RESUMEN
BACKGROUND AND AIMS: Transition from intravenous (IV) to subcutaneous (SC) administration is an option in inflammatory bowel disease (IBD) with Infliximab (IFX) or Vedolizumab (VDZ). The aim was to compare the adherence, the persistence in therapy, and quality of life (QoL) at baseline, at 6, at 12 months of SC IFX versus SC VDZ. METHODS: This was a prospective, observational, multicenter study on patients with IBD in treatment with IV IFX or VDZ who switched to SC. All patients investigated the QoL by the short IBD Questionnaire (sIBDQ) and the concerns and expectations by a 6-item survey. Any adverse events, local and systemic, were reported. Safety, concerns, and satisfaction were evaluated. RESULTS: One hundred and eight out of 93 patients were replaced, 51 to SC IFX and 42 to SC VDZ. The majority accepted the SC route. Persistence in therapy was similar between the two groups. The QoL improved after 6 months (p = 0.004), but at T12 both groups show a significant decline in QoL. SC administration has not caused any concern for patients. As safety, both groups reported a similar number of local reactions (IFX 19.60% vs VDZ 19.04%). In the IFX group were reported more systemic reactions (IFX 11.6% vs VDZ 7.14%) without the need for hospitalization. CONCLUSION: The transition from IV to SC administration is an appropriate and safe option for treatment with IFX or VDZ. It is very important to consider the patient's choice and preference. The SC administration led to a significant benefit in QoL, especially in the first 6 months of therapy.
RESUMEN
The eradication of Helicobacter pylori (H. pylori) may be difficult due to antibiotic resistance. Indeed, after one failure, a second-line therapy is needed and a bismuth containing quadruple therapy (BQT) with a three-in-one capsule formulation is becoming very popular. Therefore, we aimed to evaluate effectiveness and safety of BQT as a second-line therapy. We recruited consecutive patients with one therapy failure. For ten days patients received the three-in-one BQT Pylera® therapy, in combination with a proton-pump inhibitor (PPI), decided at the choice of the investigator, at full dose bid. The eradication rate was calculated by intention-to-treat (ITT) and per-protocol (PP)analyses and 95% confidence intervals (CI) were calculated. Seventy-three patients were recruited, 41 females and 32 males (mean age 53.0±13.1 years). Fifty-five patients failed triple therapy with amoxicillin and clarithromycin and the remaining 18 received sequential therapy. Seventy-two patients consumed at least 90% of the capsules, while only one did not complete the therapy due to adverse events (nausea and diarrhea). By ITT analysis, BQT was successful in 62 subjects (eradication rate 84.9%, 95%CI 76.7-93.1%). By PP analysis, the eradication rate was 86.1% (95%CI 78.1-94.1%).Adverse events were observed in 14 subjects (20.5%).In conclusion, our report confirmed that BQT is effective as an empiric second-line regimen.
RESUMEN
Inflammatory bowel disease (IBD) may show a wide range of extraintestinal manifestations. In this context, liver involvement is a focal point for both an adequate management of the disease and its prognosis, due to possible serious comorbidity. The association between IBD and primary sclerosing cholangitis is the most known example. This association is relevant because it implies an increased risk of both colorectal cancer and cholangiocarcinoma. Additionally, drugs such as thiopurines or biologic agents can cause drug-induced liver damage; therefore, this event should be considered when planning IBD treatment. Additionally, particular consideration should be given to the evidence that IBD patients may have concomitant chronic viral hepatitis, such as hepatitis B and hepatitis C. Chronic immunosuppressive regimens may cause a hepatitis flare or reactivation of a healthy carrier state, therefore careful monitoring of these patients is necessary. Finally, the spread of obesity has involved even IBD patients, thus increasing the risk of non-alcoholic fatty liver disease, which has already proven to be more common in IBD patients than in the non-IBD population. This phenomenon is considered an emerging issue, as it will become the leading cause of liver cirrhosis.
