MO801SAFETY AND EFFICACY OF DENOSUMAB IN HEMODYALISED PATIENTS UP TO 48 MONTHS TREATMENT FOLLOW-UP

Abstract

Abstract Background and Aims Osteoporosis in hemodialysed (HD) patients with Chronic Kidney Disease - Mineral Bone Disorder (CKD-MBD) is a debilitating clinical condition with complex therapeutic management. In fact, most of the drugs commonly used to counteract osteoporosis are generally contraindicated when Glomerular Filtration Rate (GFR) is lower than 30 ml/min. Denosumab (DMab) is a monoclonal antibody approved for the treatment of osteoporosis and does not require dose adjustment in case of impaired renal function. For this reason, since 2014 this drug has been used by nephrologists for the treatment of osteoporotic patients also in hemodialysis. Although the interest and diffusion in this specialized clinical field are growing, only few data are still available in literature. The aim of the study was to evaluate the efficacy and safety of denosumab in long-term therapies in hemodialysed patients. Method Since November 2013, a total of 19 hemodialysed patients have been treated with denosumab annually (4) or semi-annually (15) for up to 48 consecutive months. During the course of therapy, the laboratory parameters of osteo-mineral metabolism were monitored, and Qualitative UltraSonography (QUS) or Computerized Bone Mineralometry (CBM) were used alternatively, every 30 months and every 2 years, respectively (depending on guidelines recommendation for both radiological methods and timing). Results 7/19 patients completed at least 30 months of follow-up, observing a substantial stability of blood calcium and phosphorus values, against a reduction in the mean values of B-CrossLaps and ostase (respectively from 2975.32 to 1852.25 pg/ml and from 28.13 to 11.93 mcg/L). Comparison of QUS exams demonstrated improved T-score (-4.71 to -4.17) and reduced fracture risk (13% to 8%). The results of the CBMs confirmed the stability of the bone disease at the spine and the improvement of the Tscore at the femoral level (from -3.5 to -3). It should be noted that in our samples two patients achieved the longest observation period (48-month follow-up in continuous therapy), in which the stability of bone damage was observed at CBM compared to the start of treatment. Only one fracture has been recorded. Conclusion We underline that close biochemistry monitoring and careful evaluation of the therapeutic procedures before and after DMab administration helped us to minimise and promptly correct adverse effects due to hypocalcemia. In addition we are particularly satisfied to report in most patients a significant reduction of pain and an improvement of mobility. The results collected are consistent with acceptable safety and demonstrated efficacy of denosumab in hemodialysis patients.