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Original article
Small bowel Crohn's disease: Proximal lesions linked to increased inflammation and biologic treatment needs
Enfermedad de Crohn del intestino delgado: Lesiones proximales asociadas a mayor inflamación y necesidad de tratamiento biológico
João Carlos Gonçalvesa,b,c,
Corresponding author
joaoclgoncalves@outlook.com

Corresponding author.
, Cátia Arieiraa,b,c, Sofia Xaviera,b,c, Joana Magalhãesa,b,c, Maria João Moreiraa,b,c, Bruno Rosaa,b,c, José Cottera,b,c
a Gastroenterology Department, Unidade Local de Saúde do Alto Ave, Guimarães, Portugal
b Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal
c ICVS/3B's – PT Government Associate Laboratory, Braga/Guimarães, Portugal
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Crohn&#39;s disease &#40;CD&#41; is a chronic inflammatory condition that can affect any segment of the gastrointestinal tract&#44; including the esophagus&#44; stomach&#44; small bowel &#40;SB&#41; and colon&#46; The location of the disease has been demonstrated to play a role in its behavior and the likelihood of requiring surgery&#46;<a class="elsevierStyleCrossRefs" href="#bib0120"><span class="elsevierStyleSup">1&#44;2</span></a> The Montreal Classification divides CD into four groups based on the location of the disease&#58; L1&#44; involving the ileum&#59; L2&#44; involving the colon&#59; L3&#44; involving both the ileum and colon&#59; and L4&#44; which defines lesions proximal to the ileum&#44; and can be used alone or as an add-on&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">3</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Ileocolonoscopy is commonly utilized as the initial diagnostic approach for CD&#44; however it is insufficient for a comprehensive assessment of the SB&#46; In fact&#44; the European Crohn&#39;s and Colitis Organisation strongly recommends that all newly diagnosed CD patients undergo SB assessment to ensure a thorough evaluation of the disease extent&#46;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">4</span></a> Importantly&#44; ileal disease has been consistently associated with complicated disease phenotypes&#44; while the presence of jejunal disease has been linked to a higher risk of strictures and multiple surgeries&#46;<a class="elsevierStyleCrossRefs" href="#bib0120"><span class="elsevierStyleSup">1&#44;5&#44;6</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">To investigate SB lesions several modalities are available&#44; including Intestinal Ultrasound&#44; enterography by Computerized Tomography or Magnetic Resonance Imaging&#44; and Capsule Endoscopy&#46;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">4</span></a> Among these&#44; SB Capsule Endoscopy &#40;SBCE&#41; has emerged as a valuable tool in recent years&#46; The diagnostic yield of SBCE is comparable to the other modalities&#44; except in cases of proximal SB involvement where SBCE appears to be superior in detecting mucosal lesions&#46;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">7</span></a> Moreover&#44; SBCE allows for precise localization and grading of disease activity&#44; enabling clinicians adjust treatment strategies&#46;<a class="elsevierStyleCrossRefs" href="#bib0155"><span class="elsevierStyleSup">8&#8211;12</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">Despite the clinical and prognostic significance of SB CD&#44; there is a scarcity of studies that specifically address this subtype of CD&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">2</span></a> Most clinical trials and research efforts in CD tend to focus on colonic or ileocecal CD&#44; resulting in limited understanding of the unique characteristics and outcomes of SB CD&#46;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">13</span></a> Furthermore&#44; clinical studies often analyze the impact of proximal lesions in a heterogenous population of CD&#44; without specifically examining the distinct features of SB CD with proximal disease&#46;<a class="elsevierStyleCrossRefs" href="#bib0140"><span class="elsevierStyleSup">5&#44;6&#44;14</span></a> Therefore&#44; in our study&#44; we aimed to comprehensively characterize patients diagnosed with SB CD who had undergone SBCE at the time of diagnosis and evaluate their outcomes&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Materials and methods</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Study design and patients selection</span><p id="par0025" class="elsevierStylePara elsevierViewall">The current work is a retrospective case-control study that included adult patients diagnosed with CD based on clinical&#44; radiologic&#44; endoscopic&#44; and histological criteria&#46; SBCE was performed as part of the diagnostic workup&#44; and only patients with a quantified Lewis Score &#40;LS&#41; were included&#46;<a class="elsevierStyleCrossRefs" href="#bib0165"><span class="elsevierStyleSup">10&#44;11&#44;15</span></a> The study period spanned from January 2012 to December 2021&#46; Patients with L1 &#40;with or without L4&#41; disease&#44; according to the Montreal classification&#44; were included&#44; while patients with colonic involvement or stricturing&#47;fistulizing phenotypes at presentation were excluded&#46; Incomplete SBCE examinations that did not reach the cecum within the designated time of the procedure were excluded&#44; and a minimum follow-up of 12 months after SBCE was required&#46; Therapeutic changes were carried out by the assistant physician&#44; guided by clinical&#44; analytical&#44; and endoscopic findings&#46; Demographic&#44; clinical and endoscopic data were collected through review of medical records&#46; Laboratory results were obtained from blood and fecal samples collected at the time of diagnosis&#46; Smoking history was considered positive for current and previous smokers&#46; Familial history was considered positive in the cases of first-degree relatives or in two or more second-degree relatives diagnosed with inflammatory bowel disease&#46; Patients with previous biological therapies for other conditions were excluded&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">SBCE procedure</span><p id="par0030" class="elsevierStylePara elsevierViewall">Either PillCam&#8482; SB2 &#40;January of 2012&#8211;December of 2013&#41; or SB3 &#40;January of 2014&#8211;December 2021&#41; &#40;Medtronic&#174;&#41; were used&#46; Patients with increased risk of capsule retention&#44; such as patients with obstructive symptoms&#44; history of SB resection or previously known strictures&#44; were excluded&#46; Enrolled patients were instructed to start a clear liquid diet 24<span class="elsevierStyleHsp" style=""></span>h before the procedure&#44; followed by fasting for 12<span class="elsevierStyleHsp" style=""></span>h prior to the SBCE ingestion&#46; Patients taking oral iron supplements were requested to suspend it 7 days before the SBCE&#46; Patients were allowed to ingest clear liquids 2<span class="elsevierStyleHsp" style=""></span>h after SBCE ingestion and to eat a light meal 4<span class="elsevierStyleHsp" style=""></span>h later&#44; after SBCE passage into the SB&#44; which was confirmed using the real-time viewer&#46; The SBCE videos were reviewed by gastroenterologists experienced in capsule reading &#40;&#62;500 reviews&#41;&#44; using the RAPID&#8482; Reader software&#46; The reading was performed at a maximum speed of 12 frames per second in a single-view mode&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Lewis score analysis</span><p id="par0035" class="elsevierStylePara elsevierViewall">The LS is a validated quantitative scoring system that takes into consideration the presence and distribution of villous edema&#44; ulceration&#44; and stenosis in the SB&#46;<a class="elsevierStyleCrossRefs" href="#bib0165"><span class="elsevierStyleSup">10&#44;11&#44;15</span></a> Each tertile is assessed and the tertile with the highest inflammation is considered for the final calculation&#46; A LS score of &#60;135 refers to normal or clinically insignificant mucosal inflammation&#44; while a score between 135 and 790 means mild inflammation&#46; A score &#8805;790 defines moderate-to-severe inflammation&#46; The LS for each SBCE examination was calculated using the integrated calculator within the RAPID&#8482; Reader software&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Statistical analysis</span><p id="par0040" class="elsevierStylePara elsevierViewall">Statistical analysis was performed using IBM&#174; SPSS&#174; Statistics 26&#46;0 software&#46; Categorical variables were presented as frequencies and percentages&#44; while continuous variables were reported as means and standard deviations &#40;SD&#41;&#46; Two-tailed <span class="elsevierStyleItalic">p</span> values were reported&#44; and statistical significance was considered when the <span class="elsevierStyleItalic">p</span>-value was less than 0&#46;05&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Chi-square or Fisher&#39;s exact test were used for categorical variables&#44; and Student <span class="elsevierStyleItalic">t</span>-test or Mann&#8211;Whitney <span class="elsevierStyleItalic">U</span> test were used for continuous variables&#46; The normality of continuous variables was assessed using the Kolmogorov&#8211;Smirnov test and histogram distribution analysis&#44; ensuring that assumptions of normality were met before applying parametric tests&#46; This study has undergone biostatistics review&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Ethical considerations</span><p id="par0050" class="elsevierStylePara elsevierViewall">This study has been approved by the ethics local committee&#46;</p></span></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Results</span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Patient cohorts</span><p id="par0055" class="elsevierStylePara elsevierViewall">Our study included 53 patients diagnosed with active SB CD&#46; For each patient&#44; the SBCE report at the time of diagnosis was analyzed to determine the total and tertile-specific LS in the SB&#46; Based on the findings&#44; patients were categorized into two groups&#58; those with inflammatory activity limited to the third tertile only &#40;referred to as T3 group&#41;&#44; and those with inflammatory activity in the third tertile as well as proximal involvement&#44; defined by the presence of inflammatory activity in the first and&#47;or second tertile &#40;referred to as Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 group&#41;&#46; Out of the total patient population&#44; 16 patients &#40;30&#46;2&#37;&#41; were included in the T3 group&#44; while 37 patients &#40;69&#46;8&#37;&#41; were included in the Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 group&#46; We explored whether there were any significant differences between these two groups at baseline &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Clinical presentation</span><p id="par0060" class="elsevierStylePara elsevierViewall">Common symptoms of CD at presentation&#44; including abdominal pain&#44; diarrhea&#44; and&#47;or weight loss&#44; were reported in 14 patients &#40;87&#46;5&#37;&#41; in the T3 group and 35 patients &#40;94&#46;6&#37;&#41; in the Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 group&#44; with no statistically significant difference between the two sets &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;575&#41;&#46; The sex distribution among both groups was similar&#44; with 68&#46;8&#37; of patients in the T3 group and 64&#46;9&#37; of patients in the Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 group being female &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;784&#41;&#46; There were no differences in family history of inflammatory bowel disease between groups &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;161&#41; or smoking status &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;342&#41;&#46; The age at diagnosis&#44; according to the Montreal Classification&#44; also showed no significant difference between the two groups &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;158&#41;&#46; However&#44; there was a trend toward patients diagnosed at a younger age in the Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 group &#40;26 patients&#44; 70&#46;3&#37;&#41; compared to the T3 group &#40;8 patients&#44; 50&#37;&#41;&#46; There were no significant differences in perianal disease between the two groups &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;575&#41;&#46; Extraintestinal manifestations were reported in 6 patients &#40;37&#46;5&#37;&#41; in the T3 group and 6 patients &#40;16&#46;2&#37;&#41; in the Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 group&#44; with a trend toward significance &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;089&#41;&#46;</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Inflammation severity</span><p id="par0065" class="elsevierStylePara elsevierViewall">Our study revealed that the Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 group exhibited a substantially higher risk of moderate-to-severe inflammation in the SB endoscopic assessment by capsule &#40;OR 4&#46;93&#44; 95&#37; CI&#58; 1&#46;3&#8211;18&#46;3&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;013&#41;&#46; Specifically&#44; the T3 group predominantly comprised patients with mild disease &#40;75&#37;&#44; 12 patients&#41;&#44; while the Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 group had a higher proportion of patients with moderate-to-severe disease &#40;62&#46;2&#37;&#44; 23 patients&#41;&#46; Interestingly&#44; in the Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 group&#44; the inflammatory activity quantified by the LS was mainly determined by the lesions observed in the third tertile&#44; which accounted for the tertile with the highest inflammation in 68&#37; of the patients&#44; and in another 22&#37;&#44; the third tertile had a similar degree of inflammation to the first and&#47;or second tertile&#46; These findings support the idea that proximal SB lesions are associated with higher disease activity overall&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">To further test our results&#44; we conducted an analysis that included patients with inflammatory activity in the first tertile and distal segments &#40;second and third tertiles&#41;&#44; comparing them to those with inflammation exclusively in the two distal tertiles&#46; Among the 24 patients with inflammatory activity in the first tertile and distal segments&#44; 8 &#40;33&#46;3&#37;&#41; had mild disease and 16 &#40;66&#46;7&#37;&#41; had moderate-to-severe disease&#46; Conversely&#44; among the 29 patients with inflammation limited to the two distal tertiles&#44; 18 &#40;62&#46;1&#37;&#41; had mild disease and 11 &#40;37&#46;9&#37;&#41; had moderate-to-severe disease&#46; Therefore&#44; proximal inflammation&#44; defined by CD lesions in the first tertile&#44; was significantly associated with an increased inflammatory burden &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;037&#41;&#46; These results further support our conclusion that proximal lesions are associated with more severe inflammation&#46;</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Laboratory measurements</span><p id="par0075" class="elsevierStylePara elsevierViewall">Analytical parameters&#44; including hemoglobin&#44; total leukocytes&#44; neutrophils&#44; lymphocytes&#44; platelets&#44; albumin&#44; iron studies&#44; and erythrocyte sedimentation rate&#44; did not show significant differences between the two groups&#46; However&#44; fecal calprotectin&#44; which is a well-established marker of mucosal intestinal inflammation&#44; was found to be significantly higher in the Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 group&#44; with levels of 653&#46;7<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>613<span class="elsevierStyleHsp" style=""></span>&#956;g&#47;g&#44; compared to the T3 group with levels of 351&#46;6<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>515<span class="elsevierStyleHsp" style=""></span>&#956;g&#47;g &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;033&#41;&#46; Additionally&#44; although borderline significant&#44; there was a strong trend toward higher levels of C-reactive protein &#40;CRP&#41; in the Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 group &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;064&#41;&#44; further suggesting higher level of inflammation in this group&#46;</p></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Patient outcomes</span><p id="par0080" class="elsevierStylePara elsevierViewall">There were no statistically significant differences in treatment strategies at diagnosis between the T3 and Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 groups&#44; as the use of systemic corticosteroids &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;903&#41;&#44; oral budesonide &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;152&#41;&#44; immunomodulators &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;743&#41;&#44; and biologics &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;661&#41; was similar&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">We aimed to assess whether there were differing outcomes between the T3 and Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 groups after the follow-up period&#44; based on disease severity&#46; In the moderate-to-severe disease category&#44; there were 4 patients &#40;14&#46;8&#37;&#41; in the T3 group and 23 patients &#40;85&#46;2&#37;&#41; in the Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 group &#40;<a class="elsevierStyleCrossRef" href="#sec0095">Supp&#46; Table 1</a>&#41;&#46; Conversely&#44; in the mild disease category&#44; there were 12 patients &#40;46&#46;2&#37;&#41; in the T3 group and 14 patients &#40;53&#46;8&#37;&#41; in the Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 group &#40;<a class="elsevierStyleCrossRef" href="#sec0095">Supp&#46; Table 2</a>&#41;&#46; Due to the asymmetrical distribution of patients with moderate-to-severe disease&#44; we performed a subgroup analysis focusing on patients with mild inflammatory activity&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">Within the mild disease&#44; the T3 and Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 groups had a similar follow-up period &#40;T3 group&#58; 5&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;2 years <span class="elsevierStyleItalic">vs</span>&#46; Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 group&#58; 5&#46;2<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>2&#46;6 years&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;797&#59; <a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#41;&#46; Notably&#44; over the years more patients in the Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 group with mild disease had need for treatment with biologics &#40;1 patient&#44; 8&#46;3&#37;&#44; T3 group <span class="elsevierStyleItalic">vs</span>&#46; 7 patients&#44; 50&#37;&#44; Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 group&#44; OR&#58; 11&#44; 95&#37; CI&#58; 1&#46;1&#8211;109&#46;7&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;036&#41;&#46; There were no differences between the two groups concerning disease phenotype progression&#44; the number of surgeries or hospitalizations due to CD&#46; Nevertheless&#44; clinical assessment and persistent inflammation indicated by analytical and&#47;or endoscopic findings in those with proximal lesions with mild disease warranted the initiation of biologics treatment&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia></span></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Discussion</span><p id="par0095" class="elsevierStylePara elsevierViewall">Our study aimed to understand distinctive factors of proximal SB CD and its impact on patient outcomes&#46; Data in the current work suggest that the presence of CD involving the proximal segments is associated with greater disease severity&#46; Furthermore&#44; in patients with mild disease&#44; we found that therapy intensification was necessary when proximal disease was established&#44; indicating the clinical significance of disease distribution in determining treatment strategies&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">We have utilized SBCE as the gold standard for disease evaluation in SB CD&#46; It maximizes the detection of duodenal and jejunal lesions&#44; and the use of established inflammatory scores&#44; such as the LS&#44; allow for segmental analysis of the SB&#44; providing a standardized approach to quantify inflammation in this region of the gastrointestinal tract&#46;<a class="elsevierStyleCrossRefs" href="#bib0150"><span class="elsevierStyleSup">7&#44;11</span></a> Moreover&#44; SBCE is particularly advantageous as it enables the detection of mild SB mucosal inflammatory lesions such as small ulcers and villous edema that may be missed in a cross-sectional examination&#46;<a class="elsevierStyleCrossRefs" href="#bib0195"><span class="elsevierStyleSup">16&#44;17</span></a> Therefore&#44; we believe that SBCE is an excellent option for a comprehensive evaluation of the SB and for assessing SB CD extension&#44; in the absence of stenosis&#46;</p><p id="par0105" class="elsevierStylePara elsevierViewall">To our knowledge&#44; this is the first study that specifically examines SB CD using SBCE at the time of diagnosis and analyzes the impact of the disease extent&#46; The purpose was to elucidate the role of proximal SB involvement in disease severity and outcome&#46; Hence&#44; we included only patients with CD affecting the SB and excluded those with any colonic inflammation&#44; as accumulating evidence suggests that ileal&#44; ileocolonic&#44; and colonic CD have distinct pathophysiological&#44; clinical&#44; and treatment features&#46;<a class="elsevierStyleCrossRefs" href="#bib0125"><span class="elsevierStyleSup">2&#44;18&#44;19</span></a> In addition&#44; we excluded patients with complications from long-standing untreated disease to minimize the effects of diagnostic delay in SB CD&#46; As a result&#44; we believe that the relatively homogeneous population of CD patients in our study who underwent standardized SB evaluation with SBCE provides additional strength and validity to our results&#46;</p><p id="par0110" class="elsevierStylePara elsevierViewall">There is compelling evidence indicating that proximal CD&#44; specifically lesions in the duodenum and jejunum&#44; is associated with a higher risk of clinical relapse&#44; therapy intensification&#44; and surgery&#46;<a class="elsevierStyleCrossRefs" href="#bib0140"><span class="elsevierStyleSup">5&#44;6&#44;12&#44;20</span></a> This underscores the clinical significance of addressing disease extension and location in the treatment of CD&#46; Our study revealed that lesions in the proximal SB segments are associated with more mucosal inflammation as evaluated by SBCE and supported by increased fecal calprotectin levels and a trend toward elevated C-reactive protein&#46; These findings may explain the worse outcomes observed in patients with proximal CD&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall">At present&#44; there is lack of understanding regarding the management of mild CD that is confined to specific regions of the gastrointestinal tract&#44; other than the ileum and right colon&#44; or among patients with extensive disease&#46;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">13</span></a> This means that individuals with mild SB CD may experience adequate treatment delay&#44; which can lead to disease progression&#46; To address this issue&#44; in our study&#44; we analyzed the outcomes of patients both in mild and moderate-to-severe disease subgroups&#46; The group distribution of patients with moderate-to-severe disease was inadequate for further analysis&#44; so we focused our analysis on patients with mild disease only&#46; Notably&#44; we observed significant changes in the treatment strategy for patients with mild disease that had proximal lesions&#44; with nearly half of the patients receiving biological therapy during the follow-up period&#46; These findings are of high importance&#44; given the limited knowledge regarding mild SB CD management&#44; and early treatment with a biological agent leads to better clinical efficacy compared to treatment with the same biological agent later in the disease course&#46;<a class="elsevierStyleCrossRefs" href="#bib0220"><span class="elsevierStyleSup">21&#8211;23</span></a></p><p id="par0120" class="elsevierStylePara elsevierViewall">While our study provides valuable insights into the association between proximal SB involvement in CD and clinical outcomes&#44; there are limitations&#46; It is a retrospective study conducted at a single center&#44; which may limit the generalizability of our findings&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">In conclusion&#44; our study emphasizes the importance of disease location in the behavior of SB CD&#46; Early initiation of biologic therapy may be beneficial in patients with proximal disease to improve clinical outcomes&#46; However&#44; randomized multicenter prospective studies are needed to validate and modify treatment algorithms for these subgroups of patients&#46;</p></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Funding</span><p id="par0130" class="elsevierStylePara elsevierViewall">The current study did not receive any funding from external sources&#46; The data utilized in this study was generated as part of routine clinical practice and collected from patient records&#46;</p></span><span id="sec0080" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0140">Author&#39;s contributions</span><p id="par0135" class="elsevierStylePara elsevierViewall">JCG&#58; conception and design of the study&#59; data collection&#59; statistical analysis under JM&#39;s supervision&#59; manuscript drafting&#46; CA&#58; data collection&#46; SX&#58; data collection&#46; JM&#58; data collection&#59; study supervision&#59; manuscript drafting&#46; MJM&#58; data collection&#46; BR&#58; conception and design of the study&#59; data collection&#46; JC&#58; conception and design of the study&#59; study supervision&#46; All authors contributed to data interpretation&#44; critically reviewed&#44; and approved the manuscript for submission&#46;</p></span><span id="sec0085" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0145">Data sharing</span><p id="par0140" class="elsevierStylePara elsevierViewall">Requests for sharing of de-identified data by third parties will&#44; after written request to the corresponding author&#44; be considered&#46; If the request is approved and a data access agreement is signed only de-identified data will be shared&#46;</p></span><span id="sec0090" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0150">Conflict of interest</span><p id="par0145" class="elsevierStylePara elsevierViewall">The authors do not have any conflicts of interest to declare&#46;</p></span></span>"
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        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Objective</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Crohn&#39;s disease &#40;CD&#41; is heterogeneous&#44; and proximal involvement in the small bowel &#40;SB&#41; is associated with worse outcomes&#46; Nonetheless&#44; studies on the impact of duodenal and jejunal lesions in SB CD are limited&#46; This study aimed to investigate the clinical characteristics and outcomes of individuals diagnosed with SB CD&#44; comparing those with and without proximal inflammation&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">A cohort of 53 treatment-naive SB CD patients that underwent Capsule Endoscopy at diagnosis were retrospectively selected&#46; The inflammatory activity was quantified using the Lewis Score for each SB tertile&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Thirty-seven &#40;69&#46;8&#37;&#41; patients displayed inflammatory activity in the first and&#47;or second tertile together with third tertile involvement &#40;Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 group&#41;&#46; Sixteen &#40;30&#46;2&#37;&#41; had inflammation in the third tertile only &#40;T3 group&#41;&#46; Individuals in the Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 group had a higher risk for moderate-to-severe inflammation &#40;OR 4&#46;93&#44; 95&#37; CI&#58; 1&#46;3&#8211;18&#46;3&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;013&#41;&#46; A subgroup analysis for those with mild inflammatory activity showed that individuals in the Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 group initiated biologic drugs more often &#40;OR 11&#44; 95&#37; CI&#58; 1&#46;1&#8211;109&#46;7&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;036&#41;&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusion</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Proximal SB lesions are associated with increased inflammatory activity&#44; necessitating more frequent use of biologics in patients with mild disease&#46; Early detection of proximal SB CD with Capsule Endoscopy may contribute to timely treatment&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
            "identificador" => "abst0005"
            "titulo" => "Objective"
          ]
          1 => array:2 [
            "identificador" => "abst0010"
            "titulo" => "Methods"
          ]
          2 => array:2 [
            "identificador" => "abst0015"
            "titulo" => "Results"
          ]
          3 => array:2 [
            "identificador" => "abst0020"
            "titulo" => "Conclusion"
          ]
        ]
      ]
      "es" => array:3 [
        "titulo" => "Resumen"
        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Objetivo</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">La enfermedad de Crohn &#40;EC&#41; es heterog&#233;nea&#44; y la inflamaci&#243;n proximal en el intestino delgado &#40;ID&#41; se asocia a un peor pron&#243;stico&#46; Sin embargo&#44; los datos sobre el impacto de las lesiones duodenales y yeyunales en la EC del ID son limitados&#46; Este trabajo tuvo como objetivo investigar las caracter&#237;sticas cl&#237;nicas y los resultados de individuos diagnosticados con EC del ID&#44; comparando aquellos con y sin inflamaci&#243;n proximal&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">M&#233;todos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Se seleccion&#243; retrospectivamente una cohorte de 53 pacientes con EC del ID sin tratamiento previo que se sometieron a c&#225;psula endosc&#243;pica en el momento del diagn&#243;stico&#46; La actividad inflamatoria se cuantific&#243; utilizando el Score de Lewis para cada tercio del ID&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Treinta y siete pacientes &#40;69&#44;8&#37;&#41; presentaron actividad inflamatoria en el primer y&#47;o segundo tercil junto con el tercer tercil &#40;grupo Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3&#41;&#46; Diecis&#233;is &#40;30&#44;2&#37;&#41; mostraron inflamaci&#243;n &#250;nicamente en el tercer tercil &#40;grupo T3&#41;&#46; Los individuos en el grupo Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 tuvieron un mayor riesgo de inflamaci&#243;n moderada a severa &#40;OR&#58; 4&#44;93&#59; IC<span class="elsevierStyleHsp" style=""></span>95&#37;&#58; 1&#44;3-18&#44;3&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;013&#41;&#46; Un an&#225;lisis de subgrupo para aquellos con actividad inflamatoria leve mostr&#243; que los individuos en el grupo Proximal<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>T3 iniciaron el tratamiento con f&#225;rmacos biol&#243;gicos con mayor frecuencia &#40;OR&#58; 11&#59; IC<span class="elsevierStyleHsp" style=""></span>95&#37;&#58; 1&#44;1-109&#44;7&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;036&#41;&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Las lesiones proximales se asocian a mayor actividad inflamatoria&#44; requiriendo un uso m&#225;s frecuente de biol&#243;gicos en la enfermedad leve&#46; La detecci&#243;n temprana de EC del ID con c&#225;psula endosc&#243;pica puede contribuir al tratamiento m&#225;s apropiado&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
            "identificador" => "abst0025"
            "titulo" => "Objetivo"
          ]
          1 => array:2 [
            "identificador" => "abst0030"
            "titulo" => "M&#233;todos"
          ]
          2 => array:2 [
            "identificador" => "abst0035"
            "titulo" => "Resultados"
          ]
          3 => array:2 [
            "identificador" => "abst0040"
            "titulo" => "Conclusiones"
          ]
        ]
      ]
    ]
    "apendice" => array:1 [
      0 => array:1 [
        "seccion" => array:1 [
          0 => array:4 [
            "apendice" => "<p id="par0155" class="elsevierStylePara elsevierViewall">The followings are the supplementary data to this article&#58;<elsevierMultimedia ident="upi0005"></elsevierMultimedia></p>"
            "etiqueta" => "Appendix A"
            "titulo" => "Supplementary data"
            "identificador" => "sec0100"
          ]
        ]
      ]
    ]
    "multimedia" => array:3 [
      0 => array:8 [
        "identificador" => "tbl0005"
        "etiqueta" => "Table 1"
        "tipo" => "MULTIMEDIATABLA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "detalles" => array:1 [
          0 => array:3 [
            "identificador" => "at1"
            "detalle" => "Table "
            "rol" => "short"
          ]
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        "tabla" => array:2 [
          "leyenda" => "<p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">In bold&#44; significant results &#40;p<span class="elsevierStyleHsp" style=""></span>&#60;0&#46;05&#41;&#46;</p>"
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                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">0&#46;158&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Montreal A2&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="char" valign="\n
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                  \t\t\t\t">8 &#40;50&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
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                  \t\t\t\t">26 &#40;70&#46;3&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Montreal A3&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="char" valign="\n
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                  \t\t\t\t">8 &#40;50&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">11 &#40;29&#46;7&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Perianal disease&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="char" valign="\n
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                  \t\t\t\t">2 &#40;12&#46;5&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">2 &#40;5&#46;4&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;575&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Extraintestinal manifestations&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">6 &#40;37&#46;5&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">6 &#40;16&#46;2&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;089&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " colspan="4" align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">Disease severity &#8211; Lewis score</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">OR&#58; 4&#46;93&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Mild &#40;135&#8211;789&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">12 &#40;75&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">14 &#40;37&#46;8&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">95&#37; CI&#58; 1&#46;3&#8211;18&#46;3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Moderate to severe &#40;&#8805;790&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">4 &#40;25&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">23 &#40;62&#46;2&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic"><span class="elsevierStyleBold">p</span></span><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleBold">&#61;</span><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleBold">0&#46;013</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " colspan="4" align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " colspan="4" align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">Analytical parameters</span></td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Hemoglobin &#40;g&#47;dL&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">14&#46;3<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">13&#46;9<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;7&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;349&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Total leukocytes &#40;&#215;10<span class="elsevierStyleSup">3</span>&#47;&#956;l&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">7&#46;96<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">7&#46;69<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>2&#46;4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;677&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Neutrophils &#40;&#215;10<span class="elsevierStyleSup">3</span>&#47;&#956;l&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">4&#46;63<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">4&#46;66<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;8&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;948&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Lymphocytes &#40;&#215;10<span class="elsevierStyleSup">3</span>&#47;&#956;l&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">2&#46;58<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;8&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">2&#46;29<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;83&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;364&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Platelets &#40;&#215;10<span class="elsevierStyleSup">3</span>&#47;&#956;l&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">297<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>72&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">285<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>102&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;659&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Albumin &#40;g&#47;dL&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">3&#46;96<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;44&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">3&#46;79<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>042&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;223&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Serum iron &#40;&#956;&#47;dL&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">101<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>29&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">92<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>40&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;415&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Total iron binding capacity &#40;&#956;&#47;dL&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">357<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>60&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">348<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>61&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;636&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Ferritin &#40;ng&#47;dL&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">138<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>138&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">93<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>106&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;151&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>C-reactive protein &#40;mg&#47;L&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">2&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>4&#46;9&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">9&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>15&#46;8&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;064&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Erythrocyte sedimentation rate &#40;mm&#47;h&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">10&#46;9<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>9&#46;6&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">14<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>11&#46;7&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;358&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
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                  \t\t\t\t">1 &#40;7&#46;1&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">1 &#40;7&#46;1&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t  " align="char" valign="\n
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ISSN: 02105705
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