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In Table 5, the ASAS response criteria are presented according to type of intervention. A high level of usage was found in trials with biological drugs (ASAS 20 (73%), ASAS 40 (93%), ASAS partial remission (53%) and ASAS 5/6 (60%). BASDAI 50 was reported as response measure only in implementation trials (25%; n= 13).
Table 5 Usage of ASAS response criteria according to trial intervention
Intervention (%)
ASAS 20*
ASAS partial remission*
ASAS 40**
ASAS 5/6**
NSAID
2/4 (50)
0/4 (0)
0/2 (0)
0/2 (0)
Biological drugs
14/19 (73.3)
10/19 (52.6)
14/15 (93.3)
9/15 (60)
Physical therapy
1/13 (7.7)
0/13 (0)
1/11 (9.1)
1/11 (9.1)
Miscellaneous
1/2 (50)
0/2 (0)
0/2 (0)
0/2 (0)
Trials included since 2004* and 2006** according to publication date of respective response criteria
DISCUSSION
This study confirms the implementation of the ASAS/OMERACT core set in randomized clinical trials after the original publication. A substantial improvement in the utilization of ASAS-endorsed domains and to a lesser extent of ASAS-endorsed instruments overtime is evident. Additionally, an increasing number of RCTs has reported a full or nearly full spectrum of ASAS-core domains, which was observed across all interventions. Overall, the utilization of the DC-ART core set is very good and better than that of the SMARD core set.
The domains ‘physical function’, ‘peripheral joint/entheses’, ‘fatigue’ and ‘spine radiograph’ improved substantially over time. ´Physical function’ is considered an important outcome measure for the evaluation of disease evolution and additionally is a domain relevant to the patient, and is reported by a high proportion of studies (92%). Moreover, ‘BASFI’ included by ASAS as the preferred instrument, is far more often used as a method for the evaluation of ‘physical function’ (88%).
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