Table 2. Incidence and EAIR per 100 PYE of TEAEs in FINCH 4.
| FIL200Number of patients (%) with the TEAE listedEAIR per 100 PYE (95% CI) | FIL100Number of patients (%) with the TEAE listedEAIR per 100 PYE (95% CI) | |||||
| With continued FIL PYE=3572.7(n=1195) | With de novo FIL PYE=1018.5(n=335) | TotalPYE=4591.2(n=1530) | With continued FIL PYE=2568.5(n=863) | With de novo FIL PYE=985.2(n=336) | TotalPYE=3553.8(n=1199) | |
| TEAE | 1030 (86.19)93.9 (88.3 to 99.9) | 293 (87.46)92.8 (82.4 to 104.0) | 1323 (86.47)93.7 (88.7 to 98.9) | 743 (86.10)96.0 (89.3 to 103.2) | 274 (81.55)80.4 (71.2 to 90.6) | 1017 (84.82)91.3 (85.8 to 97.1) |
| Grade ≥3 TEAE | 268 (22.43)8.2 (7.3 to 9.3) | 68 (20.30)7.4 (5.7 to 9.3) | 336 (21.96)8.1 (7.2 to 9.0) | 193 (22.36)8.3 (7.2 to 9.6) | 65 (19.35)7.1 (5.5 to 9.1) | 258 (21.52)8.0 (7.0 to 9.0) |
| Serious TEAE | 237 (19.83)7.1 (6.2 to 8.1) | 63 (18.81)6.7 (5.2 to 8.6) | 300 (19.61)7.0 (6.3 to 7.9) | 165 (19.12)6.9 (5.9 to 8.1) | 68 (20.24)7.5 (5.8 to 9.5) | 233 (19.43)7.1 (6.2 to 8.1) |
| TEAE related to study drug | 394 (32.97)14.1 (12.8 to 15.6) | 116 (34.63)14.5 (12.0 to 17.4) | 510 (33.33)14.2 (13.0 to 15.5) | 261 (30.24)12.7 (11.2 to 14.4) | 101 (30.06)13.2 (10.8 to 16.0) | 362 (30.19)12.9 (11.6 to 14.3) |
| Grade ≥3 TEAE related to study drug | 78 (6.53)2.2 (1.8 to 2.8) | 21 (6.27)2.1 (1.3 to 3.2) | 99 (6.47)2.2 (1.8 to 2.7) | 55 (6.37)2.2 (1.6 to 2.8) | 12 (3.57)1.2 (0.6 to 2.2) | 67 (5.59)1.9 (1.5 to 2.4) |
| Serious TEAE related to study drug | 67 (5.61)1.9 (1.5 to 2.4) | 16 (4.78)1.6 (0.9 to 2.6) | 83 (5.42)1.8 (1.5 to 2.3) | 37 (4.29)1.5 (1.0 to 2.0) | 10 (2.98)1.0 (0.5 to 1.9) | 47 (3.92)1.3 (1.0 to 1.8) |
| TEAE leading to interruption of study drug | 484 (50.5)18.5 (16.9 to 20.2) | 123 (36.72)16.1 (13.4 to 19.3) | 607 (39.67)17.9 (16.5 to 19.4) | 304 (35.23)15.5 (13.8 to 17.4) | 132 (39.29)18.1 (15.1 to 21.5) | 436 (36.36)16.2 (14.7 to 17.8) |
| TEAE leading to premature discontinuation of study drug | 128 (10.71)3.6 (3.0 to 4.3) | 36 (10.75)3.6 (2.5 to 4.9) | 164 (10.72)3.6 (3.1 to 4.2) | 95 (11.01)3.7 (3.0 to 4.5) | 34 (10.12)3.5 (2.4 to 4.8) | 129 (10.76)3.6 (3.0 to 4.3) |
| TEAE leading to death | 34 (2.85)1.0 (0.7 to 1.3) | 5 (1.49)0.5 (0.2 to 1.1) | 39 (2.55)0.8 (0.6 to 1.2) | 12 (1.39)0.5 (0.2 to 0.8) | 7 (2.08)0.7 (0.3 to 1.5) | 19 (1.58)0.5 (0.3 to 0.8) |
| TEAEs of interest | ||||||
| Serious infection | 79 (6.61)2.2 (1.8 to 2.8) | 18 (5.37)1.8 (1.1 to 2.8) | 97 (6.34)2.1 (1.7 to 2.6) | 49 (5.68)1.9 (1.4 to 2.6) | 21 (6.25)2.2 (1.3 to 3.3) | 70 (5.84)2.0 (1.6 to 2.5) |
| Herpes zoster | 52 (4.35)1.5 (1.1 to 2.0) | 14 (4.18)1.4 (0.8 to 2.4) | 66 (4.31)1.5 (1.1 to 1.9) | 25 (2.90)1.0 (0.6 to 1.5) | 15 (4.46)1.6 (0.9 to 2.6) | 40 (3.34)1.1 (0.8 to 1.6) |
| MACE (adjudicated) | 16 (1.34)0.4 (0.3 to 0.7) | 1 (0.30)0.1 (0.0 to 0.5) | 17 (1.11)0.4 (0.2 to 0.6) | 10 (1.16)0.4 (0.2 to 0.7) | 7 (2.08)0.7 (0.3 to 1.5) | 17 (1.42)0.5 (0.3 to 0.8) |
| VTE (adjudicated) | 8 (0.67)0.2 (0.1 to 0.4) | 1 (0.30)0.1 (0.0 to 0.5) | 9 (0.59)0.2 (0.1 to 0.4) | 8 (0.93)0.3 (0.1 to 0.6) | 1 (0.30)0.1 (0.0 to 0.6) | 9 (0.75)0.3 (0.1 to 0.5) |
| Malignancy (excluding NMSC) | 29 (2.43)0.8 (0.5 to 1.2) | 13 (3.88)1.3 (0.7 to 2.2) | 42 (2.75)0.9 (0.7 to 1.2) | 20 (2.32)0.8 (0.5 to 1.2) | 8 (2.38)0.8 (0.4 to 1.6) | 28 (2.34)0.8 (0.5 to 1.1) |
| NMSC | 19 (1.59)0.5 (0.3 to 0.8) | 3 (0.90)0.3 (0.1 to 0.9) | 22 (1.44)0.5 (0.3 to 0.7) | 5 (0.58)0.2 (0.1 to 0.5) | 3 (0.89)0.3 (0.1 to 0.9) | 8 (0.67)0.2 (0.1 to 0.4) |
| Most common TEAEs (≥5% in either group) | ||||||
| COVID-19 | 145 (12.13)4.2 (3.5 to 4.9) | 41 (12.24)4.1 (3.0 to 5.6) | 186 (12.16)4.2 (3.6 to 4.8) | 80 (9.27)3.2 (2.5 to 4.0) | 36 (10.71)3.7 (2.6 to 5.2) | 116 (9.67)3.3 (2.8 to 4.0) |
| Nasopharyngitis | 131 (10.96)4.0 (3.3 to 4.7) | 32 (9.55)3.4 (2.3 to 4.8) | 163 (10.65)3.9 (3.3 to 4.5) | 105 (12.17)4.5 (3.7 to 5.5) | 28 (8.33)3.0 (2.0 to 4.4) | 133 (11.09)4.1 (3.4 to 4.9) |
| Upper respiratory tract infection | 111 (9.29)3.3 (2.7 to 4.0) | 40 (11.94)4.3 (3.1 to 5.9) | 151 (9.87)3.5 (3.0 to 4.2) | 82 (9.50)3.4 (2.7 to 4.2) | 33 (9.82)3.6 (2.5 to 5.1) | 115 (9.59)3.5 (2.9 to 4.2) |
| Rheumatoid arthritis (worsening, flare or exacerbation) | 87 (7.28)2.6 (2.1 to 3.2) | 29 (8.66)3.0 (2.0 to 4.3) | 116 (7.58)2.7 (2.2 to 3.2) | 103 (11.94)4.4 (3.6 to 5.3) | 30 (8.93)3.3 (2.2 to 4.6) | 133 (11.094.0 (3.4 to 4.8) |
| Urinary tract infection | 103 (8.62)3.0 (2.5 to 3.7) | 35 (10.45)3.7 (2.6 to 5.1) | 138 (9.02)3.2 (2.7 to 3.8) | 69 (8.00)2.8 (2.2 to 3.6) | 30 (8.93)3.2 (2.2 to 4.6) | 99 (8.26)2.9 (2.4 to 3.6) |
| Hypertension | 71 (5.94)2.1 (1.6 to 2.6) | 29 (8.66)3.0 (2.0 to 4.3) | 100 (6.54)2.3 (1.8 to 2.8) | 66 (7.65)2.7 (2.1 to 3.4) | 28 (8.33)3.0 (2.0 to 4.4) | 94 (7.84)2.8 (2.2 to 3.4) |
| Headache | 66 (5.52)1.9 (1.5 to 2.4) | 31 (9.25)3.2 (2.2 to 4.6) | 97 (6.34)2.2 (1.8 to 2.7) | 58 (6.72)2.4 (1.8 to 3.1) | 20 (5.95)2.1 (1.3 to 3.2) | 78 (6.51)2.3 (1.8 to 2.9) |
| Arthralgia | 66 (5.52)1.9 (1.5 to 2.4) | 24 (7.16)2.5 (1.6 to 3.7) | 90 (5.88)2.0 (1.6 to 2.5) | 66 (7.65)2.7 (2.1 to 3.4) | 18 (5.36)1.9 (1.1 to 3.0) | 84 (7.01)2.5 (2.0 to 3.1) |
| Latent tuberculosis | 66 (5.52)1.9 (1.5 to 2.5) | 13 (3.88)1.3 (0.7 to 2.2) | 79 (5.16)1.8 (1.4 to 2.2) | 45 (5.21)1.8 (1.3 to 2.4) | 26 (7.74)2.8 (1.8 to 4.1) | 71 (5.92)2.1 (1.6 to 2.6) |
| Bronchitis | 75 (6.28)2.2 (1.7 to 2.8) | 16 (4.78)1.6 (0.9 to 2.7) | 91 (5.95)2.1 (1.7 to 2.5) | 42 (4.87)1.7 (1.2 to 2.3) | 14 (4.17)1.5 (0.8 to 2.5) | 56 (4.67)1.6 (1.2 to 2.1) |
| Back pain | 53 (4.44)1.5 (1.1 to 2.0) | 17 (5.07)1.7 (1.0 to 2.8) | 70 (4.58)1.6 (1.2 to 2.0) | 43 (4.98)1.7 (1.2 to 2.3) | 17 (5.06)1.8 (1.0 to 2.9) | 60 (5.00)1.7 (1.3 to 2.2) |
TEAEs are defined as any adverse events that began on or after the study drug start date, up to 30 days after permanent discontinuation of study drug. Only adverse events with a start date after LTE treatment start start are considered. EAIR, exposure-adjusted incidence rate; FIL(100/200), filgotinib ( mg/ mg); LTE, long-term extension; MACE, major adverse cardiovascular event; NMSC, non-melanoma skin cancer; PYE, ; TEAE, treatment-emergent adverse event; VTE, venous thromboembolism.
EAIRexposure-adjusted incidence rateFIL(100/200)filgotinib (100 mg/200 mg)LTElong-term extensionMACEmajor adverse cardiovascular eventsNMSCnon-melanoma skin cancerPYEpatient-years of exposureTEAEtreatment-emergent adverse eventVTEvenous thromboembolism