2">Oxfordshire</region>
</placeName>
<orgName type="university">Université d'Oxford</orgName>
</affiliation>
</author>
<author>
<name sortKey="You, Seng Chan" sort="You, Seng Chan" uniqKey="You S" first="Seng Chan" last="You">Seng Chan You</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Biomedical Informatics, Ajou University School of Medicine, Suwon-si, Gyeonggi-do, South Korea.</nlm:affiliation>
<country xml:lang="fr">Corée du Sud</country>
<wicri:regionArea>Department of Biomedical Informatics, Ajou University School of Medicine, Suwon-si, Gyeonggi-do</wicri:regionArea>
<wicri:noRegion>Gyeonggi-do</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Zhang, Lin" sort="Zhang, Lin" uniqKey="Zhang L" first="Lin" last="Zhang">Lin Zhang</name>
<affiliation wicri:level="3">
<nlm:affiliation>School of Public Health, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, P.R. China.</nlm:affiliation>
<country xml:lang="fr" wicri:curation="lc">République populaire de Chine</country>
<wicri:regionArea>School of Public Health, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing</wicri:regionArea>
<placeName>
<settlement type="city">Pékin</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="4">
<nlm:affiliation>Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Melbourne School of Population and Global Health, University of Melbourne, Melbourne</wicri:regionArea>
<placeName>
<settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
</placeName>
<orgName type="university">Université de Melbourne</orgName>
</affiliation>
</author>
<author>
<name sortKey="Lovestone, Simon" sort="Lovestone, Simon" uniqKey="Lovestone S" first="Simon" last="Lovestone">Simon Lovestone</name>
<affiliation wicri:level="1">
<nlm:affiliation>Janssen-Cilag, 50-100 Holmers Farm Way, High Wycombe HP12 4EG, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Janssen-Cilag, 50-100 Holmers Farm Way, High Wycombe HP12 4EG</wicri:regionArea>
<wicri:noRegion>High Wycombe HP12 4EG</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Ryan, Patrick" sort="Ryan, Patrick" uniqKey="Ryan P" first="Patrick" last="Ryan">Patrick Ryan</name>
<affiliation wicri:level="2">
<nlm:affiliation>Janssen Research and Development, Titusville, NJ, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Janssen Research and Development, Titusville, NJ</wicri:regionArea>
<placeName>
<region type="state">New Jersey</region>
</placeName>
</affiliation>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Biomedical Informatics, Columbia University Irving Medical Center, New York, NY, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Biomedical Informatics, Columbia University Irving Medical Center, New York, NY</wicri:regionArea>
<placeName>
<region type="state">État de New York</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Prieto Alhambra, Daniel" sort="Prieto Alhambra, Daniel" uniqKey="Prieto Alhambra D" first="Daniel" last="Prieto-Alhambra">Daniel Prieto-Alhambra</name>
<affiliation wicri:level="4">
<nlm:affiliation>Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford</wicri:regionArea>
<placeName>
<settlement type="city">Oxford</settlement>
<region type="country">Angleterre</region>
<region type="comté" nuts="2">Oxfordshire</region>
</placeName>
<orgName type="university">Université d'Oxford</orgName>
</affiliation>
</author>
</analytic>
<series>
<title level="j">Rheumatology (Oxford, England)</title>
<idno type="eISSN">1462-0332</idno>
<imprint>
<date when="2020" type="published">2020</date>
</imprint>
</series>
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</fileDesc>
<profileDesc>
<textClass></textClass>
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</teiHeader>
<front>
<div type="abstract" xml:lang="en">
<p>
<b>OBJECTIVES</b>
</p>
<p>Concern has been raised in the rheumatology community regarding recent regulatory warnings that HCQ used in the coronavirus disease 2019 pandemic could cause acute psychiatric events. We aimed to study whether there is risk of incident depression, suicidal ideation or psychosis associated with HCQ as used for RA.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>METHODS</b>
</p>
<p>We performed a new-user cohort study using claims and electronic medical records from 10 sources and 3 countries (Germany, UK and USA). RA patients ≥18 years of age and initiating HCQ were compared with those initiating SSZ (active comparator) and followed up in the short (30 days) and long term (on treatment). Study outcomes included depression, suicide/suicidal ideation and hospitalization for psychosis. Propensity score stratification and calibration using negative control outcomes were used to address confounding. Cox models were fitted to estimate database-specific calibrated hazard ratios (HRs), with estimates pooled where I2 <40%.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>RESULTS</b>
</p>
<p>A total of 918 144 and 290 383 users of HCQ and SSZ, respectively, were included. No consistent risk of psychiatric events was observed with short-term HCQ (compared with SSZ) use, with meta-analytic HRs of 0.96 (95% CI 0.79, 1.16) for depression, 0.94 (95% CI 0.49, 1.77) for suicide/suicidal ideation and 1.03 (95% CI 0.66, 1.60) for psychosis. No consistent long-term risk was seen, with meta-analytic HRs of 0.94 (95% CI 0.71, 1.26) for depression, 0.77 (95% CI 0.56, 1.07) for suicide/suicidal ideation and 0.99 (95% CI 0.72, 1.35) for psychosis.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>CONCLUSION</b>
</p>
<p>HCQ as used to treat RA does not appear to increase the risk of depression, suicide/suicidal ideation or psychosis compared with SSZ. No effects were seen in the short or long term. Use at a higher dose or for different indications needs further investigation.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>TRIAL REGISTRATION</b>
</p>
<p>Registered with EU PAS (reference no. EUPAS34497; http://www.encepp.eu/encepp/viewResource.htm? id=34498). The full study protocol and analysis source code can be found at https://github.com/ohdsi-studies/Covid19EstimationHydroxychloroquine2.</p>
</div>
</front>
</TEI>
<pubmed>
<MedlineCitation Status="Publisher" Owner="NLM">
<PMID Version="1">33367863</PMID>
<DateRevised>
<Year>2021</Year>
<Month>05</Month>
<Day>14</Day>
</DateRevised>
<Article PubModel="Print-Electronic">
<Journal>
<ISSN IssnType="Electronic">1462-0332</ISSN>
<JournalIssue CitedMedium="Internet">
<PubDate>
<Year>2020</Year>
<Month>Dec</Month>
<Day>25</Day>
</PubDate>
</JournalIssue>
<Title>Rheumatology (Oxford, England)</Title>
<ISOAbbreviation>Rheumatology (Oxford)</ISOAbbreviation>
</Journal>
<ArticleTitle>Risk of depression, suicide and psychosis with hydroxychloroquine treatment for rheumatoid arthritis: a multinational network cohort study.</ArticleTitle>
<ELocationID EIdType="pii" ValidYN="Y">keaa771</ELocationID>
<ELocationID EIdType="doi" ValidYN="Y">10.1093/rheumatology/keaa771</ELocationID>
<Abstract>
<AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">Concern has been raised in the rheumatology community regarding recent regulatory warnings that HCQ used in the coronavirus disease 2019 pandemic could cause acute psychiatric events. We aimed to study whether there is risk of incident depression, suicidal ideation or psychosis associated with HCQ as used for RA.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">We performed a new-user cohort study using claims and electronic medical records from 10 sources and 3 countries (Germany, UK and USA). RA patients ≥18 years of age and initiating HCQ were compared with those initiating SSZ (active comparator) and followed up in the short (30 days) and long term (on treatment). Study outcomes included depression, suicide/suicidal ideation and hospitalization for psychosis. Propensity score stratification and calibration using negative control outcomes were used to address confounding. Cox models were fitted to estimate database-specific calibrated hazard ratios (HRs), with estimates pooled where I2 <40%.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">A total of 918 144 and 290 383 users of HCQ and SSZ, respectively, were included. No consistent risk of psychiatric events was observed with short-term HCQ (compared with SSZ) use, with meta-analytic HRs of 0.96 (95% CI 0.79, 1.16) for depression, 0.94 (95% CI 0.49, 1.77) for suicide/suicidal ideation and 1.03 (95% CI 0.66, 1.60) for psychosis. No consistent long-term risk was seen, with meta-analytic HRs of 0.94 (95% CI 0.71, 1.26) for depression, 0.77 (95% CI 0.56, 1.07) for suicide/suicidal ideation and 0.99 (95% CI 0.72, 1.35) for psychosis.</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">HCQ as used to treat RA does not appear to increase the risk of depression, suicide/suicidal ideation or psychosis compared with SSZ. No effects were seen in the short or long term. Use at a higher dose or for different indications needs further investigation.</AbstractText>
<AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">Registered with EU PAS (reference no. EUPAS34497; http://www.encepp.eu/encepp/viewResource.htm? id=34498). The full study protocol and analysis source code can be found at https://github.com/ohdsi-studies/Covid19EstimationHydroxychloroquine2.</AbstractText>
<CopyrightInformation>© The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Rheumatology.</CopyrightInformation>
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<Initials>JCE</Initials>
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<CollectiveName>OHDSI-COVID-19 consortium</CollectiveName>
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<Language>eng</Language>
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<Acronym>WT_</Acronym>
<Agency>Wellcome Trust</Agency>
<Country>United Kingdom</Country>
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<Grant>
<GrantID>RES 13-457</GrantID>
<Acronym>RD</Acronym>
<Agency>ORD VA</Agency>
<Country>United States</Country>
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<Month>12</Month>
<Day>25</Day>
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<Keyword MajorTopicYN="N">HCQ</Keyword>
<Keyword MajorTopicYN="N">depression</Keyword>
<Keyword MajorTopicYN="N">epidemiology, RA</Keyword>
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