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Center for Global Research Data

Assessment of treatment outcome using ASAS40 with etanercept in non-radiographic axSpA by baseline CRP – a re-analysis of trial data

Lead Investigator: Philip Robinson, University of Queensland
Title of Proposal Research: Assessment of treatment outcome using ASAS40 with etanercept in non-radiographic axSpA by baseline CRP – a re-analysis of trial data
Vivli Data Request: 5073
Funding Source: None
Potential Conflicts of Interest: In the last 2 years I have provided consulting to Pfizer on one occasion, in the form of one 1 hour teleconference, for which I was paid an honorarium. Prior to that I gave my paid primary care physician talk for Pfizer in April 2017. This project, whilst investigating a Pfizer produced drug is not connected in any way to Pfizer, and is a study I have initiated with a colleague to better understand the response predictors of etanercept in nr-axSpA. I am also doing this analysis across all biologics trialled in nr-axSpA.

Summary of the Proposed Research:

Non-radiographic axial spondyloarthritis (nr-axSpA) is an inflammatory arthritis affecting the spine and sacroiliac joints. Effective therapies are available, including etanercept, which is part of the anti-tumour necrosis factor (TNF) class. Previous work has demonstrated that predictors of response to anti-TNF agents include a raised C-reactive protein (CRP) (1-4). However, the level of raised CRP that predicts a response to etanercept has not been determined. This project is significant because often patients with nr-axSpA have low positive CRP levels and the level at which patients will respond to anti-TNFs like etanercept is not known. This work has the potential to provide significant guidance to practising clinicians on when it is best to commence agents like etanercept with the expectation that they will respond. Therefore, this work can provide guidance to clinicians on when etanercept use would be of limited value and when it would be of good value to the patient (and secondarily to the payer).

Requested Studies:

A MULTICENTRE, 12 WEEK DOUBLE BLIND PLACEBO CONTROLLED RANDOMIZED STUDY OF ETANERCEPT ON A BACKGROUND NSAID IN THE TREATMENT OF ADULT SUBJECTS WITH NON RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS WITH A 92 WEEK OPEN LABEL EXTENSION.
Sponsor: Pfizer, Inc.
Study ID: NCT01258738