Ferric Carboxymaltose Improves the Quality of Life of Patients with Inflammatory Bowel Disease and Iron Deficiency without Anaemia.

Background: Iron deficiency (ID) without anaemia is a common comorbidity associated with inflammatory bowel disease (IBD) that has a negative impact on health-related quality of life (HRQoL). Methods: This multicentre, prospective, observational study examined the response to, safety of and impact on HRQoL of a single 500 mg dose of intravenous ferric carboxymaltose (FCM) in patients with IBD and ID without anaemia. The diagnostic criteria for ID were low serum ferritin (<30 µg/L in the absence of inflammatory activity or <100 µg/L with inflammation) and transferrin saturation index (TSAT) < 16%. The effect on iron levels and HRQoL, according to the health status questionnaires SF-12v2 and EQ-5D, was evaluated 1 month after FCM infusion in an outpatient setting. Results: Of the 105 patients who received FCM, 98 patients completed the study. After 1 month, a single dose of FCM significantly increased serum ferritin, serum iron and TSAT. Importantly, patients reported fewer ID symptoms and problems on all EQ-5D dimensions. They also had higher EQ-5D visual analogue scale and SF-12v2 scores after treatment. FCM had similar clinical effects on men and women and on patients with Crohn's disease (n = 66) and ulcerative colitis (n = 32). Conclusion: A single dose of FCM rapidly restored iron parameters and significantly improved patients' symptoms and HRQoL at 1 month after treatment.

Real-world data on the infliximab biosimilar CT-P13 (Remsima®) in inflammatory bowel disease.

BACKGROUND: In recent years, biological therapies have revolutionized the management of inflammatory bowel disease (IBD); however, they are expensive. The development of biosimilar products has allowed us to reduce healthcare costs and improve patients' access to these treatments. Although various studies support the similarity between infliximab and its biosimilar CT-P13 in terms of efficacy and safety, there are unmet needs regarding research on these agents in the context of IBD. AIM: To analyze clinical response rates to CT-P13 and adverse events in IBD patients treated in real-life practice. METHODS: An observational, prospective, multicenter study of IBD patients treated with CT-P13 in clinical practice who were naïve to biological treatments or failed to respond to other anti-tumor necrosis factor drugs or had switched from infliximab originator was carried out. No diagnostic or follow-up interventions were conducted on patients outside usual clinical practice. The primary endpoints were clinical response rates and number of adverse events. The primary efficacy variable was the proportion of patients who were in clinical remission and/or had a clinical response at 3, 6, 9, and 12 mo. RESULTS: A total of 220 IBD patients treated with CT-P13 (Remsima®) were included in the study: 87 (40%) with ulcerative colitis and 133 (60%) with Crohn's disease. Mean age of the patients was 41.47 (SD 15.74) years, and 58% were female. Nineteen (9%) patients started treatment with CT-P13 after switching from infliximab. Of the remaining 201 patients, 142 (65%) were naïve to biologic agents. At baseline, 68.6% (n = 138/201) of patients presented with active disease. After 12 mo of treatment, 14.8% (n = 12/81) presented with active disease, and 64.2% (n = 52/81) were in clinical remission without corticosteroids. After 3 mo, 75.5% (n = 115/152) had a clinical response or achieved clinical remission, which was sustained for 12 mo (85.2%; n = 69/81). There was a decrease in specific IBD indices at 3, 6, 9, and 12 mo (P < 0.001). A total of 34 adverse events were reported by 27 (12.3%) patients, 9 (26.5%) of which were serious. CONCLUSION: CT-P13 is an effective and safe infliximab biosimilar for the treatment of IBD in real-life practice and may be a valid and attractive alternative for the treatment of IBD.

Methotrexate induced sprue-like syndrome.

A 52 year-old male patient diagnosed of ankylosing spondylitis presented with an iron deficiency anemia after a ten-month treatment of methotrexate. He did not respond to treatment with oral iron not a proton pump inhibitor and an upper endoscopy was performed. The histological study of the duodenal biopsies showed villus atrophy. After removing the methotrexate, administering intramuscular iron and undertaking a gluten-free diet, the histological and analytical alterations progressively resolved.

Factors predicting poor prognosis in ischemic colitis.

AIM: To determine the clinical, analytical and endoscopic factors related to ischemic colitis (IC) severity. METHODS: A total of 85 patients were enrolled in a retrospective study from January 1996 to May 2004. There were 53 females and 32 males (age 74.6+/-9.4 years, range 45-89 years). The patients were diagnosed as IC. The following variables were analyzed including age, sex, period of time from the appearance of symptoms to admission, medical history, medication, stool frequency, clinical symptoms and signs, blood tests (hemogram and basic biochemical profile), and endoscopic findings. Patients were divided in mild IC group and severe IC group (surgery and/or death). Qualitative variables were analyzed using chi-square test and parametric data were analyzed using Student's t test (P<0.05). RESULTS: The mild IC group was consisted of 69 patients (42 females and 27 males, average age 74.7+/-12.4 years). The severe IC group was composed of 16 patients (11 females and 5 males, average age of 73.8+/-12.4 years). One patient died because of failure of medical treatment (no surgery), 15 patients underwent surgery (6 after endoscopic diagnosis and 9 after peroperatory diagnosis). Eight of 85 patients (9.6%) died and the others were followed up as out-patients for 9.6+/-3.5 mo. Demographic data, medical history, medication and stool frequency were similar in both groups (P>0.05). Seriously ill patients had less hematochezia than slightly ill patients (37.5% vs 86.9%, P = 0.000). More tachycardia (45.4% vs 10.1%, P = 0.011) and a higher prevalence of peritonism signs (75% vs 5.7%, P = 0.000) were observed in the severe IC group while the presence and intensity of abdominal pain were similar between two groups. Two patients with severe IC had shock when admitted. Regarding analytical data, more seriously ill patients were found to have anemia and hyponatremia than the mildly ill patients (37.5% vs 10.1%, P = 0.014 and 46.6% vs 14.9%, P = 0.012, respectively). Stenosis was the only endoscopic finding that appeared more frequently in seriously ill patients than in slightly ill patients (66.6% vs 17.3%, P = 0.017). CONCLUSION: The factors that can predict poor prognosis of IC are the absence of hematochezia, tachycardia and peritonism, anemia and hyponatremia and stenosis.

Congenital splenic cyst treated with percutaneous sclerosis using alcohol.

We report a case of successful percutaneous treatment of a congenital splenic cyst using alcohol as the sclerosing agent. A 14-year-old female adolescent presented with a nonsymptomatic cystic mass located in the spleen that was believed to be congenital. After ultrasonography, a drainage catheter was placed in the cavity. About 250 ml of serous liquid was extracted and sent for microbiologic and pathologic studies to rule out an infectious or malignant origin. Immediately afterwards, complete drainage and local sclerotherapy with alcohol was performed. This therapy was repeated 8 days later, after having observed 60 ml of fluid in the drainage bag. One year after treatment the cyst has practically disappeared. We believe that treatment of splenic cyst with percutaneous puncture, ethanolization, and drainage is a valid option and it does not rule out surgery if the conservative treatment fails.