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Cynthia Aranow, MD: Efficacy of Belimumab for Patients With Systemic Lupus Erythematosus

"The primary efficacy endpoint was the proportion of patients with disease control without other immunosuppressants and prednisone-equivalent dose of ≤5 mg/day at week 52," Aranow stated.

Rheumatology Network interviewed Cynthia Aranow, MD, to discuss her upcoming ACR presentation entitled, “Efficacy and Safety of Subcutaneous Belimumab (BEL) and Rituximab (RTX) Sequential Therapy in Patients with Systemic Lupus Erythematosus (SLE): The Phase 3, Randomized, Placebo-Controlled BLISS-BELIEVE Study.” Aranow is a rheumatologist and professor at the Feinstein Institutes for Medical Research in Manhasset, New York.

Rheumatology Network: Why is disease control so difficult to achieve in SLE?

Cynthia Aranow, MD: SLE is a systemic autoimmune disease characterized by over-activity of the immune system. The autoimmune driven inflammation can affect any part of the body and is different in different individuals. The severity of this disease varies widely. Some patients have disease that can be fairly easily controlled with currently available medications, but control of disease features in other patients is extremely difficult. This is mostly because of our inability to adequately control the immune driven inflammation.

RN: Can you tell me a bit about the study design?

CA: BLISS-BELIEVE was a Phase III, multicenter, randomised, double-blind, placebo-controlled, 104-week study designed to test whether a single cycle of rituximab, when added to Benlysta, could improve disease control or remission versus Benlysta alone in adults with SLE.

The primary objective of the trial was to evaluate the combination in achieving disease control without immunosuppressants and while minimizing steroids, both of which can have long term toxic side effects and can lead to organ damage.

The primary efficacy endpoint was the proportion of patients with disease control without other immunosuppressants and prednisone-equivalent dose of ≤5 mg/day at week 52. The difference in the proportion of patients with disease control at week 52 was not statistically significant between the 2 arms, showing that addition of a single cycle of rituximab to Benlysta did not enhance the treatment effect of Benlysta alone.

RN: What were the results?

CA: The BLISS-BELIEVE study assessing the incremental contribution of rituximab to Benlysta in patients with SLE, showed that the addition of a single cycle of rituximab did not enhance the efficacy of Benlysta, but did provide further evidence of the efficacy of Benlysta alone or in combination with standard of care in SLE patients.

There was no statistically significant difference in disease control at week 52 with Benlysta + 1 cycle of rituximab versus Benlysta alone. Similar findings were seen with the secondary endpoints of clinical remission at week 64 and disease control at week 104.

RN: What is the clinical significance of these results?

CA: Levels of disease control over all 3 treatment arms (Benlysta/placebo, Benlysta/rituximab and Benlysta open label used as a reference arm to replicate clinical practice) underscore the efficacy of belimumab, with some patients maintaining disease control without immunosuppressants and significantly reduced steroids, both of which can have long term toxic side effects and can lead to organ damage.

Due to the complicated and heterogeneous nature of SLE, some patients are unable to achieve adequate disease control, remission and/or are unable to reduce or discontinue immunosuppressors and corticosteroids, which can lead to treatment toxicity in SLE. More work needs to be done in the development of treatment options for SLE.

RN: Does your team plan on doing further research on BEL?

CA: GlaxoSmithKline (GSK) is supporting a study that we have initiated looking at the effects of belimumab in patients with recently diagnosed lupus. In this multi-site trial, we are interested in seeing if belimumab treatment given early after diagnosis can alter some of the immunologic features associated with lupus. In addition to treating and controlling symptoms, we want to see if we can alter the clinical course and progression of the disease.

RN: What are you most excited about regarding the upcoming ACR?

CA: The ACR is always an exciting international conference where new information from all areas of rheumatology is presented for review and discussion. As a rheumatologist specializing in lupus and autoimmune diseases, I tend to focus upon the novel findings presented by lupus investigators. As a clinician, I am always interested in the efficacy and safety of new treatments that may result in better patient outcomes

RN: What is the biggest challenge facing rheumatologists today?

CA: This is a great question as there are still so many challenges. Despite the recent approvals of new drugs for new indications, remission and/or adequate control of disease remains an elusive target. Although awareness of autoimmune disease has markedly improved, there are still issues for early recognition and diagnosis of lupus and autoimmune disease. Failure to do so results in delays in initiation of treatment.

RN: Is there anything else you’d like our audience to know?

CA: Despite the many challenges, there is still much reason to hope. Research looking at disease mechanisms (how and why diseases occur) continues. New therapeutic targets continue to be uncovered, new drugs continue to be produced and clinical trials evaluating these new agents and approaches continues. These advances have led and will continue to lead to improved patient outcomes.