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.