Table 3.

Treatment-emergent laboratory abnormalities through April 2019 data cut.

Filgotinib + MTX, n = 497Filgotinib Monotherapy, n = 242
Patients With Postbaseline
Value, n496242
Anemia
      Grade 189 (17.9)50 (20.7)
      Grade 235 (7.1)18 (7.4)
      Grade 37 (1.4)2 (0.8)
      Grade 4NANA
Neutropenia
      Grade 138 (7.7)18 (7.4)
      Grade 229 (5.8)14 (5.8)
      Grade 34 (0.8)2 (0.8)
      Grade 42 (0.4)1 (0.4)
Lymphopenia
      Grade 129 (5.8)9 (3.7)
      Grade 2106 (21.4)41 (16.9)
      Grade 323 (4.6)7 (2.9)
      Grade 42 (0.4)0 (0)
Leukopenia
      Grade 167 (13.5)37 (15.3)
      Grade 219 (3.8)6 (2.5)
      Grade 32 (0.4)1 (0.4)
      Grade 40 (0)0 (0)
Thrombocytopenia
      Grade 124 (4.8)5 (2.1)
      Grade 22 (0.4)1 (0.4)
      Grade 31 (0.2)0 (0)
      Grade 41 (0.2)0 (0)
Cr elevation
      Grade 111 (2.2)7 (2.9)
      Grade 212 (2.4)14 (5.8)
      Grade 31 (0.2)0 (0)
      Grade 40 (0)0 (0)
Cholesterol, fasting (increased)a
      Grade 1196 (43.3)93 (43.7)
      Grade 251 (11.3)36 (16.9)
      Grade 33 (0.7)1 (0.5)
      Grade 40 (0)0 (0)
ALT elevation
      Grade 1131 (26.4)54 (22.3)
      Grade 214 (2.8)2 (0.8)
      Grade 34 (0.8)1 (0.4)
      Grade 40 (0)0 (0)
AST elevation
      Grade 1139 (28.0)45 (18.6)
      Grade 210 (2.0)2 (0.8)
      Grade 31 (0.2)1 (0.4)
      Grade 40 (0)0 (0)
  • Values are n (%) unless otherwise indicated. For each individual laboratory test, the most severe graded abnormality for that test was counted for a patient.

  • a Severity grades were defined as: Grade 1 (> ULN-300 mg/dL [7.75 mmol/L]), Grade 2 (> 300–400 mg/dL [7.75–10.34 mmol/L]), Grade 3 (> 400–500 mg/dL [10.34–12.92 mmol/L]), Grade 4 (> 500 mg/dL [12.92 mmol/L]).

  • ALT: alanine aminotransferase; AST: aspartate aminotransferase; Cr: creatinine; MTX: methotrexate; NA: not applicable; ULN: upper limit of normal.