Characteristics of 32 patients with SLE receiving rituximab biosimilar
| Characteristics | n (%) |
| Female | 29 (90.62) |
| Age (at first RTX biosimilar infusion), mean±SD, years | 36.75±15.22 |
| Disease duration, median (IQR), years | 9.50 (1.25–13.00) |
| 2012 SLICC classification criteria | |
| Clinical criteria | |
| Acute cutaneous lupus | 10 (31.25) |
| Chronic cutaneous lupus | 8 (25.00) |
| Oral ulcers | 5 (15.62) |
| Non-scarring alopecia | 8 (25.00) |
| Synovitis | 16 (50.00) |
| Serositis | 3 (9.38) |
| Renal | 16 (50.00) |
| Neurological | 9 (28.13) |
| Haemolytic anaemia | 6 (18.75) |
| Leucopenia | 14 (43.75) |
| Thrombocytopaenia | 15 (46.88) |
| Immunological criteria | |
| ANA level above laboratory reference range | 32 (100.00) |
| Anti-dsDNA antibody level above laboratory reference range | 18 (56.25) |
| Anti-Sm | 3 (9.38) |
| Antiphospholipid antibody positivity | 8 (25.00) |
| Low complement | 27 (84.38) |
| Direct Coombs test in the absence of haemolytic anaemia | 0 (0.00) |
| Comorbidity and damage | |
| Chronic HBV infection | 2 (6.25) |
| Hypertension | 8 (25.00) |
| Dyslipidaemia | 8 (25.00) |
| End-stage renal disease | 3 (9.38) |
| SLICC Damage Index, median (IQR) | 0.50 (0.00–1.00) |
| RTX biosimilar administration | |
| 1 g × 2 infusions per 2 weeks | 13 (40.63) |
| 500 mg × 2 infusions per 2 weeks | 10 (31.25) |
| 1 g × 1 infusion | 5 (15.63) |
| 500 mg × 1 infusion | 1 (3.13) |
| Other regimen | 3 (9.38) |
| RTX biosimilar-associated treatment (prior/concurrent) | |
| Glucocorticoids | 32 (100.00) |
| Oral | 32 (100.00) |
| Intravenous | 13 (40.63) |
| Immunosuppressive agents | |
| Intravenous cyclophosphamide | 12 (37.50) |
| Oral cyclophosphamide | 2 (6.25) |
| Mycophenolate mofetil | 21 (65.63) |
| Azathioprine | 14 (43.75) |
| Ciclosporin | 9 (28.13) |
| Tacrolimus | 3 (9.38) |
| Methotrexate | 6 (18.75) |
| Hydroxychloroquine | 23 (71.88) |
| Number of immunosuppressive agents (excluding antimalarial drugs) before RTX biosimilar infusion, mean±SD | 1.72±0.13 |
| Intravenous immunoglobulin | 4 (12.50) |
| Plasma exchange | 4 (12.50) |
dsDNA, double-stranded DNA; HBV, viral hepatitis B; RTX, rituximab; SLICC, Systemic Lupus International Collaborating Clinics.