Table 1.
Patient demography at entry into the study
| All (n = 392) | Rituximab (n = 247) | Control (n = 145) | |
|---|---|---|---|
| Total follow-upa (per person-years) | 2217.5 | 1369.7 | 847.8 |
| Follow-up time: mean (s.d.), years | 5.7 (3.9) | 5.5 (3.5) | 5.8 (4.3) |
| Age, mean (s.d.), years | 61.0 (16.3) | 58.3 (17.1) | 65.6 (13.6) |
| Disease duration: median (range) (months) | 15.8 (0-393.7) | 25.0 (0-393.7) | 1.6 (0-272.6) |
| Female | 205/392 (52%) | 124/247 (50%) | 81/145 (56%) |
| BMI (kg/m2) | 27.7 (14.2-56.9) | 28 (14.2-56.9) | 26.9 (17.9-51.7) |
| Ethnicity | |||
| White British | 365/392 (93%) | 230/247 (93%) | 135/145 (93%) |
| Other White | 16/392 (4%) | 10/247 (4%) | 6/145 (4%) |
| Asian | 8/392 (2%) | 6/247 (2%) | 2/145 (1%) |
| Other | 3/392 (1%) | 1/247 (0%) | 2/145 (2%) |
| Diagnosis | |||
| MPA | 90/392 (23%) | 44/247 (18%) | 46/145 (32%) |
| GPA | 302/392 (77%) | 203/247 (82%) | 99/145 (68%) |
| ANCA type at diagnosis | |||
| Anti-proteinase3 | 157/392 (40%) | 104/247 (42%) | 53/145 (37%) |
| Anti-myeloperoxidase | 73/392 (19%) | 28/247 (11%) | 45/145 (31%) |
| Negative and/or unknown | 162/392 (41%) | 115/247 (47%) | 47/145 (32%) |
| Comorbidities | |||
| Pulmonary disease (chronic)b | 69/391 (18%) | 40/246 (16%) | 29/145 (20%) |
| Cardiac disease | 38/391 (10%) | 24/246 (10%) | 14/145 (10%) |
| Malignancy | 37/39 (9%) | 26/246 (11%) | 11/145 (8%) |
| Diabetes Mellitus | 24/391 (6%) | 18/246 (7%) | 6/145 (4%) |
| Hypertension requiring treatment | 159/391 (41%) | 102/246 (41%) | 57/145 (39%) |
| Kidney disease | 61/391 (16%) | 38/246 (15%) | 23/145 (16%) |
| Kidney disease stage | |||
| II | 6/61 (10%) | 4/38 (11%) | 2/23 (9%) |
| III | 33/61 (54%) | 22/38 (58%) | 11/23 (48%) |
| IV | 10/61 (16%) | 5/38 (13%) | 5/23 (22%) |
| V | 12/61 (20%) | 7/38 (18%) | 5/23 (22%) |
| Prior immune suppressive treatment | |||
| Azathioprine | 177/392 (45%) | 144/247 (58%) | 33/145 (23%) |
| Cyclophosphamide | 273/392 (70%) | 180/247 (73%) | 93/145 (64%) |
| Steroid | 386/392 (98%) | 246/247 (100%) | 140/145 (97%) |
| Methotrexate | 0/392 (20%) | 62/247 (25%) | 18/145 (12%) |
| Mycophenolate | 127/392 (32%) | 99/247 (40%) | 28/145 (19%) |
| VDI Score | 1 (0,8) | 1 (0,8) | 0 (0,7) |
| BVAS Disease status | |||
| Severe Disease/Flare | 4/169 (2%) | 3/119 (3%) | 1/50 (2%) |
| Limited Disease/Flare | 12/169 (7%) | 9/119 (8%) | 3/50 (6%) |
| Persistent Disease | 31/169 (18%) | 22/119 (18%) | 9/50 (18%) |
| Remission | 122/169 (72%) | 85/119 (71%) | 37/50 (74%) |
| Laboratory data at entry | |||
| eGFRc (ml/min/1.73m2) | 69 (5–189) | 75 (6–189) | 61 (5–189) |
| IgGd (g/l) | 9.36 (2.9–33.6) | 8.6 (2.9–23.2) | 10.81 (4.33–33.6) |
| CD19 count (×109/l)e | 0.1 (0–0.82) | 0.1 (0–0.77) | 0.12 (0.02–0.82) |
Continuous variables are expressed as median (range) unless otherwise indicated, and categorical variables as number of sample size/total number (percentages).
a
Total follow-up was assessed until 30 September 2018.
b
Pulmonary disease (chronic) includes asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease/pulmonary fibrosis, bronchiectasis and emphysema.
c
Data were missing for 12 patients.
d
Data were missing for 19 patients.
e
Data from 125 patients in the rituximab group and 11 patients in the control group.
MPA: microscopic polyangiitis; GPA: granulomatosis with polyangiitis; VDI: Vasculitis Damage Index.