Table 2.

Summary of phase II and III studies with efficacy, safety, and pharmacokinetic characterization of upadacitinib in subjects with rheumatoid arthritis

Study	Description	Upadacitinib formulation used in the study	References
Phase II studies
BALANCE IIa	Comparison of upadacitinib to placebo in subjects with moderately to severely active RA who are on a stable background of MTX and have an inadequate response to MTX	IR capsules	[14]
BALANCE Ia	Comparison of upadacitinib to placebo in subjects with moderately to severely active RA who are on a stable background of MTX and who have an inadequate response or intolerance to anti-TNF biologic therapy	IR capsules	[13]
SELECT-SUNRISEa,b	Comparison of upadacitinib to placebo in Japanese subjects with moderately to severely active RA who are on a stable dose of csDMARDs and have an inadequate response to csDMARDs	ER tablets	[15]
Phase III studies
SELECT-COMPAREa	Comparison of upadacitinib to placebo and to adalimumab in subjects with moderately to severely active RA who are on a stable background of MTX and who have an inadequate response to MTX (MTX-IR)	ER tablets	[16]
SELECT-NEXTa	Comparison of upadacitinib to placebo in subjects with moderately to severely active RA who are on a stable dose of csDMARDs and have an inadequate response to csDMARD	ER tablets	[18]
SELECT-MONOTHERAPYa	Comparison of upadacitinib monotherapy to MTX in subjects with moderately to severely active RA with inadequate response to MTX	ER tablets	[17]
SELECT-BEYONDa	Comparison of upadacitinib to placebo in subjects with moderately to severely active RA with inadequate response or intolerance to bDMARDs who are on stable background of csDMARDs	ER tablets	[19]
SELECT-EARLYa	Comparison of upadacitinib monotherapy to MTX monotherapy in MTX-naïve subjects with moderately to severely active RA	ER tablets	[20]

bDMARDs biologic disease-modifying antirheumatic drugs, csDMARDs conventional synthetic disease-modifying antirheumatic drugs, ER extended-release, IR immediate-release, MTX methotrexate, RA rheumatoid arthritis, TNF tumor necrosis factor

^aSparse blood samples were collected for population pharmacokinetic analyses

^bStudy included intensive pharmacokinetic assessment in a cohort of subjects