Clinical SLEDAI-2K zero may be a pragmatic outcome measure in SLE studies

Objectives: Development of therapies for systemic lupus erythematosus (SLE) has in part been limited by the lack of suitable outcome measures in clinical trials. In the present post-hoc analysis of two clinical trials of belimumab, we investigated two potential outcomes, the Lupus Low Disease Activity State (LLDAS) and clinical SLE disease activity index 2000 (cSLEDAI-2K) zero, in relation to SLE responder index 4 (SRI-4).

Methods: A total of 1684 SLE patients from the BLISS-52 (n = 865) and BLISS-76 (n = 819) trials were surveyed. Physician’s Global Assessment (PGA) scores <0.5 (3-point scale) were used for comparisons. We used the chi-square test for comparisons and the phi coefficient for correlations.

Results: At week 52, LLDAS was achieved by 8.6% of patients, cSLEDAI-2K = 0 by 34.5% and SRI-4 by 45.1%. cSLEDAI-2K = 0 showed the strongest correlation with PGA <0.5 (r_φ = 0.36, P < 0.001). cSLEDAI-2K = 0 unveiled the superiority of belimumab 10 mg/kg over placebo (P = 0.003) with a magnitude which was comparable to that of SRI-4 (P < 0.001). LLDAS displayed a more moderate separation (P = 0.033).

Conclusions: LLDAS was a stringent measure. cSLEDAI-2K = 0 showed the strongest correlation with the clinician-based evaluation. Being based on the SLEDAI-2K only, cSLEDAI-2K = 0 may be considered a more pragmatic outcome measure in SLE studies compared with composite tools.     

Multidisciplinary management of liver metastases in patients with colorectal cancer: a consensus of SEOM,AEC, SEOR,SERVEI, and SEMNIM

Clinical and Translational Oncology - Colorectal cancer (CRC) has the second-highest tumor incidence and is a leading cause of death by cancer. Nearly 20% of patients with CRC will have metastases...     

Incorporation of the health care system in the west

A reflection is made, from an interpretative perspective, on the historical evolution of health care in the West. It starts from the moment that this became a way to intervene the sick and an instrument for healing diseases, focusing on original documents and written sources which account for results of historical research, which range from XV century until today. To do this, it tries to understand the health care as an ideographic body of knowledge consisting of five pieces of a puzzle composed by: the state policy of hospitals accumulation implemented in Spain, the accumulation of medical practices in what is currently Germany, the hospital wards in England, the nosological rationality in France, and the US sanitizing machine; all these movements as producers of closely linked health care developments, that are nothing more than collective actions regulated by social norms around health.