Background Systemic lupus erythematosus (SLE) is a systemic autoimmune disease, in which severe organ damage can occur. B cells play an important role in SLE pathogenesis. Rituximab (RTX) has been used for SLE therapy, after failure of first-line immunosuppressive therapy. Evidence of efficacy is still short, and RTX use was based in observational studies and case reports. Recently, two randomized controlled trials of RTX failed to demonstrate efficacy in SLE.
Objectives We aim to review the experience of our two hospitals with RTX therapy in SLE patients.
Methods We considered all SLE patients registered in the Portuguese Register (Reumapt) from two centres in Lisbon (Hospital de Santa Maria and Hospital Garcia de Orta) and focused our study on the subgroup of patients with history of rituximab exposure.
Results Our population of SLE patients is constituted by 305 patients (95,08% females), mean age 45.52±14.97. Mean age at diagnosis was 35.86±14.86 years old.
Sixteen patients (5.91%) were treated with rituximab. In these patients, age at diagnosis was 34.6years-old, similar to other SLE patients. Organ involvement was characterized based on ACR criteria: cutaneous (50%), articular (77%), neurological (16.7%), renal (33%), serositis (33%). These patients had a significantly (p<0.05) higher frequency of auto-antibodies positivity: 50% anti-SSA, 37.5% anti-phospholipids, 31% anti RNP, 25% anti-Sm.
The mean age at the beginning of treatment was 41.87years, in average 7.86 years after the diagnosis. Clinical indications for Rituximab treatment were haematological involvement (9 patients, 50%), renal involvement (3 patients, 17%), polyarthritis (2 patients, 11%) and systemic disease activity (1 patient), that did not respond to first-line treatments. Until January 2013, the maximum duration of RTX treatment was 7.34 years (mean 2.56). Previous therapy included corticosteroids (100%), azathioprine (33%), mycophenolate mophetil (22%), cyclosporine (11%) and methotrexate (5.6%).
Five of eight patients with thrombocytopenia had a sustained response to rituximab. One patient with haemolytic anemia also had a sustained response. In one patient with lupic nephritis class IV, the disease relapsed after 6 months The other two patients with nephritis (both class IV) had sustained response, which enabled to lower the dose of other immunosuppressive drugs.
Three adverse effects were reported: one infectious complication (1 case of olecranian bursitis, with isolation of Staphylococcus aureus), hypersensivity reaction during the infusion and an episode of uveitis.
Conclusions In our pratice, RTX has been used as second/third line treatment, after failure of other immunosupressive drugs, showing benefit in our patients. A distinctive immunological profile appears to exist in these patients who failed first line therapies. Low rate of adverse events was reported.
References Joan T. Merrill et al, Efficacy and Safety of Rituximab in Moderately-to-Severely Active Systemic Lupus Erythematosus, Arthritis & Rheumatism, Vol. 62, No. 1, January 2010, pp 222–233
Disclosure of Interest None Declared