CLINICAL TRIALS PROFILE FOR BENLYSTA

All Clinical Trials for BENLYSTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01160666 ↗	Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's Syndrome	Completed	Human Genome Sciences Inc.	Phase 2	2010-03-01	Sjögren's syndrome (SS) is a systemic autoimmune disease characterized by an increase in BAFF (BLyS) levels and a resulting B cell hyperactivity. B cells are involved in the pathogenesis of SS in both systemic and glandular features, and B cell downregulation may lead to a decrease of disease activity. Moreover, pathogenesis of SS is closed to that of Systemic lupus erythematosus, where Belimumab has been proven to be effective.
NCT01160666 ↗	Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's Syndrome	Completed	Assistance Publique - Hôpitaux de Paris	Phase 2	2010-03-01	Sjögren's syndrome (SS) is a systemic autoimmune disease characterized by an increase in BAFF (BLyS) levels and a resulting B cell hyperactivity. B cells are involved in the pathogenesis of SS in both systemic and glandular features, and B cell downregulation may lead to a decrease of disease activity. Moreover, pathogenesis of SS is closed to that of Systemic lupus erythematosus, where Belimumab has been proven to be effective.
NCT01532310 ↗	Belimumab (BENLYSTA®) Pregnancy Registry	Recruiting	PPD		2012-07-16	This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who have received commercially supplied belimumab within the 4 months prior to and/or during pregnancy. The registry will also evaluate outcomes of infants born to mothers who were exposed to belimumab within the 4 months prior to and/or during pregnancy. This registry will add to the current clinical experience with belimumab and will complement reproductive data from animal toxicology studies. It will also assist clinicians in weighing the potential risks against the benefits of treatment for individual patients with SLE. GlaxoSmithKline (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing Authorization.
NCT01532310 ↗	Belimumab (BENLYSTA®) Pregnancy Registry	Recruiting	GlaxoSmithKline		2012-07-16	This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who have received commercially supplied belimumab within the 4 months prior to and/or during pregnancy. The registry will also evaluate outcomes of infants born to mothers who were exposed to belimumab within the 4 months prior to and/or during pregnancy. This registry will add to the current clinical experience with belimumab and will complement reproductive data from animal toxicology studies. It will also assist clinicians in weighing the potential risks against the benefits of treatment for individual patients with SLE. GlaxoSmithKline (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing Authorization.
NCT01670565 ↗	Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis	Completed	Human Genome Sciences Inc.	Phase 2	2012-08-01	This is a 48 week, phase IIa, single center, randomized, double-blind, placebo-controlled, proof-of-concept pilot study. All participants will first be treated with mycophenolate mofetil (MMF, Cellcept) and titrated up to a dose of 2 grams/day. Following this period, half will be given either a belimumab (Benlysta®) or placebo intravenous infusion to treat early diffuse cutaneous systemic sclerosis. Belimumab/MMF is expected to improve disease activity measured by an improvement in skin thickening and stability of pulmonary function test measurements when compared to patients treated with placebo/MMF.
NCT01670565 ↗	Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis	Completed	Hospital for Special Surgery, New York	Phase 2	2012-08-01	This is a 48 week, phase IIa, single center, randomized, double-blind, placebo-controlled, proof-of-concept pilot study. All participants will first be treated with mycophenolate mofetil (MMF, Cellcept) and titrated up to a dose of 2 grams/day. Following this period, half will be given either a belimumab (Benlysta®) or placebo intravenous infusion to treat early diffuse cutaneous systemic sclerosis. Belimumab/MMF is expected to improve disease activity measured by an improvement in skin thickening and stability of pulmonary function test measurements when compared to patients treated with placebo/MMF.

Clinical Trial Conditions for BENLYSTA

Condition Name

Condition Name for BENLYSTA
Intervention	Trials
Systemic Sclerosis	2
Systemic Lupus Erythematosus	2
Granulomatosis With Polyangiitis	1
Healthy	1

Condition MeSH

Condition MeSH for BENLYSTA
Intervention	Trials
Sclerosis	2
Scleroderma, Systemic	2
Scleroderma, Diffuse	2
Lupus Erythematosus, Systemic	2

Clinical Trial Locations for BENLYSTA

Trials by Country

Trials by Country for BENLYSTA
Location	Trials
United States	18
France	2
Singapore	1
United Kingdom	1
China	1

Trials by US State

Trials by US State for BENLYSTA
Location	Trials
New York	4
North Carolina	2
Ohio	2
Missouri	2
Alabama	2

Clinical Trial Progress for BENLYSTA

Clinical Trial Phase

Clinical Trial Phase for BENLYSTA
Clinical Trial Phase	Trials
Phase 4	1
Phase 2/Phase 3	1
Phase 2	6

Clinical Trial Status

Clinical Trial Status for BENLYSTA
Clinical Trial Phase	Trials
Recruiting	6
Completed	6
Not yet recruiting	1

Clinical Trial Sponsors for BENLYSTA

Sponsor Name

Sponsor Name for BENLYSTA
Sponsor	Trials
GlaxoSmithKline	9
Human Genome Sciences Inc.	2
Assistance Publique - Hôpitaux de Paris	2

Sponsor Type

Sponsor Type for BENLYSTA
Sponsor	Trials
Other	21
Industry	13
NIH	1

BENLYSTA Market Analysis and Financial Projection

BENLYSTA (Belimumab): Clinical Trials, Market Analysis, and Projections

Introduction to BENLYSTA

BENLYSTA (belimumab) is a monoclonal antibody used in the treatment of Systemic Lupus Erythematosus (SLE) and lupus nephritis. Developed by GlaxoSmithKline (GSK), it has been a significant advancement in the management of these autoimmune diseases.

Clinical Trials Overview

Phase III Trials

BENLYSTA has undergone extensive clinical testing through several Phase III trials, including the BLISS-52, BLISS-76, BLISS-SC, EMBRACE, and NE Asia studies. These trials were randomized, double-blind, and placebo-controlled, assessing both intravenous and subcutaneous administration methods[1].

• BLISS-52 and BLISS-76: These studies involved patients receiving BENLYSTA at doses of 1 mg/kg and 10 mg/kg intravenously, along with standard therapy (ST). The primary endpoint, the SRI-4 response rate at Week 52, showed significant improvements compared to placebo groups[1].
• BLISS-SC: This study evaluated the subcutaneous administration of BENLYSTA (200 mg) and demonstrated similar efficacy to intravenous administration[1].
• EMBRACE: Although the primary endpoint was not met in this trial, it still showed numerical reductions in SLE disease activity[1].

Lupus Nephritis Trials

The BLISS-LN study, a Phase 3 trial, focused on patients with active lupus nephritis. This study achieved its primary endpoint and all major secondary endpoints, indicating that BENLYSTA could significantly improve outcomes for patients with this serious complication of SLE[4].

Early and Sustained Response

Clinical trials have shown that BENLYSTA can produce early responses, with approximately 40% of patients experiencing improvements as early as 8 weeks. However, patients are advised to commit to treatment for 6 to 9 months to fully appreciate the drug's effects[1].

Efficacy Data

SRI-4 Response Rates

• In the BLISS-52 and BLISS-76 trials, the SRI-4 response rates at Week 52 were significantly higher for patients receiving BENLYSTA compared to those on placebo plus standard therapy[1].
• For example, in the BLISS-52 trial, the SRI-4 response rate was 58% for the 10 mg/kg BENLYSTA group, compared to 44% for the placebo group[1].

Diverse Patient Population

BENLYSTA has been tested in a diverse patient population, including African-American patients, although response rates in this subgroup have been inconsistent in some studies[1].

Market Analysis

Sales and Revenue

BENLYSTA has seen consistent and significant growth since its introduction. In 2018, it generated $657 million in revenue, a substantial increase from $119 million in 2017. This growth was largely driven by the launch of the subcutaneous version of the drug. By 2020, the total revenue had risen to $919.5 million, with the majority coming from the US market[5].

Market Forecast

According to DelveInsight, BENLYSTA is expected to continue its strong market performance. The drug is projected to generate over $1 billion in revenue by 2022, with peak sales estimated to be around $1.3-1.4 billion[5].

Global Market Presence

BENLYSTA has a strong presence in the US, Europe, and international markets, including Japan and China. The drug's growth in Q4 2023 was accelerated by stronger US performance and channel inventory build, contributing to a full-year growth of 19%[2].

Competitive Landscape

Market Competitors

BENLYSTA faces competition from other approved products for SLE and emerging therapies in late-stage development. However, its established presence and ongoing research, such as the successful BLISS-LN study, position it as a leading treatment option[3][5].

Regulatory Milestones

BENLYSTA has achieved several regulatory milestones, including approvals for both intravenous and subcutaneous administration. The positive results from the BLISS-LN study have paved the way for further regulatory submissions, enhancing its market position[4].

Cost and Administration

Dosage and Administration

BENLYSTA is available in both intravenous and subcutaneous forms. The recommended dose for subcutaneous injections is 200 mg/mL, while intravenous infusions come in 120mg/5mL and 400mg/20mL single-use vials[5].

Cost

The average annual cost of BENLYSTA is approximately $45,000 per year, making it a significant investment for patients and healthcare systems[5].

Expert Insights

"Lupus nephritis is one of the most common and serious complications of SLE, occurring in up to 60% of adult patients. The results of the BLISS-LN study show that Benlysta could make a clinically meaningful improvement to the lives of these patients who currently have limited treatment options." - Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK[4].

Key Takeaways

• Clinical Efficacy: BENLYSTA has demonstrated significant efficacy in reducing SLE symptoms and improving outcomes in patients with lupus nephritis.
• Market Growth: The drug has shown consistent growth, with revenues expected to exceed $1 billion by 2022.
• Global Presence: BENLYSTA is widely available in the US, Europe, and international markets, including Japan and China.
• Competitive Landscape: Despite competition, BENLYSTA remains a leading treatment option due to its established presence and ongoing research.
• Cost and Administration: The drug is available in both intravenous and subcutaneous forms, with an average annual cost of $45,000.

FAQs

What is BENLYSTA used for?

BENLYSTA (belimumab) is used to treat Systemic Lupus Erythematosus (SLE) and lupus nephritis.

How is BENLYSTA administered?

BENLYSTA is available in both intravenous and subcutaneous forms.

What are the key findings from the BLISS-LN study?

The BLISS-LN study achieved its primary endpoint and all major secondary endpoints, indicating that BENLYSTA can significantly improve outcomes for patients with lupus nephritis.

How much does BENLYSTA cost?

The average annual cost of BENLYSTA is approximately $45,000 per year.

What is the market forecast for BENLYSTA?

BENLYSTA is projected to generate over $1 billion in revenue by 2022, with peak sales estimated to be around $1.3-1.4 billion.

Sources

1. Efficacy for Lupus | BENLYSTA (belimumab) for HCPs
   • https://www.benlystahcp.com/lupus/efficacy/
2. Q4 2023 Announcement - GSK
   • https://www.gsk.com/media/10928/fy-2023-results-announcement.pdf
3. Benlysta (belimumab) - Drug Insight and Market Forecast - 2030
   • https://www.globenewswire.com/news-release/2020/08/26/2084285/0/en/Benlysta-belimumab-Drug-Insight-and-Market-Forecast-2030.html
4. GSK announces positive headline results in phase 3 study of Benlysta in patients with lupus nephritis
   • https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-headline-results-in-phase-3-study-of-benlysta-in-patients-with-lupus-nephritis/
5. Systemic Lupus Erythematosus Market | Companies in SLE Therapy
   • https://www.delveinsight.com/blog/systemic-lupus-erythematosus-market