Brief report: enhancement of patient recruitment in rheumatoid arthritis clinical trials using a multi-biomarker disease activity score as an inclusion criterion.

Summary, in English

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.

• Författare: Ronald F van Vollenhoven; Rebecca Bolce; Karen Hambardzumyan; Saedis Saevarsdottir; Kristina Forslind; Ingemar Petersson; Eric H Sasso; C C Hwang; Oscar G Segurado; Pierre Geborek
• Avdelning/ar: Kliniska Vetenskaper, Helsingborg; Ortopedi, Lund; Reumatologi och molekylär skelettbiologi; EpiHealth: Epidemiology for Health
• Publiceringsår: 2015
• Språk: Engelska
• Sidor: 2855-2860
• Publikation/Tidskrift/Serie: Arthritis & Rheumatology
• Volym: 67
• Issue: 11
• Fulltext: - 202 kB; Download statistics
• Länkar: http://www.ncbi.nlm.nih.gov/pubmed/26213309?dopt=Abstract; http://dx.doi.org/10.1002/art.39274
• Dokumenttyp: Artikel i tidskrift
• Förlag: John Wiley & Sons Inc.
• Ämne: Rheumatology and Autoimmunity
• Status: Published
• ISBN/ISSN/Övrigt: ISSN: 2326-5205