Table 1.

Overview of the upadacitinib RA clinical development program

Study	BALANCE I [17]	BALANCE II [18]	SELECT-SUNRISEa [16]	SELECT-EARLYb [9]	SELECT-NEXT [5]	SELECT-MONOTHERAPYb [8]	SELECT-COMPARE [6]	SELECT-BEYOND [7]
Phase	IIb	IIb	IIb/III	III	III	III	III	III
Populations	TNFi-IR/Int	MTX-IR	csDMARD-IR	MTX-naïve	csDMARD-IR	MTX-IR	MTX-IR	bDMARD-IR
Number of patients randomized	276	300	197	947b	661	648b	1629	498
Background therapy	MTX	MTX	csDMARDs	–	csDMARDs	–	MTX	csDMARDs
Upadacitinib dose	3 mg twice dailyc 6 mg twice daily 12 mg twice daily 18 mg twice dailyc	3 mg twice dailyc 6 mg twice daily 12 mg twice daily 18 mg twice dailyc 24 mg once dailyc	7.5 mg once daily 15 mg once daily 30 mg once daily	7.5 mg once dailya 15 mg once daily 30 mg once daily	15 mg once daily 30 mg once daily	15 mg once daily 30 mg once daily	15 mg once daily	15 mg once daily 30 mg once daily
Comparator	Placebo	Placebo	Placebo	MTX	Placebo	MTX	Placebo Adalimumab	Placebo

bDMARD biologic disease-modifying antirheumatic drug, csDMARD conventional synthetic disease-modifying antirheumatic drug, Int intolerance, IR inadequate response/responders, MTX methotrexate, RA rheumatoid arthritis, TNFi tumor necrosis factor inhibitor

^aJapan only

^bSELECT-EARLY and SELECT-MONOTHERAPY included 138 and 61 patients, respectively, from Japan

^cPatients receiving these doses were not included in the pooled RA global population for this integrated safety analysis