BACKGROUND: A subcutaneous formulation of infliximab (IFX-SC) approved to treat patients with inflammatory bowel disease may offer improved efficacy versus intravenous infliximab. METHODS: Patients with refractory Crohn's disease (CD, n = 32) previously treated unsuccessfully with at least 2 biologics were treated with IFX-SC and followed from baseline at Week 0 (W0) to Week 30 (W30). The study's primary endpoint was the treatment's persistence at W30, while secondary goals included the analysis of serum infliximab trough levels (TL IFX), dynamics of anti-IFX antibodies (ATIs), and clinical, serum and fecal markers of CD activity during IFX-SC treatment. RESULTS: Midterm treatment persistence with the continuation of treatment after W30 was 53%. TL IFX median values showed rapid, significant upward dynamics and exceeded 15.5 μg/mL at W30, whereas median ATI levels significantly declined. Among ATI-negative patients at W0 (n = 15), only one showed IFX immunogenicity with newly developed ATIs at W30. Among ATI-positive patients at W0, ATI seroconversion from ATI-positive to ATI-negative status was observed in 10 of 17 patients (58.8%). Patients who had continued IFX-SC treatment at W30 showed significant decreases in C-reactive protein (P = .0341), fecal calprotectin (P = .0002), and Harvey-Bradshaw index (P = .0029) since W0. CONCLUSIONS: Patients with refractory CD previously treated with at least 2 biologics exhibited clinically relevant improvement with IFX-SC, which showed less immunogenic potential than IFX-IV and highly stable TL IFX.

• Klíčová slova
• Crohn’s disease, Inflammatory bowel disease, antibodies to infliximab, immunogenicity, infliximab, infliximab trough levels, subcutaneous, treatment persistence,
• Publikační typ
• časopisecké články MeSH

BACKGROUND: The societal burden of inflammatory bowel diseases (IBD) is not well documented, and further studies are needed to quantify the costs of the disease state. Thus, the aim was to estimate the societal burden and identify its predictors. METHODS: A cross-sectional questionnaire-based study complemented by objective data from patient medical records was performed for patients with Crohn's disease (CD) and ulcerative colitis (UC). RESULTS: We analyzed data from 161 patients (CD: 102, UC: 59). The overall work impairment reached 15.4%, 11.2% vs. 28.8% without/with self-reported symptoms (p = 0.006). Daily activity impairment was 19.3%, 14.1% vs. 35.6% (p < 0.001). The disability pension rate was 28%, 23% vs. 44% (p = 0.012). The total productivity loss due to absenteeism, presenteeism, and disability amounted to 7,673 €/patient/year, 6,018 vs. 12,354 €/patient/year (p = 0.000). Out-of-pocket costs amounted to 562 €/patient/year, 472 vs. 844 €/patient/year (p = 0.001). Self-reported symptoms were the strongest predictor of costs (p < 0.001). CONCLUSION: We found a high societal burden for IBD and a significant association between patient-reported disease symptoms and work disability, daily activity impairment, disability pensions, and out-of-pocket costs. Physician-reported disease activity is not a reliable predictor of costs except for out-of-pocket expenses.

• Klíčová slova
• Crohn’s disease, absenteeism, out-of-pocket costs, presenteeism, productivity costs, ulcerative colitis,
• MeSH
• Crohnova nemoc * diagnóza   MeSH
• hodnocení výsledků péče pacientem MeSH
• idiopatické střevní záněty * diagnóza   MeSH
• lidé MeSH
• průřezové studie MeSH
• ulcerózní kolitida * diagnóza   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH

BACKGROUND: Patients with inflammatory bowel disease (IBD) on immune-modifying treatment could be at an increased risk for severe coronavirus disease 2019 (COVID-19); thus, data on the efficacy and safety of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccines are essential. We conducted a prospective study of IBD patients vaccinated with BNT162b2, CX-024414, and ChAdOx1 nCoV-19 vaccines. The aim was to evaluate the rate and magnitude of seroconversion, assess the effect of different immune-modifying treatment modalities on the magnitude of anti-SARS-CoV-2 IgG antibody levels, and analyze the impact of anti-SARS-CoV-2 vaccination on the inflammatory biomarkers of IBD. METHODS: The study included 602 IBD patients and 168 immunocompetent health care workers serving as controls. Serum anti-SARS-CoV-2 IgG antibodies were measured by chemiluminescent microparticle immunoassay before the vaccination and 8 weeks after the vaccination. RESULTS: Of IBD patients, 82.2% were receiving biological treatment: most of them were treated with antitumor necrosis factor (TNF)-α inhibitors (48.5%), and just under half of them were treated with concomitant thiopurines or methotrexate, followed by vedolizumab (18.6%) and ustekinumab (15.1%). Only 8.1% of patients were on 5-aminosalicylates, and a minority (2.2%) were treatment-free. The postvaccine seropositivity rate among IBD patients and controls was 97.8% vs 100%. Median anti-SARS-CoV-2 IgG levels were lower among IBD recipients of ChAdOx1 nCoV-19 compared with 2 other vaccines (P < .0001) and control ChAdOx1 nCoV-19 recipients (P = .01). No correlation was found between serum trough levels and anti-SARS-CoV-2 IgG concentrations for any of the biological drugs used. The TNF-α inhibitors with concomitant immunosuppressive treatment but no other treatment modalities were associated with a lower postvaccination antibody response (P < .0001). When evaluating the laboratory activity of IBD by C-reactive protein and fecal calprotectin levels, no significant differences were found before the vaccination and 8 weeks after its completion. CONCLUSIONS: Our findings warrant particular attention to the anti-SARS-CoV-2 vaccination of IBD patients treated with TNF-α inhibitors with concomitant immunomodulators and show the priority of mRNA vaccines in this specific group of patients.

• Klíčová slova
• BNT162b2, COVID-19, CX-024414, ChAdOx1 nCoV-19, Inflammatory bowel disease, SARS-CoV-2, immunity, vaccination,
• MeSH
• C-reaktivní protein metabolismus   MeSH
• ChAdOx1 nCoV-19 MeSH
• COVID-19 * prevence a kontrola   MeSH
• idiopatické střevní záněty * farmakoterapie   MeSH
• imunoglobulin G MeSH
• leukocytární L1-antigenní komplex MeSH
• lidé MeSH
• methotrexát MeSH
• prospektivní studie MeSH
• protilátky virové MeSH
• SARS-CoV-2 MeSH
• TNF-alfa metabolismus   MeSH
• tvorba protilátek MeSH
• ustekinumab MeSH
• vakcína BNT162 MeSH
• vakcinace MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Názvy látek
• C-reaktivní protein MeSH
• ChAdOx1 nCoV-19 MeSH
• imunoglobulin G MeSH
• leukocytární L1-antigenní komplex MeSH
• methotrexát MeSH
• protilátky virové MeSH
• TNF-alfa MeSH
• ustekinumab MeSH
• vakcína BNT162 MeSH

BACKGROUND AND AIMS: Knowledge on the immunogenicity of anti-SARS-CoV-2 vaccines in inflammatory bowel disease [IBD] patients is limited. Therefore, SARS-CoV-2-specific T-cell responses and antibodies were analysed in 60 IBD vaccine recipients and 30 controls. METHODS: SARS-CoV-2 IgG antibodies against the viral spike protein were measured at baseline and at 8 and 26 weeks after the second vaccine dose. SARS-CoV-2 IgG antibodies against the nucleocapsid antigens were measured at week 26. A SARS-CoV-2 interferon-gamma released assay [IGRA] was performed in all vaccinees at week 26. RESULTS: At weeks 0 and 8, no differences were found in anti-spike antibodies between cohorts. At week 26, the decrease in antibody levels was more significant in the IBD cohort compared to the healthy cohort, and anti-nucleocapsid antibodies were not detected in either group. At week 26, 16 of 90 [18%] vaccinated individuals had a negative IGRA test result, seven of 90 [8%] were borderline and 67 [74%] had a positive IGRA result; 22 of the 23 individuals with negative or borderline IGRA results belonged to the IBD cohort. However, the overall functional ability of T-lymphocytes to produce interferon-gamma after the unspecific mitogen stimulation was lower in IBD patients. In vaccinated individuals with low or borderline IGRA, treatment with tumour necrosis factor-alpha inhibitors was the most frequent. In individuals with a significant drop in anti-spike antibody levels, plasmatic interferon-gamma concentrations after the specific SARS-CoV-2 stimulation were also insufficient. CONCLUSIONS: Simple humoral and cellular post-vaccination monitoring is advisable in IBD patients so that repeated vaccine doses may be scheduled.

• Klíčová slova
• COVID-19, inflammatory bowel disease, vaccination,
• MeSH
• COVID-19 * prevence a kontrola   MeSH
• humorální imunita MeSH
• idiopatické střevní záněty * farmakoterapie   MeSH
• imunoglobulin G MeSH
• interferon gama MeSH
• lidé MeSH
• protilátky virové MeSH
• SARS-CoV-2 MeSH
• vakcinace MeSH
• vakcíny proti COVID-19 MeSH
• virové vakcíny * MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• imunoglobulin G MeSH
• interferon gama MeSH
• protilátky virové MeSH
• vakcíny proti COVID-19 MeSH
• virové vakcíny * MeSH

INTRODUCTION: Anti-SARS-CoV-2 vaccine clinical trials did not include patients with immune-mediated conditions such as inflammatory bowel disease [IBD]. We aimed to describe the implementation of anti-SARS-CoV-2 vaccination among IBD patients, patients' concerns, and the side effect profile of the anti-SARS-CoV-2 vaccines, using real-world data. METHODS: An anonymous web-based self-completed survey was distributed in 36 European countries between June and July 2021. The results of the patient characteristics, concerns, vaccination status, and side effect profile were analysed. RESULTS: In all 3272 IBD patients completed the survey, 79.6% had received at least one dose of anti-SARS-CoV-2 vaccine, and 71.7% had completed the vaccination process. Patients over 60 years old had a significantly higher rate of vaccination [p < 0.001]. Patients' main concerns before vaccination were the possibility of having worse vaccine-related adverse events due to their IBD [24.6%], an IBD flare after vaccination [21.1%], and reduced vaccine efficacy due to IBD or associated immunosuppression [17.6%]. After the first dose of the vaccine, 72.4% had local symptoms and 51.4% had systemic symptoms [five patients had non-specified thrombosis]. Adverse events were less frequent after the second dose of the vaccine and in older patients. Only a minority of the patients were hospitalised [0.3%], needed a consultation [3.6%], or had to change IBD therapy [13.4%] after anti-SARS-CoV-2 vaccination. CONCLUSIONS: Although IBD patients raised concerns about the safety and efficacy of anti-SARS-CoV-2 vaccines, the implementation of vaccination in those responding to our survey was high and the adverse events were comparable to the general population, with minimal impact on their IBD.

• Klíčová slova
• COVID-19, Inflammatory bowel disease, SARS-CoV-2, vaccination,
• MeSH
• COVID-19 * prevence a kontrola   MeSH
• idiopatické střevní záněty * farmakoterapie   MeSH
• internet MeSH
• lidé středního věku MeSH
• lidé MeSH
• průzkumy a dotazníky MeSH
• senioři MeSH
• vakcinace škodlivé účinky   MeSH
• vakcíny proti COVID-19 * škodlivé účinky   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• senioři MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Evropa MeSH
• Názvy látek
• vakcíny proti COVID-19 * MeSH

BACKGROUND: The increasing complexity of advanced endoscopic techniques places a high demand on the endoscopist's expertise. Thus, live porcine models have been more frequently used for training. We briefly describe a hands-on postgraduate endoscopic course regarding a novel method of treatment of anastomotic strictures in a porcine model. METHODS: The porcine model of Crohn's disease anastomotic stricture with two artificial side-to-side ileo-colonic anastomoses was used. Participants performed endoscopic stricturotomy under supervision at one of two equipped endoscopic stations. Available animals were endoscopically re-examined 3 months after the course. RESULTS: Twelve anastomoses were prepared for the course. Eleven circumferential stricturotomies together with horizontal cut and clip placement were conducted. All anastomoses were passable for the scope after the procedure, and no case of perforation or bleeding occurred. All anastomoses available for re-examination remained passable for the endoscope after 3 months. CONCLUSION: We successfully organised the first endoscopic hands-on course for the training of endoscopic stricturotomy on a large animal model.

• Klíčová slova
• Animal model, Crohn’s disease, Inflammatory bowel disease, Interventional endoscopy, Stricturotomy, Training,
• MeSH
• Crohnova nemoc * komplikace   chirurgie   MeSH
• dilatace MeSH
• lidé MeSH
• modely nemocí na zvířatech MeSH
• prasata MeSH
• stenóza etiologie   chirurgie   MeSH
• výsledek terapie MeSH
• zvířata MeSH
• Check Tag
• lidé MeSH
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH

BACKGROUND: Most cardiac surgery patients undergo median sternotomy during open heart surgery. Sternotomy healing is an arduous, very complex, and multifactorial process dependent on many independent factors affecting the sternum and the surrounding soft tissues. Complication rates for median sternotomy range from 0.5 to 5%; however, mortality rates from complications are very variable at 7-80%. Low calcidiol concentration below 80 nmol/L results in calcium absorptive impairment and carries a risk of bone loss, which is considered as a risk factor in the sternotomy healing process. The primary objective of this clinical trial is to compare the incidence of all postoperative sternotomy healing complications in two parallel patient groups administered cholecalciferol or placebo. The secondary objectives are focused on general patient recovery process: sternal bone healing grade at the end of the trial, length of hospitalization, number of days spent in the ICU, number of days spent on mechanical lung ventilation, and number of hospital readmissions for sternotomy complications. METHODS: This clinical trial is conducted as monocentric, randomized, double-blind, placebo-controlled, with planned enrollment of 600 patients over 4 years, approximately 300 in the placebo arm and 300 in the treatment arm. Males and females from 18 to 95 years of age who fulfill the indication criteria for undergoing cardiac surgery with median sternotomy can be included in this clinical trial, if they meet the eligibility criteria. DISCUSSION: REINFORCE-D is the first monocentric trial dividing patients into groups based on serum calcidiol levels, and with dosing based on serum calcidiol levels. This trial may help to open up a wider range of postoperative healing issues. TRIAL REGISTRATION: EU Clinical Trials Register, EUDRA CT No: 2016-002606-39 . Registered on September 8, 2016.

• Klíčová slova
• Cardiac surgery, Cholecalciferol, Healing complications, Randomized clinical trial, Sternotomy, Trial design, Vitamin D,
• MeSH
• hojení ran MeSH
• kardiochirurgické výkony * škodlivé účinky   MeSH
• lidé MeSH
• pooperační komplikace etiologie   prevence a kontrola   MeSH
• sternotomie * škodlivé účinky   MeSH
• vitamin D škodlivé účinky   MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• vitamin D MeSH

Michalickova, D, Minic, R, Kotur-Stevuljevic, J, Andjelkovic, M, Dikic, N, Kostic-Vucicevic, M, Slanar, O, and Djordjevic, B. Changes in parameters of oxidative stress, immunity, and behavior in endurance athletes during a preparation period in winter. J Strength Cond Res 34(10): 2965-2973, 2020-The current study monitored markers of immunological and oxidative status in 9 male elite endurance athletes: V[Combining Dot Above]O2max: 68 ± 11 ml·kg·min, age: 24 ± 2.5 years, and training loads: 128 ± 21 metabolic equivalents-h·wk during a 3-month preparation period in winter (January-March). Self-rated state of moods evaluation (by Profile of Mood States questionnaire) was performed, and blood samples were collected at the beginning and end of the study. Spectrophotometric methods and enzyme-linked immunosorbent assay were used for parameters' determination. The level of concanavalin A (ConA)-stimulated interferon-γ (IFN-γ) from peripheral blood mononuclear cells (PBMCs) was increased (562 [147-852] vs. 1,097 [451-1842] pg·ml, p = 0.013). Also, the level of transforming growth factor-1 (TGF-β1) in serum was elevated (2.5 [1.4-5.1] vs. 7.2 [4.9-8.2] ng·ml, p = 0.015). There was no change in the level of peptidoglycan (PGN)-stimulated interleukin (IL)-10 from PBMCs. There were no significant changes in PBMCs proliferation/viability on stimulation with ConA and PGN during the study. No changes in superoxide dismutase, prooxidative-antioxidative balance, total oxidant status (TOS), and thiobarbituric acid reactive substances were observed along the study. Total antioxidant status (TAS) was increased (910 ± 174 vs. 1,090 ± 102 μmol·L, p = 0.018), and activity of paraoxonase (PON1) was decreased (523 ± 295 vs. 335 ± 183 U·L, p = 0.003) at the end of the study. Advanced oxidation protein products were increased (25 ± 7.9 vs. 42 ± 7.6 μmol·L, p = 0.011). The self-rated sense of vigor significantly declined (20 ± 2.1 vs. 14 ± 3.4, p = 0.045). In conclusion, 3 months of regular training in winter induced prominent changes in cytokines, biomarkers of oxidative stress, and antioxidative enzyme activity. These changes might increase susceptibility of athletes to disease and muscle damage and consequently lead to performance reduction.

• MeSH
• afekt fyziologie   MeSH
• biologické markery MeSH
• cytokiny metabolismus   MeSH
• dospělí MeSH
• ELISA MeSH
• fyzická vytrvalost imunologie   fyziologie   MeSH
• leukocyty mononukleární metabolismus   MeSH
• lidé MeSH
• longitudinální studie MeSH
• metabolický ekvivalent fyziologie   MeSH
• mladiství MeSH
• mladý dospělý MeSH
• nutriční stav MeSH
• oxidace-redukce MeSH
• oxidační stres fyziologie   MeSH
• sportovci * MeSH
• spotřeba kyslíku fyziologie   MeSH
• zátěžový test MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• biologické markery MeSH
• cytokiny MeSH

• MeSH
• dítě MeSH
• imunoterapie MeSH
• infekce * MeSH
• lidé MeSH
• rizikové faktory MeSH
• těhotenství MeSH
• TNF-alfa MeSH
• zpožděný efekt prenatální expozice * chemicky indukované   MeSH
• Check Tag
• dítě MeSH
• lidé MeSH
• těhotenství MeSH
• ženské pohlaví MeSH
• Publikační typ
• komentáře MeSH
• úvodníky MeSH
• Názvy látek
• TNF-alfa MeSH

BACKGROUND AND AIMS: Patients' perspectives after switching from originator to biosimilar adalimumab have yet to be assessed. We evaluated the efficacy of switching from the originator adalimumab to a biosimilar compound [SB5] in patients with inflammatory bowel disease [IBD]. METHODS: Data on IBD patients who were switched from the originator to biosimilar adalimumab [SB5] at IBD Center ISCARE were analysed. Disease activity was assessed using standard clinical indices (Harvey-Bradshaw index [HBI] for Crohn's disease [CD] and partial Mayo score for ulcerative colitis [UC]), and laboratory parameters (C-reactive protein [CRP] and faecal calprotectin [FC]). Trough levels and anti-drug antibodies were measured. Patients were evaluated 10 weeks [W10] after the switch, and results were compared with the control group of patients on originator compound. RESULTS: A total of 93 patients switched to biosimilar adalimumab were included [CD 86%] and were matched to 93 controls for age, gender, diagnosis, and disease activity. There was no difference in the disease activity in either SWITCH or ORIGINATOR cohorts between Weeks 0 and 10. Similarly, no difference was found between cohorts at both prespecified time points. Moreover, no significant differences in CRP or FC concentrations were seen between W0 and W10 either in the SWITCH, or in the ORIGINATOR cohort [p >0.05]. Adalimumab serum trough levels remained stable after the switch. No new safety signals were detected. CONCLUSIONS: Our study confirmed that switching IBD patients from the originator adalimumab to a biosimilar compound [SB5] does not affect treatment efficacy.

• Klíčová slova
• Adalimumab, biosimilar, inflammatory bowel disease,
• MeSH
• adalimumab krev   imunologie   terapeutické užití   MeSH
• biosimilární léčivé přípravky krev   terapeutické užití   MeSH
• C-reaktivní protein metabolismus   MeSH
• centra terciární péče MeSH
• Crohnova nemoc krev   farmakoterapie   MeSH
• dospělí MeSH
• feces chemie   MeSH
• gastrointestinální látky krev   imunologie   terapeutické užití   MeSH
• leukocytární L1-antigenní komplex analýza   MeSH
• lidé středního věku MeSH
• lidé MeSH
• náhrada léků MeSH
• protilátky krev   MeSH
• retrospektivní studie MeSH
• stupeň závažnosti nemoci MeSH
• ulcerózní kolitida krev   farmakoterapie   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• adalimumab MeSH
• biosimilární léčivé přípravky MeSH
• C-reaktivní protein MeSH
• gastrointestinální látky MeSH
• leukocytární L1-antigenní komplex MeSH
• protilátky MeSH