In an interview with PharmaShots, Mike Crichton, Senior Vice President, Global Therapy Area Head, Specialty & Primary Care at GSK shares his views on the European Commission's approval of Benlysta (belimumab) in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (LN).

Shots:

• The European Commission approved the expanded use of GSK's Benlysta (IV & SC) in combination with background immunosuppressive therapies for the treatment of adult patients with active LN
• The European approval follows the CHMP's positive opinion of Benlysta for use in adult patients with active LN and is supported by positive two-year results of the BLISS-LN clinical trial
• For the first time in EULAR, GSK focused on the role of eosinophils in inflammation and disease. GSK is making real progress on the science of the immune system and its presence this year reflected these strides

Tuba:  Discuss the clinical data supporting the approval of BENLYSTA for adult patients with active lupus nephritis (LN) in EU.

Mike: On behalf of GSK, I'm delighted that on May 5, we announced that BENLYSTA (belimumab) was approved in the EU in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (LN), which is a serious inflammation of the kidneys and a debilitating manifestation of systemic lupus erythematosus (SLE). Once again, following FDA approval in the US on December 20, BENLYSTA became the first and only biologic to be approved for both SLE and LN.

The EU approval is based on the positive two-year results of the BLISS-LN clinical trial, the largest phase 3 study conducted in active LN. In BLISS-LN, belimumab added to standard therapy increased response rates over two years and prevented worsening of kidney disease in patients with active LN compared to standard therapy alone. The addition of BENLYSTA to standard therapy resulted in a 49% decrease in risk to patients experiencing a renal-related event as well as a significantly higher number of study participants reaching renal response.

Tuba:  What does this new indication in Europe mean for the lupus community?

Mike: The expanded use of BENLYSTA in the EU marks a significant treatment advance for patients and physicians across Europe dealing with this complex autoimmune disease.

Active LN can occur in approximately 40% of adults with SLE and, in Europe, approximately 30% of people with SLE have biopsy-confirmed LN. For years, we have not been able to achieve remission for more than one-third of patients with LN and, despite all of our efforts with current treatments, 10% to 30% of patients with lupus kidney disease still progress to end-stage kidney disease. The data from the BLISS-LN study show that BENLYSTA added to standard therapy in the management of active LN may lead to improved long-term outcomes for patients by both increasing response rates and delaying further kidney disease progression.

Tuba:  What is BENLYSTA? Discuss its importance among the patients with LN.

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Mike: BENLYSTA, a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. BENLYSTA does not bind B cells directly or directly deplete B cell populations. By binding BLyS, BENLYSTA inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.

When BENLYSTA was first approved in 2011, it was the first treatment developed and approved specifically for SLE in more than 50 years. Today, as the first biologic approved for both SLE and LN, our portfolio stands strong on an unmatched body of clinical evidence that has established efficacy in a broad base of lupus patients, shown long-term real-world outcomes, and has provided a well-recognized safety profile.

Tuba:  Following the US and EU, in what other markets is GSK exploring approvals of BENLYSTA?

Mike: For general SLE, BENLYSTA is approved in more than 70 countries. BENLYSTA is approved in the USA, Brazil, Japan and now the European Union for adult patients with active LN. We have submitted applications for adult LN in countries such as China (CDE), Canada, Switzerland, Russia, and Taiwan with more filings to come in the coming year.

Tuba:  How is BENLYSTA beneficial in patients with kidney disease progression?

Mike: It's important to understand that organ damage begins to accrue early in SLE. With BENLYSTA now approved by the European Commission for adult patients with active LN, healthcare professionals in Europe have an option that can help treat appropriate patients early and when we can treat earlier, we can slow down the progression of organ damage.  

In BLISS-LN, the study supporting the EU approval, belimumab added to standard therapy increased response rates over two years and prevented worsening of kidney disease in patients with active LN compared to standard therapy alone. The addition of BENLYSTA to standard therapy resulted in a 49% decrease in risk to patients experiencing a renal-related event as well as a significantly higher number of study participants reaching the renal response primary endpoint.

Tuba:  Can you speak to the lifecycle innovation behind BENLYSTA?

Mike: Since 2011, GSK has been conducting the largest global post-approval research program in lupus investigating BENLYSTA in a number of different aspects of the disease, and we are proud of what we have been able to deliver. We've now had five consecutive successful pivotal trials. In addition to the BLISS-LN study, which was the basis of the current approval, in the past two years alone, we delivered results for the largest study ever conducted in lupus (BASE), our pediatric study (PLUTO), which resulted in indications in children five and older in US, Europe, Japan, and China  the first of their kind; our study in the black race (EMBRACE), and real-world evidence on the delayed progression of long term organ damage. Additionally, we have an ongoing Phase 3 trial, BLISS-BELIEVE, evaluating BENLYSTA plus a single cycle of Rituximab (RITUXAN), which is aimed at demonstrating sustained disease control while minimizing immuno-suppressants and steroids.

We look forward to working with the scientific and advocacy communities to continue to innovate and raise the bar for what is possible for the lupus community, including additional study milestones in 2021 and beyond.

Tuba:  After 10 years on the market, BENLYSTA continues to grow. What do you think has contributed to this growth?

Mike: We are committed to following the science in lupus, transforming the standard of care for people with lupus, building on decades of research, and leading with a significant investment in the science of the immune system. The coming decade will see physicians moving progressively to a targeted approach to lupus, addressing the underlying causes, modifying the disease, and improving outcomes for patients.

We have an unmatched body of clinical evidence that has established efficacy in a broad base of lupus patients, shown long-term real-world outcomes, and has provided a well-recognized safety profile.

Approximately 75% of people with SLE who may be eligible for a biologic are not one on today, so we believe there is a significant additional opportunity for growth for BENLYSTA.

Tuba:  GSK always has a strong presence at EULAR. What were you most excited about this year?

Mike: EULAR is one of the most important Rheumatology conferences of the year, so it's something we always look forward to. Given its proximity to our expanded indication approval in the EU, we were excited to focus more on the science and unmet need within LN.

Also, for the first time this year, we focused on the role of eosinophils in inflammation and disease. Overall, we're making real progress in our focus on the science of the immune system and our presence this year reflected these strides.

Image Source: The Post City

About Mike Crichton:

Mike Crichton is the Senior Vice President, Global Therapy Area Head, Specialty & Primary Care at GSK.

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