High burden of iron deficiency and different types of anemia in inflammatory bowel disease outpatients in Scandinavia: A longitudinal 2-year follow-up study Oral and intravenous iron treatment in inflammatory bowel disease: Hematological response and quality of life improvement Rapid Recurrence of IBD-Associated Anemia and Iron Deficiency After Intravenous Iron Sucrose and Erythropoietin Treatment High-dose intravenous treatment in iron deficiency anaemia in inflammatory bowel disease: early efficacy and impact on quality of life. Intravenous Iron Sucrose versus Oral Iron Supplementation for the Treatment of Iron Deficiency Anemia in Patients with Inflammatory Bowel Disease—A Randomized, Controlled, Open-Label, Multicenter Study A Novel Intravenous Iron Formulation for Treatment of Anemia in Inflammatory Bowel Disease: The Ferric Carboxymaltose (FERINJECT®) Randomized Controlled Trial Prediction of response to iron sucrose in inflammatory bowel disease-associated anemia Geriatric Inflammatory Bowel Disease: Phenotypic Presentation, Treatment Patterns, Nutritional Status, Outcomes, and Comorbidity Effect of Iron Therapy on Platelet Counts in Patients with Inflammatory Bowel Disease-Associated Anemia Oral ferrous fumarate or intravenous iron sucrose for patients with inflammatory bowel disease Safety and Efficacy of Total-Dose Infusion of Low Molecular Weight Iron Dextran for Iron Deficiency Anemia in Patients with Inflammatory Bowel Disease A 1-year trial of repeated high-dose intravenous iron isomaltoside 1000 to maintain stable hemoglobin levels in inflammatory bowel disease TREATMENT OF ANEMIA AND IMPROVEMENT OF QUALITY OF LIFE AMONG PATIENTS WITH CROHN'S DISEASE: experience using ferric carboxymaltose. A Randomized, Open-Label, Non-Inferiority Study of Intravenous Iron Isomaltoside 1,000 (Monofer) Compared With Oral Iron for Treatment of Anemia in IBD (PROCEED) FERGIcor, a randomized controlled trial on ferric carboxymaltose for iron deficiency anemia in inflammatory bowel disease. Presenting features of inflammatory bowel disease in Great Britain and Ireland Influence of inflammatory bowel disease on different dimensions of quality of life
Abstract Objective . The prevalence of anemia in inflammatory bowel disease ( IBD ) has been broadly described . The recurrence , type and burden of anemia remain unenlightened . The primary objective was to describe this . The secondary objective was to evaluate the implementation of European guidelines . Material s and methods . This longitudinal follow-up study included 300 IBD out patients from six centers in Sc and inavia . Patients were enrolled in a research cohort , in which each center included 5 % of their IBD cohort . The study was prospect ively planned , while data were retrospectively collected . The burden of anemia was calculated as number of months with anemia . A Markov model was used to calculate the probabilities of transitioning between stages . The European guidelines were used as the st and ard for anemia management . Results . Anemia affected > 50 % of IBD out patients during the 2-year observation period . Totally , 20 % of the total observation time was spent in anemia . Over the 7200 months of observation , anemia was found in 1410 months . The most frequent type was combined anemia ( 63 % ) . Combined anemia covers both anemia of chronic disease ( ACD ) and iron-deficiency anemia ( IDA ) . Pure ACD was present in 21 % of burden time , while pure IDA was present in 16 % of burden time . The European guidelines have mainly been implemented . Conclusion . Anemia affected a majority of the IBD out patients . One in five months , the patients were anemic . Anemia related to inflammation dominated the different types of anemia . Pure IDA was found in for 16 % . These findings , despite a fair implementation of guidelines Background : The aim was to evaluate the efficacy and tolerance of oral and intravenous iron treatment in anemic inflammatory bowel disease ( IBD ) patients , considering both hematological and quality ‐of‐life outcomes . Methods : We performed a prospect i ve multicenter study in IBD patients with iron deficiency anemia . Patients having hemoglobin > 10 g/dL were prescribed oral ferrous sulfate . If hemoglobin < 10 g/dL , intravenous ( sucrose ) iron was administered . Oral iron‐intolerant patients were changed to intravenous treatment .  Clinical ( Truelove/Harvey – Bradshaw ) , hematological ( response defined as hemoglobin normalization ) , and quality ‐of‐life ( shortened CCVEII‐9 question naire ) evaluations were performed at baseline and at 3 and 6 months . Results : 100 IBD patients ( 59 Crohn 's disease , 41 ulcerative colitis ) were included . Mean basal hemoglobin levels were 10.8 ± 1.3 g/dL ( range , 6.6–12.9 ) . Seventy‐eight patients received oral treatment and 22 intravenous iron .  Hemoglobin normalization was achieved in 86 % of patients : 89 % with oral , and 77 % with intravenous iron . An IBD activity increase was not demonstrated in any patient . Four patients ( 5.1 % ) showed oral iron intolerance leading to discontinuation of treatment . No adverse events were reported for intravenous iron  . Hemoglobin correlated with CCVEII‐9 ( P < 0.001 ) . The CCVEII‐9 score increased in patients who normalized hemoglobin levels in 3 months ( from 58 ± 9 to 73 ± 10 ) or 6 months ( 54 ± 9 , 68 ± 12 , and 74 ± 10 ) ( P < 0.001 ) . Conclusions : Oral iron treatment is effective and well tolerated in most IBD patients , and does not exacerbate the symptoms of the underlying IBD . Intravenous iron , on the other h and , is an effective and safe alternative treatment for iron deficiency anemia in more severely anemic or intolerant patients . Anemia correction with iron treatment is associated with a relevant improvement in the patients ' quality of life . ( Inflamm Bowel Dis 2009 OBJECTIVES : Anemia is a common complication of inflammatory bowel disease ( IBD ) and iron deficiency ( ID ) is its predominant cause . Therefore , oral and intravenous iron replacements are widely used . This study was performed to evaluate the frequency and timing of anemia and ID recurrence after a successful treatment cycle . METHODS : Medical records of patients who had received iron sucrose with or without erythropoietin ( EPO ) in one of three prospect i ve clinical trials that had been conducted at our center ( Ann Intern Med 1997 , Digestion 1999 , and Am J Gastroenterol 2001 ) were analyzed for a 5-year follow-up period . The risk for recurrence of anemia ( hemoglobin (Hb)<12/13 g per 100 ml ) and ID ( ferritin < 30 μg/l ) was evaluated by Kaplan – Meier analysis using the log-rank test . RESULTS : Eighty-eight patients were available for analysis . Patients had received a mean iron dose of 2,500 mg ( range 600–3,600 mg ) ; 33 ( 37.1 % ) patients had also received EPO . Anemia recurred in a median of 10 months ( 95 % confidence interval ( CI ) 8–12 ) and ID recurred within 19 months ( 95 % CI 11–28 ) . The iron dose had no influence on recurrence of ID or anemia . ID ( but not anemia ) recurred faster in patients with a post-treatment ferritin level < 100 μg/l ( median 4 months , 95 % CI 1–7 ) than in patients with ferritin level between 100 and 400 μg/l ( median 11 months , 95 % CI 6–16 ) and > 400 μg/l ( median 49 months , 95 % CI 32–66 ; P<0.001 ) . CONCLUSIONS : IBD-associated ID and anemia recur surprisingly fast , indicating that maintenance treatment may be needed in a portion of the patient population . Recurrence of ID ( but not anemia ) can be delayed by aim ing for high post-treatment ferritin levels BACKGROUND Anaemia and iron deficiency are very common in inflammatory bowel disease . Clinical trials have shown intravenous iron to be effective and well tolerated . However , published experience in clinical practice with specific evaluation of the effect on quality of life is limited . MATERIAL AND METHODS We carried out a prospect i ve , multicentre , observational study on the effects of ferric carboxymaltose in the treatment of iron deficiency anaemia in inflammatory bowel disease . Anaemia and iron deficiency were defined according to World Health Organization criteria . Efficacy and safety were evaluated at infusion , at 2 weeks and at 12 weeks . Quality of life was evaluated according to the SIBDQ-9 index . Complete response was defined as anaemia correction or more tan 2 g/dL increase in haemoglobin . RESULTS A total of 88 courses of ferric carboxymaltose in 72 patients were evaluated . Complete response was observed in 46 % of patients at week 2 , and 81.2 % at week 12 . Quality of life improved significatively at week 2 in both complete responders and partial responders ( p<0.0005 ) ; complete responders showed siginficantly better response ( p=0.016 ) . No predictive factor was identified . Only one transient adverse effect was observed ; however , this was severe . DISCUSSION Ferric carboxymaltose showed comparable efficacy to that demonstrated in clinical trials . After only two weeks of treatment , there was a significant improvement in quality of life , with a greater effect observed in those patients with a complete haematologic response . Intravenous iron can very quickly improve quality of life in inflammatory bowel disease OBJECTIVES : Anemia is a frequent complication in patients with inflammatory bowel disease ( IBD ) . The optimal route for iron supplementation to replenish iron stores has not been determined so far . We therefore evaluated the efficacy and safety of intravenous iron sucrose as compared with oral iron sulfate for the treatment of iron deficiency anemia ( IDA ) in patients with IBD . METHODS : A r and omized , prospect i ve , open-label , multicenter study was performed in 46 patients with anemia and transferrin saturation ≤20 % and /or serum ferritin concentrations ≤20 μg/L. The intravenous group received a single dose of iron sucrose of 7 mg iron/kg body weight , followed by five 200 mg infusions for the following 5 wks . The oral group received iron sulfate 100–200 mg per day for 6 wks . RESULTS : While a comparable increase in hemoglobin was observed for both administration routes ( median increase 0.25 g/L in the intravenous group vs 0.21 g/L in the oral group ) , only iron sucrose led to a rise in serum ferritin concentrations . Intractable gastrointestinal adverse events caused permanent study drug discontinuation in five patients ( 20.8 % ) receiving iron sulfate , whereas only one patient ( 4.5 % ) had to be withdrawn because of side effects due to iron sucrose . CONCLUSIONS : Although being equal in short-term efficacy and overall tolerability our results suggest a better gastrointestinal tolerability for iron sucrose . Larger trials are m and atory to prove a possible advantage of iron sucrose in short- and long-term efficacy as well as in tolerability over iron sulfate in the management of IDA in IBD BACKGROUND AIMS : Anemia is a common complication of inflammatory bowel diseases ( IBD ) This multicenter study tested the noninferiority and safety of a new intravenous iron preparation , ferric carboxymaltose ( FeCarb ) , in comparison with oral ferrous sulfate ( FeSulf ) in reducing iron deficiency anemia ( IDA ) in IBD . METHODS : Two hundred patients were r and omized in a 2:1 ratio ( 137 FeCarb:63 FeSulf ) to receive FeCarb ( maximum 1,000 mg iron per infusion ) at 1-wk intervals until the patients ' calculated total iron deficit was reached or FeSulf ( 100 mg b.i.d . ) for 12 wk . The primary end point was change in hemoglobin ( Hb ) from baseline to week 12 . RESULTS : The median Hb improved from 8.7 to 12.3 g/dL in the FeCarb group and from 9.1 to 12.1 g/dL in the FeSulf group , demonstrating noninferiority ( P = 0.6967 ) . Response ( defined as Hb increase of > 2.0 g/dL ) was higher for FeCarb at week 2 ( P = 0.0051 ) and week 4 ( P = 0.0346 ) . Median ferritin increased from 5.0 to 323.5 μg/L at week 2 , followed by a continuous decrease in the FeCarb group ( 43.5 μg/L at week 12 ) . In the FeSulf group , a moderate increase from 6.5 to 28.5 μg/L at week 12 was observed . Treatment-related adverse events ( AEs ) occurred in 28.5 % of the FeCarb and 22.2 % of the FeSulf groups , with discontinuation of study medication due to AEs in 1.5 % and 7.9 % , respectively . CONCLUSIONS : FeCarb is effective and safe in  IBD-associated anemia  . It is noninferior to FeSulf in terms of Hb change over 12 wk , and provides a fast Hb increase and a sufficient refill of iron stores OBJECTIVE : Inflammatory bowel disease (IBD)-associated anemia responds to i.v . iron therapy . However , because of concurrent chronic inflammation , some patients do not respond adequately . Erythropoietin therapy has been shown to be effective in the latter cohort . Our goal was to find parameters that can predict the effectiveness of iron sucrose in IBD-associated anemia . METHODS : One hundred three patients with severe IBD-associated anemia ( Hb ≤ 10.5 g/dl ) were treated prospect ively for 4 wk with iron sucrose ( total iron dose = 1.2 g ) in an open label , multicenter trial . Treatment response was defined as an increase in Hb of ≥2.0 g/dl . A logistic regression analysis was performed with treatment response as the dependent variable and the following independent variables : serum erythropoietin , mean corpuscular Hb , transferrin , ferritin , soluble transferrin receptor ( sTfR ) , C-reactive protein , interleukin 6 ( IL-6 ) , and disease activity . RESULTS : Sixty-seven of 103 patients ( 65 % ) responded to iron sucrose . From the variables under investigation , erythropoietin , sTfR , transferrin , and IL-6 were significantly associated with treatment response . The R2 values showed that erythropoietin ( 8.0 % ) , sTfR ( 11.4 % ) , and transferrin ( 10.4 % ) , but not IL-6 ( 1.3 % ) , contribute a relevant amount of information to the model . An estimated 80 % probability of treatment response was found at erythropoietin levels of > 166 U/L , sTfR levels of > 75 nmol/L , or transferrin levels of > 3.83 g/L. CONCLUSIONS : Serum erythropoietin , sTfR , and transferrin concentrations have the potential to predict the response to iron sucrose therapy in IBD-associated anemia . These parameters may help to identify individuals who benefit the most from additional erythropoietin treatment Background and Aims The U.S. population is aging and the burden of geriatric inflammatory bowel disease ( IBD ) patients has increased . Systematic data describing phenotypic presentation , treatment regimens , outcomes and comorbidities in elderly IBD patients is limited . We performed a retrospective observational study of IBD patients age ≥65 followed in a 20-hospital system to determine patterns of phenotypic presentation , treatment , polypharmacy , nutritional status and comorbidity . Methods Data were extracted from electronic medical record based on ICD-9 coding/indexed terms on Crohn ’s disease ( CD ) and ulcerative colitis ( UC ) patients . Results A total of 393 geriatric IBD patients were identified ( 49.1 % males ; 50.9 % females ; 61.8 % UC ; 38.2 % CD ; 73.4 ± 6.6 years old ) . Younger age at diagnosis of CD ( ≤64 ) was associated with greater prevalence of small bowel surgeries ( 63.6 % ) compared with those diagnosed after age ≥65 ( 20.9 % ) ( p < 0.005 ) . Fistulizing/penetrating disease was frequent in patients diagnosed with CD at a younger age ( 43.6 % compared to 7 % ) ( p < 0.005 ) . IBD maintenance treatment included : 44 % 5-ASA agents ; 31.6 % maintenance prednisone ( defined as ≥6 months treatment duration ) ; 4.8 % steroid suppositories ; 5.6 % 6MP/azathioprine ; 1.3 % methotrexate ; 1.3 % adalimumab ; 1.3 % infliximab ; 9.4 % loperamide/diphenoxylate/atropine ; 0.5 % had no IBD medications . Longer duration of CD disease correlated with vitamin B12 , vitamin D and iron deficiency . Conclusion Geriatric patients diagnosed with CD earlier in life  had greater small bowel involvement compared with new onset geriatric CD . There is low utilization of immunomodulator and biologic agents in geriatric IBD patients  . Duration of CD correlates with nutrient deficiency . Prospect i ve studies are warranted in this respect Background and Aims Secondary thrombocytosis is a clinical feature of unknown significance . In inflammatory bowel disease ( IBD ) , thrombocytosis is considered a marker of active disease ; however , iron deficiency itself may trigger platelet generation . In this study we tested the effect of iron therapy on platelet counts in patients with IBD-associated anemia . Methods Platelet counts were analyzed before and after iron therapy from four prospect i ve clinical trials . Further , changes in hemoglobin , transferrin saturation , ferritin , C-reactive protein , and leukocyte counts , before and after iron therapy were compared . In a subgroup the effect of erythropoietin treatment was tested . The results were confirmed in a large independent cohort ( FERGIcor ) . Results A total of 308 patient records were available for the initial analysis . A dose-depended drop in platelet counts ( mean 425 G/L to 320 G/L ; p<0.001 ) was found regardless of the type of iron preparation ( iron sulphate , iron sucrose , or ferric carboxymaltose ) . Concomitant erythropoietin therapy as well as parameters of inflammation ( leukocyte counts , C-reactive protein ) had no effect on the change in platelet counts . This effect of iron therapy on platelets was confirmed in the FERGIcor study cohort ( n=448 , mean platelet counts before iron therapy : 383 G/L , after : 310 G/L , p<0.001 ) . Conclusion Iron therapy normalizes elevated platelet counts in patients with IBD-associated anemia . Thus , iron deficiency is an important pathogenetic mechanism of secondary thrombocytosis in IBD Objective . Iron therapy may reinforce intestinal inflammation by catalysing production of reactive oxygen species . The effects of oral ferrous fumarate and intravenous iron sucrose on clinical disease activity and plasma redox status were investigated in patients with inflammatory bowel disease ( IBD ) . Material and methods . Nineteen patients with iron deficiency anaemia and Crohn 's disease ( 11 ) or ulcerative colitis ( 8) were included in a crossover study . The patients were r and omly assigned to start treatment with ferrous fumarate ( Neo-fer ® ) 120 mg orally once daily or iron sucrose ( Venofer ® ) 200 mg intravenously 3 times during a period of 14 days . Clinical disease activity assessment and blood and faecal analysis were performed on days 1 and 15 . Results . Following oral ferrous fumarate  clinical disease activity ( p=0.037 ) , general well-being score ( i.e. patients felt worse ) ( p=0.027 ) and abdominal pain score ( p=0.027 ) increased , while no changes were seen following iron sucrose  treatment . C-reactive protein ( CRP ) and faecal calprotectin were unchanged after both treatments . As compared with iron sucrose , ferrous fumarate  increased Crohn 's disease activity index ( CDAI ) scores of general well-being ( p=0.049 ) , whereas alterations in clinical disease activity ( p=0.14 ) and abdominal pain score ( p=0.20 ) did not differ . Ferrous fumarate did not significantly alter plasma malondialdehyde ( MDA ) or plasma antioxidants . Iron sucrose  increased plasma MDA ( p=0.004 ) and decreased plasma vitamin C ( p=0.017 ) and betacarotene ( p=0.008 ) . Conclusions . Oral ferrous fumarate , but not intravenous iron sucrose , increased clinical disease activity in IBD patients .  Intravenous iron sucrose  increased intravascular oxidative stress Background Intravenous iron has been suggested as a safe and effective treatment of anemia complicating inflammatory bowel disease ( IBD ) .  Low molecular weight ( LMW ) iron dextran has the ability to administer the patient ’s total iron requirement in a single infusion . Aims The aim of this study was to assess the safety and efficacy of the total dose of LMW iron dextran infusion for the treatment of iron deficiency in IBD . Methods Fifty IBD patients ( 27 female , 35 Crohn ’s disease , 15 ulcerative colitis ) were included in the study . Mean ± st and ard deviation ( SD ) hemoglobin and ferritin levels before the infusion were 9.88 ± 1.42 g/dl and 13.9 ± 10.9 ng/ml , respectively . A 25-mg test dose was followed by infusion of the total dose of LMW iron dextran based on the iron deficit . Several clinical and laboratory parameters were measured before and on week 4 after infusion . Results Four patients ( 8 % ) developed adverse reactions during the test infusion and did not receive the total-dose infusion . Only one patient developed an allergic reaction during the total-dose infusion . In the remaining 45 patients , the mean ± SD iron dose that was given was 1,075 ± 269 mg . The mean ± SD elevation of hematocrit and hemoglobin on week 4 was 4.9 ± 1.9 % and 1.7 ± 0.8 g/dl , respectively . Hematopoietic response was observed in 23 of 45 patients ( 51.1 % ) . Conclusion Total parenteral iron replacement with LMW iron dextran is an easy , safe , and effective alternative method for treating iron deficiency anemia in IBD . Harmless adverse reactions may develop in a minority of patients Abstract Objective . Iron isomaltoside 1000 ( Monofer ® ) is a high-dose intravenous ( IV ) iron , which in a recent 8 weeks trial in inflammatory bowel disease ( IBD ) subjects with iron deficiency anemia ( IDA ) demonstrated good tolerability and efficacy . The present trial is an extension to this trial , which evaluates the need for additional high IV iron doses to maintain a stable hemoglobin ( Hb ) ≥12.0 g/dl . Material and methods . This was a prospect i ve , open-label , 12 months trial of European IBD subjects willing to participate after completing the lead-in trial . Subjects were allowed re-dosing with 500–2000 mg single doses of iron isomaltoside 1000 infused over ∼15 min at 3 months intervals depending on a predefined algorithm . Outcome measures included Hb , safety parameters and need for additional iron dosing . Results . A total of 39 subjects were enrolled of which 34 subjects required re-dosing with a median cumulative 1-year dose of 1.8 g ( mean cumulative dose 2.2 g ) . The mean ( SD ) Hb was 12.3 ( 1.5 ) g/dl at baseline , 12.8 ( 1.6 ) g/dl at 3 months , 12.8 ( 1.6 ) g/dl at 6 months , 12.9 ( 1.4 ) g/dl at 9 months and 12.9 ( 1.6 ) g/dl at 12 months . Seventy-four percent of subjects who had an Hb ≥12.0 g/dl at baseline were able to maintain Hb ≥12.0 g/dl till the end of the trial at 12 months . Nonserious probably related hypersensitivity reactions without significant hypotension were reported at the beginning of the infusion in two subjects , who recovered without sequelae . Conclusion . Repeated treatment of iron deficiency with iron isomaltoside 1000 could avoid episodes of IDA without major safety issues . Trial registration : Clinical Trial.gov identifier : NCT01410435 OBJECTIVES Anemia is the most common hematological alteration in patients with Crohn 's disease , and is frequently related to intestinal inflammatory activity . Its cause is multifactorial and mostly associated with absolute iron deficiency ( iron deficiency anemia ) and /or functional iron deficiency ( inflammation anemia or anemia of chronic disease ) . It may also be identified through other causes , such as folic acid or vitamin B12 deficiency and secondary to adverse effects from medications ( salicylic derivatives and immunosuppressive drugs ) . In the present study , patients with active Crohn 's disease and anemia were evaluated and treated with intravenous ferric carboxymaltose . We discuss the therapeutic schemes ( doses ) , safety , results and improvement of quality of life . METHODS In the present prospect i ve study , 10 consecutive patients with Crohn 's disease , with moderate to severe activity , with anemia ( Hb : 6.7 to 10 g/dL ) , who were attended between March 2014 and March 2015 , were evaluated . Six ( 60 % ) were men and four were women , all with moderate or severe anemia ( hemoglobin < 10 g/dL ) . They were treated with a maximum of three intravenous infusions of 1000 mg of ferric carboxymaltose , of at least 15 minutes in duration . It was also sought to correlate the inflammatory Crohn 's disease activity degree ( measured using the Crohn 's Disease Activity Index , CDAI ) and C-reactive protein level with the severity of anemia . The primary outcome was an increase in Hb of ≥2 g/dL and the secondary outcome was the normalization of anemia ( Hb ≥12 g/dL for women and ≥13 g/dL for men ) and the improvement in quality of life seen 12 weeks after the last application of carboxymaltose . RESULTS Among the 10 patients studied , parenteral iron supplementation was administered in three cases during hospitalization and the others received this on an outpatient basis . The total iron dose ranged from 1,000 to 2,000 mg , with an average of 1,650 mg . Crohn 's disease activity measured using CDAI and C-reactive protein correlated with the intensity of anemia . An increase of 2 g/dL occurred in eight ( 80 % ) patients after 12 weeks and normalization of anemia was found in seven ( 70 % ) patients . Improvements in quality -of-life scores were found for all ( 100 % ) patients after 12 weeks . Carboxymaltose was well tolerated . Three patients presented adverse reactions ( two with nausea and one with headache ) of mild intensity . CONCLUSIONS Anemia is a frequent complication for Crohn 's disease patients . Intravenous iron therapy has been recommended for Crohn 's disease patients , because for these patients , oral iron absorption is very limited . This is because of the inflammatory state and " blocking " of iron entry into enterocytes through hepcidin action on ferroportin , along with the elevated rates of gastrointestinal adverse events that compromise adherence to treatment and possibly aggravate the intestinal inflammatory state . The degree of Crohn 's disease activity , as measured using CDAI and C-reactive protein , correlates with the severity of anemia .  Carboxymaltose is a safe drug , which can be administrated in high doses ( up to 1,000 mg per application per week ) and corrects anemia and iron stocks over a short period of time , with consequent improvement in quality of life OBJECTIVES : In the largest head-to-head comparison between an oral and an intravenous ( IV ) iron compound in patients with inflammatory bowel disease ( IBD ) so far , we strived to determine whether IV iron isomaltoside 1,000 is non-inferior to oral iron sulfate in the treatment of iron deficiency anemia ( IDA ) . METHODS : This prospect i ve , r and omized , comparative , open-label , non-inferiority study was conducted at 36 sites in Europe and India . Patients with known intolerance to oral iron were excluded . A total of 338 IBD patients in clinical remission or with mild disease , a hemoglobin ( Hb ) < 12 g/dl , and a transferrin saturation ( TSAT ) < 20 % were r and omized 2:1 to receive either IV iron isomaltoside 1,000 according to the Ganzoni formula ( 225 patients ) or oral iron sulfate 200 mg daily ( equivalent to 200 mg elemental iron ; 113 patients ) . An interactive web response system method was used to r and omize the eligible patient to the treatment groups . The primary end point was change in Hb from baseline to week 8 . Iron isomaltoside 1,000 and iron sulfate was compared by a non-inferiority assessment with a margin of −0.5 g/dl . The secondary end points , which tested for superiority , included change in Hb from baseline to weeks 2 and 4 , change in s-ferritin , and TSAT to week 8 , number of patients who discontinued study because of lack of response or intolerance of investigational drugs , change in total quality of life ( QoL ) score to weeks 4 and 8 , and safety . Exploratory analyses included a responder analysis ( proportion of patients with an increase in Hb ≥2 g/dl after 8 weeks ) , the effect of regional differences and total iron dose level , and other potential predictors of the treatment response . RESULTS : Non-inferiority in change of Hb to week 8 could not be demonstrated . There was a trend for oral iron sulfate being more effective in increasing Hb  than iron isomaltoside 1,000 . The estimated treatment effect was −0.37 ( 95 % confidence interval ( CI ) : −0.80 , 0.06 ) with P=0.09 in the full analysis set ( N=327 ) and −0.45 ( 95 % CI : −0.88 , −0.03 ) with P=0.04 in the per protocol analysis set ( N=299 ) . In patients treated with IV iron isomaltoside 1,000 , the mean change in s-ferritin concentration was higher with an estimated treatment effect of 48.7 ( 95 % CI : 18.6 , 78.8 ) with P=0.002 , whereas the mean change in TSAT was lower with an estimated treatment effect of −4.4 ( 95 % CI : −7.4 , −1.4 ) with P=0.005 , compared with patients treated with oral iron . No differences in changes of QoL were observed . The safety profile was similar between the groups . The proportion of responders with Hb ≥2 g/dl ( IV group : 67 % ; oral group : 61 % ) were comparable between the groups ( P=0.32 ) . Iron isomaltoside 1,000 was more efficacious with higher cumulative doses of > 1,000 mg IV . Significant predictors of Hb response to IV iron treatment were baseline Hb and C-reactive protein ( CRP ) . CONCLUSIONS : We could not demonstrate non-inferiority of IV iron isomaltoside 1,000 compared with oral iron in this study . Based on the dose – response relationship observed with the IV iron compound , we suggest that the true iron dem and of IV iron was underestimated by the Ganzoni formula in our study . Alternative calculations including Hb and CRP should be explored to gauge iron stores in patients with IBD BACKGROUND & AIMS Iron deficiency anemia ( IDA ) is common in chronic diseases and intravenous iron is an effective and recommended treatment . However , dose calculations and inconvenient administration may affect compliance and efficacy . We compared the efficacy and safety of a novel fixed-dose ferric carboxymaltose regimen ( FCM ) with individually calculated iron sucrose ( IS ) doses in patients with inflammatory bowel disease ( IBD ) and IDA . METHODS This r and omized , controlled , open-label , multicenter study included 485 patients with IDA ( ferritin < 100 μg/L , hemoglobin [ Hb ] 7 - 12 g/dL [ female ] or 7 - 13 g/dL [ male ] ) and mild-to-moderate or quiescent IBD at 88 hospitals and clinics in 14 countries . Patients received either FCM in a maximum of 3 infusions of 1000 or 500 mg iron , or Ganzoni-calculated IS dosages in up to 11 infusions of 200 mg iron . Primary end point was Hb response ( Hb increase ≥ 2 g/dL ) ; secondary end points included anemia resolution and iron status normalization by week 12 . RESULTS The results of 240  FCM-treated and 235 IS-treated patients were analyzed . More patients with FCM than IS achieved Hb response ( 150 [ 65.8 % ] vs 118 [ 53.6 % ] ; 12.2 % difference , P = .004 ) or Hb normalization ( 166 [ 72.8 % ] vs 136 [ 61.8 % ] ; 11.0 % difference , P = .015 ) . Both treatments improved quality of life scores by week 12 . Study drugs were well tolerated and drug-related adverse events were in line with drug-specific clinical experience . Deviations from scheduled total iron dosages were more frequent in the IS group . CONCLUSIONS The simpler FCM-based dosing regimen showed better efficacy and compliance , as well as a good safety profile , compared with the Ganzoni-calculated IS dose regimen Background : Reports from individual referral centres suggest that a significant proportion of children with inflammatory bowel disease ( IBD ) present after prolonged delays and with impaired growth . Aims : To prospect ively document the presenting features , delay in presentation , disease localisation , and growth in newly diagnosed cases of IBD . Methods : For 13 months , between June 1998 and June 1999 , 3247 paediatricians , adult gastroenterologists , and surgeons across the UK and Irel and were prospect ively surveyed each month and asked to report every newly diagnosed case of childhood IBD . Results : A total of 739 new IBD cases aged less than 16 years were identified . Only one quarter of Crohn ’s disease ( CD ) cases presented with the “ classic triad ” of diarrhoea , weight loss , and abdominal pain ; nearly half did not report diarrhoea . The median delay from onset of symptoms to diagnosis was 5 months ( mean 11 months ) , with one fifth having symptoms of more than one year . Delays were most common in CD and in younger children .  Short stature was noted only in those with CD and not with ulcerative colitis . One fifth of CD cases had disease activity in the jejunum and this group had significantly reduced stature . Ileo-colonic involvement was documented in most CD cases , with only a small minority having isolated ileal or isolated colonic disease . Pan-colitis was reported in most UC cases , with very few having only an isolated proctitis . Conclusions : Many children are diagnosed after prolonged delays and have growth failure . Improved knowledge of the presenting features of IBD , and earlier investigation of suspected cases , may help reduce the delays noted Objective To establish the impairment of different dimensions of quality of life in inflammatory bowel disease ( IBD ) . Design Prospect i ve observational study . Participants 289 patients [ 160 with ulcerative colitis ( UC ) and 129 with Crohn 's disease ( CD ) ] . Measures Health-related quality of life was assessed by means of the  Inflammatory Bowel Disease Question naire ( IBDQ ) and the Psychological General Well Being Index ( PGWBI ) . Results In active IBD , all dimensions of the quality of life scored significantly lower than in inactive IBD , indicating a poor quality of life . Social impairment was the least impaired dimension of the IBDQ in active UC and CD , compared with digestive and systemic symptoms . In inactive IBD , the systemic symptoms domain received the lowest score ( P < 0.01 ) . In a subgroup of 22 patients studied before and after remission , emotional function was the most impaired dimension after achieving remission . The Psychological General Well Being Index was significantly impaired in active UC [ 78.5 ( range 64–89 ) ] and CD [ 76.5 ( range 69–97 ) ] relative inactive IBD [ 104 ( range 93–111 ) ] vs 106 ( 95–113 ) , respectively;P < 0.05 ] . Conclusions Quality of life is impaired in IBD . During relapse , clinicians should pay attention to digestive symptoms and psychological distress . In remission , they should be sensitive to systemic symptoms
However , in patients with IBD flares and inadequate responses to or side effects with oral preparations , intravenous iron supplementation is the therapy of choice .
Neither oral nor intravenous therapy seems to exacerbate the clinical course of IBD , and intravenous iron therapy can be administered even in active disease stages and concomitantly with biologics .
Based on the data presented , oral iron therapy should be preferred for patients with quiescent disease stages and trivial iron deficiency  anemia unless such patients are intolerant or have an inadequate response , whereas intravenous iron supplementation may be of advantage in patients with aggravated anemia or flares of IBD because inflammation hampers intestinal absorption of iron
Abstract Anemia is the most frequent complication of inflammatory bowel disease ( IBD ) , but anemia , mostly due to iron deficiency , has long been neglected in these patients .
The aim was to briefly present the pathophysiology , followed by a balanced overview of the different forms of iron replacement available , and subsequently , to perform a systematic review of studies performed in the last decade on the treatment of iron-deficiency anemia in IBD .