Study endpoints
low disease
DISEASE, REMISSION, THIGH DISEASE, SECONDARY
The primary endpoint of the XANADU study was the proportion of patients who sustained clinical remission at week 104. As outlined in the Study design section, subjects who experienced flares, which were defined as moderate or high disease activity based on the CDAI, were re-administered either tofacitinib or MTX, and these individuals were not considered to have met the endpoint even if they regained clinical remission. Short-term low disease activity was considered as sustained remission if remission was reached again without additional treatment. The secondary endpoints were the proportion of patients who sustained low disease activity at week 104, the proportion of patients who had SAEs throughout the study, and the proportion of patients who achieved clinical remission after rescue by re-administration of tofacitinib or MTX. Subgroup exploratory analyses were performed to reveal which patients could achieve successful drug discontinuation.