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Rituxan may help patients with refractory SLE
Some patients with systemic lupus erythematosus refractory to traditional therapies had a complete or partial response or improvement of renal involvement with treatment with Rituxan, according to the results of a multicenter study in Italy.
A cohort of 145 patients with systemic lupus erythematosus (SLE) from 11 tertiary centers treated between May 2003 and August 2012 with at least one course of Rituxan (rituximab, Genentech/Biogen Idec) were studied. Patients were 89.7% women, mean age 37.3 years at initiation of treatment, had a mean disease duration of 9.3 years and responded inadequately to prior treatment.
Three treatment protocols were followed. Scheme A included two 1-g infusions 2 weeks apart (n = 118), scheme B comprised four infusions of 375 mg/m2 one week apart (n = 17) and scheme C also comprised four infusions of 375 mg/m2 one week apart, followed by two more doses 1 and 2 months later and concomitant 750-mg cyclophosphamide pulses on days 4 and 17 and three 15 mg/kg methylprednisolone pulses on days 1, 4 and 8 (n = 10).
The European Consensus Lupus Activity Measurement (ECLAM) score was used to assess disease activity at baseline, 3, 6 and 12 months. A mild to moderate ECLAM score was 5 or below and high disease activity was defined by ECLAM scores of more than 5. A partial response was defined by an ECLAM score between 1 and 3, while a complete response was defined by a score of 1 or lower. Response rates in renal or other organ involvement were assessed according to European League Against Rheumatism (EULAR) recommendations for the management of lupus nephritis and measurements of proteinuria.
At baseline, the mean ECLAM scores was 4.11. At 3 months, the mean score was 2.17, followed by 1.77 at month 6 and 1.84 at month 12. A complete or partial renal response was observed in 64 of 68 patients with glomerulonephritis with a complete response in 21 patients at 12 months.
Disease flares occurred in 47 of 119 responders, 59 patients were treated with a second course of rituximab, and 18 received a third course of treatment.
Of 32 patients who experienced adverse events, infections occurred in 22 patients and five had infusion reactions. – by Shirley Pulawski
Disclosure: The researchers report no relevant financial disclosures.