Conclusions
Based on the exposure-efficacy analyses, exposures associated with 200
mg once daily filgotinib corresponded to numerically higher ACR
responses compared with those associated with filgotinib 100 mg once
daily or lower doses, showing a plateau over higher exposures
corresponding to 200 mg for multiple efficacy endpoints [ACR20, ACR50,
ACR70, DAS28 (CRP) ≤ 3.2, and DAS28 (CRP) < 2.6]. For the
safety analyses, it was shown that filgotinib was generally well
tolerated with no exposure-dependent effects on the evaluated safety
endpoints. Overall, the exposure-response analyses supported 200 mg once
daily doses for commercialization.