Abstract

In SLE as in other rheumatic diseases, the most relevant target of intervention should be a status with controlled disease process assuring no further accrual of damage. If actual expert discussions like DORIS define the frame of such a status, clinical activity measured by a validated lupus disease activity instrument, serologic activity and therapy – because of harm - are the dimensions of remission with its duration as additional factor for outcome. Patient reported outcomes (PROs) were not included. Otherwise, if payers and reimbursement system decide about relevance, patient outcomes are clear of highest importance as target.

Looking on the evidence of PROs for outcome in SLE, PROs were never used as primary endpoint in clinical trials. In RCTs, PROs were often collected and mostly explorative analysed. There is no evidence that PROs can validly define the above described status of controlled disease. But from systematic analyses in RA, we know that pure PRO like VAS of general health status and semi PRO like tender joints are at least as relevant as more “objective” criteria like swollen joints or CRP as clearly exhibited by the ACR/Eular remission criteria for RA.

The challenge in SLE is that the discrepancies between patients' and physicians' perception and perspectives are even more distinct than in RA. Sometimes, there is the expression that physicians and patients are describing different diseases. The burden of illness in lupus is better defined by pain than by organ manifestations; the overall survival in SLE is more related to lupus nephritis than to fatigue. It is obvious that physicians should analyse the actual clinical symptoms and integrate the future consequences of their actual management in their decision, and patients are more focused on release of their actual burden.

Until today, these different and divers perspectives are no integrated, neither in RCTs nor in daily care. But such integration is mandatory, because no side imagines the complete picture of lupus, which may also produce to the poor results of clinical trials. In routine care, this behaviour causes frustration and mental distress, optimal results are prohibited.

So, the answer to what is more relevant in the management of SLE patients - clinical targets, biological targets or PROs – is the integration of all important aspects of lupus. This implies more than the statistical evaluation of the best items of all three aspects, it is the active involvement of patients in their care: patient empowerment in SLE, a fruitful process, in which both sides have to learn a lot from and about each other.