Table 1.

Summary of patient demographics and baseline disease characteristics

Study	BALANCE Ia N = 276	BALANCE IIa N = 298b
Sex, n (%)
Male	55 (20%)	62 (21%)
Female	221 (80%)	236 (79%)
Race, n (%)
White	247 (89%)	292 (98%)
Black	22 (8%)	3 (1%)
Asian	3 (1%)	0
Other	4 (1%)	3 (1%)
Age, year, mean ± SD (range)	57 ± 12 (26–88)	55 ± 12 (19–82)
Weight, kg, mean ± SD (range)	78 ± 17 (42–134)	75 ± 14 (44–122)
MTX use, n (%)	276 (100%)	298 (100%)
Baseline CRP, mg/L, mean ± SD (range)	13.4 ± 18.6 (0.08–135)	13.3 ± 18.2 (0.07–149)
Baseline DAS28‐CRP, mean ± SD (range)	5.77 ± 0.92 (3.58–7.97)	5.66 ± 0.99 (3–8.25)
Baseline RF status, n (%)
Positive	230 (83%)	260 (87%)
Negative	46 (17%)	38 (13%)
Baseline TJC, mean ± SD (range)	15.8 ± 6.9 (2–28)	15.8 ± 7.2 (0–28)
Baseline SJC, mean ± SD (range)	12.2 ± 5.8 (0–28)	11.9 ± 5.8 (2–28)
Baseline anti‐CCP status, n (%)
Positive	230 (83%)	251 (84%)
Negative	46 (17%)	47 (16%)
Prior biologics use, n (%)
Yes	276 (100%)	0
No	0	298 (100%)

CCP, cyclic citrullinated peptide; CRP, C‐reactive protein; DAS28‐CRP, disease activity score 28 based on CRP; MTX, methotrexate; RA, rheumatoid arthritis; RF, rheumatoid factor; SJC, swollen joint count; TJC, tender joint count.

^aIn BALANCE I, there were 55 patients in each upadacitinib dose group and 56 patients in the placebo group. In BALANCE II, there were 50 patients in the 3, 6, and 12 mg b.i.d. dose groups, 49 patients each in the 18 mg b.i.d. and 24 mg q.d. dose groups, and 50 patients in the placebo group. ^bA total of 300 patients were enrolled in the study and 298 were included in the exposure–response analyses. One patient in the 18 mg b.i.d. dose group and one patient in the 24 mg q.d. dose group were excluded from the analyses because their American College of Rheumatology data were insufficient to clearly define a Markov state for one or more study visits.