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Proposal 1206

Title of the Proposed Research

Efficacy of Belimumab on Mucocutaneous Involvement in Patients with Systemic Lupus Erythematosus (MUCOBEL)

Lead Researcher

Kuhn, Annegret

Affiliation

Interdisciplinary Center of Clinical Trials (IZKS)
University Clinic of Mainz
Germany

Funding Source

Research and analysis are funded by GSK.

Potential Conflicts of Interest

GSK: Research Grant, Honoraria, Travel Fees

Data Sharing Agreement Date

2 September 2015

Lay Summary

Aim of the study

The aim of the study is to retrospectively analyze data on the efficacy of belimumab on skin and mucous membrane lesions in systemic lupus erythematosus based on two published phase III trials.

Introduction

Systemic lupus erythematosus (SLE) is a life-threatening autoimmune disease affecting a broad variety of organs, including skin, joints, kidney, lungs and the heart. Skin lesions appear in 73-85% of patients with SLE and may occur at any stage of the disease. The disease can produce considerable morbidity resulting from e.g. its skin lesions (patients may suffer from disfiguring, painful scarring skin lesions, mucous membrane lesions) and therefore has a strong negative impact on quality of life.

In the last years, therapeutic advances have led to significant improvements in the treatment of SLE, but no medication has been specifically approved for skin lesions. The first-line treatment for severe skin manifestations is antimalarials, but not all patients respond to these agents. In 2011, belimumab was licensed for SLE based on two phase III studies (BLISS-52 and BLISS-76), which included 865 and 819 SLE patients, respectively. The data of both studies were combined, and Manzi et al. published a poster reporting the efficacy of belimumab on mucocutaneous (i.e., mucous membranes and skin) lesions by analyzing 7 of 18 mucocutaneous items of the “British Isles Lupus Assessment Group” (BILAG) score. The group demonstrated that treatment with antimalarials plus belimumab resulted in a higher improvement of the mucocutaneous lesions than treatment with antimalarials plus placebo.

Outcome

The data of the two phase III studies are the basis for the retrospective analysis, which will focus on the efficacy of belimumab in all 18 mucocutaneous items of the BILAG and in the 3 items of the “Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index” (SELENA-SLEDAI). Both scores were applied in the phase III trials, but only parts of the mucocutaneous data are analyzed. Furthermore, we will correlate the results with detailed characteristic demographic data of the 1684 included patients with SLE. We hypothesize that additive treatment with belimumab offers a safe and long-term treatment option for mucocutaneous lesions in patients with SLE. In addition to a publication of the planned analysis in a peer-reviewed journal, the results will be included in the German S2k Guidelines on Cutaneous Lupus Erythematosus (AWMF register number 013-060), which are currently under preparation.

Study Data Provided

Study GSK-HGS1006-C1056: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)
Study GSK-HGS1006-C1057: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)

Statistical Analysis Plan

The statistical analysis plan will be added after the research is published.

Publication Citation

The publication citation will be added after the research is published.