{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,31]],"date-time":"2026-10-31T05:29:52Z","timestamp":1793424592003,"version":"4.5.0"},"reference-count":54,"publisher":"The Endocrine Society","issue":"12","license":[{"start":{"date-parts":[[2022,9,14]],"date-time":"2022-09-14T00:00:00Z","timestamp":1663113600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,11,25]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Context<\/jats:title>\n                    <jats:p>The Kabi\/Pfizer International Growth Database (KIGS) is a large, international database (1987-2012) of children treated with recombinant human growth hormone (rhGH) in real-world settings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This work aimed to evaluate the safety and efficacy of rhGH from the full KIGS cohort.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Data were collected by investigators from children with growth disorders treated with rhGH (Genotropin [somatropin]; Pfizer). Safety was evaluated in all treated patients, and efficacy in those treated for 1 year or more. A subgroup included patients treated for 5 years or more (\u2265\u20052 years prepubertal) who had reached near-adult height (NAH). Main outcomes included adverse events (AEs), serious AEs (SAEs), and height growth.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The full KIGS cohort (N = 83 803 [58% male]) was treated for idiopathic GH deficiency (IGHD; 46.9%), organic GHD (10.0%), small for gestational age (SGA; 9.5%), Turner syndrome (TS; 9.2%), idiopathic short stature (ISS; 8.2%), and others (16.2%). Median rhGH treatment duration was 2.7 years and observation 3.1 years. SAEs occurred in 3.7% of patients and death in 0.4%. The most common SAEs were recurrence of craniopharyngioma (n = 151), neoplasm (n = 99), and cancer (n = 91); and scoliosis (n = 91). Median first-year delta height-SD score (SDS) (Prader) in prepubertal patients was 0.66 (IGHD), 0.55 (ISS), 0.58 (TS), and 0.71 (SGA). Median gains in NAH-SDS were 1.79 (IGHD), 1.37 (ISS), and 1.34 (SGA) for boys, and 2.07 (IGHD), 1.62 (ISS), 1.07 (TS), and 1.57 (SGA) for girls.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Data from KIGS, the largest and longest running international database of rhGH-treated children, show that rhGH is safe and increases short-term height gain and adult height across GHD and non-GHD conditions.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1210\/clinem\/dgac517","type":"journal-article","created":{"date-parts":[[2022,9,14]],"date-time":"2022-09-14T04:46:39Z","timestamp":1663130799000},"page":"3287-3301","source":"Crossref","is-referenced-by-count":125,"title":["Safety and Efficacy of Pediatric Growth Hormone Therapy: Results From the Full KIGS Cohort"],"prefix":"10.1210","volume":"107","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7183-5238","authenticated-orcid":false,"given":"Mohamad","family":"Maghnie","sequence":"first","affiliation":[{"name":"Department of Pediatrics, IRCCS Giannina Gaslini , Genova 16124 , Italy"},{"name":"Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health - DINOGMI, University of Genova , Genova 16124 , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3855-6157","authenticated-orcid":false,"given":"Michael B","family":"Ranke","sequence":"additional","affiliation":[{"name":"Department of Pediatric Endocrinology, University Children\u00b4s Hospital , T\u00fcbingen 72076 , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0384-3287","authenticated-orcid":false,"given":"Mitchell E","family":"Geffner","sequence":"additional","affiliation":[{"name":"The Saban Research Institute, Children's Hospital Los Angeles , Los Angeles, California 90027 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5641-7081","authenticated-orcid":false,"given":"Elpis","family":"Vlachopapadopoulou","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Growth and Development, Aglaia Kyriakou Children's Hospital , Athens 11527 , Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lourdes","family":"Ib\u00e1\u00f1ez","sequence":"additional","affiliation":[{"name":"Endocrinology, Pediatric Research Institute Sant Joan de D\u00e9u , Barcelona 08950 , Spain"},{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red de Diabetes y Enfermedades Metab\u00f3licas Asociadas (CIBERDEM), Instituto de Salud Carlos III , Madrid 28029 , 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Pfizer , Brussels 1070 , Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8211-9237","authenticated-orcid":false,"given":"Michael P","family":"Wajnrajch","sequence":"additional","affiliation":[{"name":"Rare Disease, Biopharmaceuticals, Pfizer , New York, NY 10017 , USA"},{"name":"Department of Pediatrics, New York University Langone Medical Center , New York, NY 10016 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3455-002X","authenticated-orcid":false,"given":"Agn\u00e8s","family":"Linglart","sequence":"additional","affiliation":[{"name":"Department of Pediatric Endocrinology and Diabetology for Children, AP-HP, Bic\u00eatre Paris Saclay , Le Kremlin Bic\u00eatre 94270 , France"},{"name":"APHP, Reference Center for Rare Disorders of the Calcium and Phosphate Metabolism, Fili\u00e8re OSCAR and Plateforme d\u2019Expertise Maladies Rares Paris-Sud, Bic\u00eatre Paris Saclay Hospital , Le Kremlin Bic\u00eatre 94270 , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0508-2186","authenticated-orcid":false,"given":"Renata","family":"Stawerska","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Metabolic Diseases, Polish Mother\u2019s Memorial Hospital-Research Institute , Lodz 93-338 , Poland"},{"name":"Department of Pediatric Endocrinology, Medical University of Lodz , Lodz 93-338 , Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter E","family":"Clayton","sequence":"additional","affiliation":[{"name":"Developmental Biology and Medicine, Faculty of Biology Medicine and Health, Manchester NIHR Academic Health Science Centre, University of Manchester , Manchester M13 9PL , 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Tokyo 157-8535 , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshiaki","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Tanaka Growth Clinic , Tokyo 158-0097 , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helmuth-G\u00fcnther","family":"D\u00f6rr","sequence":"additional","affiliation":[{"name":"Division of Pediatric Endocrinology, Department of Pediatrics and Adolescent Medicine, Friedrich-Alexander University of Erlangen-N\u00fcrnberg , Erlangen 91054 , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3167-0667","authenticated-orcid":false,"given":"Kerstin","family":"Albertsson-Wikland","sequence":"additional","affiliation":[{"name":"Department of Physiology\/Endocrinology, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg , Gothenburg 405 30 , Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2639-352X","authenticated-orcid":false,"given":"Michel","family":"Polak","sequence":"additional","affiliation":[{"name":"Universit\u00e9 de Paris Cit\u00e9; H\u00f4pital Universitaire Necker Enfants Malades , Paris 75015 , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1523-1536","authenticated-orcid":false,"given":"Adda","family":"Grimberg","sequence":"additional","affiliation":[{"name":"Division of Pediatric Endocrinology and Diabetes, Children\u2019s Hospital of Philadelphia , Philadelphia, Pennsylvania 19104 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"80","published-online":{"date-parts":[[2022,9,14]]},"reference":[{"issue":"8","key":"2022112511303051500_dgac517-B1","doi-asserted-by":"crossref","first-page":"901","DOI":"10.1210\/jcem-18-8-901","article-title":"Treatment of a pituitary dwarf with 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