Disease activity assessment in SLE: Do we have the right instruments?

Research output: Contribution to journalArticle

Abstract

No new therapy has been approved for systemic lupus erythematosus (SLE) in decades. Interest in SLE by pharmaceutical and biotechnology companies has increased, leading to multiple clinical trials. Unfortunately, we have now compiled quite a long list of "failed" trials. If this was due to the fact that the studied therapy did not work in SLE, we could accept it and move on. Of concern, however, is that many of the "failed" treatments had a strong "signal" of efficacy, often in subgroup analyses that made logical sense, given what was known about the mechanism of action of the treatment. This has led, understandably, to concern that there is something wrong with SLE trial designs, particularly with SLE disease activity indices.

Original languageEnglish (US)
JournalAnnals of the Rheumatic Diseases
Volume66
Issue numberSUPPL. 3
DOIs
StatePublished - Nov 2007

Fingerprint

Biotechnology
Systemic Lupus Erythematosus
Pharmaceutical Preparations
Industry
Clinical Trials
Therapeutics

ASJC Scopus subject areas

  • Rheumatology
  • Immunology

Cite this

Disease activity assessment in SLE : Do we have the right instruments? / Petri, Michelle.

In: Annals of the Rheumatic Diseases, Vol. 66, No. SUPPL. 3, 11.2007.

Research output: Contribution to journalArticle

@article{b545ac53a85a46208778314b0fb83acd,
title = "Disease activity assessment in SLE: Do we have the right instruments?",
abstract = "No new therapy has been approved for systemic lupus erythematosus (SLE) in decades. Interest in SLE by pharmaceutical and biotechnology companies has increased, leading to multiple clinical trials. Unfortunately, we have now compiled quite a long list of {"}failed{"} trials. If this was due to the fact that the studied therapy did not work in SLE, we could accept it and move on. Of concern, however, is that many of the {"}failed{"} treatments had a strong {"}signal{"} of efficacy, often in subgroup analyses that made logical sense, given what was known about the mechanism of action of the treatment. This has led, understandably, to concern that there is something wrong with SLE trial designs, particularly with SLE disease activity indices.",
author = "Michelle Petri",
year = "2007",
month = "11",
doi = "10.1136/ard.2007.078477",
language = "English (US)",
volume = "66",
journal = "Annals of the Rheumatic Diseases",
issn = "0003-4967",
publisher = "BMJ Publishing Group",
number = "SUPPL. 3",

}

TY - JOUR

T1 - Disease activity assessment in SLE

T2 - Do we have the right instruments?

AU - Petri, Michelle

PY - 2007/11

Y1 - 2007/11

N2 - No new therapy has been approved for systemic lupus erythematosus (SLE) in decades. Interest in SLE by pharmaceutical and biotechnology companies has increased, leading to multiple clinical trials. Unfortunately, we have now compiled quite a long list of "failed" trials. If this was due to the fact that the studied therapy did not work in SLE, we could accept it and move on. Of concern, however, is that many of the "failed" treatments had a strong "signal" of efficacy, often in subgroup analyses that made logical sense, given what was known about the mechanism of action of the treatment. This has led, understandably, to concern that there is something wrong with SLE trial designs, particularly with SLE disease activity indices.

AB - No new therapy has been approved for systemic lupus erythematosus (SLE) in decades. Interest in SLE by pharmaceutical and biotechnology companies has increased, leading to multiple clinical trials. Unfortunately, we have now compiled quite a long list of "failed" trials. If this was due to the fact that the studied therapy did not work in SLE, we could accept it and move on. Of concern, however, is that many of the "failed" treatments had a strong "signal" of efficacy, often in subgroup analyses that made logical sense, given what was known about the mechanism of action of the treatment. This has led, understandably, to concern that there is something wrong with SLE trial designs, particularly with SLE disease activity indices.

UR - http://www.scopus.com/inward/record.url?scp=35648981178&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=35648981178&partnerID=8YFLogxK

U2 - 10.1136/ard.2007.078477

DO - 10.1136/ard.2007.078477

M3 - Article

C2 - 17934099

AN - SCOPUS:35648981178

VL - 66

JO - Annals of the Rheumatic Diseases

JF - Annals of the Rheumatic Diseases

SN - 0003-4967

IS - SUPPL. 3

ER -