Filgotinib + MTX | Filgotinib Monotherapy | |
---|---|---|
Exposure | ||
Patients, n | 497 | 242 |
Total patient-yrs | 1764.0 | 817.7 |
Mean (SD), yrs | 3.55 (1.57) | 3.38 (1.59) |
TEAEs | n (EAIR/100 PYE) | n (EAIR/100 PYE) |
Any TEAE | 434 (24.6) | 211 (25.8) |
Any TEAE leading to premature discontinuation of study drug or study | 131 (7.4) | 77 (9.4) |
Any TEAE leading to temporary interruption of any study drug | 111 (6.3) | 44 (5.4) |
Serious TEAE | 54 (3.1) | 35 (4.3) |
Treatment-related TEAE | 242 (13.7) | 116 (14.2) |
Treatment-related serious TEAEa | 9 (0.5) | 10 (1.2) |
Deathb | 3 (0.2) | 3 (0.4) |
Most common TEAEs (≥ 5% in either treatment group)c | ||
Mycobacterium tuberculosis complex test positive | 53 (3.0) | 38 (4.6) |
Upper respiratory tract infection | 52 (2.9) | 35 (4.3) |
Urinary tract infection | 56 (3.2) | 26 (3.2) |
Nasopharyngitis | 56 (3.2) | 20 (2.4) |
Hypertension | 52 (2.9) | 21 (2.6) |
Bronchitis | 51 (2.9) | 17 (2.1) |
Hypercholesterolemia | 36 (2.0) | 28 (3.4) |
Headache | 28 (1.6) | 26 (3.2) |
Dyslipidemia | 32 (1.8) | 13 (1.6) |
Rheumatoid arthritis | 32 (1.8) | 13 (1.6) |
Back pain | 31 (1.8) | 11 (1.3) |
Influenza | 30 (1.7) | 10 (1.2) |
Lymphopenia | 29 (1.6) | 11 (1.3) |
Pharyngitis | 28 (1.6) | 10 (1.2) |
Diarrhea | 28 (1.6) | 9 (1.1) |
Gastroenteritis | 27 (1.5) | 9 (1.1) |
HZV | 22 (4.4) | 12 (5.0) |
Blood creatinine increased | 11 (2.2) | 18 (7.4) |
Hypertriglyceridemia | 16 (3.2) | 12 (5.0) |
Blood cholesterol increased | 8 (1.6) | 17 (7.0) |
Lymphocyte count decreased | 11 (2.2) | 14 (5.8) |
Adverse events of special interestd | ||
Any infections | 288 (16.3) | 130 (15.9) |
Serious infections | 11 (0.6) | 14 (1.7) |
HZV | 23 (1.3) | 12 (1.5) |
Malignancy, excluding NMSCe | 9 (0.5) | 5 (0.6) |
NMSC | 6 (0.3) | 1 (0.1) |
MACEf | 3 (0.2) | 2 (0.2) |
DVT and/or PEf | 1 (0.1)g | 0 |
GI perforation | 1 (0.1)h | 0 |
Active tuberculosis | 0 | 0 |
↵a Filgotinib + MTX: pneumonia (2), HZV infection (2), asthenia (1), abdominal wall infection (1), breast cancer (1), colon adenoma (1), diffuse large B cell lymphoma (1); filgotinib monotherapy: pneumonia (2), NHL (2); Escherichia urinary tract infection (1), jaw abscess (1), liver hemangioma (1), squamous cell carcinoma (1), spontaneous abortion (1), renal cyst (1).
↵b Filgotinib + MTX: meningococcal meningitis, leiomyosarcoma, DVT/PE; filgotinib monotherapy: pneumonia, NHL (2).
↵c Occurring in ≥ 5% of a proportion of patients in either treatment group.
↵d Includes TEAEs and non-TEAEs.
↵e Of the 13 patients with treatment-emergent malignancies, 4 were hematologic (3 NHL and 1 diffuse large B cell lymphoma) and 9 were solid tumors (2 lung cancer, 2 breast cancer, 1 each colon cancer, gallbladder adenocarcinoma, metastatic leiomyosarcoma, melanoma, and renal cancer).
↵f Positively adjudicated events.
↵g Patient had simultaneous DVT and PE.
↵h Procedural small bowel perforation.
AE: adverse event; DVT: deep vein thrombosis; EAIR: exposure-adjusted incidence rate; GI: gastrointestinal; HZV: herpes zoster virus; MACE: major adverse cardiovascular event; MTX: methotrexate; NHL: non-Hodgkin lymphoma; NMSC: nonmelanoma skin cancer; PE: pulmonary embolism; PYE: patient-years of exposure; TEAE: treatment-emergent adverse event.