{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,4]],"date-time":"2025-11-04T10:49:46Z","timestamp":1762253386655,"version":"3.37.3"},"reference-count":41,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,4,29]],"date-time":"2020-04-29T00:00:00Z","timestamp":1588118400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2020,4,29]],"date-time":"2020-04-29T00:00:00Z","timestamp":1588118400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100011218","name":"Sandoz","doi-asserted-by":"publisher","award":["NA"],"award-info":[{"award-number":["NA"]}],"id":[{"id":"10.13039\/100011218","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Endocr Disord"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n<jats:title>Background<\/jats:title>\n<jats:p>In 2007, Omnitrope\u00ae was the first biosimilar recombinant human growth hormone (rhGH) to be approved in Sweden for treatment in adults and children. Over 10 years\u2019 safety and effectiveness data for biosimilar rhGH can now be presented.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>PATRO Children and PATRO Adults are multicenter, longitudinal, observational, post-marketing surveillance studies. Eligible patients include children 0\u201318\u2009years and adults receiving biosimilar rhGH treatment. Adverse events (AEs) are monitored for safety evaluation. Growth variables in children and metabolic data in adults are recorded for effectiveness evaluation.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Results<\/jats:title>\n<jats:p>As of January 2019, data from 136 children (48% male) were reported from Swedish centers. Mean age in rhGH treatment-na\u00efve patients at study entry (<jats:italic>n<\/jats:italic>\u2009=\u2009114) was 7.5\u2009years, with mean 3.6\u2009years treatment duration. No severe AEs of diabetes, impaired glucose tolerance, or malignancy were reported. The most frequently reported AE was nasopharyngitis (<jats:italic>n<\/jats:italic>\u2009=\u200916 patients). No clinically relevant anti-hGH or neutralizing antibodies were observed. The mean change from baseline in height standard deviation score (SDS) in na\u00efve prepubertal GH deficiency patients was +\u20090.79 at 1\u2009year, +\u20091.27 at 2\u2009years, and\u2009+\u20091.55 at 3\u2009years. Data from 293 adults (44% rhGH-na\u00efve, 51% male) were included. Fatigue was the most frequently reported AE (<jats:italic>n<\/jats:italic>\u2009=\u200926 patients). The incidence of new neoplasms or existing neoplasm progression was 23.8 patients per 1000 patient-years. Type 2 diabetes mellitus was reported in four patients. At baseline in rhGH-na\u00efve adults, mean (SD) body mass index (BMI) was 29.1 (5.6) kg\/m<jats:sup>2<\/jats:sup> and mean (SD) insulin-like growth factor (IGF)-I SDS was \u2212\u20093.0 (1.4). Mean daily dose increased from 0.1\u2009mg at baseline to 0.3\u2009mg after 4\u2009years. IGF-I SDS normalized during the first year of treatment. Mean BMI and glucose were unchanged over 4\u2009years, while low\u2212\/high-density lipoprotein cholesterol ratio decreased.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Conclusions<\/jats:title>\n<jats:p>For the first time, Swedish data from the PATRO Children and Adults studies are presented. The 10-year data suggest that biosimilar rhGH is well tolerated across pediatric and adult indications. Safety and effectiveness were similar to previous reports for other rhGH preparations. These results need to be confirmed in larger cohorts, highlighting the importance of long-term post-marketing studies.<\/jats:p>\n<\/jats:sec>","DOI":"10.1186\/s12902-020-0535-4","type":"journal-article","created":{"date-parts":[[2020,4,29]],"date-time":"2020-04-29T19:03:17Z","timestamp":1588186997000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Ten years with biosimilar rhGH in clinical practice in Sweden \u2013 experience from the prospective PATRO children and adult studies"],"prefix":"10.1186","volume":"20","author":[{"given":"Elena","family":"Lundberg","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Berit","family":"Kristr\u00f6m","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hichem","family":"Zouater","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna","family":"Deleskog","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charlotte","family":"H\u00f6ybye","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,4,29]]},"reference":[{"issue":"11","key":"535_CR1","first-page":"3990","volume":"85","author":"GHR Society","year":"2000","unstructured":"Society GHR. 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J Clin Endocrinol Metab. 2011;96(6):1587\u2013609.","journal-title":"J Clin Endocrinol Metab"}],"container-title":["BMC Endocrine Disorders"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12902-020-0535-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12902-020-0535-4\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12902-020-0535-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,4,28]],"date-time":"2021-04-28T23:34:06Z","timestamp":1619652846000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcendocrdisord.biomedcentral.com\/articles\/10.1186\/s12902-020-0535-4"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,4,29]]},"references-count":41,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2020,12]]}},"alternative-id":["535"],"URL":"https:\/\/doi.org\/10.1186\/s12902-020-0535-4","relation":{},"ISSN":["1472-6823"],"issn-type":[{"type":"electronic","value":"1472-6823"}],"subject":[],"published":{"date-parts":[[2020,4,29]]},"assertion":[{"value":"2 October 2019","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"12 April 2020","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"29 April 2020","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The PATRO studies were approved by the Ethics Committee at the University of Lund, Lund, Sweden (PATRO Children: NR 2009\/765) and at Stockholm, Sweden (PATRO Adults: NR 2011\/1212\u201331). Written informed consent was obtained from participants (and\/or their parents\/guardians where the patient was aged <\u200918\u2009years).","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"No personal of identifying patient information is included in the manuscript, therefore consent to publish is not required.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"EL has nothing to declare. BK has received honoraria for lectures and consultation from Merck Darmstadt, Novo Nordisk, Pfizer, Sandoz, and GeneScience Pharmaceuticals Co, and has been a member of Pfizer iGRO board since 2013. HZ is an employee of Sandoz Biopharmaceutical c\/o HEXAL AG. AD is an employee of Sandoz A\/S, Denmark. CH has received honoraria for lectures and consultation from Novo Nordisk, Pfizer, and Sandoz, and is a member of the Global Steering Committee for the PATRO Adults study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"55"}}