Little is known about how the change from intravenous to subcutaneous vedolizumab in a real-life setting in inflammatory bowel disease patients on stable maintenance therapy affects clinical outcomes. We compared the data on vedolizumab serum trough concentration, efficacy, and safety prior to and six months after the switch from intravenous to subcutaneous vedolizumab. In total, 24 patients, 13 with ulcerative colitis (UC) and 11 with Crohn’s disease (CD), were included. Mean serum trough concentration of intravenous vedolizumab was significantly lower than mean serum trough concentration of subcutaneous vedolizumab (p = 0.002). There was no significant difference between C-reactive protein levels, fecal calprotectin levels or clinical scores (Harvey–Bradshaw index or Partial Mayo score) prior to transition to subcutaneous vedolizumab and after 6 months. In four (16.7%) patients, two CD and two UC, therapy was discontinued during the follow-up period with a median of 5 months (minimum–maximum: 4–6). In all patients, therapy was discontinued due to loss of response. In total, 13 adverse events were reported by 11 patients, and the most common adverse event was COVID-19. No serious adverse events were reported. In conclusion, subcutaneous vedolizumab has shown to be effective and safe in patients on previously established maintenance therapy with intravenous vedolizumab.
Background Within the past 20 years infliximab (IFX), a monoclonal antibody targeting tumor necrosis factor-alpha, has become an established therapy for inducing and maintaining remission in inflammatory bowel disease (IBD). IFX therapeutic drug monitoring (TDM) using the point-of-care (POC) methods showed to be able to produce results fast enough to allow IFX dose adjustments before drug infusion. This study aimed to compare IFX quantification using two POC tests, Procise IFX (Procise Dx) and Quantum Blue Infliximab assay (Bühlmann Laboratories AG). Methods Serum samples from 22 IBD patients (M=64%) on IFX maintenance therapy were collected immediately before drug infusion. Capillary blood was also collected from 6 IBD patients by finger prick using whole blood pipettes (Procise Dx). Crohn’s disease (CD) was diagnosed in 12 patients and ulcerative colitis (UC) in 10 patients. For method comparison, a Passing Bablok regression was used and for qualitative comparison weighted kappa statistic was obtained after stratification of results by therapeutic range (<3 mg/l, ≥3 to 7 mg/L, and ≥7 mg/L). Results Both methods measured lower IFX concentrations in CD patients (4,95 (0,65 – 5,80) mg/L) than in UC patients (8,50 (4,80 – 12,20) mg/L). In two patients with confirmed IFX antibodies, both methods showed immeasurably low IFX concentrations. Passing Bablok regression analysis of IFX concentration in serum sample has showed a proportional deviation between two POC methods (y=0.416 (-0.654 to 1.279) + 0.753 (0.648 to 0.923)x). A good comparison has been observed for capillary blood measured using Procise IFX test and serum samples measured using Quantum Blue Infliximab assay (y=-2.732 (-4.315 to 1,867) + 1.263 (0.278 to 1.566)x), although IFX concentration was lower in capillary blood. Classification of results according to therapeutic interval showed good agreement for serum samples and serum and whole capillary blood measurements (κ=0.79 (0.59–0.999 and κ=0.80 (0.45–1.00), respectively). Conclusion Because of proportional differences, two POC tests can’t be used interchangeably for longitudinal TDM of IFX in IBD patients. There is a need for caution in the interpretation of IFX in whole blood, due to its possibly lower concentration.
The main symptoms of coronavirus disease (COVID-19) are fever, cough, tiredness, and loss of smell and taste. Gastrointestinal symptoms are less common. A 38-year-old female patient, previously healthy, presented with a history of hematochezia up to 8 times per day, followed by abdominal cramps, urgency, and chills for two days. She did not have any respiratory symptoms and was previously vaccinated for COVID-19. She was afebrile, with normal vital signs. Blood samples showed normal complete blood count and increased C-reactive protein (CRP), fibrinogen, and D-dimer levels (66 mg/L, 4.1 g/L, and 2302 μ/L FEU, respectively). Stool samples for stool culture, C. difficile, and viral examination came back negative. On day 3, she reported a mild cough, fever and loss of smell and taste. Nasopharyngeal swab for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) PCR test came back positive. On day 6, the patient still had hematochezia accompanied by abdominal cramps, but fever and respiratory symptoms withdrew. CRP, fibrinogen, and D-dimers were still elevated, as well as liver enzyme levels. Sigmoidoscopy was performed with biopsies taken from sigmoid and rectum for histology and PCR SARS-CoV-2 testing. CT angiography showed no signs of thrombosis in mesenteric veins or arteries. PCR test for SARS-CoV-2 virus from rectal biopsy sample was positive. Patient was treated with methylprednisolone iv for two days and peroral prednisone afterwards, with mesalamine, metronidazole and enoxaparin. Sigmoidoscopy was repeated after two weeks showing only mild hyperemia. At that time, the patient had normal stool, normal CRP, liver enzyme, fibrinogen, and D-dimer levels, and normocytic anemia (hemoglobin level of 103 g/L). We wanted to show that severe gastrointestinal symptoms, such as hemorrhagic colitis, can be the main presentation of COVID-19, even in young patients with no prior comorbidities. In such a case, PCR test in biopsy samples can be performed to prove SARS-CoV-2 infection of bowel mucosa.
Background COVID-19 pandemic completely changed the world during the past year, but its’ greatest impact was on healthcare system. As inflammatory bowel diseases (IBD) are chronic conditions, and patients are in constant interaction with healthcare system and are treated with immunosuppressive therapies, they present a particularly vulnerable group of patients during the pandemic. Methods Aim of this study was to survey IBD patients’ opinion on the impact of COVID-19 on their mental health, availability and quality of healthcare and their opinion on vaccination. We created a questionnaire that was posted to web based IBD patient group that gather patients from our geographical, Adriatic-Balkan, region (Croatia, Bosnia and Hercegovina, Serbia, Macedonia and Montenegro). Patients answered questions anonymously. Answers were created as yes/no, in grades from 1 (no impact/fear) to 5 (very large impact/very severe fear) or by choosing one of the offered answers. In total, 167 responses were received between December 2020 and March 2021, and were analyzed by descriptive statistics. Results A total of 167 IBD patients filled the questionnaire, of which 116 (69,5%) were female. Median age was 36 years (min. 15, max. 62 ys). Most patients did not have COVID-19 (82,6%). A little over half of patients believe that IBD patients are at higher risk of developing COVID-19 (n=97, 58,1%). COVID-19 pandemic has a moderate to large impact on their mental health in majority of patients (n=106, 63,5%) and 99 patients (59,3%) feel moderate to severe fear for their own health because of the pandemic. Most of the information about COVID-19 patients found on the internet (44,3%), from patients’ associations (26,3%) and from their IBD doctor (22,8%). Same number of patients (n=48, 28,7%) feel no impact or very large impact of pandemic on availability to IBD team. Most of patients did not change their IBD therapy during the pandemic (86,8%), and majority (62,3%) felt there was no impact of pandemic on the availability to their therapy. Almost half of patients (49,7%) feel that the quality of healthcare system is worse since the beginning of the pandemic. More than half of patients (57,5%) do not want to be vaccinated against COVID-19. Conclusion COVID-19 pandemic had a moderate to large impact on mental health in majority of patients. It is particularly important that patients receive correct information about COVID-19 from medical professionals, and patients’ association groups are very useful channel for patient education that should be used more. More than half of patients do not want to be vaccinated, showing the importance of patient education even more.
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