Evidence map›Paper›PMID 32393664›Full record

ArticleThe Journal of rheumatology2020

Hydroxychloroquine in Patients with Rheumatic Disease Complicated by COVID-19: Clarifying Target Exposures and the Need for Clinical Trials.

Stephen J Balevic, Christoph P Hornik, Thomas P Green, Megan E B Clowse, Daniel Gonzalez, Anil R Maharaj, Laura E Schanberg, Amanda M Eudy, Geeta K Swamy, Brenna L Hughes and 1 more

Open access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The Journal of rheumatology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
4.1field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Covid-19 and autoimmunity.Autoimmunity reviews · 2020
    Review
  9. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

Stephen J BalevicFrom the Department of Rheumatology and Immunology, Duke University School of Medicine, Durham, North Carolina, USA; Duke Clinical Research Institute, Durham, North Carolina, USA; Department of Pediatrics, and the Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine, Durham, North Carolina, USA; Department of Pediatrics, Northwestern University, Feinberg School of Medicine, Evanston, Illinois, USA; Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA. This study was supported by the Rheumatology Research Foundation's Scientist Development Award, the Thrasher Research Fund, the Childhood Arthritis and Rheumatology Research Alliance/Arthritis Foundation, the Derfner Foundation, NIGMS/NICHD (2T32GM086330-06), NICHD (5R01-HD076676-04, HHSN275201000003I), and a Duke Health/Private Diagnostic Clinic ENABLE grant. The Atherosclerosis Prevention in Pediatric Lupus Erythematosus [APPLE (ClinicalTrials. gov: NCT00065806)] trial is supported by the US National Institutes of Health (NIH) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) contract N01-AR-2-2265, the Edna and Fred L. Mandel Jr. Center for Hypertension and Atherosclerosis, and Pfizer, which provided atorvastatin and matching placebo. S.J.B. receives support from the NIH (5R01-HD076676-04, 1R01HD083003-01, HHSN275201000003I, HHSN275201800003I, HHSN272201500006I 5U24-TR001608-03), the US Food and Drug Administration (5U18FD006298-03), the Patient-Centered Outcomes Research Institute (PCORI), the Rheumatology Research Foundation's Scientist Development Award, the Thrasher Research Fund, and the Childhood Arthritis and Rheumatology Research Alliance/Arthritis Foundation. C.P.H. receives salary support for research from the National Institute for Child Health and Human Development (NICHD; 1K23HD090239; R13HD102136), National Heart Lung and Blood Institute (R61/R33HL147833), FDA (1R01-FD006099, PI: Laughon; and 5U18-FD006298, PI: Benjamin), the US government for his work in pediatric clinical pharmacology (Government Contract HHSN275201800003I, PI: Benjamin under the Best Pharmaceuticals for Children Act), the nonprofit Burrhoughs Wellcome Fund, and other sponsors for drug development in adults and children (dcri.org/about-us/ conflict-of-interest). D.G. receives support for research from the Eunice Kennedy Shriver NICHD (5R01HD096435). A.M. receives research support from the Thrasher Research Fund (www.thrasherresearch.org). L.E.S. receives support for research from the NIH (U19AR069522), PCORI (8177), and the Childhood Arthritis and Rheumatology Research Alliance. She is on the Data Safety Monitoring Board for investigational product trials for UCB (Cimzia) and Sanofi (sarilumab). Sanofi is a maker of hydroxychloroquine. Samples used in this publication were collected as part of NIH/NIAMS (N01-AR-2-2265). A.M.E. receives support from the NIH National Center for Advancing Translational Sciences. G.K.S. receives support for research from the NIH (UG1 HD068258‑06, HHSN272201300017I, 1UL1TR002553-01, R21AI132677) and the Centers for Disease Control and Prevention (200-2012-53663). She chairs an Independent Data Monitoring Committee for GlaxoSmithKline (RSV vaccine trials). M.C.W. receives support for research from the NIH (1R01-HD076676‑01A1 and 1K24-AI143971), National Institute of Allergy and Infectious Diseases (HHSN272201500006I and HHSN272201300017I), NICHD (HHSN275201000003I), FDA (5U18-FD006298), and the industry for drug development in adults and children. S.J. Balevic, MD, MHS, Department of Rheumatology and Immunology, and Department of Pediatrics, Duke University School of Medicine, and Duke Clinical Research Institute; C.P. Hornik, MD, PhD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine; T.P. Green, MD, MS, Department of Pediatrics, Northwestern University, Feinberg School of Medicine; M.E. Clowse, MD, MPH, Department of Rheumatology and Immunology, Duke University School of Medicine; D. Gonzalez, PharmD, PhD, Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill; A.R. Maharaj, PhD, Duke Clinical Research Institute; L.E. Schanberg, MD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine; A.M. Eudy, PhD, Department of Rheumatology and Immunology, Duke University School of Medicine; G.K. Swamy, MD, Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine; B.L. Hughes, MD, MSc, Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine; M. Cohen-Wolkowiez, MD, PhD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine. Address correspondence to Dr. S.J. Balevic, Department of Rheumatology and Immunology, Duke University School of Medicine, 2301 Erwin Road, CHC, T-Level, Durham, North Carolina 27710, USA. E-mail: stephen.balevic@duke.edu. Full Release Article. For details see Reprints and Permissions at jrheum. org. Accepted for publication May 14, 2019.ORCID https://orcid.org/0000-0002-4016-1680
Christoph P HornikFrom the Department of Rheumatology and Immunology, Duke University School of Medicine, Durham, North Carolina, USA; Duke Clinical Research Institute, Durham, North Carolina, USA; Department of Pediatrics, and the Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine, Durham, North Carolina, USA; Department of Pediatrics, Northwestern University, Feinberg School of Medicine, Evanston, Illinois, USA; Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA. This study was supported by the Rheumatology Research Foundation's Scientist Development Award, the Thrasher Research Fund, the Childhood Arthritis and Rheumatology Research Alliance/Arthritis Foundation, the Derfner Foundation, NIGMS/NICHD (2T32GM086330-06), NICHD (5R01-HD076676-04, HHSN275201000003I), and a Duke Health/Private Diagnostic Clinic ENABLE grant. The Atherosclerosis Prevention in Pediatric Lupus Erythematosus [APPLE (ClinicalTrials. gov: NCT00065806)] trial is supported by the US National Institutes of Health (NIH) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) contract N01-AR-2-2265, the Edna and Fred L. Mandel Jr. Center for Hypertension and Atherosclerosis, and Pfizer, which provided atorvastatin and matching placebo. S.J.B. receives support from the NIH (5R01-HD076676-04, 1R01HD083003-01, HHSN275201000003I, HHSN275201800003I, HHSN272201500006I 5U24-TR001608-03), the US Food and Drug Administration (5U18FD006298-03), the Patient-Centered Outcomes Research Institute (PCORI), the Rheumatology Research Foundation's Scientist Development Award, the Thrasher Research Fund, and the Childhood Arthritis and Rheumatology Research Alliance/Arthritis Foundation. C.P.H. receives salary support for research from the National Institute for Child Health and Human Development (NICHD; 1K23HD090239; R13HD102136), National Heart Lung and Blood Institute (R61/R33HL147833), FDA (1R01-FD006099, PI: Laughon; and 5U18-FD006298, PI: Benjamin), the US government for his work in pediatric clinical pharmacology (Government Contract HHSN275201800003I, PI: Benjamin under the Best Pharmaceuticals for Children Act), the nonprofit Burrhoughs Wellcome Fund, and other sponsors for drug development in adults and children (dcri.org/about-us/ conflict-of-interest). D.G. receives support for research from the Eunice Kennedy Shriver NICHD (5R01HD096435). A.M. receives research support from the Thrasher Research Fund (www.thrasherresearch.org). L.E.S. receives support for research from the NIH (U19AR069522), PCORI (8177), and the Childhood Arthritis and Rheumatology Research Alliance. She is on the Data Safety Monitoring Board for investigational product trials for UCB (Cimzia) and Sanofi (sarilumab). Sanofi is a maker of hydroxychloroquine. Samples used in this publication were collected as part of NIH/NIAMS (N01-AR-2-2265). A.M.E. receives support from the NIH National Center for Advancing Translational Sciences. G.K.S. receives support for research from the NIH (UG1 HD068258‑06, HHSN272201300017I, 1UL1TR002553-01, R21AI132677) and the Centers for Disease Control and Prevention (200-2012-53663). She chairs an Independent Data Monitoring Committee for GlaxoSmithKline (RSV vaccine trials). M.C.W. receives support for research from the NIH (1R01-HD076676‑01A1 and 1K24-AI143971), National Institute of Allergy and Infectious Diseases (HHSN272201500006I and HHSN272201300017I), NICHD (HHSN275201000003I), FDA (5U18-FD006298), and the industry for drug development in adults and children. S.J. Balevic, MD, MHS, Department of Rheumatology and Immunology, and Department of Pediatrics, Duke University School of Medicine, and Duke Clinical Research Institute; C.P. Hornik, MD, PhD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine; T.P. Green, MD, MS, Department of Pediatrics, Northwestern University, Feinberg School of Medicine; M.E. Clowse, MD, MPH, Department of Rheumatology and Immunology, Duke University School of Medicine; D. Gonzalez, PharmD, PhD, Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill; A.R. Maharaj, PhD, Duke Clinical Research Institute; L.E. Schanberg, MD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine; A.M. Eudy, PhD, Department of Rheumatology and Immunology, Duke University School of Medicine; G.K. Swamy, MD, Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine; B.L. Hughes, MD, MSc, Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine; M. Cohen-Wolkowiez, MD, PhD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine. Address correspondence to Dr. S.J. Balevic, Department of Rheumatology and Immunology, Duke University School of Medicine, 2301 Erwin Road, CHC, T-Level, Durham, North Carolina 27710, USA. E-mail: stephen.balevic@duke.edu. Full Release Article. For details see Reprints and Permissions at jrheum. org. Accepted for publication May 14, 2019.ORCID https://orcid.org/0000-0001-7056-8759
Thomas P GreenFrom the Department of Rheumatology and Immunology, Duke University School of Medicine, Durham, North Carolina, USA; Duke Clinical Research Institute, Durham, North Carolina, USA; Department of Pediatrics, and the Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine, Durham, North Carolina, USA; Department of Pediatrics, Northwestern University, Feinberg School of Medicine, Evanston, Illinois, USA; Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA. This study was supported by the Rheumatology Research Foundation's Scientist Development Award, the Thrasher Research Fund, the Childhood Arthritis and Rheumatology Research Alliance/Arthritis Foundation, the Derfner Foundation, NIGMS/NICHD (2T32GM086330-06), NICHD (5R01-HD076676-04, HHSN275201000003I), and a Duke Health/Private Diagnostic Clinic ENABLE grant. The Atherosclerosis Prevention in Pediatric Lupus Erythematosus [APPLE (ClinicalTrials. gov: NCT00065806)] trial is supported by the US National Institutes of Health (NIH) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) contract N01-AR-2-2265, the Edna and Fred L. Mandel Jr. Center for Hypertension and Atherosclerosis, and Pfizer, which provided atorvastatin and matching placebo. S.J.B. receives support from the NIH (5R01-HD076676-04, 1R01HD083003-01, HHSN275201000003I, HHSN275201800003I, HHSN272201500006I 5U24-TR001608-03), the US Food and Drug Administration (5U18FD006298-03), the Patient-Centered Outcomes Research Institute (PCORI), the Rheumatology Research Foundation's Scientist Development Award, the Thrasher Research Fund, and the Childhood Arthritis and Rheumatology Research Alliance/Arthritis Foundation. C.P.H. receives salary support for research from the National Institute for Child Health and Human Development (NICHD; 1K23HD090239; R13HD102136), National Heart Lung and Blood Institute (R61/R33HL147833), FDA (1R01-FD006099, PI: Laughon; and 5U18-FD006298, PI: Benjamin), the US government for his work in pediatric clinical pharmacology (Government Contract HHSN275201800003I, PI: Benjamin under the Best Pharmaceuticals for Children Act), the nonprofit Burrhoughs Wellcome Fund, and other sponsors for drug development in adults and children (dcri.org/about-us/ conflict-of-interest). D.G. receives support for research from the Eunice Kennedy Shriver NICHD (5R01HD096435). A.M. receives research support from the Thrasher Research Fund (www.thrasherresearch.org). L.E.S. receives support for research from the NIH (U19AR069522), PCORI (8177), and the Childhood Arthritis and Rheumatology Research Alliance. She is on the Data Safety Monitoring Board for investigational product trials for UCB (Cimzia) and Sanofi (sarilumab). Sanofi is a maker of hydroxychloroquine. Samples used in this publication were collected as part of NIH/NIAMS (N01-AR-2-2265). A.M.E. receives support from the NIH National Center for Advancing Translational Sciences. G.K.S. receives support for research from the NIH (UG1 HD068258‑06, HHSN272201300017I, 1UL1TR002553-01, R21AI132677) and the Centers for Disease Control and Prevention (200-2012-53663). She chairs an Independent Data Monitoring Committee for GlaxoSmithKline (RSV vaccine trials). M.C.W. receives support for research from the NIH (1R01-HD076676‑01A1 and 1K24-AI143971), National Institute of Allergy and Infectious Diseases (HHSN272201500006I and HHSN272201300017I), NICHD (HHSN275201000003I), FDA (5U18-FD006298), and the industry for drug development in adults and children. S.J. Balevic, MD, MHS, Department of Rheumatology and Immunology, and Department of Pediatrics, Duke University School of Medicine, and Duke Clinical Research Institute; C.P. Hornik, MD, PhD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine; T.P. Green, MD, MS, Department of Pediatrics, Northwestern University, Feinberg School of Medicine; M.E. Clowse, MD, MPH, Department of Rheumatology and Immunology, Duke University School of Medicine; D. Gonzalez, PharmD, PhD, Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill; A.R. Maharaj, PhD, Duke Clinical Research Institute; L.E. Schanberg, MD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine; A.M. Eudy, PhD, Department of Rheumatology and Immunology, Duke University School of Medicine; G.K. Swamy, MD, Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine; B.L. Hughes, MD, MSc, Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine; M. Cohen-Wolkowiez, MD, PhD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine. Address correspondence to Dr. S.J. Balevic, Department of Rheumatology and Immunology, Duke University School of Medicine, 2301 Erwin Road, CHC, T-Level, Durham, North Carolina 27710, USA. E-mail: stephen.balevic@duke.edu. Full Release Article. For details see Reprints and Permissions at jrheum. org. Accepted for publication May 14, 2019.
Megan E B ClowseFrom the Department of Rheumatology and Immunology, Duke University School of Medicine, Durham, North Carolina, USA; Duke Clinical Research Institute, Durham, North Carolina, USA; Department of Pediatrics, and the Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine, Durham, North Carolina, USA; Department of Pediatrics, Northwestern University, Feinberg School of Medicine, Evanston, Illinois, USA; Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA. This study was supported by the Rheumatology Research Foundation's Scientist Development Award, the Thrasher Research Fund, the Childhood Arthritis and Rheumatology Research Alliance/Arthritis Foundation, the Derfner Foundation, NIGMS/NICHD (2T32GM086330-06), NICHD (5R01-HD076676-04, HHSN275201000003I), and a Duke Health/Private Diagnostic Clinic ENABLE grant. The Atherosclerosis Prevention in Pediatric Lupus Erythematosus [APPLE (ClinicalTrials. gov: NCT00065806)] trial is supported by the US National Institutes of Health (NIH) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) contract N01-AR-2-2265, the Edna and Fred L. Mandel Jr. Center for Hypertension and Atherosclerosis, and Pfizer, which provided atorvastatin and matching placebo. S.J.B. receives support from the NIH (5R01-HD076676-04, 1R01HD083003-01, HHSN275201000003I, HHSN275201800003I, HHSN272201500006I 5U24-TR001608-03), the US Food and Drug Administration (5U18FD006298-03), the Patient-Centered Outcomes Research Institute (PCORI), the Rheumatology Research Foundation's Scientist Development Award, the Thrasher Research Fund, and the Childhood Arthritis and Rheumatology Research Alliance/Arthritis Foundation. C.P.H. receives salary support for research from the National Institute for Child Health and Human Development (NICHD; 1K23HD090239; R13HD102136), National Heart Lung and Blood Institute (R61/R33HL147833), FDA (1R01-FD006099, PI: Laughon; and 5U18-FD006298, PI: Benjamin), the US government for his work in pediatric clinical pharmacology (Government Contract HHSN275201800003I, PI: Benjamin under the Best Pharmaceuticals for Children Act), the nonprofit Burrhoughs Wellcome Fund, and other sponsors for drug development in adults and children (dcri.org/about-us/ conflict-of-interest). D.G. receives support for research from the Eunice Kennedy Shriver NICHD (5R01HD096435). A.M. receives research support from the Thrasher Research Fund (www.thrasherresearch.org). L.E.S. receives support for research from the NIH (U19AR069522), PCORI (8177), and the Childhood Arthritis and Rheumatology Research Alliance. She is on the Data Safety Monitoring Board for investigational product trials for UCB (Cimzia) and Sanofi (sarilumab). Sanofi is a maker of hydroxychloroquine. Samples used in this publication were collected as part of NIH/NIAMS (N01-AR-2-2265). A.M.E. receives support from the NIH National Center for Advancing Translational Sciences. G.K.S. receives support for research from the NIH (UG1 HD068258‑06, HHSN272201300017I, 1UL1TR002553-01, R21AI132677) and the Centers for Disease Control and Prevention (200-2012-53663). She chairs an Independent Data Monitoring Committee for GlaxoSmithKline (RSV vaccine trials). M.C.W. receives support for research from the NIH (1R01-HD076676‑01A1 and 1K24-AI143971), National Institute of Allergy and Infectious Diseases (HHSN272201500006I and HHSN272201300017I), NICHD (HHSN275201000003I), FDA (5U18-FD006298), and the industry for drug development in adults and children. S.J. Balevic, MD, MHS, Department of Rheumatology and Immunology, and Department of Pediatrics, Duke University School of Medicine, and Duke Clinical Research Institute; C.P. Hornik, MD, PhD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine; T.P. Green, MD, MS, Department of Pediatrics, Northwestern University, Feinberg School of Medicine; M.E. Clowse, MD, MPH, Department of Rheumatology and Immunology, Duke University School of Medicine; D. Gonzalez, PharmD, PhD, Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill; A.R. Maharaj, PhD, Duke Clinical Research Institute; L.E. Schanberg, MD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine; A.M. Eudy, PhD, Department of Rheumatology and Immunology, Duke University School of Medicine; G.K. Swamy, MD, Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine; B.L. Hughes, MD, MSc, Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine; M. Cohen-Wolkowiez, MD, PhD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine. Address correspondence to Dr. S.J. Balevic, Department of Rheumatology and Immunology, Duke University School of Medicine, 2301 Erwin Road, CHC, T-Level, Durham, North Carolina 27710, USA. E-mail: stephen.balevic@duke.edu. Full Release Article. For details see Reprints and Permissions at jrheum. org. Accepted for publication May 14, 2019.ORCID https://orcid.org/0000-0002-8579-3470
Daniel GonzalezFrom the Department of Rheumatology and Immunology, Duke University School of Medicine, Durham, North Carolina, USA; Duke Clinical Research Institute, Durham, North Carolina, USA; Department of Pediatrics, and the Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine, Durham, North Carolina, USA; Department of Pediatrics, Northwestern University, Feinberg School of Medicine, Evanston, Illinois, USA; Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA. This study was supported by the Rheumatology Research Foundation's Scientist Development Award, the Thrasher Research Fund, the Childhood Arthritis and Rheumatology Research Alliance/Arthritis Foundation, the Derfner Foundation, NIGMS/NICHD (2T32GM086330-06), NICHD (5R01-HD076676-04, HHSN275201000003I), and a Duke Health/Private Diagnostic Clinic ENABLE grant. The Atherosclerosis Prevention in Pediatric Lupus Erythematosus [APPLE (ClinicalTrials. gov: NCT00065806)] trial is supported by the US National Institutes of Health (NIH) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) contract N01-AR-2-2265, the Edna and Fred L. Mandel Jr. Center for Hypertension and Atherosclerosis, and Pfizer, which provided atorvastatin and matching placebo. S.J.B. receives support from the NIH (5R01-HD076676-04, 1R01HD083003-01, HHSN275201000003I, HHSN275201800003I, HHSN272201500006I 5U24-TR001608-03), the US Food and Drug Administration (5U18FD006298-03), the Patient-Centered Outcomes Research Institute (PCORI), the Rheumatology Research Foundation's Scientist Development Award, the Thrasher Research Fund, and the Childhood Arthritis and Rheumatology Research Alliance/Arthritis Foundation. C.P.H. receives salary support for research from the National Institute for Child Health and Human Development (NICHD; 1K23HD090239; R13HD102136), National Heart Lung and Blood Institute (R61/R33HL147833), FDA (1R01-FD006099, PI: Laughon; and 5U18-FD006298, PI: Benjamin), the US government for his work in pediatric clinical pharmacology (Government Contract HHSN275201800003I, PI: Benjamin under the Best Pharmaceuticals for Children Act), the nonprofit Burrhoughs Wellcome Fund, and other sponsors for drug development in adults and children (dcri.org/about-us/ conflict-of-interest). D.G. receives support for research from the Eunice Kennedy Shriver NICHD (5R01HD096435). A.M. receives research support from the Thrasher Research Fund (www.thrasherresearch.org). L.E.S. receives support for research from the NIH (U19AR069522), PCORI (8177), and the Childhood Arthritis and Rheumatology Research Alliance. She is on the Data Safety Monitoring Board for investigational product trials for UCB (Cimzia) and Sanofi (sarilumab). Sanofi is a maker of hydroxychloroquine. Samples used in this publication were collected as part of NIH/NIAMS (N01-AR-2-2265). A.M.E. receives support from the NIH National Center for Advancing Translational Sciences. G.K.S. receives support for research from the NIH (UG1 HD068258‑06, HHSN272201300017I, 1UL1TR002553-01, R21AI132677) and the Centers for Disease Control and Prevention (200-2012-53663). She chairs an Independent Data Monitoring Committee for GlaxoSmithKline (RSV vaccine trials). M.C.W. receives support for research from the NIH (1R01-HD076676‑01A1 and 1K24-AI143971), National Institute of Allergy and Infectious Diseases (HHSN272201500006I and HHSN272201300017I), NICHD (HHSN275201000003I), FDA (5U18-FD006298), and the industry for drug development in adults and children. S.J. Balevic, MD, MHS, Department of Rheumatology and Immunology, and Department of Pediatrics, Duke University School of Medicine, and Duke Clinical Research Institute; C.P. Hornik, MD, PhD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine; T.P. Green, MD, MS, Department of Pediatrics, Northwestern University, Feinberg School of Medicine; M.E. Clowse, MD, MPH, Department of Rheumatology and Immunology, Duke University School of Medicine; D. Gonzalez, PharmD, PhD, Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill; A.R. Maharaj, PhD, Duke Clinical Research Institute; L.E. Schanberg, MD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine; A.M. Eudy, PhD, Department of Rheumatology and Immunology, Duke University School of Medicine; G.K. Swamy, MD, Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine; B.L. Hughes, MD, MSc, Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine; M. Cohen-Wolkowiez, MD, PhD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine. Address correspondence to Dr. S.J. Balevic, Department of Rheumatology and Immunology, Duke University School of Medicine, 2301 Erwin Road, CHC, T-Level, Durham, North Carolina 27710, USA. E-mail: stephen.balevic@duke.edu. Full Release Article. For details see Reprints and Permissions at jrheum. org. Accepted for publication May 14, 2019.ORCID https://orcid.org/0000-0002-8579-3470
Anil R MaharajFrom the Department of Rheumatology and Immunology, Duke University School of Medicine, Durham, North Carolina, USA; Duke Clinical Research Institute, Durham, North Carolina, USA; Department of Pediatrics, and the Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine, Durham, North Carolina, USA; Department of Pediatrics, Northwestern University, Feinberg School of Medicine, Evanston, Illinois, USA; Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA. This study was supported by the Rheumatology Research Foundation's Scientist Development Award, the Thrasher Research Fund, the Childhood Arthritis and Rheumatology Research Alliance/Arthritis Foundation, the Derfner Foundation, NIGMS/NICHD (2T32GM086330-06), NICHD (5R01-HD076676-04, HHSN275201000003I), and a Duke Health/Private Diagnostic Clinic ENABLE grant. The Atherosclerosis Prevention in Pediatric Lupus Erythematosus [APPLE (ClinicalTrials. gov: NCT00065806)] trial is supported by the US National Institutes of Health (NIH) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) contract N01-AR-2-2265, the Edna and Fred L. Mandel Jr. Center for Hypertension and Atherosclerosis, and Pfizer, which provided atorvastatin and matching placebo. S.J.B. receives support from the NIH (5R01-HD076676-04, 1R01HD083003-01, HHSN275201000003I, HHSN275201800003I, HHSN272201500006I 5U24-TR001608-03), the US Food and Drug Administration (5U18FD006298-03), the Patient-Centered Outcomes Research Institute (PCORI), the Rheumatology Research Foundation's Scientist Development Award, the Thrasher Research Fund, and the Childhood Arthritis and Rheumatology Research Alliance/Arthritis Foundation. C.P.H. receives salary support for research from the National Institute for Child Health and Human Development (NICHD; 1K23HD090239; R13HD102136), National Heart Lung and Blood Institute (R61/R33HL147833), FDA (1R01-FD006099, PI: Laughon; and 5U18-FD006298, PI: Benjamin), the US government for his work in pediatric clinical pharmacology (Government Contract HHSN275201800003I, PI: Benjamin under the Best Pharmaceuticals for Children Act), the nonprofit Burrhoughs Wellcome Fund, and other sponsors for drug development in adults and children (dcri.org/about-us/ conflict-of-interest). D.G. receives support for research from the Eunice Kennedy Shriver NICHD (5R01HD096435). A.M. receives research support from the Thrasher Research Fund (www.thrasherresearch.org). L.E.S. receives support for research from the NIH (U19AR069522), PCORI (8177), and the Childhood Arthritis and Rheumatology Research Alliance. She is on the Data Safety Monitoring Board for investigational product trials for UCB (Cimzia) and Sanofi (sarilumab). Sanofi is a maker of hydroxychloroquine. Samples used in this publication were collected as part of NIH/NIAMS (N01-AR-2-2265). A.M.E. receives support from the NIH National Center for Advancing Translational Sciences. G.K.S. receives support for research from the NIH (UG1 HD068258‑06, HHSN272201300017I, 1UL1TR002553-01, R21AI132677) and the Centers for Disease Control and Prevention (200-2012-53663). She chairs an Independent Data Monitoring Committee for GlaxoSmithKline (RSV vaccine trials). M.C.W. receives support for research from the NIH (1R01-HD076676‑01A1 and 1K24-AI143971), National Institute of Allergy and Infectious Diseases (HHSN272201500006I and HHSN272201300017I), NICHD (HHSN275201000003I), FDA (5U18-FD006298), and the industry for drug development in adults and children. S.J. Balevic, MD, MHS, Department of Rheumatology and Immunology, and Department of Pediatrics, Duke University School of Medicine, and Duke Clinical Research Institute; C.P. Hornik, MD, PhD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine; T.P. Green, MD, MS, Department of Pediatrics, Northwestern University, Feinberg School of Medicine; M.E. Clowse, MD, MPH, Department of Rheumatology and Immunology, Duke University School of Medicine; D. Gonzalez, PharmD, PhD, Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill; A.R. Maharaj, PhD, Duke Clinical Research Institute; L.E. Schanberg, MD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine; A.M. Eudy, PhD, Department of Rheumatology and Immunology, Duke University School of Medicine; G.K. Swamy, MD, Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine; B.L. Hughes, MD, MSc, Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine; M. Cohen-Wolkowiez, MD, PhD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine. Address correspondence to Dr. S.J. Balevic, Department of Rheumatology and Immunology, Duke University School of Medicine, 2301 Erwin Road, CHC, T-Level, Durham, North Carolina 27710, USA. E-mail: stephen.balevic@duke.edu. Full Release Article. For details see Reprints and Permissions at jrheum. org. Accepted for publication May 14, 2019.
Laura E SchanbergFrom the Department of Rheumatology and Immunology, Duke University School of Medicine, Durham, North Carolina, USA; Duke Clinical Research Institute, Durham, North Carolina, USA; Department of Pediatrics, and the Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine, Durham, North Carolina, USA; Department of Pediatrics, Northwestern University, Feinberg School of Medicine, Evanston, Illinois, USA; Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA. This study was supported by the Rheumatology Research Foundation's Scientist Development Award, the Thrasher Research Fund, the Childhood Arthritis and Rheumatology Research Alliance/Arthritis Foundation, the Derfner Foundation, NIGMS/NICHD (2T32GM086330-06), NICHD (5R01-HD076676-04, HHSN275201000003I), and a Duke Health/Private Diagnostic Clinic ENABLE grant. The Atherosclerosis Prevention in Pediatric Lupus Erythematosus [APPLE (ClinicalTrials. gov: NCT00065806)] trial is supported by the US National Institutes of Health (NIH) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) contract N01-AR-2-2265, the Edna and Fred L. Mandel Jr. Center for Hypertension and Atherosclerosis, and Pfizer, which provided atorvastatin and matching placebo. S.J.B. receives support from the NIH (5R01-HD076676-04, 1R01HD083003-01, HHSN275201000003I, HHSN275201800003I, HHSN272201500006I 5U24-TR001608-03), the US Food and Drug Administration (5U18FD006298-03), the Patient-Centered Outcomes Research Institute (PCORI), the Rheumatology Research Foundation's Scientist Development Award, the Thrasher Research Fund, and the Childhood Arthritis and Rheumatology Research Alliance/Arthritis Foundation. C.P.H. receives salary support for research from the National Institute for Child Health and Human Development (NICHD; 1K23HD090239; R13HD102136), National Heart Lung and Blood Institute (R61/R33HL147833), FDA (1R01-FD006099, PI: Laughon; and 5U18-FD006298, PI: Benjamin), the US government for his work in pediatric clinical pharmacology (Government Contract HHSN275201800003I, PI: Benjamin under the Best Pharmaceuticals for Children Act), the nonprofit Burrhoughs Wellcome Fund, and other sponsors for drug development in adults and children (dcri.org/about-us/ conflict-of-interest). D.G. receives support for research from the Eunice Kennedy Shriver NICHD (5R01HD096435). A.M. receives research support from the Thrasher Research Fund (www.thrasherresearch.org). L.E.S. receives support for research from the NIH (U19AR069522), PCORI (8177), and the Childhood Arthritis and Rheumatology Research Alliance. She is on the Data Safety Monitoring Board for investigational product trials for UCB (Cimzia) and Sanofi (sarilumab). Sanofi is a maker of hydroxychloroquine. Samples used in this publication were collected as part of NIH/NIAMS (N01-AR-2-2265). A.M.E. receives support from the NIH National Center for Advancing Translational Sciences. G.K.S. receives support for research from the NIH (UG1 HD068258‑06, HHSN272201300017I, 1UL1TR002553-01, R21AI132677) and the Centers for Disease Control and Prevention (200-2012-53663). She chairs an Independent Data Monitoring Committee for GlaxoSmithKline (RSV vaccine trials). M.C.W. receives support for research from the NIH (1R01-HD076676‑01A1 and 1K24-AI143971), National Institute of Allergy and Infectious Diseases (HHSN272201500006I and HHSN272201300017I), NICHD (HHSN275201000003I), FDA (5U18-FD006298), and the industry for drug development in adults and children. S.J. Balevic, MD, MHS, Department of Rheumatology and Immunology, and Department of Pediatrics, Duke University School of Medicine, and Duke Clinical Research Institute; C.P. Hornik, MD, PhD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine; T.P. Green, MD, MS, Department of Pediatrics, Northwestern University, Feinberg School of Medicine; M.E. Clowse, MD, MPH, Department of Rheumatology and Immunology, Duke University School of Medicine; D. Gonzalez, PharmD, PhD, Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill; A.R. Maharaj, PhD, Duke Clinical Research Institute; L.E. Schanberg, MD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine; A.M. Eudy, PhD, Department of Rheumatology and Immunology, Duke University School of Medicine; G.K. Swamy, MD, Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine; B.L. Hughes, MD, MSc, Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine; M. Cohen-Wolkowiez, MD, PhD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine. Address correspondence to Dr. S.J. Balevic, Department of Rheumatology and Immunology, Duke University School of Medicine, 2301 Erwin Road, CHC, T-Level, Durham, North Carolina 27710, USA. E-mail: stephen.balevic@duke.edu. Full Release Article. For details see Reprints and Permissions at jrheum. org. Accepted for publication May 14, 2019.
Amanda M EudyFrom the Department of Rheumatology and Immunology, Duke University School of Medicine, Durham, North Carolina, USA; Duke Clinical Research Institute, Durham, North Carolina, USA; Department of Pediatrics, and the Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine, Durham, North Carolina, USA; Department of Pediatrics, Northwestern University, Feinberg School of Medicine, Evanston, Illinois, USA; Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA. This study was supported by the Rheumatology Research Foundation's Scientist Development Award, the Thrasher Research Fund, the Childhood Arthritis and Rheumatology Research Alliance/Arthritis Foundation, the Derfner Foundation, NIGMS/NICHD (2T32GM086330-06), NICHD (5R01-HD076676-04, HHSN275201000003I), and a Duke Health/Private Diagnostic Clinic ENABLE grant. The Atherosclerosis Prevention in Pediatric Lupus Erythematosus [APPLE (ClinicalTrials. gov: NCT00065806)] trial is supported by the US National Institutes of Health (NIH) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) contract N01-AR-2-2265, the Edna and Fred L. Mandel Jr. Center for Hypertension and Atherosclerosis, and Pfizer, which provided atorvastatin and matching placebo. S.J.B. receives support from the NIH (5R01-HD076676-04, 1R01HD083003-01, HHSN275201000003I, HHSN275201800003I, HHSN272201500006I 5U24-TR001608-03), the US Food and Drug Administration (5U18FD006298-03), the Patient-Centered Outcomes Research Institute (PCORI), the Rheumatology Research Foundation's Scientist Development Award, the Thrasher Research Fund, and the Childhood Arthritis and Rheumatology Research Alliance/Arthritis Foundation. C.P.H. receives salary support for research from the National Institute for Child Health and Human Development (NICHD; 1K23HD090239; R13HD102136), National Heart Lung and Blood Institute (R61/R33HL147833), FDA (1R01-FD006099, PI: Laughon; and 5U18-FD006298, PI: Benjamin), the US government for his work in pediatric clinical pharmacology (Government Contract HHSN275201800003I, PI: Benjamin under the Best Pharmaceuticals for Children Act), the nonprofit Burrhoughs Wellcome Fund, and other sponsors for drug development in adults and children (dcri.org/about-us/ conflict-of-interest). D.G. receives support for research from the Eunice Kennedy Shriver NICHD (5R01HD096435). A.M. receives research support from the Thrasher Research Fund (www.thrasherresearch.org). L.E.S. receives support for research from the NIH (U19AR069522), PCORI (8177), and the Childhood Arthritis and Rheumatology Research Alliance. She is on the Data Safety Monitoring Board for investigational product trials for UCB (Cimzia) and Sanofi (sarilumab). Sanofi is a maker of hydroxychloroquine. Samples used in this publication were collected as part of NIH/NIAMS (N01-AR-2-2265). A.M.E. receives support from the NIH National Center for Advancing Translational Sciences. G.K.S. receives support for research from the NIH (UG1 HD068258‑06, HHSN272201300017I, 1UL1TR002553-01, R21AI132677) and the Centers for Disease Control and Prevention (200-2012-53663). She chairs an Independent Data Monitoring Committee for GlaxoSmithKline (RSV vaccine trials). M.C.W. receives support for research from the NIH (1R01-HD076676‑01A1 and 1K24-AI143971), National Institute of Allergy and Infectious Diseases (HHSN272201500006I and HHSN272201300017I), NICHD (HHSN275201000003I), FDA (5U18-FD006298), and the industry for drug development in adults and children. S.J. Balevic, MD, MHS, Department of Rheumatology and Immunology, and Department of Pediatrics, Duke University School of Medicine, and Duke Clinical Research Institute; C.P. Hornik, MD, PhD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine; T.P. Green, MD, MS, Department of Pediatrics, Northwestern University, Feinberg School of Medicine; M.E. Clowse, MD, MPH, Department of Rheumatology and Immunology, Duke University School of Medicine; D. Gonzalez, PharmD, PhD, Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill; A.R. Maharaj, PhD, Duke Clinical Research Institute; L.E. Schanberg, MD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine; A.M. Eudy, PhD, Department of Rheumatology and Immunology, Duke University School of Medicine; G.K. Swamy, MD, Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine; B.L. Hughes, MD, MSc, Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine; M. Cohen-Wolkowiez, MD, PhD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine. Address correspondence to Dr. S.J. Balevic, Department of Rheumatology and Immunology, Duke University School of Medicine, 2301 Erwin Road, CHC, T-Level, Durham, North Carolina 27710, USA. E-mail: stephen.balevic@duke.edu. Full Release Article. For details see Reprints and Permissions at jrheum. org. Accepted for publication May 14, 2019.ORCID https://orcid.org/0000-0002-3107-5545
Geeta K SwamyFrom the Department of Rheumatology and Immunology, Duke University School of Medicine, Durham, North Carolina, USA; Duke Clinical Research Institute, Durham, North Carolina, USA; Department of Pediatrics, and the Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine, Durham, North Carolina, USA; Department of Pediatrics, Northwestern University, Feinberg School of Medicine, Evanston, Illinois, USA; Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA. This study was supported by the Rheumatology Research Foundation's Scientist Development Award, the Thrasher Research Fund, the Childhood Arthritis and Rheumatology Research Alliance/Arthritis Foundation, the Derfner Foundation, NIGMS/NICHD (2T32GM086330-06), NICHD (5R01-HD076676-04, HHSN275201000003I), and a Duke Health/Private Diagnostic Clinic ENABLE grant. The Atherosclerosis Prevention in Pediatric Lupus Erythematosus [APPLE (ClinicalTrials. gov: NCT00065806)] trial is supported by the US National Institutes of Health (NIH) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) contract N01-AR-2-2265, the Edna and Fred L. Mandel Jr. Center for Hypertension and Atherosclerosis, and Pfizer, which provided atorvastatin and matching placebo. S.J.B. receives support from the NIH (5R01-HD076676-04, 1R01HD083003-01, HHSN275201000003I, HHSN275201800003I, HHSN272201500006I 5U24-TR001608-03), the US Food and Drug Administration (5U18FD006298-03), the Patient-Centered Outcomes Research Institute (PCORI), the Rheumatology Research Foundation's Scientist Development Award, the Thrasher Research Fund, and the Childhood Arthritis and Rheumatology Research Alliance/Arthritis Foundation. C.P.H. receives salary support for research from the National Institute for Child Health and Human Development (NICHD; 1K23HD090239; R13HD102136), National Heart Lung and Blood Institute (R61/R33HL147833), FDA (1R01-FD006099, PI: Laughon; and 5U18-FD006298, PI: Benjamin), the US government for his work in pediatric clinical pharmacology (Government Contract HHSN275201800003I, PI: Benjamin under the Best Pharmaceuticals for Children Act), the nonprofit Burrhoughs Wellcome Fund, and other sponsors for drug development in adults and children (dcri.org/about-us/ conflict-of-interest). D.G. receives support for research from the Eunice Kennedy Shriver NICHD (5R01HD096435). A.M. receives research support from the Thrasher Research Fund (www.thrasherresearch.org). L.E.S. receives support for research from the NIH (U19AR069522), PCORI (8177), and the Childhood Arthritis and Rheumatology Research Alliance. She is on the Data Safety Monitoring Board for investigational product trials for UCB (Cimzia) and Sanofi (sarilumab). Sanofi is a maker of hydroxychloroquine. Samples used in this publication were collected as part of NIH/NIAMS (N01-AR-2-2265). A.M.E. receives support from the NIH National Center for Advancing Translational Sciences. G.K.S. receives support for research from the NIH (UG1 HD068258‑06, HHSN272201300017I, 1UL1TR002553-01, R21AI132677) and the Centers for Disease Control and Prevention (200-2012-53663). She chairs an Independent Data Monitoring Committee for GlaxoSmithKline (RSV vaccine trials). M.C.W. receives support for research from the NIH (1R01-HD076676‑01A1 and 1K24-AI143971), National Institute of Allergy and Infectious Diseases (HHSN272201500006I and HHSN272201300017I), NICHD (HHSN275201000003I), FDA (5U18-FD006298), and the industry for drug development in adults and children. S.J. Balevic, MD, MHS, Department of Rheumatology and Immunology, and Department of Pediatrics, Duke University School of Medicine, and Duke Clinical Research Institute; C.P. Hornik, MD, PhD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine; T.P. Green, MD, MS, Department of Pediatrics, Northwestern University, Feinberg School of Medicine; M.E. Clowse, MD, MPH, Department of Rheumatology and Immunology, Duke University School of Medicine; D. Gonzalez, PharmD, PhD, Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill; A.R. Maharaj, PhD, Duke Clinical Research Institute; L.E. Schanberg, MD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine; A.M. Eudy, PhD, Department of Rheumatology and Immunology, Duke University School of Medicine; G.K. Swamy, MD, Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine; B.L. Hughes, MD, MSc, Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine; M. Cohen-Wolkowiez, MD, PhD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine. Address correspondence to Dr. S.J. Balevic, Department of Rheumatology and Immunology, Duke University School of Medicine, 2301 Erwin Road, CHC, T-Level, Durham, North Carolina 27710, USA. E-mail: stephen.balevic@duke.edu. Full Release Article. For details see Reprints and Permissions at jrheum. org. Accepted for publication May 14, 2019.ORCID https://orcid.org/0000-0001-5092-6993
Brenna L HughesFrom the Department of Rheumatology and Immunology, Duke University School of Medicine, Durham, North Carolina, USA; Duke Clinical Research Institute, Durham, North Carolina, USA; Department of Pediatrics, and the Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine, Durham, North Carolina, USA; Department of Pediatrics, Northwestern University, Feinberg School of Medicine, Evanston, Illinois, USA; Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA. This study was supported by the Rheumatology Research Foundation's Scientist Development Award, the Thrasher Research Fund, the Childhood Arthritis and Rheumatology Research Alliance/Arthritis Foundation, the Derfner Foundation, NIGMS/NICHD (2T32GM086330-06), NICHD (5R01-HD076676-04, HHSN275201000003I), and a Duke Health/Private Diagnostic Clinic ENABLE grant. The Atherosclerosis Prevention in Pediatric Lupus Erythematosus [APPLE (ClinicalTrials. gov: NCT00065806)] trial is supported by the US National Institutes of Health (NIH) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) contract N01-AR-2-2265, the Edna and Fred L. Mandel Jr. Center for Hypertension and Atherosclerosis, and Pfizer, which provided atorvastatin and matching placebo. S.J.B. receives support from the NIH (5R01-HD076676-04, 1R01HD083003-01, HHSN275201000003I, HHSN275201800003I, HHSN272201500006I 5U24-TR001608-03), the US Food and Drug Administration (5U18FD006298-03), the Patient-Centered Outcomes Research Institute (PCORI), the Rheumatology Research Foundation's Scientist Development Award, the Thrasher Research Fund, and the Childhood Arthritis and Rheumatology Research Alliance/Arthritis Foundation. C.P.H. receives salary support for research from the National Institute for Child Health and Human Development (NICHD; 1K23HD090239; R13HD102136), National Heart Lung and Blood Institute (R61/R33HL147833), FDA (1R01-FD006099, PI: Laughon; and 5U18-FD006298, PI: Benjamin), the US government for his work in pediatric clinical pharmacology (Government Contract HHSN275201800003I, PI: Benjamin under the Best Pharmaceuticals for Children Act), the nonprofit Burrhoughs Wellcome Fund, and other sponsors for drug development in adults and children (dcri.org/about-us/ conflict-of-interest). D.G. receives support for research from the Eunice Kennedy Shriver NICHD (5R01HD096435). A.M. receives research support from the Thrasher Research Fund (www.thrasherresearch.org). L.E.S. receives support for research from the NIH (U19AR069522), PCORI (8177), and the Childhood Arthritis and Rheumatology Research Alliance. She is on the Data Safety Monitoring Board for investigational product trials for UCB (Cimzia) and Sanofi (sarilumab). Sanofi is a maker of hydroxychloroquine. Samples used in this publication were collected as part of NIH/NIAMS (N01-AR-2-2265). A.M.E. receives support from the NIH National Center for Advancing Translational Sciences. G.K.S. receives support for research from the NIH (UG1 HD068258‑06, HHSN272201300017I, 1UL1TR002553-01, R21AI132677) and the Centers for Disease Control and Prevention (200-2012-53663). She chairs an Independent Data Monitoring Committee for GlaxoSmithKline (RSV vaccine trials). M.C.W. receives support for research from the NIH (1R01-HD076676‑01A1 and 1K24-AI143971), National Institute of Allergy and Infectious Diseases (HHSN272201500006I and HHSN272201300017I), NICHD (HHSN275201000003I), FDA (5U18-FD006298), and the industry for drug development in adults and children. S.J. Balevic, MD, MHS, Department of Rheumatology and Immunology, and Department of Pediatrics, Duke University School of Medicine, and Duke Clinical Research Institute; C.P. Hornik, MD, PhD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine; T.P. Green, MD, MS, Department of Pediatrics, Northwestern University, Feinberg School of Medicine; M.E. Clowse, MD, MPH, Department of Rheumatology and Immunology, Duke University School of Medicine; D. Gonzalez, PharmD, PhD, Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill; A.R. Maharaj, PhD, Duke Clinical Research Institute; L.E. Schanberg, MD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine; A.M. Eudy, PhD, Department of Rheumatology and Immunology, Duke University School of Medicine; G.K. Swamy, MD, Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine; B.L. Hughes, MD, MSc, Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine; M. Cohen-Wolkowiez, MD, PhD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine. Address correspondence to Dr. S.J. Balevic, Department of Rheumatology and Immunology, Duke University School of Medicine, 2301 Erwin Road, CHC, T-Level, Durham, North Carolina 27710, USA. E-mail: stephen.balevic@duke.edu. Full Release Article. For details see Reprints and Permissions at jrheum. org. Accepted for publication May 14, 2019.
Michael Cohen-WolkowiezFrom the Department of Rheumatology and Immunology, Duke University School of Medicine, Durham, North Carolina, USA; Duke Clinical Research Institute, Durham, North Carolina, USA; Department of Pediatrics, and the Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine, Durham, North Carolina, USA; Department of Pediatrics, Northwestern University, Feinberg School of Medicine, Evanston, Illinois, USA; Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA. This study was supported by the Rheumatology Research Foundation's Scientist Development Award, the Thrasher Research Fund, the Childhood Arthritis and Rheumatology Research Alliance/Arthritis Foundation, the Derfner Foundation, NIGMS/NICHD (2T32GM086330-06), NICHD (5R01-HD076676-04, HHSN275201000003I), and a Duke Health/Private Diagnostic Clinic ENABLE grant. The Atherosclerosis Prevention in Pediatric Lupus Erythematosus [APPLE (ClinicalTrials. gov: NCT00065806)] trial is supported by the US National Institutes of Health (NIH) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) contract N01-AR-2-2265, the Edna and Fred L. Mandel Jr. Center for Hypertension and Atherosclerosis, and Pfizer, which provided atorvastatin and matching placebo. S.J.B. receives support from the NIH (5R01-HD076676-04, 1R01HD083003-01, HHSN275201000003I, HHSN275201800003I, HHSN272201500006I 5U24-TR001608-03), the US Food and Drug Administration (5U18FD006298-03), the Patient-Centered Outcomes Research Institute (PCORI), the Rheumatology Research Foundation's Scientist Development Award, the Thrasher Research Fund, and the Childhood Arthritis and Rheumatology Research Alliance/Arthritis Foundation. C.P.H. receives salary support for research from the National Institute for Child Health and Human Development (NICHD; 1K23HD090239; R13HD102136), National Heart Lung and Blood Institute (R61/R33HL147833), FDA (1R01-FD006099, PI: Laughon; and 5U18-FD006298, PI: Benjamin), the US government for his work in pediatric clinical pharmacology (Government Contract HHSN275201800003I, PI: Benjamin under the Best Pharmaceuticals for Children Act), the nonprofit Burrhoughs Wellcome Fund, and other sponsors for drug development in adults and children (dcri.org/about-us/ conflict-of-interest). D.G. receives support for research from the Eunice Kennedy Shriver NICHD (5R01HD096435). A.M. receives research support from the Thrasher Research Fund (www.thrasherresearch.org). L.E.S. receives support for research from the NIH (U19AR069522), PCORI (8177), and the Childhood Arthritis and Rheumatology Research Alliance. She is on the Data Safety Monitoring Board for investigational product trials for UCB (Cimzia) and Sanofi (sarilumab). Sanofi is a maker of hydroxychloroquine. Samples used in this publication were collected as part of NIH/NIAMS (N01-AR-2-2265). A.M.E. receives support from the NIH National Center for Advancing Translational Sciences. G.K.S. receives support for research from the NIH (UG1 HD068258‑06, HHSN272201300017I, 1UL1TR002553-01, R21AI132677) and the Centers for Disease Control and Prevention (200-2012-53663). She chairs an Independent Data Monitoring Committee for GlaxoSmithKline (RSV vaccine trials). M.C.W. receives support for research from the NIH (1R01-HD076676‑01A1 and 1K24-AI143971), National Institute of Allergy and Infectious Diseases (HHSN272201500006I and HHSN272201300017I), NICHD (HHSN275201000003I), FDA (5U18-FD006298), and the industry for drug development in adults and children. S.J. Balevic, MD, MHS, Department of Rheumatology and Immunology, and Department of Pediatrics, Duke University School of Medicine, and Duke Clinical Research Institute; C.P. Hornik, MD, PhD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine; T.P. Green, MD, MS, Department of Pediatrics, Northwestern University, Feinberg School of Medicine; M.E. Clowse, MD, MPH, Department of Rheumatology and Immunology, Duke University School of Medicine; D. Gonzalez, PharmD, PhD, Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill; A.R. Maharaj, PhD, Duke Clinical Research Institute; L.E. Schanberg, MD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine; A.M. Eudy, PhD, Department of Rheumatology and Immunology, Duke University School of Medicine; G.K. Swamy, MD, Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine; B.L. Hughes, MD, MSc, Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University School of Medicine; M. Cohen-Wolkowiez, MD, PhD, Duke Clinical Research Institute, and Department of Pediatrics, Duke University School of Medicine. Address correspondence to Dr. S.J. Balevic, Department of Rheumatology and Immunology, Duke University School of Medicine, 2301 Erwin Road, CHC, T-Level, Durham, North Carolina 27710, USA. E-mail: stephen.balevic@duke.edu. Full Release Article. For details see Reprints and Permissions at jrheum. org. Accepted for publication May 14, 2019.ORCID https://orcid.org/0000-0002-2458-2266
Duke University · USNorthwestern University · US

Funding

COVID-19 Supplement - Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)U24TR001608 · NCATS · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K., HERNANDEZ, ADRIAN · 2016 to 2022
$177.0M
Support for QA/QC for Prior Approval ProcessUL1TR002553 · NCATS · DUKE UNIVERSITY · PI LI, JENNIFER S, MCNAMARA, JAMES O. · 2018 to 2023
$58.5M
Northwestern University Clinical and Translational Science Institute (NUCATS)UL1TR001422 · NCATS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI D'AQUILA, RICHARD · 2015 to 2023
$56.8M
UNC-Duke Collaborative Clinical Pharmacology Postdoctoral Training Program-Evaluation SupplementT32GM086330 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KIM L.R. BROUWER, Daniel Gonzalez · 2011 to 2026
$8.5M
Safety of Sildenafil in Premature Infants with Severe Bronchopulmonary DysplasiaR33HL147833 · NHLBI · DUKE UNIVERSITY · PI HORNIK, CHRISTOPH, LAUGHON, MATTHEW · 2021 to 2023
$6.8M
Global Pediatric Clinical Trials NetworkU18FD006298 · FDA · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL, HORNIK, CHRISTOPH · 2017 to 2021
$5.5M
Enhancing Meaningfulness and Usefulness of Pediatric and Caregiver PROMIS Measures Across Illness GroupsU19AR069522 · NIAMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI REEVE, BRYCE B, SCHANBERG, LAURA E · 2015 to 2015
$2.9M
Physiologically-Based Pharmacokinetic Models for Optimal Drug Dosing in ChildrenR01HD076676 · NICHD · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2014 to 2017
$2.6M
Physiologically-Based Pharmacokinetic Modeling to Guide Drug Dosing in Children with ObesityR01HD096435 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DUMOND, JULIE BRUMER · 2018 to 2022
$2.0M
Safety of Sildenafil in Premature Infants at Risk of Bronchopulmonary DysplasiaR01FD006099 · FDA · UNIV OF NORTH CAROLINA CHAPEL HILL · PI LAUGHON, MATTHEW · 2018 to 2022
$2.0M
Pharmacokinetic and pharmacogenomic approach to indomethacin therapy in pregnancyR01HD083003 · NICHD · UNIVERSITY OF TEXAS MED BR GALVESTON · PI RYTTING, ERIK · 2015 to 2018
$1.5M
Mentoring in Clinical Pharmacology and Early Phase TrialsK24AI143971 · NIAID · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2019 to 2023
$895k
FDA HHS R01 FD006099FDA HHS U18 FD006298NCATS NIH HHS U24 TR001608NCATS NIH HHS UL1 TR001422NCATS NIH HHS UL1 TR002553NHLBI NIH HHS R33 HL147833NIAAA NIH HHS HHSN275201000003CNIAID NIH HHS HHSN272201300017CNIAID NIH HHS HHSN272201300017INIAID NIH HHS HHSN272201500006CNIAID NIH HHS K24 AI143971NIAID NIH HHS R21 AI132677NIAMS NIH HHS K23 AR075874NIAMS NIH HHS U19 AR069522NICHD NIH HHS HHSN275201000003INICHD NIH HHS K23 HD090239NICHD NIH HHS R01 HD076676NICHD NIH HHS R01 HD083003NICHD NIH HHS R01 HD096435NICHD NIH HHS R13 HD102136NICHD NIH HHS UG1 HD068258NIGMS NIH HHS T32 GM086330Wellcome Trust
6 · The paper itself

Abstract

objectiveTo characterize hydroxychloroquine (HCQ) exposure in patients with rheumatic disease receiving longterm HCQ compared to target concentrations with reported antiviral activity against the coronavirus disease 2019 caused by SARS-CoV-2 (COVID-19).

methodsWe evaluated total HCQ concentrations in serum and plasma from published literature values, frozen serum samples from a pediatric systemic lupus erythematosus trial, and simulated concentrations using a published pharmacokinetic model during pregnancy. For each source, we compared observed or predicted HCQ concentrations to target concentrations with reported antiviral activity against SARS-CoV-2.

resultsThe average total serum/plasma HCQ concentrations were below the lowest SARS-CoV-2 target of 0.48 mg/l in all studies. Assuming the highest antiviral target exposure (total plasma concentration of 4.1 mg/l), all studies had about one-tenth the necessary concentration for

conclusionWe found that the average patient receiving treatment with HCQ for rheumatic diseases, including children and non-pregnant/pregnant adults, are unlikely to achieve total serum or plasma concentrations shown to inhibit SARS-CoV-2

Identifiers

PMID32393664
PMCPMC7655510
OpenAlexW3024912601

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