Table 2.

Summary of AEs and AEs of special interest through Week 204.

Filgotinib + MTXFilgotinib Monotherapy
Exposure
      Patients, n497242
      Total patient-yrs1764.0817.7
      Mean (SD), yrs3.55 (1.57)3.38 (1.59)
TEAEsn (EAIR/100 PYE)n (EAIR/100 PYE)
      Any TEAE434 (24.6)211 (25.8)
      Any TEAE leading to premature discontinuation of study drug or study131 (7.4)77 (9.4)
      Any TEAE leading to temporary interruption of any study drug111 (6.3)44 (5.4)
      Serious TEAE54 (3.1)35 (4.3)
      Treatment-related TEAE242 (13.7)116 (14.2)
      Treatment-related serious TEAEa9 (0.5)10 (1.2)
      Deathb3 (0.2)3 (0.4)
Most common TEAEs (≥ 5% in either treatment group)c
      Mycobacterium tuberculosis complex test positive53 (3.0)38 (4.6)
      Upper respiratory tract infection52 (2.9)35 (4.3)
      Urinary tract infection56 (3.2)26 (3.2)
      Nasopharyngitis56 (3.2)20 (2.4)
      Hypertension52 (2.9)21 (2.6)
      Bronchitis51 (2.9)17 (2.1)
      Hypercholesterolemia36 (2.0)28 (3.4)
      Headache28 (1.6)26 (3.2)
      Dyslipidemia32 (1.8)13 (1.6)
      Rheumatoid arthritis32 (1.8)13 (1.6)
      Back pain31 (1.8)11 (1.3)
      Influenza30 (1.7)10 (1.2)
      Lymphopenia29 (1.6)11 (1.3)
      Pharyngitis28 (1.6)10 (1.2)
      Diarrhea28 (1.6)9 (1.1)
      Gastroenteritis27 (1.5)9 (1.1)
      HZV22 (4.4)12 (5.0)
      Blood creatinine increased11 (2.2)18 (7.4)
      Hypertriglyceridemia16 (3.2)12 (5.0)
      Blood cholesterol increased8 (1.6)17 (7.0)
      Lymphocyte count decreased11 (2.2)14 (5.8)
Adverse events of special interestd
      Any infections288 (16.3)130 (15.9)
      Serious infections11 (0.6)14 (1.7)
      HZV23 (1.3)12 (1.5)
      Malignancy, excluding NMSCe9 (0.5)5 (0.6)
      NMSC6 (0.3)1 (0.1)
      MACEf3 (0.2)2 (0.2)
      DVT and/or PEf1 (0.1)g0
      GI perforation1 (0.1)h0
      Active tuberculosis00
  • 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.