Rhumatologie
INTRODUCTION
find the whole article here ==>https://rmdopen.bmj.com/content/rmdopen/8/1/e002106.full.pdf
Author affiliations
1 Hopital Cochin, Rheumatology, University of Paris, Paris, France
2 Biostatistics, RCTs, Lyon, France
3 Medical affairs, Novartis Pharma SAS, Rueil-Malmaison, France
4 Rhumatologie, University of Montpellier, Montpellier, France
5 Rheumatologt, Université de Bretagne Occidentale, Brest, France
6 Rheumatology, Université Clermont Auvergne, Clermont-Ferrand, France
7 Rheumatology, Université Toulouse III Paul Sabatier, Toulouse, France
8 Rheumatology, Université de Franche-Comté, Besancon, France
9 Rheumatology, Université de Tours, Tours, France
10 Rheumatology, Hopital Albert Chenevier, Creteil, France
These recommendations are mainly based on evidence showing that high disease activity is one of the main predisposing factors of subsequent structural
progression and negative impact on the functional status of the patients. Although this recommendation is obviously strictly followed in the context of clinical trials, there is a huge gap in its implementation in daily practice. One of the reasons of this gap might be the lack of clear evidence at the individual level that the assessment and reporting in the medical records of these disease activity outcome measures are of real benefit for the patients. However, it is
quite challenging to show that there is such benefit. One might consider that a positive strategy trial in which the treatment decision is driven by the value of a composite index (eg, the assessment of ASDAS in the TIght COntrol in SPondyloArthritis (TICOSPA) is an argument for the assessment and reporting of these composite indices in daily practice. However, one could also debate that the results of these strategy trials have been obtained in a quite rigorous clinical context and are mainly driven by the intensification of the treatment in case the value of the composite index is above a certain threshold (e., an
ASDAS value >2.1 in the TICOSPA trial). Data from daily practice might be more relevant at least in countries/regions/settings where such assessments
and reporting are not mandatory and/or not financially supported by health authorities, which is the case for France. Moreover, the definition of a ‘benefit at the individual level’ is also challenging. When evaluating the use of bDMARDs, one might consider that the retention rate to therapy over time is reflecting a better effectiveness of the respective bDMARD.