Qualitative Feasibility of Patient-Centered Mixed-Methods Analysis of SLE Patient Experience Trajectories: The BLISS Trials

Trial description: Due to the significant heterogeneity of the clinical, biological, social and functional manifestations of Systemic Lupus Erythematosus (SLE), it has been difficult to define and assess therapeutic responses to new treatments. The BLISS 52 and BLISS 76 studies implemented a novel composite primary endpoint, the SLE Responder Index (SRI), which demonstrated efficacy in a seropositive SLE population. A question arises whether assessment of outcome at a single time point may adequately reflect the experience of SLE patients. The purpose of this study is to explore novel longitudinal follow up strategies, rather than assessing subjects at a single time point, to describe SLE patient experience trajectories in the BLISS studies. A range of clinical, biological, social and functional variables will be examined to investigate the characteristics of individual patients whose trajectories either improved or worsened during follow up.