Response criteria for cutaneous SLE in clinical trials

Marta Mosca; Michael Lockshin; Matthias Schneider; Matthew H. Liang; Joerg Albrecht; Martin Aringer; Stefano Bombardieri; Jill Buyon; Richard Cervera; Paola dePablo; Barri J. Fessler; Rebecca Fischer-Betz; Victoria Gall; Dafna Gladman; Nicolas Hunzelman; Joachim R. Kalden; Thomas Krieg; Annegret Kuhn; Lela Lee; David Norris; Jutta Richter; Animesh Sinha; Josef Smolen; Richard Sontheimer; Cristof Specker; Victoria P. Werth

Response criteria for cutaneous SLE in clinical trials

Marta Mosca, Michael Lockshin, Matthias Schneider, Matthew H. Liang^*, Joerg Albrecht, Martin Aringer, Stefano Bombardieri, Jill Buyon, Richard Cervera, Paola dePablo, Barri J. Fessler, Rebecca Fischer-Betz, Victoria Gall, Dafna Gladman, Nicolas Hunzelman, Joachim R. Kalden, Thomas Krieg, Annegret Kuhn, Lela Lee, David NorrisJutta Richter, Animesh Sinha, Josef Smolen, Richard Sontheimer, Cristof Specker, Victoria P. Werth

^*Corresponding author for this work

Research output: Contribution to journal › Review article › peer-review

5 Citations (Scopus)

Abstract

Systemic lupus erythematosus (SLE) is a complex phenotype characterized by a wide variety of clinical manifestations but the skin is involved in 70-80% of patients. Acute cutaneous lupus erythematosus lesions, like other organ manifestations of SLE wax and wane with other manifestations of active disease and quantifying it is a useful a "signal" to screen new therapies in SLE and pre- and post-treatment biopsies can be additionally informative. The ACR has recommended a priori response criteria for SLE Activity Measures (2) and that these be used along with organ specific response criteria in clinical trials. We review the literature on evaluation of skin manifestations in lupus erythematosus (LE) and propose the parameters of evaluating responsiveness and criteria for minimal clinically important changes in skin manifestations. The Committee presents two options for grading skin manifestations. These recommendations add to the tools of SLE trials.

Original language	English
Pages (from-to)	666-671
Number of pages	6
Journal	Clinical and Experimental Rheumatology
Volume	25
Issue number	5
Publication status	Published - Sept 2007

Keywords

Clinical trials
Cutaneous lupus
Response criteria
Severity
SLE

ASJC Scopus subject areas

Rheumatology
Immunology and Allergy
Immunology

Cite this

Mosca, M., Lockshin, M., Schneider, M., Liang, M. H., Albrecht, J., Aringer, M., Bombardieri, S., Buyon, J., Cervera, R., dePablo, P., Fessler, B. J., Fischer-Betz, R., Gall, V., Gladman, D., Hunzelman, N., Kalden, J. R., Krieg, T., Kuhn, A., Lee, L., ... Werth, V. P. (2007). Response criteria for cutaneous SLE in clinical trials. Clinical and Experimental Rheumatology, 25(5), 666-671.

@article{e4beb0da750541c6b8d0a5359ba85790,

title = "Response criteria for cutaneous SLE in clinical trials",

abstract = "Systemic lupus erythematosus (SLE) is a complex phenotype characterized by a wide variety of clinical manifestations but the skin is involved in 70-80% of patients. Acute cutaneous lupus erythematosus lesions, like other organ manifestations of SLE wax and wane with other manifestations of active disease and quantifying it is a useful a {"}signal{"} to screen new therapies in SLE and pre- and post-treatment biopsies can be additionally informative. The ACR has recommended a priori response criteria for SLE Activity Measures (2) and that these be used along with organ specific response criteria in clinical trials. We review the literature on evaluation of skin manifestations in lupus erythematosus (LE) and propose the parameters of evaluating responsiveness and criteria for minimal clinically important changes in skin manifestations. The Committee presents two options for grading skin manifestations. These recommendations add to the tools of SLE trials.",

keywords = "Clinical trials, Cutaneous lupus, Response criteria, Severity, SLE",

author = "Marta Mosca and Michael Lockshin and Matthias Schneider and Liang, {Matthew H.} and Joerg Albrecht and Martin Aringer and Stefano Bombardieri and Jill Buyon and Richard Cervera and Paola dePablo and Fessler, {Barri J.} and Rebecca Fischer-Betz and Victoria Gall and Dafna Gladman and Nicolas Hunzelman and Kalden, {Joachim R.} and Thomas Krieg and Annegret Kuhn and Lela Lee and David Norris and Jutta Richter and Animesh Sinha and Josef Smolen and Richard Sontheimer and Cristof Specker and Werth, {Victoria P.}",

year = "2007",

month = sep,

language = "English",

volume = "25",

pages = "666--671",

journal = "Clinical and Experimental Rheumatology",

issn = "0392-856X",

publisher = "Clinical and Experimental Rheumatology S.A.S.",

number = "5",

}

Mosca, M, Lockshin, M, Schneider, M, Liang, MH, Albrecht, J, Aringer, M, Bombardieri, S, Buyon, J, Cervera, R, dePablo, P, Fessler, BJ, Fischer-Betz, R, Gall, V, Gladman, D, Hunzelman, N, Kalden, JR, Krieg, T, Kuhn, A, Lee, L, Norris, D, Richter, J, Sinha, A, Smolen, J, Sontheimer, R, Specker, C & Werth, VP 2007, 'Response criteria for cutaneous SLE in clinical trials', Clinical and Experimental Rheumatology, vol. 25, no. 5, pp. 666-671.

TY - JOUR

T1 - Response criteria for cutaneous SLE in clinical trials

AU - Mosca, Marta

AU - Lockshin, Michael

AU - Schneider, Matthias

AU - Liang, Matthew H.

AU - Albrecht, Joerg

AU - Aringer, Martin

AU - Bombardieri, Stefano

AU - Buyon, Jill

AU - Cervera, Richard

AU - dePablo, Paola

AU - Fessler, Barri J.

AU - Fischer-Betz, Rebecca

AU - Gall, Victoria

AU - Gladman, Dafna

AU - Hunzelman, Nicolas

AU - Kalden, Joachim R.

AU - Krieg, Thomas

AU - Kuhn, Annegret

AU - Lee, Lela

AU - Norris, David

AU - Richter, Jutta

AU - Sinha, Animesh

AU - Smolen, Josef

AU - Sontheimer, Richard

AU - Specker, Cristof

AU - Werth, Victoria P.

PY - 2007/9

Y1 - 2007/9

N2 - Systemic lupus erythematosus (SLE) is a complex phenotype characterized by a wide variety of clinical manifestations but the skin is involved in 70-80% of patients. Acute cutaneous lupus erythematosus lesions, like other organ manifestations of SLE wax and wane with other manifestations of active disease and quantifying it is a useful a "signal" to screen new therapies in SLE and pre- and post-treatment biopsies can be additionally informative. The ACR has recommended a priori response criteria for SLE Activity Measures (2) and that these be used along with organ specific response criteria in clinical trials. We review the literature on evaluation of skin manifestations in lupus erythematosus (LE) and propose the parameters of evaluating responsiveness and criteria for minimal clinically important changes in skin manifestations. The Committee presents two options for grading skin manifestations. These recommendations add to the tools of SLE trials.

AB - Systemic lupus erythematosus (SLE) is a complex phenotype characterized by a wide variety of clinical manifestations but the skin is involved in 70-80% of patients. Acute cutaneous lupus erythematosus lesions, like other organ manifestations of SLE wax and wane with other manifestations of active disease and quantifying it is a useful a "signal" to screen new therapies in SLE and pre- and post-treatment biopsies can be additionally informative. The ACR has recommended a priori response criteria for SLE Activity Measures (2) and that these be used along with organ specific response criteria in clinical trials. We review the literature on evaluation of skin manifestations in lupus erythematosus (LE) and propose the parameters of evaluating responsiveness and criteria for minimal clinically important changes in skin manifestations. The Committee presents two options for grading skin manifestations. These recommendations add to the tools of SLE trials.

KW - Clinical trials

KW - Cutaneous lupus

KW - Response criteria

KW - Severity

KW - SLE

UR - http://www.scopus.com/inward/record.url?scp=37349107131&partnerID=8YFLogxK

M3 - Review article

C2 - 18078611

AN - SCOPUS:37349107131

SN - 0392-856X

VL - 25

SP - 666

EP - 671

JO - Clinical and Experimental Rheumatology

JF - Clinical and Experimental Rheumatology

IS - 5

ER -

Response criteria for cutaneous SLE in clinical trials

Abstract

Keywords

ASJC Scopus subject areas

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