{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T16:34:28Z","timestamp":1780331668281,"version":"3.54.1"},"reference-count":16,"publisher":"Springer Science and Business Media LLC","license":[{"start":{"date-parts":[[2021,3,20]],"date-time":"2021-03-20T00:00:00Z","timestamp":1616198400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,3,20]],"date-time":"2021-03-20T00:00:00Z","timestamp":1616198400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Sandoz\/Hexal AG"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Pituitary"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n              <jats:title>Purpose<\/jats:title>\n              <jats:p>To evaluate safety and effectiveness of biosimilar recombinant human growth hormone (rhGH; Omnitrope\u00ae) in adults with growth hormone deficiency (GHD), using data from the PATRO Adults study.<\/jats:p>\n            <\/jats:sec><jats:sec>\n              <jats:title>Methods<\/jats:title>\n              <jats:p>PATRO Adults was a post-marketing surveillance study conducted in hospitals and specialized endocrinology units across Europe. The primary objective was to assess the safety of rhGH in adults treated in routine clinical practice. All adverse events (AEs) were monitored and recorded for the complete duration of Omnitrope\u00ae treatment. Effectiveness was evaluated as a secondary objective.<\/jats:p>\n            <\/jats:sec><jats:sec>\n              <jats:title>Results<\/jats:title>\n              <jats:p>As of January 2020, 1447 patients (50.9% male) had been enrolled from 82 centers in 9 European countries. Most patients had adult-onset GHD (n\u2009=\u20091179; 81.5%); 721 (49.8%) were rhGH-na\u00efve at study entry. Overall, 1056 patients (73.0%) reported adverse events (AEs; n\u2009=\u20095397 events); the majority were mild-to-moderate in intensity. Treatment-related AEs were reported in 117 patients (8.1%; n\u2009=\u2009189 events); the most commonly reported (MedDRA preferred terms) were arthralgia (n\u2009=\u200919), myalgia (n\u2009=\u200916), headache (n\u2009=\u200914), and edema peripheral (n\u2009=\u200910). In total, 495 patients (34.2%) had serious AEs (SAEs; n\u2009=\u20091131 events); these were considered treatment-related in 28 patients (1.9%; n\u2009=\u200935 events). Mean (standard deviation) IGF-I SDS increased from \u2013 2.34 (1.47) at baseline to \u2013 0.23 (1.65) at 12\u00a0months, and remained relatively stable thereafter (up to 3\u00a0years). Body mass index remained stable between baseline and 3\u00a0years.<\/jats:p>\n            <\/jats:sec><jats:sec>\n              <jats:title>Conclusion<\/jats:title>\n              <jats:p>Data from PATRO Adults indicate biosimilar rhGH (Omnitrope<jats:sup>\u00ae<\/jats:sup>) is not associated with any unexpected safety signals, and is effective in adults with GHD treated in real-world clinical practice.<\/jats:p>\n            <\/jats:sec>","DOI":"10.1007\/s11102-021-01139-2","type":"journal-article","created":{"date-parts":[[2021,3,20]],"date-time":"2021-03-20T03:02:44Z","timestamp":1616209364000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Safety and effectiveness of replacement with biosimilar growth hormone in adults with growth hormone deficiency: results from an international, post-marketing surveillance study (PATRO Adults)"],"prefix":"10.1007","author":[{"given":"Charlotte","family":"H\u00f6ybye","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Beck-Peccoz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert D.","family":"Murray","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suat","family":"Simsek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G\u00fcnter","family":"Stalla","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian J.","family":"Strasburger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dragan","family":"Urosevic","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hichem","family":"Zouater","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gudmundur","family":"Johannsson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,3,20]]},"reference":[{"issue":"26","key":"1139_CR1","doi-asserted-by":"publisher","first-page":"2551","DOI":"10.1056\/NEJMra1817346","volume":"380","author":"S Melmed","year":"2019","unstructured":"Melmed S (2019) Pathogenesis and diagnosis of growth hormone deficiency in adults. 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RDM has received research funding from Sandoz, Ipsen, and Pfizer; has received lecture fees from Pfizer; and is a member of the global steering committee for the PATRO Adults study. PBP and SS are members of the global steering committee for the PATRO Adults study. GS has received honoraria for scientific advisory work and\/or reimbursement of delegate fees for congresses\/seminars and\/or travel costs and\/or research grants from the HRA, Ipsen, Lilly, Novartis, NovoNordisk, Pfizer, Sandoz, and Shire; and is a member of the global steering committee for the PATRO Adults study. CJS is a member of the German PATRO advisory board, and has received advisory honoraria or speaker fees from Sandoz, NovoNordisk, Ipsen, Ascendis, and Pfizer. GJ has served as a consultant for Novo Nordisk, Shire, and AstraZeneca, and has received lecture fees from Eli Lilly, Ipsen, Novartis, Novo Nordisk, Merck Serono, Otsuka, and Pfizer. DU and HM are employees of Sandoz.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The PATRO Adults study protocol was approved by the ethics review committee of all participating centers in accordance with national laws and regulations. Written informed consent was obtained from all participating patients. The study was approved by the following ethics committees: Czech Republic: Etick\u00e1 komise V\u0161eobecn\u00e9 fakultn\u00ed nemocnice v Praze, 128 08 Praha 2; Multicentrick\u00e1 etick\u00e1 komise Fakultn\u00ed nemocnice Hradec Kr\u00e1lov\u00e9, 500 05 Hradec Kr\u00e1lov\u00e9. Germany: Medical Council of Bavaria Ethics Committee, 81677 M\u00fcnchen; Medical Council of Hamburg Ethics Committee, 22083 Hamburg; Medical Council of Saxony Ethics Committee, 01099 Dresden; Medical Council of Thuringia Ethics Committee, 07751 Jena; \u00c4rztekammer Hessen, 60488 Frankfurt am Main; Medical Council of Lower Saxony Ethics Committee, 30175 Hannover; Medical Faculty of University of Hannover Ethics Committee, 30625 Hannover; Medical Faculty of University of W\u00fcrzburg Ethics Committee, 97078 W\u00fcrzburg; Medical Faculty of University of T\u00fcbingen Ethics Committee, 72074 T\u00fcbingen; Medical Faculty of University of Erlangen Ethics Committee, 91054 Erlangen; Medical Council of Westphalia-Lippe Ethics Committee, 48147 M\u00fcnster; Medical Council of Baden-Wurttemberg Ethics Committee, 70597 Stuttgart; Medical Faculty of University of Aachen Ethics Committee, 52074 Aachen; Medical Council of Berlin Ethics Committee, 10707 Berlin; Ethikkommission an der Medizinischen Fakult\u00e4t der Universit\u00e4t Leipzig, 04109 Leipzig, Germany; Medical Faculty of Ludwig-Maximilian University Munich Ethics Committee, 80336 Munich; Bayerische Landes\u00e4rztekammer, 81677 M\u00fcnchen. Spain: Comit\u00e9 de \u00c9tica de Investigaci\u00f3n de los Hospitales Universitarios Virgen Macarena\u2014Virgen del Rocio, 41013 Sevilla; Comit\u00e9 \u00c9tico de Investigaci\u00f3n Cl\u00ednica Hospital Universitari Vall d\u2019Hebron, 08035 Barcelona. UK: NRES Committee South Central\u2014Southampton A, Bristol BS1 2NT. Italy: Comitato di Etica Della Fondazione Irccs ca\u2019 Granda Ospedale Maggiore, 20122 MILANO; Comitato Etico Dell\u2019Azienda Ospedaliera Universitaria S. Martino Di Genova, 16132 GENOVA; Comitato Etico Dell\u2019Azienda Ospedaliera Universitaria S. Giovanni Battista Di Torino, 10126 TORINO; Comitato Etico di Area Vasta Emilia Centro (CE-AVEC) c\/o Ufficio Ricerca e Innovazione, Azienda Ospedaliero Universitaria di Ferrara, 44121 FERRARA; Comitato Etico Delle Aziende Sanitarie Dell\u2019Umbria; Segreteria Scientifico Amministrativa, 06073 PERUGIA; Comitato Etico per le attivit\u00e0 biomediche \u201cCarlo Romano\u201d, dell\u2019Universit\u00e0 degli Studi di Napoli Federico II, Segreteria tecnico-scientifica, 80131 NAPOLI; Comitato Etico Dell\u2019Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I\u2014G.M. Lancisi\u2014G. Salesi Di Ancona, 60126 ANCONA; Comitato Etico Per La Sperimentazione Dell\u2019Azienda Ospedaliera Di Padova, 35128 PADOVA. The Netherlands: METC Isala, 8000 GK Zwolle; Wetenschapsbureau, 1815 GM Alkmaar. Sweden: Regionala Etikpr\u00f6vningsn\u00e4mnden i Stockholm, 171 77 Stockholm. France: Institut National des Donn\u00e9es de Sant\u00e9, 94220 Charenton-le-Pont; Comit\u00e9 Consultatif pour le Traitement de l\u2019Information en mati\u00e8re de Recherche pour la Sant\u00e9, 75231 Paris cedex 05.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"As part of the informed consent process, all patients provided written consent for the publication of data collected in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}}]}}