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THU0310 Relationship between Corticosteroids and Unfavorable Medical Effects. A Study under The Share System Based on The Clinical Trial Belimumab in Subjects with Systemic Lupus Erythematosus (BLISS-76)
  1. S. Emamikia1,
  2. C. Gentline1,
  3. M. Backheden2,
  4. K. Chatzidionysiou1,
  5. L. Arnaud1,
  6. R.F. van Vollenhoven1
  1. 1ClinTRID, Karolinska Institute
  2. 2Dept. of Learning, Informatics, Management and Ethics, Unit for Medical Statistics, Stockholm, Sweden

Abstract

Background Corticosteroids (CSs) are used to control moderate to severe manifestations in Systemic Lupus Erythematosus (SLE) patients. CSs have rapid and strong favorable effects in controlling the disease manifestations but have very significant side-effects and long-term adverse consequences when used at high doses for prolonged periods of time. However, detailed quantitative information on the relationship between CS exposure (dosage and duration) and side-effects in the literature is limited.

Objectives To obtain a better understanding of the exact relationship between exposures to CSs and possible adverse events (AEs).

Methods Data from the BLISS-76 clinical trial, which are owned by the sponsor company GSK, were accessed through an agreement under the SHARE mechanism, whereby investigators are granted access for performing pre-specified analyses within the dataset [1]. We focused our analyses on AEs that were frequently reported or where a causal relationship with CSs could be suspected. We studied the relationship between AEs CSs at baseline (BL) as well as during the trial.

Results Among the 819 patients included in BLISS-76, 623 (76.1%) were treated with CSs at BL. Significantly higher proportions of the following AEs: anemia, pyrexia and oral herpes were found in patients treated with CSs at BL compared to those who were not (5.6% vs. 1.5%, p=0.018; 10.1% vs. 5.1%, p=0.031; 5.0% vs. 1.5%, p=0.039, respectively). In contrast, the reverse was observed for nausea and sinusitis (12.2% vs. 20.4%, p=0.007; 8.5% vs. 13.8%, p=0.038, respectively) (Figure 1). The following AEs: cataract, glaucoma/ocular hypertension, osteopenia, musculoskeletal disorders, myalgia, cardiac disorders, hypertension, type 2 diabetes/hyperglycaemia, hypercholesterolaemia/hyperlipidaemia, peptic ulcer, skin ulcer and cushingoid, were numerically but not statistically more frequent in patients with CSs at BL compared to those without.

Conclusions The SHARE mechanism is a useful tool for allowing detailed independent analyses of sponsored clinical trial data. Our results suggest that anemia, pyrexia and oral herpes are associated with CS-exposure in a large clinical trial of patients with SLE. Notably,the use of CSs was associated with reduced occurrence of nausea and sinusitis.

  1. Nisen, P. and F. Rockhold, Access to patient-level data from GlaxoSmithKline clinical trials. N Engl J Med, 2013. 369(5): p. 475–8.

Acknowledgement We would like to thank: April Thompson (GSK), Janine Hodgson (GSK), Adam LaManna (SAS) and Yogan Kisten (ClinTRID).

Disclosure of Interest S. Emamikia: None declared, C. Gentline: None declared, M. Backheden: None declared, K. Chatzidionysiou: None declared, L. Arnaud Consultant for: L. Arnaud has received honoraria and invitations to international meetings from GSK, R. van Vollenhoven Grant/research support from: AbbVie, Amgen, BMS, GSK, Pfizer, Roche, UCB, Consultant for: AbbVie, Biotest, BMS, Crescendo, GSK, Janssen, Lilly, Merck, Pfizer, Roche, UCB, Vertex

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