Rituxan Effective as Maintenance Therapy for Difficult-to-treat SLE Patients, Study Says

Rituxan (rituximab) can be effective as maintenance therapy for difficult-to-treat patients with systemic lupus erythematosus, allowing them to cut their use of corticosteroids and immunosuppressive agents, a new study says. However, relapses continue to occur frequently, mostly in patients with active joint disease.

The study, “Rituximab as maintenance treatment for systemic Lupus Erythematosus: a multicentre observational study of 147 patients,” was published in the journal Arthritis & Rheumatology.

While current treatments for systemic lupus erythematosus (SLE) are able to induce remission, patients frequently experience relapses. Therefore, a significant need exists for improving the management of SLE in the maintenance phase of treatment.

Rituxan, by Genentech and Biogen, has been widely used to treat autoimmune diseases, and has shown promise in retrospective and prospective clinical trials. However, it has not shown great efficacy in the treatment of SLE in a real-world setting.

The discrepancy between the results from the clinical trials and those seen in real world suggests that perhaps only a small subset of patients would benefit from the therapy.

Hence, a group of Italian and British researchers set out to learn more about the use of Rituxan in SLE patients by describing the treatment outcomes of a European cohort. The researchers placed an emphasis on Rituxan’s role as a maintenance agent.

The cohort included all patients who received Rituxan as induction therapy across four centres in the United Kingdom and Italy between 2004 and 2016, and a subgroup of patients treated with Rituxan as maintenance therapy.

Among the 147 patients included in the study, 67 (45%) had a complete response, 41 (28%) had a partial response, and 39 (27%) experienced treatment failure at the six-month mark. The patients’ disease activity and need for corticosteroid treatment had decreased significantly by this point.

After conducting statistical analysis, the researchers determined that receiving a low number of immunosuppressive therapies previously and low levels of C4 (a component of the immune system) were associated with a lower risk of treatment failure.

Next, the researchers looked specifically at the 80 patients who received Rituxan maintenance treatment over a median of 24.5 months. Of them, 52 patients experienced a total of 85 relapses, mainly in the joints and skin, which were more frequent between six and 12 months of treatment.

At the last Rituxan infusion, 84% of the patients were in remission, and 35% of the patients never experienced a disease flare during the maintenance treatment and presented low accumulation of damage.

Statistical analysis showed that patients with active joint disease at the start of the study were nearly four times more likely to experience flares during the maintenance treatment. However, the researchers also found that patients who received Rituxan as maintenance treatment lived a similar period of time without relapse, compared with those given a single course of Rituxan to induce remission.

Rituxan maintenance treatment is “a potential treatment option in difficult to treat patients. Relapses occur during [maintenance therapy] and are more likely in those with active articular disease at the time of the first [treatment],” the investigators concluded.