FIL200 was non-inferior to adalimumab. Trial registration number “type”:”clinical-trial”,”attrs”:”text”:”NCT02889796″,”term_id”:”NCT02889796″NCT02889796. pneumonia before week 24 and one patient with active after week 24. Grade 3/4 changes in laboratory ideals are shown in table 4. was significantly higher for FIL200 (76.6%) and FIL100 (69.8%) versus placebo (49.9%; treatment difference (95% CI), 26.7% (20.6% to 32.8%) and 19.9% (13.6% to 26.2%), respectively; both p 0.001). Filgotinib was superior to placebo in important secondary endpoints assessing RA signs and symptoms, physical function and structural damage. FIL200 was non-inferior to adalimumab in terms of Disease Activity Score in 28 bones with C reactive protein 3.2 at week 12 (p 0.001); FIL100 did not achieve non-inferiority. Adverse events and laboratory abnormalities were similar among active treatment arms. Conclusions Filgotinib improved RA signs and symptoms, improved physical function, inhibited radiographic progression and was well tolerated in individuals with RA with inadequate response to MTX. FIL200 Piperidolate hydrochloride was non-inferior to adalimumab. Trial sign up number “type”:”clinical-trial”,”attrs”:”text”:”NCT02889796″,”term_id”:”NCT02889796″NCT02889796. pneumonia before week 24 and one patient with active after week 24. Grade 3/4 changes in laboratory ideals are demonstrated in table 4. Mean haemoglobin levels were stable or improved across all treatment arms, with no imbalance in individual decreased haemoglobin events or grade 3 changes. Decreases in neutrophil and lymphocyte levels were seen in filgotinib-treated and adalimumab-treated individuals. Grade 3 lymphopaenia and neutropaenia were more frequent in individuals receiving filgotinib versus placebo. The majority of white cell count abnormalities were grade 1/2, not associated with illness, and resolved at follow-up screening. No grade 3 changes in platelet counts were observed. Higher imply creatinine Piperidolate hydrochloride levels were observed in individuals receiving filgotinib versus adalimumab or placebo. Grade 3/4 serum creatinine elevations were reported in three individuals: one receiving FIL100 and two receiving placebo, all before week 24. Mean creatine kinase and low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol levels were improved in individuals treated with filgotinib versus placebo, without meaningful switch in the LDL to HDL cholesterol percentage. Table 4 Laboratory ideals Piperidolate hydrochloride and grade 3 abnormalities through week 24 and week 52 thead ?PBO-controlled period (weeks 0C24)Weeks 0C52FIL200 br / (n=475)FIL100 Piperidolate hydrochloride br / (n=480)ADA br / (n=325)PBO br / (n=475)FIL200 br / (n=475)FIL100 br / (n=480)ADA br / (n=325)PBOOn FIL200 period br / (n=190)About FIL100 period br / (n=191)About PBO period br / (n=475) /thead Haemoglobin, g/L2 (11)1 (10)2 (10)0 (9)5 (11)3 (11)5 (10)5 (9)2 (9)NA?Grade 3, n (%)2 (0.4)3 (0.6)2 (0.6)4 (0.9)4 (0.8)5 (1.0)3 (0.9)004 (0.9)Neutrophils, 109/L?1.0 (1.9)?0.9 (2.0)?1.2 (2.0)?0.2 (1.9)?1.0 (2.0)?0.9 (1.9)?1.3 (2.3)?0.8 (1.8)?0.5 (1.7)NA?Grade 3 or 4 4, n (%)5 (1.1)5 (1.0)*1 (0.3)2 (0.4)5 (1.1)6 (1.3)1 (0.3)01 (0.5)2 (0.4)Lymphocytes, 109/L?0.1 (0.6)?0.1 (0.6)0.3 (0.6)?0.1 (0.5)?0.2 (0.6)?0.1 (0.5)0.4 (0.6)?0.1 (0.5)?0.0 (0.6)NA?Grade 3 or 4 4?, n (%)11 (2.3)*6 (1.3)2 (0.6)3 (0.6)15 (3.2)11 (2.3)3 (0.9)4 (2.1)2 (1.1)3 (0.6)Platelets, 109/L?30 (61.0)?28 (62.4)?34 (63.8)?8 (65.3)?26 (66.8)?31 (56.6)?31 (70.9)?17 (59.2)?7 (65.2)NAALT, U/L6 (23.8)4 (20.7)6 (19.2)2 (19.2)6 (33.0)6 (23.7)6 (18.7)5 (25.3)2 (18.3)NA?Grade 3 or Piperidolate hydrochloride 4 4, n (%)3 (0.6)4 (0.8)6 (1.9)5 (1.1)9 (1.9)8 (1.7)8 (2.5)2 (1.1)05 (1.1)AST, U/L6 (16.8)5 (14.0)4 (13.2)2 (14.3)7 (22.7)6 (14.5)4 (12.6)6 (18.9)3 (15.3)NA?Grade 3 or 4 4, n (%)3 (0.6)2 (0.4)2 (0.6)1 (0.2)6 (1.3)3 (0.6)3 (0.9)1 (0.5)01 (0.2)Creatinine, mg/dL0.1 (0.1)0.1 (0.1)0.0 (0.1)0.0 (0.1)0.1 (0.1)0.1 (0.1)0.0 (0.1)0.1 (0.1)0.0 (0.1)NA?Grade 3 or 4 4, n (%)01 (0.2)02 (0.4)01 (0.2)0002 (0.4)Creatine kinase, U/L54 (89.5)34 (64.4)9 (70.1)4 (78.6)56 (92.3)37 (63.9)15 (77.0)57 (163.6)26 (46.5)NA?Grade 3 or 4 4, n (%)4 (0.8)?2 (0.4)*1 (0.3)3 (0.6)6 (1.3)3 (0.6)1 (0.3)1 (0.5)03 (0.6)LDL cholesterol, mg/dL15 (29.1)12 (25.9)7 (21.7)5 (23.4)24 (27.6)20 (26.8)12 (25.0)13 (29.6)10 (22.7)NA?% switch16 (29.2)13 (27.7)9 (20.5)7 (23.6)25 (29.3)21 (28.5)12 (22.6)13 (22.9)11 (21.3)NAHDL cholesterol, mg/dL12 (14.9)5 (12.8)3 (11.8)?1 (11.0)13 (14.4)7 (13.3)4 (11.0)12 (11.7)6 (14.3)NA?% switch21 (25.7)11 (22.0)7 (20.6)0 (20.5)24 (26.5)14 (23.4)9 (20.1)24 (22.6)11 (26.3)NALDL:HDL percentage?0.1 (0.6)0.1 (0.6)0.0 (0.5)0.1 (0.7)0.0 (0.6)0.1 (0.6)0.1 (0.5)?0.2 (0.6)0.0 (0.5)NA?% switch?0.6 (31.1)6.4 (36.4)4.5 (23.6)10.3 (29.2)3.8 (30.8)9.5 (29.5)6.0 (24.5)?6.5 (23.0)2.6 (23.6)NA Open in a separate window Absolute ideals are presented as mean (SD) change from baseline at weeks 24 and 52 unless otherwise specified. Severity was graded using Common Terminology Criteria for Adverse Events Version 4.03. *Grade 4 in one patient. ?Lymphocytes decreased. ?Grade 4 in two individuals. Fasting values; not available for all individuals. ADA, adalimumab; ALT, alanine aminotransferase; AST, aspartate aminotransferase; FIL100, filgotinib 100?mg; FIL200, filgotinib 200?mg; HDL, high-density lipoprotein; LDL, low-density SIGLEC1 lipoprotein; NA, not assessed; PBO, placebo. Conversation The FINCH 1 study assessed filgotinib, an oral JAK-1-preferential inhibitor, to address the unmet needs for RA treatment.