Serum urate as a proposed surrogate outcome measure in gout trials: From the OMERACT working group

Melanie Birger Morillon; Robin Christensen; Jasvinder A Singh; Nicola Dalbeth; Kenneth Saag; William J Taylor; Tuhina Neogi; Martin A Kennedy; Birthe M Pedersen; Geraldine M McCarthy; Beverley Shea; Cesar Diaz-Torne; Sara K Tedeschi; Rebecca Grainger; Abhishek Abhishek; Angelo Gaffo; Sabrina Mai Nielsen; Alexander Noerup; Lee S Simon; Marissa Lassere; Peter Tugwell; Lisa K Stamp; For The Omeract Gout Working Group

doi:10.1016/j.semarthrit.2021.11.004

Serum urate as a proposed surrogate outcome measure in gout trials: From the OMERACT working group

Melanie Birger Morillon, Robin Christensen, Jasvinder A Singh, Nicola Dalbeth, Kenneth Saag, William J Taylor, Tuhina Neogi, Martin A Kennedy, Birthe M Pedersen, Geraldine M McCarthy, Beverley Shea, Cesar Diaz-Torne, Sara K Tedeschi, Rebecca Grainger, Abhishek Abhishek, Angelo Gaffo, Sabrina Mai Nielsen, Alexander Noerup, Lee S Simon, Marissa LasserePeter Tugwell, Lisa K Stamp, For The Omeract Gout Working Group

The Parker Institute

Abstract

Serum urate (SU) is the most common primary efficacy outcome in trials of urate-lowering therapies for gout. Despite this, it is not formally considered a validated surrogate outcome. In this paper we will outline the definitions of biomarkers and surrogate outcome measures, respectively as well as the available frameworks and challenges in the assessment of the validity of serum urate as a surrogate in gout (i.e. a reasonable replacement for gout symptoms).

Original language	English
Journal	Seminars in Arthritis and Rheumatism
Volume	51
Issue number	6
Pages (from-to)	1378-1385
Number of pages	8
ISSN	0049-0172
DOIs	https://doi.org/10.1016/j.semarthrit.2021.11.004
Publication status	Published - Dec 2021

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Morillon, M. B., Christensen, R., Singh, J. A., Dalbeth, N., Saag, K., Taylor, W. J., Neogi, T., Kennedy, M. A., Pedersen, B. M., McCarthy, G. M., Shea, B., Diaz-Torne, C., Tedeschi, S. K., Grainger, R., Abhishek, A., Gaffo, A., Nielsen, S. M., Noerup, A., Simon, L. S., ... Gout Working Group, F. T. O. (2021). Serum urate as a proposed surrogate outcome measure in gout trials: From the OMERACT working group. Seminars in Arthritis and Rheumatism, 51(6), 1378-1385. https://doi.org/10.1016/j.semarthrit.2021.11.004

Morillon, MB , Christensen, R, Singh, JA, Dalbeth, N, Saag, K, Taylor, WJ, Neogi, T, Kennedy, MA, Pedersen, BM, McCarthy, GM, Shea, B, Diaz-Torne, C, Tedeschi, SK, Grainger, R, Abhishek, A, Gaffo, A, Nielsen, SM, Noerup, A, Simon, LS, Lassere, M, Tugwell, P, Stamp, LK & Gout Working Group, FTO 2021, 'Serum urate as a proposed surrogate outcome measure in gout trials: From the OMERACT working group', Seminars in Arthritis and Rheumatism, vol. 51, no. 6, pp. 1378-1385. https://doi.org/10.1016/j.semarthrit.2021.11.004

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title = "Serum urate as a proposed surrogate outcome measure in gout trials: From the OMERACT working group",

abstract = "Serum urate (SU) is the most common primary efficacy outcome in trials of urate-lowering therapies for gout. Despite this, it is not formally considered a validated surrogate outcome. In this paper we will outline the definitions of biomarkers and surrogate outcome measures, respectively as well as the available frameworks and challenges in the assessment of the validity of serum urate as a surrogate in gout (i.e. a reasonable replacement for gout symptoms).",

author = "Morillon, {Melanie Birger} and Robin Christensen and Singh, {Jasvinder A} and Nicola Dalbeth and Kenneth Saag and Taylor, {William J} and Tuhina Neogi and Kennedy, {Martin A} and Pedersen, {Birthe M} and McCarthy, {Geraldine M} and Beverley Shea and Cesar Diaz-Torne and Tedeschi, {Sara K} and Rebecca Grainger and Abhishek Abhishek and Angelo Gaffo and Nielsen, {Sabrina Mai} and Alexander Noerup and Simon, {Lee S} and Marissa Lassere and Peter Tugwell and Stamp, {Lisa K} and {Gout Working Group}, {For The Omeract}",

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T1 - Serum urate as a proposed surrogate outcome measure in gout trials

T2 - From the OMERACT working group

AU - Morillon, Melanie Birger

AU - Christensen, Robin

AU - Singh, Jasvinder A

AU - Dalbeth, Nicola

AU - Saag, Kenneth

AU - Taylor, William J

AU - Neogi, Tuhina

AU - Kennedy, Martin A

AU - Pedersen, Birthe M

AU - McCarthy, Geraldine M

AU - Shea, Beverley

AU - Diaz-Torne, Cesar

AU - Tedeschi, Sara K

AU - Grainger, Rebecca

AU - Abhishek, Abhishek

AU - Gaffo, Angelo

AU - Nielsen, Sabrina Mai

AU - Noerup, Alexander

AU - Simon, Lee S

AU - Lassere, Marissa

AU - Tugwell, Peter

AU - Stamp, Lisa K

AU - Gout Working Group, For The Omeract

PY - 2021/12

Y1 - 2021/12

N2 - Serum urate (SU) is the most common primary efficacy outcome in trials of urate-lowering therapies for gout. Despite this, it is not formally considered a validated surrogate outcome. In this paper we will outline the definitions of biomarkers and surrogate outcome measures, respectively as well as the available frameworks and challenges in the assessment of the validity of serum urate as a surrogate in gout (i.e. a reasonable replacement for gout symptoms).

AB - Serum urate (SU) is the most common primary efficacy outcome in trials of urate-lowering therapies for gout. Despite this, it is not formally considered a validated surrogate outcome. In this paper we will outline the definitions of biomarkers and surrogate outcome measures, respectively as well as the available frameworks and challenges in the assessment of the validity of serum urate as a surrogate in gout (i.e. a reasonable replacement for gout symptoms).

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U2 - 10.1016/j.semarthrit.2021.11.004

DO - 10.1016/j.semarthrit.2021.11.004

M3 - Review

C2 - 34839932

SN - 0049-0172

VL - 51

SP - 1378

EP - 1385

JO - Seminars in Arthritis and Rheumatism

JF - Seminars in Arthritis and Rheumatism

IS - 6

ER -

Serum urate as a proposed surrogate outcome measure in gout trials: From the OMERACT working group

Abstract

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