Background/Purpose: B-lymphocytes (BL) play a critical role in Systemic Lupus Erythematosus (SLE). BL depletion therapy still remains an attractive option, despite the disappointing results of randomized controlled trials (RCTs).

Methods: Twelve SLE patients [2 males, mean age 43.8 yrs (29-54)] with polyarthralgia and multiorgan involvement including class IV or III/V (ISN/RPS) glomerulonephritis (9 cases), skin lesions (9 cases, with necrotizing ulcers in 3), polyneuropathy (7 cases), CNS involvement (2), lymphoadenopathy (6) e polysierositis (5) have been treated with an IBLD protocol: Six patients were refractory or intolerant to conventional immunosuppressive therapy. Six patients were given the following induction regimen as a front line therapy. Protocol: Rituximab (RTX)  375 mg/sm on days 1, 8, 15, 22, and 2 more doses after one and two months, associated with 2 IV administrations of 10 mg/kg of cyclophosphamide, and 3 methylprednisolone pulses (15 mg/kg) followed by oral prednisone (0.8 mg/die, rapidly tapered to 5 mg/day  12 weeks). No further immunosuppressive maintenance therapy has been given.

Results: ITBLD obtained a complete depletion of CD20+ BL for 12-18 months. Patients had been followed-up for 48.9 (25-93) months.  Significant decreases (p<0.05) were found in the levels of ESR (baseline mean value: 54.2 mm; 3 months: 33; end of follow-up: 14.9), anti-dsDNA antibodies (baseline: 192 U; 3 months: 112; end of follow-up: 17), and proteinuria (baseline: 4.9 g/24 hours; 3 months: 0.97; end of follow-up: 0.22). C4 values (baseline 11 mg/dl) significantly increased (p<0.05) after 3 months (22 mg/dl) and at the end of the follow-up (20 mg/dl). Three patients relapsed after 36, 41 and 72 months, respectively. They showed again a complete remission after re-treatment over 13-48 months of observation

Conclusion: A promising role of RTX in an intensified protocol of induction therapy can be envisaged in patients for whom avoiding immunosuppressive maintenance therapy and sparing steroids are particularly appealing. Moreover, our data confirm the opportunity to reconsider the regimens of BL depletion in the treatment of the most severe or refractory forms of SLE despite the disappointing results of RCTs.

« Back to 2015 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/intensified-treatment-of-b-lymphocyte-depletion-itbld-without-immunosuppressive-maintenance-treatment-as-a-rescue-therapy-in-refractory-lupus-nephritis-ln-a-4-year-observation/