Fundamento jurídico del principio de interés superior del niño

It is unlikely that an industry sponsored trial will be conducted to compare belimumab with rituximab or other new biological interventions for SLE. The cost of a sufficiently powered study to discriminate between such treatments is likely to be too great for such studies to be undertaken independently of industry sponsorship. In view of the relative expense of belimumab and the lack of clear demonstration of a dose response relationship it is possible that in the real world belimumab may be employed at doses less than 10mg/kg. Useful research could be undertaken to monitor such usage and the 24 week response rates elicited.

Due to the paucity of long-term evidence for the continued benefit of belimumab and its safety, monitoring and surveillance of patients who have been treated with belimumab are therefore necessary. Further investigation is needed in patients excluded in the current BLISS-52 and BLISS-76 trials who had severe lupus nephritis or central nervous system manifestations of the disease. The two trials were limited in the inclusions of black patients, who for example account for approximately 25% of lupus patients in the USA. These patients also tend to have more severe disease than the general lupus population. In an earlier Phase II study of belimumab, black patients did significantly better than non-black patients. In contrast the reported Phase III trials found black patients treated with belimumab performed worse than those given placebo. These discrepancies needed to be considered further.

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Although BLyS (B-Lymphocyte stimulator) is raised in SLE, reducing its activity with belimumab in SLE patients appears to have only a very modest effect. In RCTs a large proportion of patients in the belimumab group responded, but the placebo group response indicated that many would have responded irrespective of receiving belimumab. In a Targeted population with higher response rates the effect of belimumab remained relatively modest. On this basis, research should be directed at identifying additional factors that independently, or together with BLyS play a role in the pathology of SLE. Until such factors are identified it is probable that the traditional armamentarium of interventions will remain core for the treatment of most SLE patients.

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APPENDICES