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Rationale and design of PATRO Adults, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope(®) for the treatment of adult patients with growth hormone deficiency.

Therapeutic advances in endocrinology and metabolism

Beck-Peccoz P, Minuto F, Leal-Cerro A, Zabransky M, Stalla G.
PMID: 23148199
Ther Adv Endocrinol Metab. 2012 Jun;3(3):85-91. doi: 10.1177/2042018812444152.

OBJECTIVE: To describe the rationale and design of PATRO Adults, a postmarketing surveillance study of the long-term efficacy and safety of somatropin (Omnitrope(®)) for the treatment of adult patients with growth hormone deficiency (GHD).METHODS: PATRO Adults is an observational,...

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Beck-Peccoz P, Minuto F, Leal-Cerro A, et al. Rationale and design of PATRO Adults, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope(®) for the treatment of adult patients with growth hormone deficiency. Ther Adv Endocrinol Metab. 2012;3(3):85-91doi: 10.1177/2042018812444152.
Beck-Peccoz, P., Minuto, F., Leal-Cerro, A., Zabransky, M., & Stalla, G. (2012). Rationale and design of PATRO Adults, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope(®) for the treatment of adult patients with growth hormone deficiency. Therapeutic advances in endocrinology and metabolism, 3(3), 85-91. https://doi.org/10.1177/2042018812444152
Beck-Peccoz, Paolo, et al. "Rationale and design of PATRO Adults, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope(®) for the treatment of adult patients with growth hormone deficiency." Therapeutic advances in endocrinology and metabolism vol. 3,3 (2012): 85-91. doi: https://doi.org/10.1177/2042018812444152
Beck-Peccoz P, Minuto F, Leal-Cerro A, Zabransky M, Stalla G. Rationale and design of PATRO Adults, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope(®) for the treatment of adult patients with growth hormone deficiency. Ther Adv Endocrinol Metab. 2012 Jun;3(3):85-91. doi: 10.1177/2042018812444152. PMID: 23148199; PMCID: PMC3474653.
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PKA regulatory subunit R2B is required for murine and human adipocyte differentiation.

Endocrine connections

Peverelli E, Ermetici F, Corbetta S, Gozzini E, Avagliano L, Zappa MA, Bulfamante G, Beck-Peccoz P, Spada A, Mantovani G.
PMID: 24145613
Endocr Connect. 2013 Oct 28;2(4):196-207. doi: 10.1530/EC-13-0049. Print 2013.

ADIPOGENESIS IS A COMPLEX PROCESS MODULATED BY SEVERAL FACTORS, INCLUDING CAMP SIGNALING. THE MAIN CAMP TARGET IS PROTEIN KINASE A (PKA), A TETRAMERIC ENZYME WITH FOUR REGULATORY SUBUNITS SHOWING TISSUE-SPECIFIC EXPRESSION AND FUNCTION: PRKAR2B is the main regulatory subunit...

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Peverelli E, Ermetici F, Corbetta S, et al. PKA regulatory subunit R2B is required for murine and human adipocyte differentiation. Endocr Connect. 2013;2(4):196-207doi: 10.1530/EC-13-0049.
Peverelli, E., Ermetici, F., Corbetta, S., Gozzini, E., Avagliano, L., Zappa, M. A., Bulfamante, G., Beck-Peccoz, P., Spada, A., & Mantovani, G. (2013). PKA regulatory subunit R2B is required for murine and human adipocyte differentiation. Endocrine connections, 2(4), 196-207. https://doi.org/10.1530/EC-13-0049
Peverelli, Erika, et al. "PKA regulatory subunit R2B is required for murine and human adipocyte differentiation." Endocrine connections vol. 2,4 (2013): 196-207. doi: https://doi.org/10.1530/EC-13-0049
Peverelli E, Ermetici F, Corbetta S, Gozzini E, Avagliano L, Zappa MA, Bulfamante G, Beck-Peccoz P, Spada A, Mantovani G. PKA regulatory subunit R2B is required for murine and human adipocyte differentiation. Endocr Connect. 2013 Oct 28;2(4):196-207. doi: 10.1530/EC-13-0049. Print 2013. PMID: 24145613; PMCID: PMC3847920.
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2013 European thyroid association guidelines for the diagnosis and treatment of thyrotropin-secreting pituitary tumors.

European thyroid journal

Beck-Peccoz P, Lania A, Beckers A, Chatterjee K, Wemeau JL.
PMID: 24783044
Eur Thyroid J. 2013 Jun;2(2):76-82. doi: 10.1159/000351007. Epub 2013 May 07.

Hyperthyroidism is mainly due to autoimmune thyroid disorders or toxic goiter, and very rarely to the presence of thyrotropin (TSH)-secreting pituitary adenomas (TSHomas). These tumors are characterized by high levels of circulating free thyroid hormones (FT4 and FT3) in...

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Beck-Peccoz P, Lania A, Beckers A, et al. 2013 European thyroid association guidelines for the diagnosis and treatment of thyrotropin-secreting pituitary tumors. Eur Thyroid J. 2013;2(2):76-82doi: 10.1159/000351007.
Beck-Peccoz, P., Lania, A., Beckers, A., Chatterjee, K., & Wemeau, J. L. (2013). 2013 European thyroid association guidelines for the diagnosis and treatment of thyrotropin-secreting pituitary tumors. European thyroid journal, 2(2), 76-82. https://doi.org/10.1159/000351007
Beck-Peccoz, P, et al. "2013 European thyroid association guidelines for the diagnosis and treatment of thyrotropin-secreting pituitary tumors." European thyroid journal vol. 2,2 (2013): 76-82. doi: https://doi.org/10.1159/000351007
Beck-Peccoz P, Lania A, Beckers A, Chatterjee K, Wemeau JL. 2013 European thyroid association guidelines for the diagnosis and treatment of thyrotropin-secreting pituitary tumors. Eur Thyroid J. 2013 Jun;2(2):76-82. doi: 10.1159/000351007. Epub 2013 May 07. PMID: 24783044; PMCID: PMC3821512.
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Erratum to: Long-term safety and efficacy of Omnitrope.

Journal of endocrinological investigation

Ferone D, Profka E, Gasco V, Ambrosio MR, Colao A, Di Somma C, Puxeddu E, Arnaldi G, Pagano C, Zecchi E, Pietropoli A, Beck-Peccoz P.
PMID: 28421564
J Endocrinol Invest. 2017 Jun;40(6):679-681. doi: 10.1007/s40618-017-0664-4.

No abstract available.

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Ferone D, Profka E, Gasco V, et al. Erratum to: Long-term safety and efficacy of Omnitrope. J Endocrinol Invest. 2017;40(6):679-681doi: 10.1007/s40618-017-0664-4.
Ferone, D., Profka, E., Gasco, V., Ambrosio, M. R., Colao, A., Di Somma, C., Puxeddu, E., Arnaldi, G., Pagano, C., Zecchi, E., Pietropoli, A., & Beck-Peccoz, P. (2017). Erratum to: Long-term safety and efficacy of Omnitrope. Journal of endocrinological investigation, 40(6), 679-681. https://doi.org/10.1007/s40618-017-0664-4
Ferone, D, et al. "Erratum to: Long-term safety and efficacy of Omnitrope." Journal of endocrinological investigation vol. 40,6 (2017): 679-681. doi: https://doi.org/10.1007/s40618-017-0664-4
Ferone D, Profka E, Gasco V, Ambrosio MR, Colao A, Di Somma C, Puxeddu E, Arnaldi G, Pagano C, Zecchi E, Pietropoli A, Beck-Peccoz P. Erratum to: Long-term safety and efficacy of Omnitrope. J Endocrinol Invest. 2017 Jun;40(6):679-681. doi: 10.1007/s40618-017-0664-4. PMID: 28421564; PMCID: PMC6828524.
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Correction to: Multiple endocrine neoplasia type 1: analysis of germline MEN1 mutations in the Italian multicenter MEN1 patient database.

Endocrine

Marini F, Giusti F, Fossi C, Cioppi F, Cianferotti L, Masi L, Boaretto F, Zovato S, Cetani F, Colao A, Davì MV, Faggiano A, Fanciulli G, Ferolla P, Ferone D, Loli P, Mantero F, Marcocci C, Opocher G, Beck-Peccoz P, Persani L, Scillitani A, Guizzardi F, Spada A, Tomassetti P, Tonelli F, Brandi ML.
PMID: 30032405
Endocrine. 2018 Oct;62(1):234-241. doi: 10.1007/s12020-018-1668-3.

The original version of this article unfortunately contained a mistake in Table 2. The table 2 was truncated in the original publication. The full table 2 is given below.

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Marini F, Giusti F, Fossi C, et al. Correction to: Multiple endocrine neoplasia type 1: analysis of germline MEN1 mutations in the Italian multicenter MEN1 patient database. Endocrine. 2018;62(1):234-241doi: 10.1007/s12020-018-1668-3.
Marini, F., Giusti, F., Fossi, C., Cioppi, F., Cianferotti, L., Masi, L., Boaretto, F., Zovato, S., Cetani, F., Colao, A., Davì, M. V., Faggiano, A., Fanciulli, G., Ferolla, P., Ferone, D., Loli, P., Mantero, F., Marcocci, C., Opocher, G., Beck-Peccoz, P., Persani, L., Scillitani, A., Guizzardi, F., Spada, A., Tomassetti, P., Tonelli, F., & Brandi, M. L. (2018). Correction to: Multiple endocrine neoplasia type 1: analysis of germline MEN1 mutations in the Italian multicenter MEN1 patient database. Endocrine, 62(1), 234-241. https://doi.org/10.1007/s12020-018-1668-3
Marini, Francesca, et al. "Correction to: Multiple endocrine neoplasia type 1: analysis of germline MEN1 mutations in the Italian multicenter MEN1 patient database." Endocrine vol. 62,1 (2018): 234-241. doi: https://doi.org/10.1007/s12020-018-1668-3
Marini F, Giusti F, Fossi C, Cioppi F, Cianferotti L, Masi L, Boaretto F, Zovato S, Cetani F, Colao A, Davì MV, Faggiano A, Fanciulli G, Ferolla P, Ferone D, Loli P, Mantero F, Marcocci C, Opocher G, Beck-Peccoz P, Persani L, Scillitani A, Guizzardi F, Spada A, Tomassetti P, Tonelli F, Brandi ML. Correction to: Multiple endocrine neoplasia type 1: analysis of germline MEN1 mutations in the Italian multicenter MEN1 patient database. Endocrine. 2018 Oct;62(1):234-241. doi: 10.1007/s12020-018-1668-3. PMID: 30032405.
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Classification and proposed nomenclature for inherited defects of thyroid hormone action, cell transport, and metabolism.

European thyroid journal

Refetoff S, Bassett JH, Beck-Peccoz P, Bernal J, Brent G, Chatterjee K, De Groot LJ, Dumitrescu AM, Jameson JL, Kopp PA, Murata Y, Persani L, Samarut J, Weiss RE, Williams GR, Yen PM.
PMID: 24847459
Eur Thyroid J. 2014 Mar;3(1):7-9. doi: 10.1159/000358180. Epub 2014 Mar 04.

No abstract available.

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Refetoff S, Bassett JH, Beck-Peccoz P, et al. Classification and proposed nomenclature for inherited defects of thyroid hormone action, cell transport, and metabolism. Eur Thyroid J. 2014;3(1):7-9doi: 10.1159/000358180.
Refetoff, S., Bassett, J. H., Beck-Peccoz, P., Bernal, J., Brent, G., Chatterjee, K., De Groot, L. J., Dumitrescu, A. M., Jameson, J. L., Kopp, P. A., Murata, Y., Persani, L., Samarut, J., Weiss, R. E., Williams, G. R., & Yen, P. M. (2014). Classification and proposed nomenclature for inherited defects of thyroid hormone action, cell transport, and metabolism. European thyroid journal, 3(1), 7-9. https://doi.org/10.1159/000358180
Refetoff, Samuel, et al. "Classification and proposed nomenclature for inherited defects of thyroid hormone action, cell transport, and metabolism." European thyroid journal vol. 3,1 (2014): 7-9. doi: https://doi.org/10.1159/000358180
Refetoff S, Bassett JH, Beck-Peccoz P, Bernal J, Brent G, Chatterjee K, De Groot LJ, Dumitrescu AM, Jameson JL, Kopp PA, Murata Y, Persani L, Samarut J, Weiss RE, Williams GR, Yen PM. Classification and proposed nomenclature for inherited defects of thyroid hormone action, cell transport, and metabolism. Eur Thyroid J. 2014 Mar;3(1):7-9. doi: 10.1159/000358180. Epub 2014 Mar 04. PMID: 24847459; PMCID: PMC4005262.
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Hypothalamic-Pituitary Axis in Non-Functioning Pituitary Adenomas: Focus on the Prevalence of Isolated Central Hypoadrenalism.

Neuroendocrinology

Carosi G, Malchiodi E, Ferrante E, Sala E, Verrua E, Profka E, Giavoli C, Filopanti M, Beck-Peccoz P, Spada A, Mantovani G.
PMID: 25924873
Neuroendocrinology. 2015;102(4):267-273. doi: 10.1159/000430815. Epub 2015 Apr 29.

INTRODUCTION: Non-functioning pituitary adenomas (NFPA) account for about 40% of pituitary tumors. Pituitary deficiencies are present at diagnosis in 60-80% of NFPA, and, classically, growth hormone (GH) secretion is lost first, while adrenocorticotropic hormone is expected to disappear last....

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Carosi G, Malchiodi E, Ferrante E, et al. Hypothalamic-Pituitary Axis in Non-Functioning Pituitary Adenomas: Focus on the Prevalence of Isolated Central Hypoadrenalism. Neuroendocrinology. 2015;102(4):267-273doi: 10.1159/000430815.
Carosi, G., Malchiodi, E., Ferrante, E., Sala, E., Verrua, E., Profka, E., Giavoli, C., Filopanti, M., Beck-Peccoz, P., Spada, A., & Mantovani, G. (2015). Hypothalamic-Pituitary Axis in Non-Functioning Pituitary Adenomas: Focus on the Prevalence of Isolated Central Hypoadrenalism. Neuroendocrinology, 102(4), 267-273. https://doi.org/10.1159/000430815
Carosi, Giulia, et al. "Hypothalamic-Pituitary Axis in Non-Functioning Pituitary Adenomas: Focus on the Prevalence of Isolated Central Hypoadrenalism." Neuroendocrinology vol. 102,4 (2015): 267-273. doi: https://doi.org/10.1159/000430815
Carosi G, Malchiodi E, Ferrante E, Sala E, Verrua E, Profka E, Giavoli C, Filopanti M, Beck-Peccoz P, Spada A, Mantovani G. Hypothalamic-Pituitary Axis in Non-Functioning Pituitary Adenomas: Focus on the Prevalence of Isolated Central Hypoadrenalism. Neuroendocrinology. 2015;102(4):267-273. doi: 10.1159/000430815. Epub 2015 Apr 29. PMID: 25924873.
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Malignancy risk in adults with growth hormone deficiency undergoing long-term treatment with biosimilar somatropin (Omnitrope.

Therapeutic advances in endocrinology and metabolism

Beck-Peccoz P, Höybye C, Murray RD, Simsek S, Zabransky M, Zouater H, Stalla G.
PMID: 32973992
Ther Adv Endocrinol Metab. 2020 Sep 10;11:2042018820943377. doi: 10.1177/2042018820943377. eCollection 2020.

BACKGROUND: To assess the safety (particularly the occurrence of malignancies) of growth hormone (GH) replacement (OmnitropeMETHODS: PATRO Adults is being conducted in hospitals and specialized endocrinology clinics across Europe. All enrolled patients who receive ⩾1 dose of OmnitropeRESULTS: As...

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Beck-Peccoz P, Höybye C, Murray RD, et al. Malignancy risk in adults with growth hormone deficiency undergoing long-term treatment with biosimilar somatropin (Omnitrope. Ther Adv Endocrinol Metab. 2020;11:2042018820943377doi: 10.1177/2042018820943377.
Beck-Peccoz, P., Höybye, C., Murray, R. D., Simsek, S., Zabransky, M., Zouater, H., & Stalla, G. (2020). Malignancy risk in adults with growth hormone deficiency undergoing long-term treatment with biosimilar somatropin (Omnitrope. Therapeutic advances in endocrinology and metabolism, 112042018820943377. https://doi.org/10.1177/2042018820943377
Beck-Peccoz, Paolo, et al. "Malignancy risk in adults with growth hormone deficiency undergoing long-term treatment with biosimilar somatropin (Omnitrope." Therapeutic advances in endocrinology and metabolism vol. 11 (2020): 2042018820943377. doi: https://doi.org/10.1177/2042018820943377
Beck-Peccoz P, Höybye C, Murray RD, Simsek S, Zabransky M, Zouater H, Stalla G. Malignancy risk in adults with growth hormone deficiency undergoing long-term treatment with biosimilar somatropin (Omnitrope. Ther Adv Endocrinol Metab. 2020 Sep 10;11:2042018820943377. doi: 10.1177/2042018820943377. eCollection 2020. PMID: 32973992; PMCID: PMC7491215.
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MEN1 gene mutations are a rare event in patients with sporadic neuroendocrine tumors.

European journal of internal medicine

Asteria C, Anagni M, Fugazzola L, Faglia G, Vezzadini P, Beck-Peccoz P.
PMID: 12144911
Eur J Intern Med. 2002 Aug;13(5):319-323. doi: 10.1016/s0953-6205(02)00064-x.

BACKGROUND: Neuroendocrine tumors of the gastroenteropancreatic (GEP) tract are encountered either as a sporadic type or as part of multiple endocrine neoplasia type 1 (MEN-1) syndrome. Inactivating MEN1 gene mutations have been found to be responsible for this syndrome...

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Asteria C, Anagni M, Fugazzola L, et al. MEN1 gene mutations are a rare event in patients with sporadic neuroendocrine tumors. Eur J Intern Med. 2002;13(5):319-323doi: 10.1016/s0953-6205(02)00064-x.
Asteria, C., Anagni, M., Fugazzola, L., Faglia, G., Vezzadini, P., & Beck-Peccoz, P. (2002). MEN1 gene mutations are a rare event in patients with sporadic neuroendocrine tumors. European journal of internal medicine, 13(5), 319-323. https://doi.org/10.1016/s0953-6205(02)00064-x
Asteria, C, et al. "MEN1 gene mutations are a rare event in patients with sporadic neuroendocrine tumors." European journal of internal medicine vol. 13,5 (2002): 319-323. doi: https://doi.org/10.1016/s0953-6205(02)00064-x
Asteria C, Anagni M, Fugazzola L, Faglia G, Vezzadini P, Beck-Peccoz P. MEN1 gene mutations are a rare event in patients with sporadic neuroendocrine tumors. Eur J Intern Med. 2002 Aug;13(5):319-323. doi: 10.1016/s0953-6205(02)00064-x. PMID: 12144911.
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Reevaluation of Acromegalic Patients in Long-Term Remission according to Newly Proposed Consensus Criteria for Control of Disease.

International journal of endocrinology

Verrua E, Ferrante E, Filopanti M, Malchiodi E, Sala E, Giavoli C, Arosio M, Lania AG, Ronchi CL, Mantovani G, Beck-Peccoz P, Spada A.
PMID: 25587273
Int J Endocrinol. 2014;2014:581594. doi: 10.1155/2014/581594. Epub 2014 Dec 21.

Acromegaly guidelines updated in 2010 revisited criteria of disease control: if applied, it is likely that a percentage of patients previously considered as cured might present postglucose GH nadir levels not adequately suppressed, with potential implications on management. This...

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Verrua E, Ferrante E, Filopanti M, et al. Reevaluation of Acromegalic Patients in Long-Term Remission according to Newly Proposed Consensus Criteria for Control of Disease. Int J Endocrinol. 2014;2014:581594doi: 10.1155/2014/581594.
Verrua, E., Ferrante, E., Filopanti, M., Malchiodi, E., Sala, E., Giavoli, C., Arosio, M., Lania, A. G., Ronchi, C. L., Mantovani, G., Beck-Peccoz, P., & Spada, A. (2014). Reevaluation of Acromegalic Patients in Long-Term Remission according to Newly Proposed Consensus Criteria for Control of Disease. International journal of endocrinology, 2014581594. https://doi.org/10.1155/2014/581594
Verrua, Elisa, et al. "Reevaluation of Acromegalic Patients in Long-Term Remission according to Newly Proposed Consensus Criteria for Control of Disease." International journal of endocrinology vol. 2014 (2014): 581594. doi: https://doi.org/10.1155/2014/581594
Verrua E, Ferrante E, Filopanti M, Malchiodi E, Sala E, Giavoli C, Arosio M, Lania AG, Ronchi CL, Mantovani G, Beck-Peccoz P, Spada A. Reevaluation of Acromegalic Patients in Long-Term Remission according to Newly Proposed Consensus Criteria for Control of Disease. Int J Endocrinol. 2014;2014:581594. doi: 10.1155/2014/581594. Epub 2014 Dec 21. PMID: 25587273; PMCID: PMC4283389.
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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).

Pituitary

Höybye C, Beck-Peccoz P, Murray RD, Simsek S, Stalla G, Strasburger CJ, Urosevic D, Zouater H, Johannsson G.
PMID: 33742320
Pituitary. 2021 Aug;24(4):622-629. doi: 10.1007/s11102-021-01139-2. Epub 2021 Mar 20.

PURPOSE: To evaluate safety and effectiveness of biosimilar recombinant human growth hormone (rhGH; Omnitrope®) 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...

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Höybye C, Beck-Peccoz P, Murray RD, et al. 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). Pituitary. 2021;24(4):622-629doi: 10.1007/s11102-021-01139-2.
Höybye, C., Beck-Peccoz, P., Murray, R. D., Simsek, S., Stalla, G., Strasburger, C. J., Urosevic, D., Zouater, H., & Johannsson, G. (2021). 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). Pituitary, 24(4), 622-629. https://doi.org/10.1007/s11102-021-01139-2
Höybye, Charlotte, et al. "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)." Pituitary vol. 24,4 (2021): 622-629. doi: https://doi.org/10.1007/s11102-021-01139-2
Höybye C, Beck-Peccoz P, Murray RD, Simsek S, Stalla G, Strasburger CJ, Urosevic D, Zouater H, Johannsson G. 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). Pituitary. 2021 Aug;24(4):622-629. doi: 10.1007/s11102-021-01139-2. Epub 2021 Mar 20. PMID: 33742320; PMCID: PMC8270854.
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