Clinical Study Data Request
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Proposal 1084

Title of the Proposed Research

Studies on the relationship between corticosteroids and unfavorable medical effects. A study based on the BLISS-52 and BLISS-76 clinical trials.

Lead Researcher

Ronald van Vollenhoven, MD, PhD


Karolinska Institute
Department of Medicine
Stockholm, Sweden

Funding Source

This project will require personnel resources that are funded the by the Karolinska Institute.

Potential Conflicts of Interest


Data Sharing Agreement Date

17 Mar 2015

Lay Summary

Corticosteroids are widely used medications for the treatment of systemic lupus erythematosus. They have rapid and strong favorable effects in controlling the disease manifestations but very significant side-effect and long-term adverse consequences especially when used at high dosages for prolonged periods of time. Many of these side-effects are known but the exact relationship between the exposures, i.e., how long the patient has been taking which dosages and the specific side-effects have not been characterized very well. In order to weigh the benefits of other therapies against the use of corticosteroids it would be very beneficial to have a better understanding of the exact relationship between corticosteroids and their side-effects.

This proposal is not only relevant for the specific disease under study. Corticosteroids are used very widely in many areas of medicine and the total numbers of patients affected by the negative consequences of corticosteroid treatment are innumerable. Thus, the results of this study may have bearing on many areas in medicine.

Here, we are proposing to use data from two large clinical trials in SLE to study the relationship between corticosteroid exposure and a range of negative consequences of this. The results will be directly applicable to patients with SLE which is a not uncommon disease of the immune system where autoimmune reactions cause inflammation in many different organs and organ systems. However the results will also be applicable to other patient categories who are treated with corticosteroids.

Aims and objectives of the research: We aim to obtain a better understanding of the exact relationship between exposure to corticosteroids and possible negative consequences.

How the research will be conducted: We will be using data from the BLISS- 52 and BLISS-76 clinical trials which were done in patients with moderately active systemic lupus erythematosus. We will tally those adverse events that were reported in these trials where a causal relationship with corticosteroids can be suspected. We will then correlate this with the dosages of corticosteroids that the patients where on prior to the trial and during the trial and obtain information about the relationship between duration, dosages, and cumulative exposure. In the end we expect to achieve an improvement in our ability to inform patients about the benefits versus risks of treatment with corticosterioids which indirectly will also inform about the benefits and risk of treatment with other medications. However, note that this research project will not address the specific risk-benefit relationships in the treatment of SLE with other

Study Data Provided

Study 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 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

This will be added after the research is published.

Publication Citation