Liver enzyme and lipid panel parameters at month 3, by baseline BMI category and treatment group
| Baseline BMI category | ||||
| <25 kg/m2 (underweight/normal) | ≥25–<30 kg/m2 (overweight) | ≥30–<35 kg/m2 (class 1 obesity) | ≥35 kg/m2 (class 2 and 3 obesity) | |
| Liver function test | ||||
| ALT, % change from baseline, mean (SD) (N) | ||||
| Tofacitinib 5 mg two times a day | 22.67 (73.7) (46) | 12.70 (52.9) (84) | 15.81 (50.5) (56) | 34.13 (68.8) (40) |
| Tofacitinib 10 mg two times a day | 19.91 (41.9) (43) | 34.33 (123.4) (78)* | 21.22 (41.2) (60) | 27.30 (40.3) (41) |
| Placebo | 16.54 (84.7) (58) | 11.68 (58.4) (66) | 7.23 (46.1) (62) | 11.39 (48.0) (35) |
| ALT, IU/L, mean (SD) (N) | ||||
| Tofacitinib 5 mg two times a day | 22.93 (16.71) (46) | 26.42 (14.37) (84) | 30.50 (22.19) (56) | 31.88 (19.06) (40) |
| Tofacitinib 10 mg two times a day | 20.19 (10.39) (43) | 28.87 (15.68) (78) | 31.83 (13.63) (60) | 31.44 (13.93) (41) |
| Placebo | 18.02 (9.97) (58) | 26.33 (15.56) (66) | 24.53 (12.09) (62) | 27.17 (18.63) (35) |
| AST, % change from baseline, mean (SD) (N) | ||||
| Tofacitinib 5 mg two times a day | 13.67 (36.0) (46) | 13.97 (42.2) (83) | 10.22 (30.8) (55) | 32.52 (52.9) (40) |
| Tofacitinib 10 mg two times a day | 18.07 (43.1) (43) | 20.13 (43.1) (78) | 16.25 (32.0) (59) | 19.05 (33.5) (41) |
| Placebo | 5.70 (31.9) (58) | 6.32 (42.0) (66) | 3.01 (29.7) (62) | 1.17 (26.0) (35) |
| AST, IU/L, mean (SD) (N) | ||||
| Tofacitinib 5 mg two times a day | 22.67 (7.89) (46) | 24.23 (9.81) (83) | 25.22 (10.02) (55) | 28.20 (16.34) (40) |
| Tofacitinib 10 mg two times a day | 22.70 (8.90) (43) | 26.03 (8.86) (78) | 26.29 (8.47) (59) | 27.15 (8.17) (41) |
| Placebo | 19.50 (5.48) (58) | 24.85 (17.92) (66) | 20.44 (6.09) (62) | 20.69 (8.91) (35) |
| Lipid panel† | ||||
| LDL, % change from baseline, mean (SD) (N) | ||||
| Tofacitinib 5 mg two times a day | 4.29 (15.1) (45) | 12.22 (24.2) (73) | 7.08 (18.3) (53) | 12.11 (19.3) (37) |
| Tofacitinib 10 mg two times a day | 16.88 (27.3) (40) | 14.96 (24.8) (71) | 13.03 (26.0) (57) | 11.35 (26.8) (33) |
| Placebo | 1.77 (21.0) (57) | 7.27 (17.7) (61) | 4.98 (21.2) (56) | 1.98 (13.4) (31) |
| HDL, % change from baseline, mean (SD) (N) | ||||
| Tofacitinib 5 mg two times a day | 6.64 (13.4) (45) | 13.27 (24.9) (78) | 5.33 (14.3) (53) | 11.80 (21.9) (38) |
| Tofacitinib 10 mg two times a day | 20.05 (21.0) (40) | 9.63 (18.9) (72) | 15.59 (17.0) (58) | 14.88 (18.0) (36) |
| Placebo | -2.16 (18.4) (57) | 0.87 (15.5) (64) | -1.15 (13.8) (58) | 0.24 (16.6) (32) |
| Total cholesterol, % change from baseline, mean (SD) (N) | ||||
| Tofacitinib 5 mg two times a day | 3.70 (11.2) (45) | 11.42 (17.4) (79) | 6.27 (13.0) (53) | 10.41 (9.3) (38) |
| Tofacitinib 10 mg two times a day | 15.90 (20.7) (40) | 12.16 (17.3) (73) | 12.94 (18.1) (58) | 7.62 (18.8) (37) |
| Placebo | −0.56 (12.6) (57) | 4.35 (14.0) (64) | 3.50 (15.1) (58) | -0.57 (9.4) (32) |
| Triglycerides, % change from baseline, mean (SD) (N) | ||||
| Tofacitinib 5 mg two times a day | 0.37 (29.6) (45) | 9.87 (42.9) (79) | 14.72 (47.6) (53) | 11.20 (32.7) (38) |
| Tofacitinib 10 mg two times a day | 12.12 (59.2) (40) | 23.21 (57.8) (72) | 16.86 (45.9) (58) | 9.84 (62.3) (36) |
| Placebo | 8.53 (38.1) (57) | 8.76 (49.1) (64) | 17.54 (53.8) (58) | 0.12 (31.8) (32) |
N indicates the number of patients assessed at baseline and month 3. All patients received a stable dose of one csDMARD throughout each study.
*High SD value due to a per cent change in ALT level of 1037.50 reported for one patient. Note that this value was not considered to be clinically significant, and had decreased at retesting.
†Data on lipids for patients in fasting state only.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; BMI, body mass index; csDMARD, conventional synthetic disease-modifying antirheumatic drug; HDL, high-density lipoprotein; IU/L, international units/litre; LDL, low-density lipoprotein.