PMID- 33742320 OWN - NLM STAT- MEDLINE DCOM- 20211203 LR - 20211214 IS - 1573-7403 (Electronic) IS - 1386-341X (Print) IS - 1386-341X (Linking) VI - 24 IP - 4 DP - 2021 Aug TI - 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). PG - 622-629 LID - 10.1007/s11102-021-01139-2 [doi] AB - PURPOSE: To evaluate safety and effectiveness of biosimilar recombinant human growth hormone (rhGH; Omnitrope(R)) in adults with growth hormone deficiency (GHD), using data from the PATRO Adults study. METHODS: 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(R) treatment. Effectiveness was evaluated as a secondary objective. RESULTS: 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 = 1179; 81.5%); 721 (49.8%) were rhGH-naive at study entry. Overall, 1056 patients (73.0%) reported adverse events (AEs; n = 5397 events); the majority were mild-to-moderate in intensity. Treatment-related AEs were reported in 117 patients (8.1%; n = 189 events); the most commonly reported (MedDRA preferred terms) were arthralgia (n = 19), myalgia (n = 16), headache (n = 14), and edema peripheral (n = 10). In total, 495 patients (34.2%) had serious AEs (SAEs; n = 1131 events); these were considered treatment-related in 28 patients (1.9%; n = 35 events). Mean (standard deviation) IGF-I SDS increased from - 2.34 (1.47) at baseline to - 0.23 (1.65) at 12 months, and remained relatively stable thereafter (up to 3 years). Body mass index remained stable between baseline and 3 years. CONCLUSION: Data from PATRO Adults indicate biosimilar rhGH (Omnitrope((R))) is not associated with any unexpected safety signals, and is effective in adults with GHD treated in real-world clinical practice. CI - (c) 2021. The Author(s). FAU - Hoybye, Charlotte AU - Hoybye C AD - Department of Endocrinology and Department of Molecular Medicine and Surgery, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden. FAU - Beck-Peccoz, Paolo AU - Beck-Peccoz P AD - Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca Granda Ospedale Maggiore Policlinico, Via Pietro Custodi 16, 20136, Milano, Italy. FAU - Murray, Robert D AU - Murray RD AD - Leeds Centre for Diabetes & Endocrinology, Leeds Teaching Hospitals NHS Trust, Leeds, LS9 7TF, UK. FAU - Simsek, Suat AU - Simsek S AD - Department of Internal Medicine/Endocrinology, Northwest Clinics Alkmaar, Wilhelminalaan 12, 1815 JD, Alkmaar, The Netherlands. FAU - Stalla, Gunter AU - Stalla G AD - Medicover Neuroendokrinologie und Medizinische Klinik und Poliklinik IV der, Ludwig-Maximilians-Universitat, Orleansplatz 3, 81667, Munchen, Germany. FAU - Strasburger, Christian J AU - Strasburger CJ AD - Department of Medicine for Endocrinology, Diabetes and Nutritional Medicine, Charite Universitatsmedizin, Berlin, Germany. FAU - Urosevic, Dragan AU - Urosevic D AD - Sandoz Biopharmaceuticals, Fabrikstrasse 2, 4056, Basel, Switzerland. FAU - Zouater, Hichem AU - Zouater H AD - Sandoz Biopharmaceutical, c/o HEXAL AG, Industriestr. 18, 83607, Holzkirchen, Germany. hichem.zouater@sandoz.com. FAU - Johannsson, Gudmundur AU - Johannsson G AD - Department of Endocrinology, Sahlgrenska University Hospital, Goteborg, Sweden. LA - eng PT - Journal Article DEP - 20210320 PL - United States TA - Pituitary JT - Pituitary JID - 9814578 RN - 0 (Biosimilar Pharmaceuticals) RN - 0 (Recombinant Proteins) RN - 12629-01-5 (Human Growth Hormone) RN - 9002-72-6 (Growth Hormone) SB - IM MH - Biosimilar Pharmaceuticals/adverse effects MH - Dwarfism, Pituitary MH - Female MH - Growth Disorders/drug therapy MH - Growth Hormone MH - Human Growth Hormone/therapeutic use MH - Humans MH - Longitudinal Studies MH - Male MH - *Product Surveillance, Postmarketing MH - Recombinant Proteins PMC - PMC8270854 OTO - NOTNLM OT - Adults OT - Biosimilars OT - Growth hormone OT - Growth hormone deficiency OT - Omnitrope(R) COIS- CH has acted as an investigator for Sandoz, Pfizer, and NovoNordisk; has received lecture fees from Sandoz, Pfizer, and NovoNordisk; and is a member of the global steering committee for the PATRO Adults study. 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. EDAT- 2021/03/21 06:00 MHDA- 2021/12/15 06:00 PMCR- 2021/03/20 CRDT- 2021/03/20 06:47 PHST- 2021/02/26 00:00 [accepted] PHST- 2021/03/21 06:00 [pubmed] PHST- 2021/12/15 06:00 [medline] PHST- 2021/03/20 06:47 [entrez] PHST- 2021/03/20 00:00 [pmc-release] AID - 10.1007/s11102-021-01139-2 [pii] AID - 1139 [pii] AID - 10.1007/s11102-021-01139-2 [doi] PST - ppublish SO - Pituitary. 2021 Aug;24(4):622-629. doi: 10.1007/s11102-021-01139-2. Epub 2021 Mar 20.