We analyzed the incidence of lower extremity amputations (LEAs) in the 3rd Health Care Area of Madrid before and after the March 2008 introduction of a multidisciplinary team for managing diabetic foot disease. We compared the amputation rates in people with and without diabetes during 2 periods: before (2001-2007) and after (2008-2011) the introduction of a Multidisciplinary Diabetic Foot Unit (MDFU). We also analyzed the trend of the amputation rates by joinpoint regression analysis and measured the annual percentage change (APC). During the study period, 514 nontraumatic LEAs were performed, 374 (73%) in people with diabetes and 140 (27%) in people without the disease. The incidence of LEAs showed a significant reduction in major amputations in people with diabetes, from 6.1 per 100 000 per year (95% confidence interval [CI] = 4.9 to 7.2), in the 2001 to 2007 period, to 4.0 per 100 000 per year (95% CI = 2.6 to 5.5) in the 2008 to 2011 period (P = .020). There were no changes in incidence of minor or total amputations in the diabetic population or in amputations in the nondiabetic population during the study period. Joinpoint regression analysis showed a significant reduction in the incidence of major LEAs in diabetic population with an APC of -6.6% (95% CI = -10.2 to -2.8; P = .003), but there were no other significant changes. This study demonstrates that the introduction of a multidisciplinary team, coordinated by an endocrinologist and a podiatrist, for managing diabetic foot disease is associated with a reduction in the incidence of major amputations in patients with diabetes.
5065 Background: The recent introduction of Lu-177 PSMA for the treatment of castration-resistant prostate cancer (CRPC) has been met with much excitement. Initial reports of clinical response are promising, despite known inter- and intra-patient molecular heterogeneity. In this study, we examined the utility of PSMA protein expression in metastatic tumor tissues as a predictor of lesion-specific response to Lu-177 PSMA therapy in men with CRPC. Methods: Between 2015-2020, 19 patients with metastases at multiple sites underwent metastatic lesion biopsy, Ga-68 PSMA PET imaging, and subsequent treatment with three cycles of Lu-177 PSMA. A monoclonal anti-PSMA antibody (EPITOMICS (USA), 1:50) was used to semi-quantitatively assess PSMA protein expression in the biopsy specimen. The histoscore (range 0-300) was derived from intensity and extent of the immunohistochemistry staining and was determined by experienced genitourinary pathologists. Imaging evaluation was performed according to the Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) criteria. We assessed the association of the PSMA protein expression in metastatic tumor tissues and the lesion-specific response to Lu-177 PSMA therapy. Results: In 12 patients with biopsy specimens available for staining, PSMA expression correlated with enhancement (SUVmax) of the biopsy site on Ga-68 PSMA PET imaging (rs = 0.63). Of the nine patients with repeat imaging after Lu-177 PSMA therapy, five (55.6%) had a lesion-specific response at the site of biopsy. PSMA expression on immunohistochemistry was unable to accurately predict lesion-specific response in univariable analysis (p = 0.81, 95% CI 94.6-76.6). Among the five men with a lesion-specific response, three (60%) experienced overall progression based on PERCIST. There was no association between lesion-specific response and overall progression (p = 0.64). Conclusions: In patients with multiple metastases, PSMA protein expression from a single site biopsy was not predictive of site-specific Lu-177 PSMA response based on PERCIST. Additional studies are necessary to further interrogate the clinical consequence of PSMA expression heterogeneity in metastatic sites as well as the mechanisms underpinning resistance to Lu-177 PSMA in patients with CRPC.
Background Anakinra (ANK) is a recombinant interleukin-1 receptor antagonist currently used for treating autoinflammatory syndromes. Objectives To describe patient characteristics and their response to ANK in a tertiary centre between 2004 and 2011. Methods Retrospective study of 35 children treated with ANK. Demographic, clinical, analytical and genetic data were recorded. They were considered as responders when they reached analytic and clinical normalization and corticosteroids could then be discontinued. Results The sample included 21 boys and 14 girls, aged 3 days - 13 years old. Patient characteristics and response to ANK are summarised in the table [(values are expressed as n (%), median, mean (minimum-maximum)]. Responders were older at disease onset (p=0.032) and showed a high number of neutrophils (p=0.002). Nineteen (54%) cases met the criteria for systemic-onset juvenile idiopathic arthritis (SoJIA), 10 of them responded and their median time to start treatment was 1.6 years, being 4.5 for non-responders. Sixteen (46%) children did not meet the criteria for SoJIA, and 8 responded. The median time to start ANK in this group was 0.9 years for responders and 1.1 for non-responders respectively. Genetic testing performed in 27 patients showed mutation in 14 (8 MEFV, 2 TNRFSF1A, 2 NLRP3, 1 MVK y 1 NOD2), 6 of them were responders (4 MEFV, 1 NLRP3 y 1 MVK). SoJIA Responders (N=10)Total Responders (N=18)Non responders (N=17) Age at onset (y)5, 5 (0.9-9)5, 6 (0-13)3, 4 (0.9-12) Time to start ANK (y)1.6, 2.6 (0.4-6)1.3, 2.8 (0.15-11)1.2, 3.4 (0.15-15) Follow-up time (y)5, 6 (2.5-9)5, 6 (1-16)4, 7 (0.7-16) Boys/Girls6 (60)/4 (40)11 (61)/7 (39)10 (59)/7 (41) Arthritis12, 11 (1-19)3, 6 (0-19)5, 8 (0-28) Rash10 (100)17 (95)13 (76) Serositis3 (30)6 (33)3 (18) Adenomegaly7 (70)9 (50)10 (59) MAS1 (10)3 (17)2 (12) ESR (mm/h)54, 66 (27-124)52, 56 (13-124)61, 53 (5-100) CRP (mg/l)55, 74 (9-158)52, 65 (0.8-158)25, 43 (0.2-138) Neutrophils (×103/μl)11.7, 14 (8.7-28)12.4, 15 (2.8-34)6.5, 7 (2.3-15) Genetic testing8 (80)16 (89)11 (65) Mutation3 (30)6 (33)8 (47) Asymptomatic10 (100)18 (100)12 (71) Conclusions In spite of study limitations, responders were older at disease onset and showed a higher number of neutrophils. Moreover, it seems that patients with SoJIA who had the shortest time of evolution responded better than those with longer disease duration. References The pattern of response to anti-interleukin-1 treatment distinguishes two subsets of patients with systemic-onset juvenile idiopathic arthritis. Gattorno M et al. Arthritis Rheum 2008;58:1505-15. Anakinra: a safe and effective first-line treatment in systemic onset juvenile idiopathic arthritis (SoJIA). Hedrich CM et al. Rheumatol Int 2011 Nov 15 (Epub ahead of print). Disclosure of Interest None Declared
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