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Objective:To update the follow-up of the Euro-Lupus Nephritis Trial (ELNT), a randomised prospective trial comparing low-dose (LD) and high-dose (HD) intravenous (IV) cyclophosphamide (CY) followed by azathioprine (AZA) as treatment for proliferative lupus nephritis.Patients and methods:Data for survival and kidney function were prospectively collected during a 10-year period for the 90 patients randomised in the ELNT, except in 6 lost to follow-up.Results:Death, sustained doubling of serum creatinine and end-stage renal disease rates did not differ between the LD and HD group (5/44 (11%) vs 2/46 (4%), 6/44 (14%) vs 5/46 (11%) and 2/44 (5%) vs 4/46 (9%), respectively) nor did mean serum creatinine, 24 h proteinuria and damage score at last follow-up. Most patients in both groups were still treated with glucocorticoids, other immunosuppressant agents and blood pressure lowering drugs. After 10 years of follow-up, the positive predictive value for a good outcome of an early drop in proteinuria in response to initial immunosuppressive therapy was confirmed.Conclusion:The data confirm that a LD IVCY regimen followed by AZA—the “Euro-Lupus regimen”—achieves good clinical results in the very long term.

Background:Stratification of patients affected with systemic autoimmune diseases according to clinical and endotypic features may provide valuable insights to disease mechanisms and expected response to target treatments. Belimumab is increasingly used as add-on therapy in refractory systemic lupus erythematosus (SLE), yet the heterogeneity of patients undergoing belimumab was not thoroughly investigated. Unsupervised machine learning allows cluster profiling through unbiased assessment of multiple variables in the model.Objectives:In this study we aimed at exploring clusters defined by clinical and/or laboratory features across patients initiating belimumab due to refractory SLE, and to investigate possible relationships with clinical outcome at different timepoints.Methods:We analyzed data from the Italian multicentric SLE database (LIRE – Lupus Italian REgistry) encompassing prospectively collected records of patients commencing a novel treatment due to refractory SLE. We selected patients initiating belimumab. Multiple Factor Analysis for Mixed Data (FAMD) was employed to differentiate patient clusters. To define the number of clusters, Hierarchical Clustering on Principal Components was performed using Ward’s criterion and a Euclidian distance metric on the selected FAMD principal components. Inter-cluster inertia gain was used to determine the optimal division level.Disease activity was measured by SLE-disease activity index (SLEDAI-2K), damage by the SLICC damage index (SDI). Clinical response was defined as clinical (c)SLEDAI-2K=0 and was evaluated at 6 and 12 months (T6 and T12). Logistic regression analysis was performed to assess clustering effect on response rates. Significance was set at 5%.Results:Hierarchical clustering identified five principal components recapitulating 4 main clusters from 125 SLE patients initiating belimumab (Figure 1A). Cluster 2 (n=28) included patients with renal involvement and enhanced complement consumption while Cluster 3 (n=14) exhibited activity in neuropsychiatric and cardiovascular domains. Cluster 3 displayed the highest baseline SDI (p=0.006) enriched in neurological and cardiovascular items (p<0.001), and the lowest baseline hydroxychloroquine intake (78.6% vs. 95.2%, p=0.05). Cluster 4 (n=28) gathered patients with haematological abnormalities, while Cluster 1 (n=55) included patients showing no identifiable disease pattern yet entailing a lower SDI.Response trajectories throughout T6 and T12 were comparable across clusters, with Cluster 2 showing a numerically higher proportion of cSLEDAI-2K responders at T12 (70.8% vs. 52.3%, p=0.082) (Figure 1B). Clustering did not predict clinical response. SDI at T6 and T12 was significantly greater in Cluster 3 (p<0.01 for both), yet damage accrued significantly within Cluster 1 throughout month 12 (0 (0-2) vs. 1 (1-2), p<0.001) (Figure 1C).Conclusion:Unsupervised clustering highlighted the clinical heterogeneity of patients candidate to belimumab due to refractory SLE. Although clustering did not clearly predict clinical outcome in this cohort, a greater response rate seems likely in patients with active serology and renal involvement. Combining expert judgement with machine learning may enable optimized eligibility and prediction of response upon belimumab treatment.Figure 1.REFERENCES:NIL.Acknowledgements:Prof. Antonella Zambon, Anna Zanetti, Isabella Sala (University Milan Bicocca); Greta Carrara (Centro Studi SIR).Disclosure of Interests:Mariele Gatto GSK, AZ, Janssen, Vincenzo Venerito: None declared, Davide Rozza: None declared, Gianpiero Landolfi: None declared, Carlo Alberto Scirè: None declared, Gian Domenico Sebastiani: None declared, Fabrizio Conti: None declared, Andrea Doria GSK, AZ, Celgene, Eli Lilly, Roche, Pfizer, BMS, GSK.

Background:After Sars-CoV-2 outbreak, considering its high mortality and diffusiveness, a mass worldwide vaccination campaign was put in place. Some groups of patients were prioritized in this process. Among them, Systemic Lupus Erythematosus (SLE) ones were considered at high risk of death from COVID-19, especially due to the immunosuppressive (Is) drugs administered. Moreover, at vaccines release there was a complete absence of efficacy and safety data in patients with autoimmune diseases, since phase III trials of most vaccines excluded subjects on Is drugs.Objectives:To assess the impact of Is drugs on BNT162b2 mRNA vaccine’s immunogenicity and safety in SLE patients.Methods:This is a prospective real-life study on consecutively enrolled SLE patients conducted between March 2022 and January 2023. Inclusion criteria: age > 18 and < 70 years, SLE diagnosis (according to EULAR/ACR 2019 criteria) prior to SarS-CoV-2 outbreak, vaccination with 3 doses of BNT162b2 vaccine. Exclusion criteria: high disease activity (SLEDAI-2K >10) or ongoing disease flare at inclusion, treatment with Rituximab or intravenous Immunoglobulins in the last 12 or 2 months respectively. Patients were enrolled 7 days after their 3rd vaccine shot (T0) when demographic and clinical data as well as ongoing therapies (Table 1) were collected, along with eventual adverse events. 6 months (T1) and 12 months (T2) after their 3rd dose, humoral and cellular immune responses were evaluated (both qualitatively and quantitatively). The former analysing anti-receptor binding domain (RBD) IgG antibodies (Ab) with an immunoassay analyser and neutralizing (Neu) Ab through a microneutralization assay. The latter was evaluated analysing interferon (IFN)γ release using an enzyme-linked immunosorbent assay after stimulating whole blood with Sars-CoV-2 peptides.Then, patients were divided in two groups based on therapy at vaccination:-Is: patients receiving an Is drug, including prednisone at dosage higher than 5mg/day, regardless of concomitant Hydroxychloroquine (HCQ) therapy-Non-Is: patients not receiving any Is drugs (i.e. HCQ or prednisone (lower than 5mg/day) alone or in combination; patients not receiving any drug for SLE)The two groups were then compared to establish the influence of eventual Is drugs on immune response after a full vaccination cycle.Results:51 patients were enrolled at T0 (Table 1). Comparing the two groups, no differences emerged for either demographic or clinical parameters, apart for a higher number of SarS-CoV-2 infections in the Non-Is group (p<0.0001). Equally, local and systemic adverse events did not differ among the groups and no life-threatening events were registered. Regarding immune response (Table 2), all patients were available at T1 follow-up visit. 47 (92.2%) showed anti-RBD Ab and 25 (49%) Neu Ab; cellular response was detectable in 43 (84.3%) subjects. The only significant difference regarded Neu Ab, which resulted higher in the Non-Is group both qualitatively (p=0.02) and quantitatively (p=0.02). 28 patients (54.9%) returned at T2. Anti-RBD Ab were still present in 26 patients (92.8%), while Neu Ab in 20 (71.4%). Cellular response was detectable in 25 (89.3%) patients. Both for humoral and cellular response, no significant difference was detectable comparing the two groups Is and Non-Is patients. Lastly, a significant correlation was found between anti-RBD Ab and both Neu Ab and cellular response (data not shown) both at T1 (p<0.001 and =0.002, respectively) and T2 (p<0.001 and =0.005, respectively).Conclusion:Anti-SarS-CoV-2 BNT162b2 mRNA vaccine can induce a persistent immune response in SLE patients while being safe and well tolerated. In fact, even in patients on Is therapy, immune response can be retrieved 1 year after its administration – without being influenced by Is therapies at vaccination. Indeed, Is therapy reduced Neu Ab production without otherwise interfering with the other immune response components. Moreover, whilst no life-threatening events were registered, Is therapies were not associated with adverse events onset.REFERENCES:[1] Aiello A. (2021) Int J Infect Dis, 106:338.[2] Tan SY. (2023) Rheumatology (Oxford), 62(5): 1757.Acknowledgements:NIL.Disclosure of Interests:None declared.

Background:Systemic Lupus Erythematosus (SLE) is a heterogeneous, inflammatory, chronic autoimmune disease presenting various complexities in both diagnostic procedures and therapeutic interventions. By integrating shared decision-making into the SLE management approach, healthcare providers can empower patients to actively participate in their care, fostering improved adherence to treatment plans and overall outcomes.Objectives:This study aims to enhance shared-decision making by investigating patient preferences alongside physicians’ preferences regarding SLE treatment features. It involves integrating and comparing clinical priorities with patient perspectives.Methods:A board consisting of 11 clinicians experts in SLE, 2 patient representatives and a statistician specializing in DCE, reached a consensus on conducting complementary DCEs. The goal is to investigate whether physician and patient preferences align while maintaining consistent attributes and levels. This approach provides a direct assessment of relative preferences and hypothetical treatment approaches in SLE. The DCE methodological approach is commonly used to measure the relative importance assigned to treatment attributes, offering valuable insights into the perceptions of treatment decision-making for both clinicians and patients. The parameter estimates from the model were interpreted as relative preference weights (PWs), indicating the average relative preference for one attribute level over other levels (i.e., the relative strength of utility for each attribute level). The mean PWs were used to calculate the relative importance (RI) of each attribute. A separate sample size calculation for the DCEs was conducted, following the Orme’s rule-of-thumb, and simulations were performed using Sawtooth Software Lighthouse Studio (9.14.2).Results:95 clinicians (57% females, 71% rheumatologists) involved in the care of patients with SLE, with a median age of 45 years (range 31-71), participated in the physician-based DCE, and 410 patients with SLE (95% females) with a median age 50 years (range 18-80) participated in the patient-based DCE.In both group of respondents, the most important attribute were related to the “probability of worsening after 12 months of treatment” (RI=22%) and, in the physician-based DCE, this was synonymous with the “progression of organ damage after 12 months” (RI=41%) (Figure 1). For patients, the second most important attribute was the reduction of glucocorticoid dose after 6 months. Patients (RI=19%) and physicians (RI=11%) both prioritized the short-term goal of tapering prednisone to ≤5mg/day. However, physicians place greater preference (RI=19%) to the “reduction in disease activity levels after 6 months” while, surprisingly, “time to achieve a satisfactory clinical response to treatment” held the least importance for patients (RI=9%) (Figure 2). Significant differences between the two respondents groups were observed regarding the route of drug administration, with patients assigning greater priority (15%) compared to physicians (RI=7%). Notably, patients were willing to accept intravenous administration as long as it resulted in a reduction in the glucocorticoid dosage.Conclusion:This is the first DCE study involving patients and physicians to inform shared-decision making. The results will play a crucial role in aligning clinician priorities with patient’s values and preferences, considering their individual circumstances.REFERENCES:NIL.Figure 1.Relative importance of treatment attributes.Figure 2.Utilities by levels of treatment attributes.Acknowledgements:This work was supported with an unconditional grant by AstraZeneca Italy.Disclosure of Interests:None declared.

BackgroundInterstitial lung disease (ILD) related to rheumatoid arthritis (RA) significantly impacts on quality of life and survival of the patients. Data about prevalence and natural history of RA-ILD are only partially known and mainly based on retrospective studies. The recent introduction of antifibrotic drugs have allowed for the first time the opportunity to treat ILD in RA patients; in fact, INBUILD study demonstrated the efficacy of nintedanib in the treatment of progressive fibrosing ILD different than idiopathic pulmonary fibrosis (IPF), including RA-ILD, but the prevalence of RA-ILD patients that may potentially benefit from nintedanib therapy remain unknown.ObjectivesAim of the present multicenter Italian study was to investigate the prevalence of fibrosing progressive patterns in a cross-sectional cohort of non-selected RA-ILD patients.MethodsWe enrolled in the study all RA patients according to 2010 EULAR/ACR classification criteria, with an ILD confirmed at high resolution computed tomography (HRCT) and with a follow-up of at least 24 months.According to the current indication of nintedanib, patients were defined as having a progressive fibrosing ILD in case of a relative decline in forced vital capacity (FVC) ≥10% predicted and/or an increased extent of fibrotic changes on chest imaging in a 24 month-period. Respiratory symptoms were excluded to reduce possible bias due to the retrospective interpretation of cough and dyspnoea.ResultsOne hundred and thirty-four RA-ILD patients were enrolled in the study (males/females 54/80, mean age 72±9.5 years, mean RA and ILD duration 13.1±9.5 and 4.6±4.1 years, respectively. Anticitrullinated peptides antibodies (ACPA) and rheumatoid factor (RF) were recorded in 76.2% and 87.6% of cases, respectively.According to radiologic features, ILD was classified as probable or definite usual interstitial pneumonia (UIP) in 50.7% of patients, NSIP in 19.4% and other patterns in 29.8%. A fibrosing pattern was reported in 73.9% of cases (all patients with UIP pattern, 57.7% of patients with NSIP and 40% with other pattern). A relative decline of 6.8% of forced vital capacity (FVC) was recorded during the follow-up, without significant difference between fibrosing and non-fibrosing ILD (6.3%±13.8 vs 5.9%±21.3, respectively). A relative FVC decline ≥ 10% and/or a progression of radiologic fibrotic involvement was observed in 38.8% of patients. As expected, a significant difference in relative decline of FVC was recorded between progressive and non-progressive ILD (15.7%±16.4 vs -1.3%±8.3, respectively). Globally, a fibrosing progressive pattern was recorded in 35.8% of patients (48/134, 48.5% of patients with fibrosing pattern). Of interest, also 11.4% of patients with a non-fibrosing pattern showed a progressive behavior of disease (see Figure 1).ConclusionThe recent introduction of nintedanib for the treatment of fibrosing progressive ILD different by IPF has potentially changed the paradigm for the treatment of RA-ILD. In fact, for the first time, rheumatologist has a therapy available with efficacy on RA related lung involvement.This study shows some limitations. The retrospective design and the need of serial HRCT and FVC could induce an overestimation of progressive disease (pulmonary function could not have been properly evaluated in asymptomatic patients). On the other hand, the exclusion of symptoms, such as a worsening of dyspnea and cough, might underestimate the prevalence of progressive lung disease. Finally, some patients were already treated with antifibrotic drugs, possibly influencing the evolution of lung disease in the last 2 years.In conclusion, about a third of RA-ILD patients shows a fibrosing progressive pattern of ILD and might benefit of antifibrotic treatment, alone or in combination with anti-rheumatic drugs. For RA patients with progressive non-fibrosing ILD, we need more studies to establish the best therapeutic approach.References[1] Flaherty KR et al. N Engl J Med 2019;381:1718-1727[2] Manfredi A, et al. Expert Rev Clin Immunol. 2021;17:485-97Figure 1.AcknowledgementsI have no acknowledgement to declare.Disclosure of InterestsAndreina Manfredi Speakers bureau: BMS, Lilly, and.Boehringer-Ingelheim, Vincenzo Venerito: None declared, Massimiliano Cazzato: None declared, Stefano Gentileschi: None declared, Laura La Corte: None declared, Anna Maria Iuliano: None declared, Giulia Cassone: None declared, Caterina Vacchi: None declared, Caterina Tomassini: None declared, Alessandra Rai: None declared, Marlea Lavista: None declared, Dario Andrisani: None declared, Elenia Laurino: None declared, Claudia Canofari: None declared, elisa pedrollo: None declared, Fabiola Atzeni: None declared, Gian Domenico Sebastiani: None declared, Bruno Frediani: None declared, Marta Mosca: None declared, Florenzo Iannone: None declared, Marco Sebastiani Speakers bureau: BMS, Pfizer, and Boehringer-Ingelheim, Consultant of: Lilly, Grant/research support from: BMS, Pfizer.

Aims/hypothesis Glucagon-like peptide 1 (GLP-1) is a major incretin, mainly produced by the intestinal L cells, with beneficial actions on pancreatic beta cells. However, while in vivo only very small amounts of GLP-1 reach the pancreas in bioactive form, some observations indicate that GLP-1 may also be produced in the islets. We performed comprehensive morphological, functional and molecular studies to evaluate the presence and various features of a local GLP-1 system in human pancreatic islet cells, including those from type 2 diabetic patients. Methods The presence of insulin, glucagon, GLP-1, proconvertase (PC) 1/3 and PC2 was determined in human pancreas by immunohistochemistry with confocal microscopy. Islets were isolated from non-diabetic and type 2 diabetic donors. GLP-1 protein abundance was evaluated by immunoblotting and matrix-assisted laser desorption–ionisation-time of flight (MALDI–TOF) mass spectrometry. Single alpha and beta cell suspensions were obtained by enzymatic dissociation and FACS sorting. Glucagon and GLP-1 release were measured in response to nutrients. Results Confocal microscopy showed the presence of GLP-1-like and PC1/3 immunoreactivity in subsets of alpha cells, whereas GLP-1 was not observed in beta cells. The presence of GLP-1 in isolated islets was confirmed by immunoblotting, followed by mass spectrometry. Isolated islets and alpha (but not beta) cell fractions released GLP-1, which was regulated by glucose and arginine. PC1/3 (also known as PCSK1 ) gene expression was shown in alpha cells. GLP-1 release was significantly higher from type 2 diabetic than from non-diabetic isolated islets. Conclusions/interpretation We have shown the presence of a functionally competent GLP-1 system in human pancreatic islets, which resides in alpha cells and might be modulated by type 2 diabetes.

Background:Clinical remission is the main target in the management of Rheumatoid Arthritis (RA) patients. Different indexes are used to assess remission, among which the Boolean-based and index-based remission definitions (the latter using the simplified or clinical disease activity index SDAI, CDAI) and the less stringent Disease Activity Score on 28 joints (DAS28).Whatever the clinical remission definition applied, it frequently don‘t reflect a “complete” remission condition, indeed several authors found residual active synovitis at ultrasonography (US) and its presence is predictive of disease relapses. There is no consensus yet about which target joints should be included in the US assessment of RA patients in clinical remission, and consequently, several sets of joints have been evaluated so far.We have previously demonstrated that the US evaluation of only 4 target joints (wrists and II metacarpophalangeal (MCP) joints) allows to reach a high sensitivity in detecting subclinical active synovitis in RA patients in clinical remission. Upadacitinib is a selective JAK1 inhibitor that achieved significantly higher remission rates than adalimumab and abatacept in RA patients, however, real-life data are still scarce. Here we present the 24-weeks data of the UPAdacitinib Rheumatoid Arthritis REmission UltraSonography (UPARAREMUS) study.Objectives:The primary end-point of the study was the proportion of patients achieving “complete” remission at week 24. Secondary end-points were the proportion of patients achieving clinical remission with each composite measure (CDAI, DAS28crp, and SDAI) at week 12 and 24 the changes from baseline to week 12 and week 24 in the DAS28crp, CDAI, and SDAI.Methods:This is a longitudinal multicenter observational study, enrolling bio-naïve and bio-inadequate responders RA patients. Clinical assessment of disease activity and US of 4 target joints (wrists and II MCF bilaterally) were performed at baseline, week 12 and 24. US was carried ou by experts rheumatologists who had passed an inter-observer reliability test. US-detected synovitis and PD synovitis were scored according to a 0-3 semi-quantitative simplified score. Clinical remission was defined as: DAS28crp<2.6 or CDAI≤2.8 or SDAI≤3.3. US remission was defined as the absence of PD signal ≥ 2 in one target joints, or PD≥1 in two target joints. “Complete” remission was defined as clinical remission plus US remission. Median values at baseline, at week-12 and week-24, in the DAS28crp, CDAI and SDAI were calculated and compared using the Wilcoxon non-parametric test. Proportions, medians, and interquartile ranges were calculated as appropriate and logistic regression was used to evaluate if there were baseline factors associated with complete remission, adjusting for the effect of confoundersResults:A total of 60 RA patients were enrolled (clinical and demographic characteristics are resumed in Figure 1).After 12 weeks and 24 weeks respectively, 40% and 63.6% of patients achieved complete remission (Figure 2). The following parameters were associated with complete remission: being bio-naïve and having a shorter disease duration, although at multivariate analysis significant OR was found only for being bio-naïve [(aOR 4.09 (95%CI 1.05-15.9) p=0.04]. After 12 weeks, 45% of patients achieved clinical remission with at least one of the remission indices, three out of these patients did not reach US remission (13%). At 24 weeks, the percentage of patients achieving clinical remission improved to 65.4% and the proportion of patients w/o an associated US remission further decrease to 3%.A significant reduction in disease activity was registered during the follow-up with each composite measure (Figure 2).Conclusion:UPARAREMUS is the first study evaluating the efficacy of upadacitinib in reaching both clinical and US remission in RA patients. A 24-weeks upadacitinib treatment led to complete remission in a high percentage of enrolled patients. The only baseline parameter associated with a higher chance of reaching complete remission at multivariate analysis was being bio-naïveFigure 1.Baseline characteristics of enrolled rheumatoid arthritis (RA) patientsREFERENCES:NIL.Acknowledgements:NIL.Disclosure of Interests:Andrea Picchianti-Diamanti This is an Investigator Initiated Study externally supported by Abbvie, Maria Sofia Cattaruzza: None declared, Simonetta Salemi: None declared, Roberta Di Rosa: None declared, Giorgio Sesti: None declared, Maria Sole Chimenti: None declared, Arianna D’Antonio: None declared, Bruno Frediani: None declared, Caterina Baldi: None declared, Gloria Crepaldi: None declared, Michele Maria Luchetti: None declared, Valentino Paci: None declared, Alen Zabotti: None declared, Ivan Giovannini: None declared, Marco Canzoni: None declared, Gian Domenico Sebastiani: None declared, Chiara Scirocco: None declared, Carlo Perricone: None declared, Bruno Laganà: None declared, Annamaria Iagnocco: None declared.

Objective. Fragility fractures (FF) resulting from osteoporosis pose a significant public health challenge in Italy, with considerable socio-health and economic implications. Despite the availability of safe and effective drugs, osteoporosis remains underdiagnosed and undertreated, leaving over 2 million high-risk Italian women without treatment. This paper aims to identify and propose key improvements in the management of osteoporosis, focusing particularly on the critical issues related to the use of anabolic drugs in secondary prevention, according to the current Italian Medicines Agency (AIFA) Note 79. Methods. The Expert Panel, composed of nine recognized Italian experts in rheumatology, analyzed current practices, prescribing criteria, and the most recent literature. Three main reasons for revising the indications on pharmacological treatment of osteoporosis were identified: inadequate treatment of osteoporosis, new evidence regarding frontline placement of anabolics in high-risk conditions, and emerging sequential or combined strategies. Results. The proposed improvements include the adoption of the Derived Fracture Risk Assessment algorithm for accurate fracture risk assessment, revision of AIFA Note 79 to reflect current evidence, improved prescribing appropriateness, broader access to anabolic agents, and the provision of sequential therapies with antiresorptives for teriparatide. These changes aim to enhance patient outcomes, streamline healthcare processes, and address the high percentage of undertreated individuals. Conclusions. This expert opinion emphasizes the importance of the appropriate use of anabolic drugs to reduce FF and associated costs while ensuring the sustainability of the National Health Service. The proposed recommendations are in line with the latest scientific evidence, providing a comprehensive strategy to optimize the management of osteoporosis in Italy.   On behalf of the Study Group on Osteoporosis and Skeletal Metabolic Diseases of the Italian Society of Rheumatology.

Infant anthropometry and body composition have been previously assessed to gauge the impact of intrauterine growth restriction (IUGR) at birth, but the interplay between prenatal Doppler measurements and postnatal development has not been studied in this setting. The present investigation was performed to assess the significance of prenatal Doppler findings relative to postnatal anthropometrics and body composition in IUGR newborns over the first 12 months of life. Consecutive cases of singleton pregnancies with suspected IUGR were prospectively enrolled over 12 months. Fetal biometry and prenatal Doppler ultrasound examinations were performed. Body composition was assessed by absorptiometry at ages 10 days, and at 4 and 12 months. A total of 48 pregnancies qualifying as IUGR were studied. Doppler parameters were normal in 26 pregnancies. The remaining 22 deviated from normal, marked by an Umbilical Artery Pulsatility Index (UA-PI) >95th centil or Cerebro-placental ratio (CPR) <5th centile. No significant differences emerged when comparing anthropometry and body composition at each time point, in relation to Doppler findings. Specifically, those IUGR newborns with and without abnormal Doppler findings had similar weight, length, body mass index, lean and fat mass, and bone mineral content throughout the first 12 months of life. In a separate analysis, when comparing IUGR newborns by Doppler (abnormal UA-PI vs. abnormal CPR), anthropometry and body composition did not differ significantly. Infants with IUGR maintain a pattern of body composition during the first year of life that is independent of prenatal Doppler findings. Future studies with larger sample sizes and correlating with hormonal status are warranted to further extend the phenotypic characterization of the various conditions now classified under the common label of IUGR.