Response to rituximab biosimilar at 6 months after treatment of patients with SLE
| Clinical parameter | Patients evaluable for outcome | Baseline | 6 months | P value | Overall response* (%) |
| Modified SLEDAI-2K, median (IQR) | 32 | 4 (1.25–8.00) | 1 (0.00–5.75) | 0.005 | 8/32 (25.00) |
| Anti-dsDNA level, median (IQR), IU/mL | 20 | 10.70 (0.00–109.28) | 0.00 (0.00–89.68) | 0.041 | – |
| C3 mean±SD (range), g/L | 32 | 0.90±0.33 (0.23–1.60) | 1.05±0.28 (0.55–1.55) | 0.015 | – |
| Prednisolone dose, median (IQR), mg | 32 | 20 (12.50–40.00) | 10 (7.50–15.00) | <0.001 | – |
| Response according to specific organ† | Response (%) | ||||
| NPSLE | 7 | – | – | – | 7/7 (100.00) |
| Seizure | 1 | – | – | – | 1 |
| Myelitis‡ | 1 | – | – | – | 1 |
| Peripheral neuropathy‡ | 2 | – | – | – | 2 |
| Organic brain syndrome | 2 | – | – | – | 2 |
| Lupus headache | 1 | – | – | – | 1 |
| Vasculitis | 2 | – | – | – | 2/2 (100.00) |
| Gastrointestinal‡ | 1 | – | – | – | 1 |
| Cutaneous | 1 | – | – | – | 1 |
| Arthritis | 3 | – | – | – | 3/3 (100.00) |
| Proteinuria, median (IQR), g/day | 13 | 4.10 (1.20–6.65) | 0.85 (0.36–2.45) | 0.012 | 8/13 (61.54) |
| Rash | 1 | – | – | – | 1/1 (100.00) |
| Thrombocytopaenia (<140 x 109/L), median (IQR) | 9 | 74 x 109 (42 x 109–108.5 x 109) | 186.5 x 109 (132 x 109–241.75 x 109) | 0.092 | 5/9 (55.56) |
| Leucopenia (<4 x 109/L), median (IQR) | 3 | 3.16 x 109 (1.20 x 109–3.97 x 109) | 3.68 x 109 (1.88 x 109–3.84 x 109) | 0.285 | 0/3 (0.00) |
| Others | 1 | – | – | – | 1/1 (100.00) |
| Total response | 39 | – | – | – | 28/39 (71.79) |
*Reduction in SLEDAI-2K or modified SLEDAI-2K score of ≥4.
†≥50% improvement according to SLEDAI-2K Responder Index-50 definitions; six patients had more than one specific organ involvement.
‡Significant improvement (≥50%) of initial disease, based on clinical judgement.
dsDNA, double-stranded DNA; NPSLE, neuropsychiatric SLE; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index-2000.