Ferric carboxymaltose for anemia in Crohn’s disease patients at a tertiary center:A retrospective observational cohort study

BACKGROUND Although the gastrointestinal tract is the most affected by Crohn’s disease(CD),the condition triggers other consequent manifestations,and iron deficiency anemia(IDA)is one of the most common.Intravenous(IV)iron replacement is currently available through several drugs,such as ferric hydroxide sucrose and ferric carboxymaltose(FCM).However,the clinical management of these conditions can be challenging.AIM To elucidate the drug’s effectiveness,the present study analyzed,through medical records,the clinical and epidemiological data of a cohort of patients with active CD who received IV FCM for the IDA treatment.METHODS This retrospective observational study included 25 patients with active CD,severe anemia,and refractory to previous conventional treatments.Patients were evaluated two times:During the last treatment with ferric hydroxide sucrose and treatment with FCM.RESULTS After treatment with FCM,parameters of IDA assessment significantly improved,serum hemoglobin(Hb)levels increased in 93%of patients(P<0.0001),and in 44%,there was an increase of≥2 g/dL in a single application.In addition,86%of the patients showed an increase in serum iron(P<0.0001)and ferritin(P=0.0008)and 50%in transferrin saturation(P=0.01).The serum iron levels at baseline showed a negative association with the ileal and colonic CD and use of biologics and a positive association with patients who developed CD later in life after the age of 40(A3)and with a stenosing(B2)and fistulizing(B3)phenotype.The values of Hb and hematocrit after ferric hydroxide sucrose treatment remained similar to those found before treatment.CONCLUSION This study demonstrated that FCM is an important therapeutic strategy for treating IDA in CD patients,achieving satisfactory results in refractory cases.

A randomized,controlled,open label non-inferiority trial of intravenous ferric carboxymaltose versus iron sucrose in patients with iron deficiency anemia in China

Iron deficiency(ID)and ID anemia(IDA)pose significant public health concerns in China.Although iron sucrose(IS)treatment is well-established in the country,ferric carboxymaltose(FCM)offers the advantage of higher doses and fewer infusions.This open label,randomized,controlled,non-inferiority trial was conducted at multiple sites in China to compare the outcomes of FCM(maximum of 2 doses,500 or 1000 mg iron)and IS(up to 11 infusions,200 mg iron)treatments in subjects with IDA.The primary endpoint was the achievement of hemoglobin(Hb)response(an increase of⩾2 g/dL from baseline)within 8 weeks,whereas secondary endpoints included changes in Hb,transferrin saturation,and serum ferritin levels.Among the 371 randomized subjects,a similar percentage of subjects treated with FCM and IS achieved Hb-response(FCM 99.4%,IS 98.3%),thereby confirming the non-inferiority of FCM compared with IS(difference 1.12(−2.15,4.71;95%confidence interval(CI))).Furthermore,a significantly higher proportion of FCM-treated subjects achieved early Hb-response at Week 2(FCM 85.2%,IS 73.2%;difference 12.1(3.31,20.65;95%CI)).Additionally,the increase in TSAT and serum ferritin levels from baseline was significantly greater at all time points for FCM-treated subjects.The safety profiles of FCM and IS were comparable,with the exception of transient hypophosphatemia and pyrexia,which are consistent with FCM’s known safety profile.In conclusion,FCM proves to be an efficacious treatment for IDA,providing faster Hb-response and correction of ID with fewer administrations than IS.

Diagnosis and treatment of iron-deficiency anemia in gastrointestinal bleeding:A systematic review

BACKGROUND Anemia is considered a public health issue and is often caused by iron deficiency.Iron-deficiency anemia(IDA)often originates from blood loss from lesions in the gastrointestinal tract in men and postmenopausal women,and its prevalence among patients with gastrointestinal bleeding has been estimated to be 61%.However,few guidelines regarding the appropriate investigation of patients with IDA due to gastrointestinal bleeding have been published.AIM To review current evidence and guidelines concerning IDA management in gastrointestinal bleeding patients to develop recommendations for its diagnosis and therapy.METHODS Five gastroenterology experts formed the Digestive Bleeding and Anemia Workgroup and conducted a systematic literature search in PubMed and professional association websites.MEDLINE(via PubMed)searches combined medical subject headings(MeSH)terms and the keywords“gastrointestinal bleeding”with“iron-deficiency anemia”and“diagnosis”or“treatment”or“management”or“prognosis”or“prevalence”or“safety”or“iron”or“transfusion”or“quality of life”,or other terms to identify relevant articles reporting the management of IDA in patients over the age of 18 years with gastrointestinal bleeding;retrieved studies were published in English between January 2003 and April 2019.Worldwide professional association websites were searched for clinical practice guidelines.Reference lists from guidelines were reviewed to identify additional relevant articles.The recommendations were developed by consensus during two meetings and were supported by the published literature identified during the systematic search.RESULTS From 494 Literature citations found during the initial literature search,17 original articles,one meta-analysis,and 13 clinical practice guidelines were analyzed.Based on the published evidence and clinical experience,the workgroup developed the following ten recommendations for the management of IDA in patients with gastrointestinal bleeding:(1)Evaluation of hemoglobin and iron status;(2)Laboratory testing;(3)Target treatment population identification;(4)Indications for erythrocyte transfusion;(5)Treatment targets for erythrocyte transfusion;(6)Indications for intravenous iron;(7)Dosages;(8)Monitoring;(9)Indications for intravenous ferric carboxymaltose treatment;and(10)Treatment targets and monitoring of patients.The workgroup also proposed a summary algorithm for the diagnosis and treatment of IDA in patients with acute or chronic gastrointestinal bleeding,which should be implemented during the hospital stay and follow-up visits after patient discharge.CONCLUSION These recommendations may serve as a starting point for clinicians to better diagnose and treat IDA in patients with gastrointestinal bleeding,which ultimately may improve health outcomes in these patients.

patients with inflammatory bowel disease:Mechanisms and possible clinical impact

BACKGROUND High-dose intravenous iron is an effective treatment option for iron deficiency(ID)or ID anaemia(IDA)in inflammatory bowel disease(IBD).However,treatment with ferric carboxymaltose(FCM)has been associated with the development of hypophosphatemia.AIM To investigate mechanisms behind the development of hypophosphatemia after intravenous iron treatment,and disclose symptoms and clinical manifestations related to hypophosphatemia short-term.METHODS A prospective observational study of adult IBD patients with ID or IDA was conducted between February 1,2017 and July 1,2018 at two separate university hospitals in the southeast region of Norway.Patients received one dose of 1000 mg of either FCM or ferric derisomaltose(FDI)and were followed for an observation period of at least 7 wk.Blood and urine samples were collected for relevant analyses at baseline,week 2 and at week 6.Clinical symptoms were assessed at the same timepoints using a respiratory function test,a visual analogue scale,and a health-related quality of life questionnaire.RESULTS A total of 106 patients was available for analysis in this study.The FCM treatment group consisted of 52 patients and hypophosphatemia was present in 72.5%of the patients at week 2,and in 21.6%at week 6.In comparison,the FDI treatment group consisted of 54 patients and 11.3%of the patients had hypophosphatemia at week 2,and 3.7%at week 6.The difference in incidence was highly significant at both week 2 and 6(P<0.001 and P<0.013,respectively).We observed a significantly higher mean concentration of intact fibroblast growth factor 23(P<0.001),a significant rise in mean urine fractional excretion of phosphate(P=0.004),a significant decrease of 1,25-dihydroxyvitamin D(P<0.001)and of ionised calcium levels(P<0.012)in the FCM-treated patients compared with patients who received FDI.No clinical symptoms could with certainty be related to hypophosphatemia,since neither the respiratory function test,SF-36(36-item short form health survey)or the visual analogue scale scores resulted in significant differences between patients who developed hypophosphatemia or not.CONCLUSION Fibroblast growth factor 23 has a key role in FCM induced hypophosphatemia,probably by inducing loss of phosphate in the urine.Short-term clinical impact of hypophosphatemia was not demonstrated.