Characteristics of the cohort with comparison between patients with and without hepatic cholestasis.
| No Hepatic Cholestasis, n = 298 | Hepatic Cholestasis, n = 216 | Total, N = 514 | P* | |
|---|---|---|---|---|
| Demographic and clinical characteristics | ||||
| Male sex, n (%) | 106 (35.6) | 74 (34.3) | 180 (35.0) | 0.83 |
| Age, yrs | 74.5 (7.5) | 74.8 (8.1) | 74.6 (7.8) | 0.46 |
| Body weight, kg | 62.8 (12.1) | 64.4 (13.2) | 63.5 (12.6) | 0.29 |
| Hypertension, n/N (%) | 129/295 (43.7) | 97/215 (45.1) | 226/510 (44.3) | 0.82 |
| Diabetes, n/N (%) | 37/296 (12.5) | 28 (13.0) | 65/512 (12.7) | 0.98 |
| Dyslipidemia, n/N (%) | 35/295 (11.9) | 22 (10.2) | 57/511 (11.2) | 0.66 |
| Delay to diagnosis, d | 87.4 (92.1) | 76.2 (80.3) | 82.7 (87.5) | 0.12 |
| No. of ACR criteria met | 4.0 (1.0) | 4.1 (0.9) | 4.0 (0.9) | 0.14 |
| Acute disease onset, n/N (%) | 123/294 (41.8) | 93/211 (44.1) | 216/505 (42.8) | 0.68 |
| Fever, n/N (%) | 115/294 (39.1) | 91/214 (42.3) | 206/508 (40.6) | 0.52 |
| Weight loss > 5%, n/N (%) | 110/291 (37.8) | 101/210 (48.1) | 211/501 (42.1) | 0.03 |
| Polymyalgia symptoms, n (%) | 88 (29.5) | 69 (31.9) | 157 (30.5) | 0.62 |
| Systemic (masked) GCA, n (%) | 34 (11.4) | 25 (11.6) | 59 (11.5) | > 0.99 |
| Headache, n (%) | 239 (80.2) | 174 (80.6) | 413 (80.4) | > 0.99 |
| Scalp tenderness, n/N (%) | 137/286 (47.9) | 110/212 (51.9) | 247/498 (49.6) | 0.43 |
| Facial/orbital edema, n/N (%) | 41 (13.8) | 29/214 (13.6) | 70/512 (13.7) | > 0.99 |
| Jaw claudication, n/N (%) | 86 (29.1) | 81 (37.5) | 167/512 (32.6) | 0.06 |
| Permanent visual loss, n (%) | 40 (13.4) | 29 (13.4) | 69 (13.4) | > 0.99 |
| Ischemic stroke, n (%) | 15 (5.0) | 5 (2.3) | 20 (3.9) | 0.18 |
| Limb artery involvement, n (%) | 31 (10.4) | 17 (7.9) | 48 (9.4) | 0.42 |
| Mean ENT symptomsa, n | 1.7 (1.7) | 2.0 (2.0) | 1.8 (1.8) | 0.08 |
| Imaging and pathological findings | ||||
| Imaging of the aorta, n/N (%) | 113/283 (39.9) | 74/200 (37.0) | 187/483 (38.7) | 0.58 |
| Presence of aortitis, n (%) | 55 (18.5) | 19 (8.8) | 74 (14.4) | < 0.01 |
| Positive TAB result, n/N (%) | 190/281 (67.6) | 157/212 (74.1) | 347/493 (70.4) | 0.15 |
| Laboratory results | ||||
| Mean ESR, mm/h | 78.5 (28.8) | 94.9 (25.9) | 85.2 (28.8) | < 0.001 |
| Mean CRP, mg/L | 79.2 (57.2) | 119.6 (72.1) | 96.1 (66.8) | < 0.001 |
| Mean fibrinogen level, g/L | 6.6 (1.5) | 7.3 (1.8) | 6.9 (1.7) | < 0.001 |
| Mean hemoglobin, g/L | 116.5 (16.4) | 112.1 (17.7) | 114.6 (17.1) | 0.01 |
| Mean leukocyte count, G/L | 8.7 (2.5) | 9.8 (3.7) | 9.1 (3.1) | < 0.001 |
| Mean platelet count, G/L | 398 (133) | 479 (176) | 432 (157) | < 0.001 |
| Mean serum albumin, g/L | 34.9 (5.3) | 32.6 (5.9) | 33.9 (5.7) | < 0.001 |
| Positive IgG aCL, n/N (%) | 47/234 (20.1) | 33/158 (20.9) | 80/392 (20.4) | 0.95 |
| Treatment and outcomes | ||||
| Pulse methylprednisolone, n (%) | 78 (26.2) | 59 (27.3) | 137 (26.7) | 0.85 |
| Initial prednisone dose, mg/kg/d | 0.79 (0.17) | 0.78 (0.16) | 0.78 (0.16) | 0.22 |
| Dose at 3 mos, mg/d | 17.2 (5.9) | 18.6 (5.8) | 17.8 (5.9) | < 0.01 |
| Dose at 6 mos, mg/d | 11.1 (4.1) | 12.5 (4.8) | 11.7 (4.4) | < 0.01 |
| Dose at 12 mos, mg/d | 6.7 (4.1) | 7.4 (4.4) | 6.94 (4.2) | 0.08 |
| Use of GC-sparing treatment, n (%) | 64 (21.5) | 43 (19.9) | 107 (20.8) | 0.75 |
| Treatment stopped, n/N (%) | 181/297 (60.9) | 134/215 (62.3) | 315/512 (61.5) | 0.82 |
| Treatment duration, mos | 27.2 (25.2) | 27.8 (23.9) | 27.5 (24.6) | 0.97 |
| Treatment duration in recovered patients, mos | 27.9 (15.3) | 31.7 (20.4) | 29.5 (17.7) | 0.41 |
| No. of relapses/patientb | 1.0 (1.2) | 1.1 (1.3) | 1.0 (1.3) | 0.58 |
| Recovered patientsc, n (%) | 165 (55.4) | 120 (55.6) | 285 (55.4) | 1.00 |
| Death, n (%) | 93 (31.2) | 95 (44.0) | 188 (36.6) | < 0.01 |
| Death during GC treatment, n (%) | 29 (9.7) | 26 (12.0) | 55 (10.7) | 0.64 |
Values are expressed as mean (SD) unless indicated otherwise.
↵* Proportions were analyzed using Pearson chi-square tests; comparisons of continuous variables were performed with t tests.
↵a ENT includes jaw claudication, difficulty opening mouth, toothache, earache, tongue pain, sore throat, dry cough, and carotidodynia.
↵b Before 2003, relapse was defined as the recurrence of clinical symptoms or inflammatory variables that were attributable to GCA and required increased medication. Thereafter, only events involving clinical symptoms, or persistently raised acute-phase reactants with demonstration of new large-vessel involvement, were labeled as relapses.
↵c Patients free of relapse for at least 12 months following the cessation of GC treatment. aCL: anticardiolipin antibody; ACR: American College of Rheumatology; CRP: C-reactive protein; ENT: ear, nose, and throat; ESR: erythrocyte sedimentation rate; GC: glucocorticoid; GCA: giant cell arteritis; TAB: temporal artery biopsy.