Advanced

The use of a multi-biomarker disease activity score as an inclusion criterion in rheumatoid arthritis clinical trials may enhance patient recruitment.

van Vollenhoven, Ronald F; Bolce, Rebecca; Hambardzumyan, Karen; Saevarsdottir, Saedis; Forslind, Kristina LU ; Petersson, Ingemar LU ; Sasso, Eric H; Hwang, C C; Segurado, Oscar G and Geborek, Pierre LU (2015) In Arthritis & rheumatology (Hoboken, N.J.) 67(11). p.2855-2860
Abstract
Objective Rheumatoid arthritis (RA) clinical trials often exclude patients with low C-reactive protein (CRP), slowing trial enrollment. We evaluated whether RA patients with a high multi-biomarker disease activity (MBDA) score (>44) among those with low CRP (≤10 mg/L) could complement patients with CRP >10mg/L to enhance patient recruitment without affecting clinical trial outcomes. Methods We evaluated patients from the Swedish pharmacotherapy (SWEFOT) trial, which had no CRP selection criteria. Clinical outcomes were assessed after 3 months of methotrexate (MTX) monotherapy for MTX-naïve patients (N=220) and after add-on therapy from Months 3 to 12 for MTX-inadequate responder (IR) patients (N=127). Radiographic outcomes were... (More)
Objective Rheumatoid arthritis (RA) clinical trials often exclude patients with low C-reactive protein (CRP), slowing trial enrollment. We evaluated whether RA patients with a high multi-biomarker disease activity (MBDA) score (>44) among those with low CRP (≤10 mg/L) could complement patients with CRP >10mg/L to enhance patient recruitment without affecting clinical trial outcomes. Methods We evaluated patients from the Swedish pharmacotherapy (SWEFOT) trial, which had no CRP selection criteria. Clinical outcomes were assessed after 3 months of methotrexate (MTX) monotherapy for MTX-naïve patients (N=220) and after add-on therapy from Months 3 to 12 for MTX-inadequate responder (IR) patients (N=127). Radiographic outcomes were assessed at 1 year for all patients. Within each cohort, outcomes were compared between patients with CRP ≤10 mg/L and MBDA score >44 at the start of the respective treatment interval versus those with CRP >10 mg/L. Results Patients with baseline CRP ≤10 mg/L and MBDA score >44 at baseline had comparable clinical and radiographic outcomes to those for patients with CRP>10 mg/L. This broadened definition of inclusion criteria identified an additional 24% MTX-naïve and 47% MTX-IR patients. Conclusion Patient recruitment of RA clinical trials may be substantially enhanced by using "CRP >10 mg/L and/or MBDA score >44" as an inclusion criterion, without diminishing clinical or radiographic outcomes. This article is protected by copyright. All rights reserved. (Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Arthritis & rheumatology (Hoboken, N.J.)
volume
67
issue
11
pages
2855 - 2860
publisher
Wiley-Blackwell
external identifiers
  • pmid:26213309
  • wos:000363881400009
  • scopus:84946083507
ISSN
2326-5205
DOI
10.1002/art.39274
language
English
LU publication?
yes
id
6edac393-238c-40a7-ad56-4836a082ee21 (old id 7720639)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/26213309?dopt=Abstract
date added to LUP
2015-08-10 17:20:21
date last changed
2017-04-09 03:21:43
@article{6edac393-238c-40a7-ad56-4836a082ee21,
  abstract     = {Objective Rheumatoid arthritis (RA) clinical trials often exclude patients with low C-reactive protein (CRP), slowing trial enrollment. We evaluated whether RA patients with a high multi-biomarker disease activity (MBDA) score (>44) among those with low CRP (≤10 mg/L) could complement patients with CRP >10mg/L to enhance patient recruitment without affecting clinical trial outcomes. Methods We evaluated patients from the Swedish pharmacotherapy (SWEFOT) trial, which had no CRP selection criteria. Clinical outcomes were assessed after 3 months of methotrexate (MTX) monotherapy for MTX-naïve patients (N=220) and after add-on therapy from Months 3 to 12 for MTX-inadequate responder (IR) patients (N=127). Radiographic outcomes were assessed at 1 year for all patients. Within each cohort, outcomes were compared between patients with CRP ≤10 mg/L and MBDA score >44 at the start of the respective treatment interval versus those with CRP >10 mg/L. Results Patients with baseline CRP ≤10 mg/L and MBDA score >44 at baseline had comparable clinical and radiographic outcomes to those for patients with CRP>10 mg/L. This broadened definition of inclusion criteria identified an additional 24% MTX-naïve and 47% MTX-IR patients. Conclusion Patient recruitment of RA clinical trials may be substantially enhanced by using "CRP >10 mg/L and/or MBDA score >44" as an inclusion criterion, without diminishing clinical or radiographic outcomes. This article is protected by copyright. All rights reserved.},
  author       = {van Vollenhoven, Ronald F and Bolce, Rebecca and Hambardzumyan, Karen and Saevarsdottir, Saedis and Forslind, Kristina and Petersson, Ingemar and Sasso, Eric H and Hwang, C C and Segurado, Oscar G and Geborek, Pierre},
  issn         = {2326-5205},
  language     = {eng},
  number       = {11},
  pages        = {2855--2860},
  publisher    = {Wiley-Blackwell},
  series       = {Arthritis & rheumatology (Hoboken, N.J.)},
  title        = {The use of a multi-biomarker disease activity score as an inclusion criterion in rheumatoid arthritis clinical trials may enhance patient recruitment.},
  url          = {http://dx.doi.org/10.1002/art.39274},
  volume       = {67},
  year         = {2015},
}