RESEARCH - The importance of reporting disease activity states in RA clinical trials

[Guest guest]

Arthritis Rheum. 2008 Sep;58(9):2622-31.

The importance of reporting disease activity states in rheumatoid

arthritis clinical trials.

Aletaha D, Funovits J, Smolen JS.

Medical University of Vienna, Vienna, Austria.

OBJECTIVE: To compare the value of reporting treatment effects in

rheumatoid arthritis (RA) as relative change from baseline (e.g.,

American College of Rheumatology [ACR] responder status) with the

value of evaluating absolute disease activity states (e.g.,

remission).

METHODS: We pooled data from several recent RA clinical trials and

evaluated patients who had completed a 1-year treatment period (n =

629). We compared levels of functional impairment and radiographic

progression among patients meeting the ACR 50% or 70% improvement

criteria (ACR50 and ACR70 responders, respectively) who attained

remission of disease, low disease activity, or moderate disease

activity after 1 year, as assessed by the Simplified Disease Activity

Index and the Disease Activity Score in 28 joints.

RESULTS: Within the ACR50 and ACR70 responder groups, functional

disability and radiographic progression were lowest in patients who

had attained disease remission at 1 year, compared with those who had

attained low or moderate disease activity. When patients attained the

same disease activity category, physical function and radiographic

progression did not differ significantly with different response

states.

CONCLUSION: Functional and radiographic outcomes are different in

patients depending on the disease activity category they attain, even

if the same level of response (change from baseline) is achieved.

Among patients who attain the same disease activity category, the

degree of response they experience does not seem to matter. Assessing

actual disease activity as well as disease activity states should

constitute an integral part of clinical trial data reporting.

PMID: 18759299

http://www.ncbi.nlm.nih.gov/pubmed/18759299

--

Not an MD