Evidence map›Paper›PMID 36102184›Full record

ArticleThe Journal of clinical endocrinology and metabolism2022

Safety and Efficacy of Pediatric Growth Hormone Therapy: Results From the Full KIGS Cohort.

Mohamad Maghnie, Michael B Ranke, Mitchell E Geffner, Elpis Vlachopapadopoulou, Lourdes Ibáñez, Martin Carlsson, Wayne Cutfield, Raoul Rooman, Roy Gomez, Michael P Wajnrajch and 11 more

Open access · bronzeAbstract read
In one paragraph

Article in The Journal of clinical endocrinology and metabolism, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 76 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
76citing papers in PubMed, 4 pooled it
13.5field-weighted citation impact, top 1% 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

76 citing papers in PubMed, 4 syntheses or guidelines pooled it, 104 citations in OpenAlex.

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16 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 19 institutions in 14 countries.

Mohamad MaghnieDepartment of Pediatrics, IRCCS Giannina Gaslini, Genova 16124, Italy.ORCID 0000-0002-7183-5238
Michael B RankeDepartment of Pediatric Endocrinology, University Children´s Hospital, Tübingen 72076, Germany.ORCID 0000-0002-3855-6157
Mitchell E GeffnerThe Saban Research Institute, Children's Hospital Los Angeles, Los Angeles, California 90027, USA.ORCID 0000-0002-0384-3287
Elpis VlachopapadopoulouDepartment of Endocrinology, Growth and Development, Aglaia Kyriakou Children's Hospital, Athens 11527, Greece.ORCID 0000-0001-5641-7081
Lourdes IbáñezEndocrinology, Pediatric Research Institute Sant Joan de Déu, Barcelona 08950, Spain.
Martin CarlssonRare Disease, Biopharmaceuticals, Pfizer, New York, NY 10017, USA.ORCID 0000-0003-3106-0754
Wayne CutfieldLiggins Institute, University of Auckland, Auckland 1142, New Zealand.ORCID 0000-0001-6107-3682
Raoul RoomanPendoCon, Putte 2580, Belgium.
Roy GomezEuropean Medical Affairs, Pfizer, Brussels 1070, Belgium.ORCID 0000-0001-7029-1542
Michael P WajnrajchRare Disease, Biopharmaceuticals, Pfizer, New York, NY 10017, USA.ORCID 0000-0002-8211-9237
Agnès LinglartDepartment of Pediatric Endocrinology and Diabetology for Children, AP-HP, Bicêtre Paris Saclay, Le Kremlin Bicêtre 94270, France.ORCID 0000-0003-3455-002X
Renata StawerskaDepartment of Endocrinology and Metabolic Diseases, Polish Mother's Memorial Hospital-Research Institute, Lodz 93-338, Poland.ORCID 0000-0002-0508-2186
Peter E ClaytonDevelopmental Biology and Medicine, Faculty of Biology Medicine and Health, Manchester NIHR Academic Health Science Centre, University of Manchester, Manchester M13 9PL, UK.
Feyza Darendelilerİstanbul University, Istanbul Faculty of Medicine, Pediatric Endocrinology Unit, İstanbul 34452, Turkey.ORCID 0000-0003-4786-0780
Anita C S Hokken-KoelegaPediatrics, Subdivision of Endocrinology, Erasmus University Medical Center, Rotterdam 3015 GD, the Netherlands.ORCID 0000-0002-1384-7628
Reiko HorikawaDivision of Endocrinology and Metabolism, National Center for Child Health and Development, Tokyo 157-8535, Japan.ORCID 0000-0003-3429-3246
Toshiaki TanakaTanaka Growth Clinic, Tokyo 158-0097, Japan.
Helmuth-Günther DörrDivision of Pediatric Endocrinology, Department of Pediatrics and Adolescent Medicine, Friedrich-Alexander University of Erlangen-Nürnberg, Erlangen 91054, Germany.
Kerstin Albertsson-WiklandDepartment of Physiology/Endocrinology, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg 405 30, Sweden.ORCID 0000-0003-3167-0667
Michel PolakUniversité de Paris Cité; Hôpital Universitaire Necker Enfants Malades, Paris 75015, France.ORCID 0000-0003-2639-352X
Adda GrimbergDivision of Pediatric Endocrinology and Diabetes, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, USA.ORCID 0000-0002-1523-1536
Pfizer (United States) · USAssistance Publique – Hôpitaux de Paris · FRChildren's Hospital of Los Angeles · USChildren's Hospital of Philadelphia · USErasmus MC · NLFriedrich-Alexander-Universität Erlangen-Nürnberg · DEHôpital Necker-Enfants Malades · FRHospital Sant Joan de Déu Barcelona · ESIstanbul University · TRIstituto Giannina Gaslini · ITManchester Academic Health Science Centre · GBMedical University of Lodz · PLNational Center For Child Health and Development · JPPanagiotis & Aglaia Kyriakou Children's Hospital · GRPfizer (Belgium) · BETanaka Holdings (Japan) · JPUniversity Children's Hospital Tübingen · DEUniversity of Auckland · NZUniversity of Gothenburg · SE

Funding

Pfizer
6 · The paper itself

Abstract

contextThe 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.

objectiveThis work aimed to evaluate the safety and efficacy of rhGH from the full KIGS cohort.

methodsData 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 (≥ 2 years prepubertal) who had reached near-adult height (NAH). Main outcomes included adverse events (AEs), serious AEs (SAEs), and height growth.

resultsThe 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.

conclusionData 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.

Indexed as

Dwarfism, PituitaryHuman Growth HormoneAdultBody HeightChildFemaleGrowth DisordersGrowth HormoneHumansMaleRecombinant ProteinsGrowth HormoneHuman Growth HormoneRecombinant Proteinschildrenefficacygrowth hormoneKIGSsafetyshort stature

Identifiers

PMID36102184
PMCPMC9693805
OpenAlexW4295755914

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.