Clinical and MRI responses to etanercept in early non-radiographic XXXX : 48-week results from the EMBARK study.

@entity1 @entity32 @entity1691
OBJECTIVE: To evaluate the efficacy and safety of etanercept (ETN) after 48   weeks in @entity1 with early active non-radiographic @entity1691 (nr-axSpA). METHODS: @entity1 meeting Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA, but not modified New York radiographic criteria, received double-blind ETN 50   mg/week or placebo (PBO) for 12   weeks, then open-label ETN (ETN/ETN or PBO/ETN). Clinical, health, productivity, MRI and safety outcomes were assessed and the 48-week data are presented here. RESULTS: 208/225 @entity1 (92%) entered the open-label phase at week 12 (ETN, n=102; PBO, n=106). The percentage of @entity1 achieving ASAS40 increased from 33% to 52% between weeks 12 and 48 for ETN/ETN and from 15% to 53% for PBO/ETN (within-group p value <0.001 for both). For ETN/ETN and PBO/ETN, the EuroQol 5 Dimensions utility score improved by 0.14 and 0.08, respectively, between baseline and week 12 and by 0.23 and 0.22 between baseline and week 48. Between weeks 12 and 48, @entity1691 Research Consortium of Canada sacroiliac joint (SIJ) scores decreased by -1.1 for ETN/ETN and by -3.0 for PBO/ETN, p<0.001 for both. @entity32 and C-reactive protein correlated with several clinical outcomes at weeks 12 and 48. CONCLUSIONS: @entity1 with early active nr-axSpA demonstrated improvement from week 12 in clinical, health, productivity and MRI outcomes that was sustained to 48   weeks. TRIAL REGISTRATION NUMBER: NCT01258738.
