Post-radioiodine Graves’ management: the PRAGMA study

Petros Perros; Ansu Basu; Kristien Boelaert; Colin Dayan; Bijay Vaidya; Graham R. Williams; John H Lazarus; Janis  Hickey; William M Drake; Anna  Crown; Stephen M  Orme; Andrew Johnson; David W. Ray; Graham P. Leese; T Hugh  Jones; Prakash Abraham; Ashley Grossman; Aled Rees; Salman Razvi; Fraser W  Gibb; Carla  Moran; Asgar  Madathil; Miloš P.  Žarković; Zoe  Plummer; Sheba  Jarvis; Agnieszka  Falinska; Anand  Velusamy; Violet  Sanderson; Nadia  Parian; Stephen L Atkin; Akheel A  Syed; Thozhukat Sathyapalan; Sath  Nag; Jackie Gilbert; Helena Gleeson; Miles J.  Levy; Colin Johnston; Nigel  Sturrock; Stuart Bennett; Biswa  Mishra; Isha  Malik; Niki Karavitaki

doi:10.1111/cen.14719

Post-radioiodine Graves’ management: the PRAGMA study

Petros Perros, Ansu Basu, Kristien Boelaert, Colin Dayan, Bijay Vaidya, Graham R. Williams, John H Lazarus, Janis Hickey, William M Drake, Anna Crown, Stephen M Orme, Andrew Johnson, David W. Ray, Graham P. Leese, T Hugh Jones, Prakash Abraham, Ashley Grossman, Aled Rees, Salman Razvi, Fraser W GibbCarla Moran, Asgar Madathil, Miloš P. Žarković, Zoe Plummer, Sheba Jarvis, Agnieszka Falinska, Anand Velusamy, Violet Sanderson, Nadia Parian, Stephen L Atkin, Akheel A Syed, Thozhukat Sathyapalan, Sath Nag, Jackie Gilbert, Helena Gleeson, Miles J. Levy, Colin Johnston, Nigel Sturrock, Stuart Bennett, Biswa Mishra, Isha Malik, Niki Karavitaki

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Abstract

Design
Retrospective, multi-centre, observational study.

Patients
Adult patients with Graves’ disease treated with radioiodine with 12 months’ follow-up.

Measurements
Euthyroidism was defined as both serum thyrotropin (TSH) and free thyroxine (FT4) within their reference ranges or, when only one was available, it was within its reference range; hypothyroidism as TSH ≥ 10 mu/L, or subnormal FT4 regardless of TSH; hyperthyroidism as TSH below and FT4 above their reference ranges; dysthyroidism as the sum of hypo- and hyperthyroidism; subclinical hypothyroidism as normal FT4 and TSH between the upper limit of normal and <10 mu/L; subclinical hyperthyroidism as low TSH and normal FT4

Results
Of 812 patients studied post-radioiodine, hypothyroidism occurred in 80.7% and hyperthyroidism in 48.6% of patients. Three principal post-radioiodine management strategies were employed: (a) anti-thyroid drugs alone, (b) levothyroxine alone and (c) combination of the two. Differences among these were small. Adherence to national guidelines regarding monitoring thyroid function in the first 6 months was low (21.4–28.7%). No negative outcomes (new-onset/exacerbation of Graves’ orbitopathy, weight gain, cardiovascular events), were associated with dysthyroidism. There were significant differences in demographics, clinical practice, and thyroid status post-radioiodine between centres.

Conclusions
Dysthyroidism in the 12 months post-radioiodine was common. Differences between post-radioiodine strategies were small, suggesting these interventions alone are unlikely to address the high frequency of dysthyroidism.

CLINICAL TRIAL REGISTRATION
Clinical.trials.gov (identifier No. NCT01885533).

Original language	English
Pages (from-to)	664-675
Journal	Clinical Endocrinology
Volume	97
Issue number	5
Early online date	11 Mar 2022
DOIs	https://doi.org/10.1111/cen.14719
Publication status	E-pub ahead of print - 11 Mar 2022

Keywords

Graves' disease
hyperthyroidism
hypothyroidism
radioiodine
thyroid

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10.1111/cen.14719Licence: None: All rights reserved

PerrosP2022Post
This is the peer reviewed version of the following article: Perros, P, Basu, A, Boelaert, K, et al. Postradioiodine Graves' management: The PRAGMA study. Clin Endocrinol. 2022, which has been published in final form at https://doi.org/10.1111/cen.14719. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions. This article may not be enhanced, enriched or otherwise transformed into a derivative work, without express permission from Wiley or by statutory rights under applicable legislation. Copyright notices must not be removed, obscured or modified. The article must be linked to Wiley’s version of record on Wiley Online Library and any embedding, framing or otherwise making available the article or pages thereof by third parties from platforms, services and websites other than Wiley Online Library must be prohibited.
Accepted author manuscript, 1.3 MBLicence: Other (please specify with Rights Statement)

Cite this

Perros, P., Basu, A., Boelaert, K., Dayan, C., Vaidya, B., Williams, G. R., Lazarus, J. H., Hickey, J., Drake, W. M., Crown, A., Orme, S. M., Johnson, A., Ray, D. W., Leese, G. P., Jones, T. H., Abraham, P., Grossman, A., Rees, A., Razvi, S., ... Karavitaki, N. (2022). Post-radioiodine Graves’ management: the PRAGMA study. Clinical Endocrinology, 97(5), 664-675. Advance online publication. https://doi.org/10.1111/cen.14719

@article{5cea7b09ec554b06ab9560d89c117f59,

title = "Post-radioiodine Graves{\textquoteright} management: the PRAGMA study",

abstract = "DesignRetrospective, multi-centre, observational study.PatientsAdult patients with Graves{\textquoteright} disease treated with radioiodine with 12 months{\textquoteright} follow-up.MeasurementsEuthyroidism was defined as both serum thyrotropin (TSH) and free thyroxine (FT4) within their reference ranges or, when only one was available, it was within its reference range; hypothyroidism as TSH ≥ 10 mu/L, or subnormal FT4 regardless of TSH; hyperthyroidism as TSH below and FT4 above their reference ranges; dysthyroidism as the sum of hypo- and hyperthyroidism; subclinical hypothyroidism as normal FT4 and TSH between the upper limit of normal and <10 mu/L; subclinical hyperthyroidism as low TSH and normal FT4ResultsOf 812 patients studied post-radioiodine, hypothyroidism occurred in 80.7% and hyperthyroidism in 48.6% of patients. Three principal post-radioiodine management strategies were employed: (a) anti-thyroid drugs alone, (b) levothyroxine alone and (c) combination of the two. Differences among these were small. Adherence to national guidelines regarding monitoring thyroid function in the first 6 months was low (21.4–28.7%). No negative outcomes (new-onset/exacerbation of Graves{\textquoteright} orbitopathy, weight gain, cardiovascular events), were associated with dysthyroidism. There were significant differences in demographics, clinical practice, and thyroid status post-radioiodine between centres.ConclusionsDysthyroidism in the 12 months post-radioiodine was common. Differences between post-radioiodine strategies were small, suggesting these interventions alone are unlikely to address the high frequency of dysthyroidism.CLINICAL TRIAL REGISTRATIONClinical.trials.gov (identifier No. NCT01885533).",

keywords = "Graves' disease, hyperthyroidism, hypothyroidism, radioiodine, thyroid",

author = "Petros Perros and Ansu Basu and Kristien Boelaert and Colin Dayan and Bijay Vaidya and Williams, {Graham R.} and Lazarus, {John H} and Janis Hickey and Drake, {William M} and Anna Crown and Orme, {Stephen M} and Andrew Johnson and Ray, {David W.} and Leese, {Graham P.} and Jones, {T Hugh} and Prakash Abraham and Ashley Grossman and Aled Rees and Salman Razvi and Gibb, {Fraser W} and Carla Moran and Asgar Madathil and {\v Z}arkovi{\'c}, {Milo{\v s} P.} and Zoe Plummer and Sheba Jarvis and Agnieszka Falinska and Anand Velusamy and Violet Sanderson and Nadia Parian and Atkin, {Stephen L} and Syed, {Akheel A} and Thozhukat Sathyapalan and Sath Nag and Jackie Gilbert and Helena Gleeson and Levy, {Miles J.} and Colin Johnston and Nigel Sturrock and Stuart Bennett and Biswa Mishra and Isha Malik and Niki Karavitaki",

year = "2022",

month = mar,

day = "11",

doi = "10.1111/cen.14719",

language = "English",

volume = "97",

pages = "664--675",

journal = "Clinical Endocrinology",

issn = "0300-0664",

publisher = "Wiley",

number = "5",

}

Perros, P, Basu, A, Boelaert, K, Dayan, C, Vaidya, B, Williams, GR, Lazarus, JH, Hickey, J, Drake, WM, Crown, A, Orme, SM, Johnson, A, Ray, DW, Leese, GP, Jones, TH, Abraham, P, Grossman, A, Rees, A, Razvi, S, Gibb, FW, Moran, C, Madathil, A, Žarković, MP, Plummer, Z, Jarvis, S, Falinska, A, Velusamy, A, Sanderson, V, Parian, N, Atkin, SL, Syed, AA, Sathyapalan, T, Nag, S, Gilbert, J, Gleeson, H, Levy, MJ, Johnston, C, Sturrock, N, Bennett, S, Mishra, B, Malik, I & Karavitaki, N 2022, 'Post-radioiodine Graves’ management: the PRAGMA study', Clinical Endocrinology, vol. 97, no. 5, pp. 664-675. https://doi.org/10.1111/cen.14719

TY - JOUR

T1 - Post-radioiodine Graves’ management

T2 - the PRAGMA study

AU - Perros, Petros

AU - Basu, Ansu

AU - Boelaert, Kristien

AU - Dayan, Colin

AU - Vaidya, Bijay

AU - Williams, Graham R.

AU - Lazarus, John H

AU - Hickey, Janis

AU - Drake, William M

AU - Crown, Anna

AU - Orme, Stephen M

AU - Johnson, Andrew

AU - Ray, David W.

AU - Leese, Graham P.

AU - Jones, T Hugh

AU - Abraham, Prakash

AU - Grossman, Ashley

AU - Rees, Aled

AU - Razvi, Salman

AU - Gibb, Fraser W

AU - Moran, Carla

AU - Madathil, Asgar

AU - Žarković, Miloš P.

AU - Plummer, Zoe

AU - Jarvis, Sheba

AU - Falinska, Agnieszka

AU - Velusamy, Anand

AU - Sanderson, Violet

AU - Parian, Nadia

AU - Atkin, Stephen L

AU - Syed, Akheel A

AU - Sathyapalan, Thozhukat

AU - Nag, Sath

AU - Gilbert, Jackie

AU - Gleeson, Helena

AU - Levy, Miles J.

AU - Johnston, Colin

AU - Sturrock, Nigel

AU - Bennett, Stuart

AU - Mishra, Biswa

AU - Malik, Isha

AU - Karavitaki, Niki

PY - 2022/3/11

Y1 - 2022/3/11

N2 - DesignRetrospective, multi-centre, observational study.PatientsAdult patients with Graves’ disease treated with radioiodine with 12 months’ follow-up.MeasurementsEuthyroidism was defined as both serum thyrotropin (TSH) and free thyroxine (FT4) within their reference ranges or, when only one was available, it was within its reference range; hypothyroidism as TSH ≥ 10 mu/L, or subnormal FT4 regardless of TSH; hyperthyroidism as TSH below and FT4 above their reference ranges; dysthyroidism as the sum of hypo- and hyperthyroidism; subclinical hypothyroidism as normal FT4 and TSH between the upper limit of normal and <10 mu/L; subclinical hyperthyroidism as low TSH and normal FT4ResultsOf 812 patients studied post-radioiodine, hypothyroidism occurred in 80.7% and hyperthyroidism in 48.6% of patients. Three principal post-radioiodine management strategies were employed: (a) anti-thyroid drugs alone, (b) levothyroxine alone and (c) combination of the two. Differences among these were small. Adherence to national guidelines regarding monitoring thyroid function in the first 6 months was low (21.4–28.7%). No negative outcomes (new-onset/exacerbation of Graves’ orbitopathy, weight gain, cardiovascular events), were associated with dysthyroidism. There were significant differences in demographics, clinical practice, and thyroid status post-radioiodine between centres.ConclusionsDysthyroidism in the 12 months post-radioiodine was common. Differences between post-radioiodine strategies were small, suggesting these interventions alone are unlikely to address the high frequency of dysthyroidism.CLINICAL TRIAL REGISTRATIONClinical.trials.gov (identifier No. NCT01885533).

AB - DesignRetrospective, multi-centre, observational study.PatientsAdult patients with Graves’ disease treated with radioiodine with 12 months’ follow-up.MeasurementsEuthyroidism was defined as both serum thyrotropin (TSH) and free thyroxine (FT4) within their reference ranges or, when only one was available, it was within its reference range; hypothyroidism as TSH ≥ 10 mu/L, or subnormal FT4 regardless of TSH; hyperthyroidism as TSH below and FT4 above their reference ranges; dysthyroidism as the sum of hypo- and hyperthyroidism; subclinical hypothyroidism as normal FT4 and TSH between the upper limit of normal and <10 mu/L; subclinical hyperthyroidism as low TSH and normal FT4ResultsOf 812 patients studied post-radioiodine, hypothyroidism occurred in 80.7% and hyperthyroidism in 48.6% of patients. Three principal post-radioiodine management strategies were employed: (a) anti-thyroid drugs alone, (b) levothyroxine alone and (c) combination of the two. Differences among these were small. Adherence to national guidelines regarding monitoring thyroid function in the first 6 months was low (21.4–28.7%). No negative outcomes (new-onset/exacerbation of Graves’ orbitopathy, weight gain, cardiovascular events), were associated with dysthyroidism. There were significant differences in demographics, clinical practice, and thyroid status post-radioiodine between centres.ConclusionsDysthyroidism in the 12 months post-radioiodine was common. Differences between post-radioiodine strategies were small, suggesting these interventions alone are unlikely to address the high frequency of dysthyroidism.CLINICAL TRIAL REGISTRATIONClinical.trials.gov (identifier No. NCT01885533).

KW - Graves' disease

KW - hyperthyroidism

KW - hypothyroidism

KW - radioiodine

KW - thyroid

UR - http://www.scopus.com/inward/record.url?scp=85126783449&partnerID=8YFLogxK

U2 - 10.1111/cen.14719

DO - 10.1111/cen.14719

M3 - Article

SN - 0300-0664

VL - 97

SP - 664

EP - 675

JO - Clinical Endocrinology

JF - Clinical Endocrinology

IS - 5

ER -

Post-radioiodine Graves’ management: the PRAGMA study

Abstract

Keywords

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