Table 3.

EAIR of adverse events per 100 PYE by baseline BMI (integrated data from FINCH 1–4 and DARWIN 1–3)

	FIL dose (mg)	n (%) EAIR (95% CI)
		BMI (kg/m2)
		< 25 PYE 3062.8	25 to < 30 PYE 2640.1	≥ 30 PYE 2382.2
TEAEs	200	704 (81.4) 34.5 (32.0, 37.1)	622 (84.7) 35.7 (33.0, 38.6)	555 (83.1) 36.6 (33.7, 39.8)
	100	452 (73.7) 44.3 (40.4, 48.6)	385 (71.8) 43.0 (38.9, 47.5)	393 (78.9) 45.3 (41.1, 50.0)
Serious TEAEs	200	109 (12.6) 5.3 (4.4, 6.4)	102 (13.9) 5.8 (4.8, 7.1)	107 (16.0) 7.1 (5.8, 8.5)
	100	77 (12.6) 7.6 (6.0, 9.4)	58 (10.8) 6.5 (5.0, 8.4)	70 (14.1) 8.1 (6.4, 10.2)
Deaths	200	7 (0.8) 0.3 (0.2, 0.7)	9 (1.2) 0.5 (0.3, 1.0)	7 (1.0) 0.5 (0.2, 1.0)
	100	4 (0.7) 0.4 (0.1, 1.0)	3 (0.6) 0.3 (0.1, 1.0)	2 (0.4) 0.2 (0.1, 0.9)
Venous thrombotic and embolic events	200	2 (0.2) 0.1 (0.0, 0.4)	2 (0.3) 0.1 (0.0, 0.5)	7 (1.0) 0.5 (0.2, 1.0)
	100	1 (0.2) 0.1 (0.0, 0.7)	1 (0.2) 0.1 (0.0, 0.8)	2 (0.4) 0.2 (0.1, 0.9)
Major adverse cardiovascular events	200	7 (0.8) 0.3 (0.2, 0.7)	5 (0.7) 0.3 (0.1, 0.7)	7 (1.0) 0.5 (0.2, 1.0)
	100	6 (1.0) 0.6 (0.3, 1.3)	3 (0.6) 0.3 (0.1, 1.0)	5 (1.0) 0.6 (0.2, 1.4)
Serious infections	200	23 (2.7) 1.1 (0.7, 1.7)	30 (4.1) 1.7 (1.2, 2.5)	27 (4.0) 1.8 (1.2, 2.6)
	100	27 (4.4) 2.6 (1.8, 3.9)	11 (2.1) 1.2 (0.7, 2.2)	19 (3.8) 2.2 (1.4, 3.4)
Herpes zoster	200	32 (3.7) 1.6 (1.1, 2.2)	25 (3.4) 1.4 (1.0, 2.1)	27 (4.0) 1.8 (1.2, 2.6)
	100	10 (1.6) 1.0 (0.5, 1.8)	11 (2.1) 1.2 (0.7, 2.2)	9 (1.8) 1.0 (0.5, 2.0)
Malignancy (excluding nonmelanoma skin cancer)	200	11 (1.3) 0.5 (0.3, 1.0)	13 (1.8) 0.7 (0.4, 1.3)	8 (1.2) 0.5 (0.3, 1.1)
	100	6 (1.0) 0.6 (0.3, 1.3)	4 (0.7) 0.4 (0.2, 1.2)	7 (1.4) 0.8 (0.4, 1.7)

Safety analysis set. EAIR and its 95% CI were estimated using Poisson regression by treatment with an offset of natural logarithm of exposure time. PYE is defined as (last dose date—first dose date + 1)/365.25

BMI body mass index, CI confidence interval, EAIR exposure-adjusted incidence rate, FIL filgotinib, PYE patient-years of exposure, TEAE treatment-emergent adverse event