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Response to Letter to the Editor From Virú-Loza and Chávez-Nomberto: “Safety and Efficacy of Pediatric Growth Hormone Therapy: Results From the Full KIGS Cohort”

Response to Letter to the Editor From Virú-Loza and Chávez-Nomberto: “Safety and Efficacy of... The Journal of Clinical Endocrinology & Metabolism, 2023, 108, e356–e357 https://doi.org/10.1210/clinem/dgad055 Advance access publication 31 January 2023 Letter to the Editor Response Response to Letter to the Editor From Virú-Loza and Chávez-Nomberto: “Safety and Efficacy of Pediatric Growth Hormone Therapy: Results From the Full KIGS Cohort” 1,2 3 4 Mohamad Maghnie, Michael B. Ranke, Mitchell E. Geffner, 5 6,7 8 9 Elpis Vlachopapadopoulou, Lourdes Ibáñez, Martin Carlsson, Wayne Cutfield, 10 11 8,12 13,14 Raoul Rooman, Roy Gomez, Michael P. Wajnrajch, Agnès Linglart, 15,16 17 18 19 Renata Stawerska, Peter E. Clayton, Feyza Darendeliler, Anita C. S. Hokken-Koelega, 20 21 22 23 Reiko Horikawa, Toshiaki Tanaka, Helmuth-Günther Dörr, Kerstin Albertsson-Wikland, 24 25 Michel Polak, and Adda Grimberg Department of Pediatrics, IRCCS Giannina Gaslini, Genova 16124, Italy Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health - DINOGMI, University of Genova, Genova 16124, Italy Department of Pediatric Endocrinology, University Children´s Hospital, Tübingen 72076, Germany The Saban Research Institute, Children’s Hospital Los Angeles, Los Angeles, CA 90027, USA Department of Endocrinology, Growth and Development, Aglaia Kyriakou Children’s Hospital, Athens 11527, Greece Endocrinology, Pediatric Research Institute Sant Joan de Déu, Barcelona 08950, Spain Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid 28029, Spain Rare Disease, Biopharmaceuticals, Pfizer, New York, NY 10017, USA Liggins Institute, University of Auckland, Auckland 1142, New Zealand PendoCon, Putte 2580, Belgium European Medical Affairs, Pfizer, Brussels 1070, Belgium Department of Pediatrics, New York University Langone Medical Center, New York, NY 10016, USA Department of Pediatric Endocrinology and Diabetology for Children, AP-HP, Bicêtre Paris Saclay, Le Kremlin Bicêtre 94270, France APHP, Reference Center for Rare Disorders of the Calcium and Phosphate Metabolism, Filière OSCAR and Plateforme d’Expertise Maladies Rares Paris-Sud, Bicêtre Paris Saclay Hospital, Le Kremlin Bicêtre 94270, France Department of Endocrinology and Metabolic Diseases, Polish Mother’s Memorial Hospital-Research Institute, Lodz 93-338, Poland Department of Pediatric Endocrinology, Medical University of Lodz, Lodz 93-338, Poland Developmental Biology and Medicine, Faculty of Biology Medicine and Health, Manchester NIHR Academic Health Science Centre, University of Manchester, Manchester M13 9PL, UK Istanbul University, Istanbul Faculty of Medicine, Pediatric Endocrinology Unit, Istanbul 34452, Turkey Pediatrics, Subdivision of Endocrinology, Erasmus University Medical Center, Rotterdam 3015 GD, the Netherlands Division of Endocrinology and Metabolism, National Center for Child Health and Development, Tokyo 157-8535, Japan Tanaka Growth Clinic, Tokyo 158-0097, Japan Division of Pediatric Endocrinology, Department of Pediatrics and Adolescent Medicine, Friedrich-Alexander University of Erlangen Nürnberg, Erlangen 91054, Germany Department of Physiology/Endocrinology, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg 405 30, Sweden Université de Paris Cité; Hôpital Universitaire Necker Enfants Malades, Paris 75015, France Division of Pediatric Endocrinology and Diabetes, Children’s Hospital of Philadelphia, Philadelphia, PA 19104, USA Correspondence: Adda Grimberg, MD, Division of Pediatric Endocrinology and Diabetes, Children’s Hospital of Philadelphia, 3401 Civic Center Blvd, Philadelphia, PA 19104, USA. Email: [email protected]. Abbreviation: GH, growth hormone. To the Editor, Growth Hormone Therapy: Results From the Full KIGS We thank Virú-Loza and Chávez-Nomberto for highlighting Cohort” (1), and agree with their conclusion “that longer some of the limitations and concerns raised in the discussion follow-up and adequate comparisons are needed to have bet- section of our paper, “Safety and Efficacy of Pediatric ter information on whether or not there is a higher incidence Received: 12 January 2023. Editorial Decision: 25 January 2023. Corrected and Typeset: 21 February 2023 © The Author(s) 2023. Published by Oxford University Press on behalf of the Endocrine Society. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. The Journal of Clinical Endocrinology & Metabolism, 2023, Vol. 108, No. 6 e357 of some types of cancer or higher-risk subgroups” (2). Our pa- member of the KIGS Strategic Advisory Board; recipient of per was never intended as the final imprimatur of the safety of investigator-initiated independent research grants from Novo pediatric growth hormone (GH) therapy; it could not be. Nordisk and Pfizer; and has received lecture fees from In the face of worrisome indirect evidence, challenges and lim- Merck-Serono, Novo Nordisk, and Pfizer. T.T. has consulted itations in the direct evidence of long-term (especially into for JCR Pharmaceuticals. H.G.D. has received honoraria for adulthood) safety, as well as changes in both GH treatment lectures from Ferring, Ipsen, Novo Nordisk, and Pfizer. M.P. practices and its recipients over time, continued scrutiny of is on the advisory board for IPSEN Increlex Registry, Novo Nordisk, and Pfizer France; has received grants from Ipsen, GH safety is needed (3). Rather, our paper was intended to le- Merck, Novo Nordisk, Pfizer, Sandoz, and Sanofi; and has verage real-world clinical data on more than 80 000 children French institutional public grants from ANR PHRC. A.G. has treated with recombinant human GH in more than 50 countries to provide, as described by Abucham and Boguszewski, “a consulted for Pfizer and received an investigator-initiated inde unique and valuable source of good-quality documentation of pendent research grant from Pfizer. R.S. has received independ - diverse growth disorders and their treatment outcomes” (4). ent research support from OPKO, Pfizer, and Sandoz. M.C., R.G., and M.P.W. are employees and stockholders/stock grant holders of Pfizer. L.I., P.E.C., F.D., R.H., and K.A.-W. have Disclosures nothing to disclose. M.M. has received research support from Merck Serono and Pfizer, and has consulted for Ascendis, BioMarin, Ferring, References Merck Serono, Novo Nordisk, Pfizer, and Sandoz. M.B.R. has received speaker fees from Mediagnost, Merck, Pfizer, 1. Maghnie M, Ranke MB, Geffner ME, et al. Safety and efficacy of and Sandoz. M.E.G. has a research contract from Novo pediatric growth hormone therapy: results from the full KIGS cohort. J Clin Endocrinol Metab. 2022;107(12):3287-3301. Nordisk; serves as a consultant for and/or on advisory boards 2. Virú-Loza MA, Chávez-Nomberto RE. Letter to the Editor from for Adrenas, Eton Pharmaceuticals, Neurocrine Biosciences, Virú-Loza and Chávez-Nomberto: “Safety and efficacy of pediatric Novo Nordisk, and Pfizer; is a member of a data safety mon - growth hormone therapy: results from the full KIGS cohort”. itoring board for Aeterna Zentaris and Ascendis; and receives J Clin Endocrinol Metab. 2023;108(6):e354-e355. royalties from McGraw-Hill and UpToDate. E.V. has received 3. Grimberg A. Cardiovascular disease in former pediatric recipients of research support from Ascendis, OPKO, and Pfizer. W.C. has growth hormone: another look at growth hormone safety. JAMA received research support from Pfizer. R.R. is a past member Pediatr. 2021;175(2):e205232. of the KIGS Strategic Advisory Board and serves as a consultant 4. Abucham J, Boguszewski MCS. From the full KIGS cohort: on safety for Pfizer. A.L. has received speaker fees from Alexion, Kyowa and efficacy of growth hormone treatment. J Clin Endocrinol Metab. 2023;108(1):e1-e2. Kirin, Novo Nordisk, Pfizer, and Sandoz. A.C.S.H.-K. is a past http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png The Journal of Clinical Endocrinology & Metabolism Oxford University Press

Response to Letter to the Editor From Virú-Loza and Chávez-Nomberto: “Safety and Efficacy of Pediatric Growth Hormone Therapy: Results From the Full KIGS Cohort”

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Oxford University Press
Copyright
© The Author(s) 2023. Published by Oxford University Press on behalf of the Endocrine Society.
ISSN
0021-972X
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1945-7197
DOI
10.1210/clinem/dgad055
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Abstract

The Journal of Clinical Endocrinology & Metabolism, 2023, 108, e356–e357 https://doi.org/10.1210/clinem/dgad055 Advance access publication 31 January 2023 Letter to the Editor Response Response to Letter to the Editor From Virú-Loza and Chávez-Nomberto: “Safety and Efficacy of Pediatric Growth Hormone Therapy: Results From the Full KIGS Cohort” 1,2 3 4 Mohamad Maghnie, Michael B. Ranke, Mitchell E. Geffner, 5 6,7 8 9 Elpis Vlachopapadopoulou, Lourdes Ibáñez, Martin Carlsson, Wayne Cutfield, 10 11 8,12 13,14 Raoul Rooman, Roy Gomez, Michael P. Wajnrajch, Agnès Linglart, 15,16 17 18 19 Renata Stawerska, Peter E. Clayton, Feyza Darendeliler, Anita C. S. Hokken-Koelega, 20 21 22 23 Reiko Horikawa, Toshiaki Tanaka, Helmuth-Günther Dörr, Kerstin Albertsson-Wikland, 24 25 Michel Polak, and Adda Grimberg Department of Pediatrics, IRCCS Giannina Gaslini, Genova 16124, Italy Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health - DINOGMI, University of Genova, Genova 16124, Italy Department of Pediatric Endocrinology, University Children´s Hospital, Tübingen 72076, Germany The Saban Research Institute, Children’s Hospital Los Angeles, Los Angeles, CA 90027, USA Department of Endocrinology, Growth and Development, Aglaia Kyriakou Children’s Hospital, Athens 11527, Greece Endocrinology, Pediatric Research Institute Sant Joan de Déu, Barcelona 08950, Spain Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid 28029, Spain Rare Disease, Biopharmaceuticals, Pfizer, New York, NY 10017, USA Liggins Institute, University of Auckland, Auckland 1142, New Zealand PendoCon, Putte 2580, Belgium European Medical Affairs, Pfizer, Brussels 1070, Belgium Department of Pediatrics, New York University Langone Medical Center, New York, NY 10016, USA Department of Pediatric Endocrinology and Diabetology for Children, AP-HP, Bicêtre Paris Saclay, Le Kremlin Bicêtre 94270, France APHP, Reference Center for Rare Disorders of the Calcium and Phosphate Metabolism, Filière OSCAR and Plateforme d’Expertise Maladies Rares Paris-Sud, Bicêtre Paris Saclay Hospital, Le Kremlin Bicêtre 94270, France Department of Endocrinology and Metabolic Diseases, Polish Mother’s Memorial Hospital-Research Institute, Lodz 93-338, Poland Department of Pediatric Endocrinology, Medical University of Lodz, Lodz 93-338, Poland Developmental Biology and Medicine, Faculty of Biology Medicine and Health, Manchester NIHR Academic Health Science Centre, University of Manchester, Manchester M13 9PL, UK Istanbul University, Istanbul Faculty of Medicine, Pediatric Endocrinology Unit, Istanbul 34452, Turkey Pediatrics, Subdivision of Endocrinology, Erasmus University Medical Center, Rotterdam 3015 GD, the Netherlands Division of Endocrinology and Metabolism, National Center for Child Health and Development, Tokyo 157-8535, Japan Tanaka Growth Clinic, Tokyo 158-0097, Japan Division of Pediatric Endocrinology, Department of Pediatrics and Adolescent Medicine, Friedrich-Alexander University of Erlangen Nürnberg, Erlangen 91054, Germany Department of Physiology/Endocrinology, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg 405 30, Sweden Université de Paris Cité; Hôpital Universitaire Necker Enfants Malades, Paris 75015, France Division of Pediatric Endocrinology and Diabetes, Children’s Hospital of Philadelphia, Philadelphia, PA 19104, USA Correspondence: Adda Grimberg, MD, Division of Pediatric Endocrinology and Diabetes, Children’s Hospital of Philadelphia, 3401 Civic Center Blvd, Philadelphia, PA 19104, USA. Email: [email protected]. Abbreviation: GH, growth hormone. To the Editor, Growth Hormone Therapy: Results From the Full KIGS We thank Virú-Loza and Chávez-Nomberto for highlighting Cohort” (1), and agree with their conclusion “that longer some of the limitations and concerns raised in the discussion follow-up and adequate comparisons are needed to have bet- section of our paper, “Safety and Efficacy of Pediatric ter information on whether or not there is a higher incidence Received: 12 January 2023. Editorial Decision: 25 January 2023. Corrected and Typeset: 21 February 2023 © The Author(s) 2023. Published by Oxford University Press on behalf of the Endocrine Society. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. The Journal of Clinical Endocrinology & Metabolism, 2023, Vol. 108, No. 6 e357 of some types of cancer or higher-risk subgroups” (2). Our pa- member of the KIGS Strategic Advisory Board; recipient of per was never intended as the final imprimatur of the safety of investigator-initiated independent research grants from Novo pediatric growth hormone (GH) therapy; it could not be. Nordisk and Pfizer; and has received lecture fees from In the face of worrisome indirect evidence, challenges and lim- Merck-Serono, Novo Nordisk, and Pfizer. T.T. has consulted itations in the direct evidence of long-term (especially into for JCR Pharmaceuticals. H.G.D. has received honoraria for adulthood) safety, as well as changes in both GH treatment lectures from Ferring, Ipsen, Novo Nordisk, and Pfizer. M.P. practices and its recipients over time, continued scrutiny of is on the advisory board for IPSEN Increlex Registry, Novo Nordisk, and Pfizer France; has received grants from Ipsen, GH safety is needed (3). Rather, our paper was intended to le- Merck, Novo Nordisk, Pfizer, Sandoz, and Sanofi; and has verage real-world clinical data on more than 80 000 children French institutional public grants from ANR PHRC. A.G. has treated with recombinant human GH in more than 50 countries to provide, as described by Abucham and Boguszewski, “a consulted for Pfizer and received an investigator-initiated inde unique and valuable source of good-quality documentation of pendent research grant from Pfizer. R.S. has received independ - diverse growth disorders and their treatment outcomes” (4). ent research support from OPKO, Pfizer, and Sandoz. M.C., R.G., and M.P.W. are employees and stockholders/stock grant holders of Pfizer. L.I., P.E.C., F.D., R.H., and K.A.-W. have Disclosures nothing to disclose. M.M. has received research support from Merck Serono and Pfizer, and has consulted for Ascendis, BioMarin, Ferring, References Merck Serono, Novo Nordisk, Pfizer, and Sandoz. M.B.R. has received speaker fees from Mediagnost, Merck, Pfizer, 1. Maghnie M, Ranke MB, Geffner ME, et al. Safety and efficacy of and Sandoz. M.E.G. has a research contract from Novo pediatric growth hormone therapy: results from the full KIGS cohort. J Clin Endocrinol Metab. 2022;107(12):3287-3301. Nordisk; serves as a consultant for and/or on advisory boards 2. Virú-Loza MA, Chávez-Nomberto RE. Letter to the Editor from for Adrenas, Eton Pharmaceuticals, Neurocrine Biosciences, Virú-Loza and Chávez-Nomberto: “Safety and efficacy of pediatric Novo Nordisk, and Pfizer; is a member of a data safety mon - growth hormone therapy: results from the full KIGS cohort”. itoring board for Aeterna Zentaris and Ascendis; and receives J Clin Endocrinol Metab. 2023;108(6):e354-e355. royalties from McGraw-Hill and UpToDate. E.V. has received 3. Grimberg A. Cardiovascular disease in former pediatric recipients of research support from Ascendis, OPKO, and Pfizer. W.C. has growth hormone: another look at growth hormone safety. JAMA received research support from Pfizer. R.R. is a past member Pediatr. 2021;175(2):e205232. of the KIGS Strategic Advisory Board and serves as a consultant 4. Abucham J, Boguszewski MCS. From the full KIGS cohort: on safety for Pfizer. A.L. has received speaker fees from Alexion, Kyowa and efficacy of growth hormone treatment. J Clin Endocrinol Metab. 2023;108(1):e1-e2. Kirin, Novo Nordisk, Pfizer, and Sandoz. A.C.S.H.-K. is a past

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Published: Jan 31, 2023

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