Professor Maxime Dougados - EMBARK poster data
Professor Maxime Dougados gives an overview of EMBARK poster data.
About the speaker
Maxime Dougados is a professor of rheumatology at René Descartes University and Hôpital Cochin in Paris.
Can you explain your poster on change in SIJ structural radiographic damage after 2 years of etanercept treatment compared to a contemporary cohort in nr-AxSpA?
During the EULAR congress in Madrid we had the opportunity to present the results of an analysis comparing two cohorts, DESIR and EMBARK, in terms of the changes in structural parameters observed at a plain pelvic X-Ray at the sacroiliac joint level. So we have to come back to the two populations. First EMBARK, EMBARK is a clinical trial sponsored by Pfizer evaluating Etanercept in patients with non-radiographic axial spondyloarthritis, it was two parts.
The first twelve weeks was a randomized, placebo-controlled trial but for our purpose, the most interesting was the long-term extension. All the patients received Etanercept during two years and at baseline and after two years we collected both plain pelvic X-ray and MRI of the sacroiliac joints. So in this population we had the opportunity to look at the changes in the structural parameters for the pelvic X-rays. We have presented at ACR last year the fact that there was no change in the EMBARK patients but the main criticism is that there was no control. So how do you make a control in patients with non-radiographic axSpA received a drug during two years?
So what we have done is that we have tried to compare these patients to an external cohort, but contemporary to the EMBARK trial, is the DESIR cohort. DESIR is a long-term follow-up of patients with recent onset spondyloarthritis in France. In which we have collected as well MRI and X-ray. So we took the films from the cohorts, we anonymised them and then we gave them to readers, unaware of the chronology of the films and unaware of the study arm that is either EMBARK or DESIR cohort. And so we were in a position to compare the changes during the two years follow up in terms of structural parameters at the sacroiliac joint level in patients receiving Etanercept during two years versus patients not receiving any biologic during two years but matching in terms of disease activity at baseline. And to make a long story short the results showed that there was a statistically significant difference between the two groups in terms of structural changes in favour of Etanercept. That means less erosion after two years in the EMBARK cohort than in the DESIR cohort, suggesting for the first time that within two years, using plain X-ray it’s possible to suggest a structural effect of anti-TNF in axial spondyloarthritis.
Can you explain your poster on change in MRI structural lesions in the SIJ after 2 years of etanercept treatment compared to a contemporary cohort in nr-AxSpA?
At EULAR in Madrid in June we had the opportunity to present in fact two posters, one concerning the plain X-rays but also one showing the data we observed through MRI. Usually when we are speaking about MRI or the sacroiliac joints, all of us, in particular rheumatologists have inflammation in mind, subchondral bone edema. Here we are not discussing inflammation, observed MRI or sacroiliac joint. We have observed this in the EMBARK trial, showing a clear treatment effect in favour of Etanercept against placebo but here we are presenting the structural parameters in particular sclerosis, erosion, observed after two years with the same methodology that we did for the plain X-ray. And the results are that again there is data suggesting a structural effect that is less progression in the EMBARK cohort in comparison to the DESIR cohort.
PP-ENB-GBR-0604 - Date of preparation August 2017