Table 2.
Baseline clinical characteristics, laboratory measures and association with clinical outcomes and depletion in SLE.
| Baseline measure or characteristic | Mean (SD) or number (%) positive, Na N = 262 |
Effect on BILAG response (Major or Partial Clinical Response) at 6 months: OR (95% CI), p-value, Nb N = 262 |
Effect on BILAG Major Clinical Response at 6 months: OR (95% CI), p-value, Nb N = 262 |
Effect on complete B-cell depletion: OR (95% CI), p-value, Nb N = 85 |
|---|---|---|---|---|
| Age at first RTX cycle (effect per 10 Years) | 40 (14), 262 | 0.81 (0.67–0.98), 0.03, 262 | 0.88 (0.73–1.06), 0.17, 262 | 0.91 (0.67–1.24), 0.56, 85 |
| Sex (Female) | 238 (91%), 262 | 1.55 (0.66–3.66), 0.31, 262 | 1.05 (0.43–2.56), 0.91, 262 | 0.53 (0.05–6.02), 0.61, 85 |
| Ethnicity | ||||
| Caucasian | 161 (61.5%) | 1.06 (0.62–1.80), 0.84, 262c | 1.18 (0.70–1.98), 0.54, 262c | 1.13 (0.45–2.84), 0.80, 85c |
| South Asian | 39 (14.9%) | |||
| Chinese/SE Asian | 13 (5.0%) | |||
| Afro-Caribbean | 31 (11.8%) | |||
| Mixed/Undisclosed | 18 (6.8%) | |||
| Disease Duration at first RTX cycle (effect per year) | 8,6 261 | 0.99 (0.96–1.02), 0.56, 261 | 0.99 (0.96–1.03), 0.64, 261 | 1.03 (0.96–1.10), 0.45, 85 |
| Concomitant DMARDsd | 60 (70.6%), 85 | 0.69 (0.22–2.14), 0.52, 85 | 0.81 (0.31–2.11), 0.66, 85 | 0.99 (0.39–2.51), 0.98, 85 |
| Concomitant anti-malarials, | 225 (85.9%), 262 | 1.32 (0.64–2.72), 0.45, 262 | 0.96 (0.46–1.99), 0.91, 262 | 1.94 (0.67–5.61), 0.22, 85 |
| Concomitant oral prednisolone | 193 (73.7%), 262 | 0.80 (0.44–1.46), 0.48, 262 | 1.06 (0.59–1.90), 0.84, 262 | 1.10 (0.42–2.90), 0.85, 85 |
| No. positive autoantibodies | 1.9 (1.3), 186 | 1.13 (0.89–1.43), 0.33, 186 | 1.02 (0.82–1.28), 0.86, 186 | 0.80 (0.57–1.12), 0.19, 85 |
| anti-Ro | 98 (49.2%), 199 | |||
| anti-La | 38 (19.1%), 199 | |||
| anti-Sm | 55 (28.4%), 194 | |||
| anti-RNP | 67 (33.8%), 198 | |||
| Anti-dsDNA positive | 137 (52.5%), 261 | 1.33 (0.79–2.25), 0.28, 261 | 1.13 (0.68–1.88), 0.65, 261 | 0.71 (0.30–1.67), 0.43, 85 |
| ENA positive | 130 (69.9%), 186 | 1.02 (0.51–2.01), 0.96, 261 | 1.05 (0.55–2.02), 0.88, 261 | 0.54 (0.21–1.36), 0.19, 81 |
| Low C3 and/or C4 titre | 120 (46%), 261 | 1.49 (0.88–2.53), 0.14, 261 | 1.57 (0.94–2.63), 0.08, 261 | 0.35 (0.14–0.88), 0.03, 85 |
| Immunoglobulin (g/L) | ||||
| IgM | 1.33 (1.9), 238 | 0.90 (0.76–1.07), 0.22, 238 | 0.99 (0.86–1.15), 0.93, 238 | 1.52 (0.82–2.82), 0.18, 78 |
| IgA | 3.88 (1.9), 238 | 0.94 (0.78–1.12), 0.49, 238 | 0.98 (0.84–1.14), 0.76, 238 | 0.70 (0.47–1.06), 0.09, 78 |
| IgG | 16.9 (5.4), 238 | 0.97 (0.93–1.01), 0.12, 238 | 1.00 (0.98–1.01), 0.60, 238 | 0.95 (0.88–1.02), 0.13, 78 |
| ESR (mm/h) | 30.4,27 192 | 0.99 (0.98–1.00), 0.05, 192 | 1.00 (0.99–1.01), 0.88, 192 | 0.99 (0.97–1.01), 0.30, 62 |
| Total B-cell counts (x 109/L)d | 0.1263 (0.13), 73 | 1.00 (1.00–1.01), 0.74, 73 | 1.00 (1.00–1.01), 0.09, 73 | 1.00 (1.00–1.00), 0.79, 73 |
| Naïve B-cell counts (x 109/L)d | 0.0928 (0.09), 71 | 1.00 (0.99–1.01), 0.99, 71 | 1.00 (1.00–1.01), 0.17, 71 | 1.00 (0.99–1.00), 0.54, 71 |
| Memory B-cell counts (x 109/L)d | 0.0292 (0.07), 71 | 1.00 (0.99–1.02), 0.68, 71 | 1.02 (0.99–1.04), 0.22, 71 | 1.00 (0.99–1.01), 0.71, 71 |
| Plasmablast counts (x 109/L)d | 0.0054 (0.01), 71 | 0.98 (0.90–1.06), 0.60, 71 | 0.95 (0.87–1.04), 0.23, 71 | 0.88 (0.80–0.98), 0.02, 71 |
| Global BILAG score | 22 (9.7), 262 | 1.00 (0.97–1.02), 0.83, 262 | 1.00 (0.97–1.03), 0.93, 262 | 1.00 (0.96–1.04), 0.96, 85 |
| SLEDAI-2K score | 10.8 (5.7), 262 | 1.06 (1.00–1.11), 0.03, 262 | 1.02 (0.98–1.07), 0.40, 262 | 0.97 (0.90–1.05), 0.46, 85 |
| Active BILAG domains (A/B Grade) | ||||
| General | 36 (14.1%) | – | – | – |
| Mucocutaneous | 129 (49.2%) | |||
| Neurology | 52 (19.8%) | |||
| Musculoskeletal | 121 (46.2%) | |||
| Cardiorespiratory | 44 (17.2%) | |||
| Gastrointestinal | 18 (6.9%) | |||
| Ophthalmic | 9 (3.4%) | |||
| Renal | 114 (43.1%) | |||
| Haematology | 23 (9.5%) | |||
The Bolding indicate variables with statistically significant association with the corresponding outcomes to rituximab. All p-values should be in Italic to separate this from effect on clinical outcomes and number of sample size. BILAG, British Isles Lupus Assessment Group; ENA, extract nuclear antigen; ESR, erythrocyte sedimentation rate; SE, South East; SLEDAI-2K, SLE Disease Activity Index v.2000.
Sample size varies in different analyses due to missing clinical data. The number (N) in each set of analyses is given.
OR, 95% CI, p-value and number of observations for the effect of the baseline characteristic on clinical response measures or complete B-cell depletion at 6 weeks. Peripheral blood B-cell depletion data were only available for the Leeds cohort.
Due to sample size for each ethnicity category, comparison was made between Caucasian (reference) vs Non-Caucasian.
Data were only available from the Leeds cohort. All remaining missing data was missing at random.