Súhrn: Východiská: Zápalový dotazník o ochoreniach hrubého čreva (IBDQ – inflammatory bowel disease questionnaire) je široko používaný dotazník na hodnotenie kvality života u pacientov so zápalovým ochorením čriev (IBD – inflammatory bowel disease). Hoci bol tento dotazník prijatý a potvrdený v niekoľkých jazykoch, ešte nebol potvrdený v slovenskom jazyku. Ciele: Cieľom tejto štúdie bolo aplikovať metódy a kritériá používané v niekoľkých adaptačných štúdiách na posúdenie platnosti a spoľahlivosti prispôsobeného IBDQ. Metódy: V tejto prierezovej štúdii sme zhromaždili dáta pomocou 90 dotazníkov IBD (ulcerózna kolitída (UC) 39 a Crohnova choroba (CD) 51 dotazníkov) od 82 po sebe nasledujúcich pacientov z centra IBD v Ružinovskej fakultnej nemocnici v Bratislave. Všetkým pacientom boli poskytnuté tri dotazníky: krátka forma IBD dotazníka (SIBDQ – short inflammatory bowel disease questionnaire), prieskum Short Form (SF-36), Harvey-Bradshawov index (HBI) u pacientov s CD a parciálneho Mayo Score (pMayo) u pacientov s UC. Na základe údajov sme hodnotili slovenskú verziu SIBDQ pre platnosť s použitím miery konvergencie Pearsonova korelačného koefi cientu, spoľahlivosť pomocou Cronbachovho interného testu konzistencie a prijateľnosti a zrozumiteľnosti jazyka pomocou stupnice Likert. Výsledky: Slovenská verzia SIBDQ bola tiež vysoko korelovaná v porovnaní s SF-36 (UC r = 0,87 a CD r = 0,81; oba s p < 0,01), HBI (CD r = – 0,82; p < 0,01) a pMayo (UC r = –0,86; p < 0,01). Spoľahlivosť slovenskej verzie SIBDQ bola veľmi významná u UC (Cronbachov alfa koefi cient 0,96 pre zložku klinickej prezentácie a 0,85 pre zložku sociálneho obmedzenia) a CD (0,92 pre zložku klinickej prezentácie a 0,84 pre zložku sociálneho obmedzenia). Percento akceptovateľnosti všetkých dotazníkov SIBDQ u UC a CD pacientov zostalo konštantné na 100 %. Zrozumiteľnosť jazyka bola hodnotená sedembodovou stupnicou Likert, v ktorej sa zistilo, že 93,15 % pacientov súhlasilo s tým, že dotazník bol jazykovo správny a zrozumiteľný. Záver: Slovenská verzia SIBDQ je platný, spoľahlivý a vysoko prijateľný nástroj na meranie kvality života pacientov s UC a CD.

Background: The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a widely used questionnaire for health-related quality of life assessment in patients with inflammatory bowel disease (IBD). Although this questionnaire has been adopted and validated in several languages, it has not yet been validated in the Slovak language. Aims: The aim of this study was to apply the methods and criteria used by several adaptation studies for assessing the validity and reliability of the adapted SIBDQ. Methods: In this cross-sectional study, we collected data using 90 IBD questionnaires (ulcerative colitis (UC) 39 and Crohn’s disease (CD) 51 questionnaires) from 82 consecutive patients from the IBD centre at the Ružinov University Hospital in Bratislava. All patients were given three questionnaires: SIBDQ, Short Form survey (SF-36), Harvey-Bradshaw index (HBI) for CD patients and partial Mayo Score (pMayo) score for UC patients. Based on the data, we assessed the Slovak version of the SIBDQ for validity using the convergence rate of the Pearson correlation coefficient, reliability using Cronbach's alpha internal consistency test, and acceptance and linguistic understandability using the Likert scale. Results: The Slovak version of the SIBDQ was also highly correlated when compared to SF-36 (UC r = 0.87 and CD r = 0.81; both with p < 0.01), HBI (CD r = 0.82; p < 0.01), and pMayo (UC r = 0.86; p < 0.01). Reliability of the Slovak version of the SIBDQ was highly significant in both UC (Cronbach's alpha coefficient was 0.96 for clinical presentation component and 0.85 for psychosocial limitation component) and CD (0.92 for clinical presentation component and 0.84 for psychosocial limitation component). Acceptability percentage of all SIBDQ questionnaires in UC and CD patients stayed constant at 100%. Linguistic understandability was evaluated with a seven-point Likert scale, which found that 93.15% of the patients strongly agreed that the questionnaire was linguistically understandable. Conclusion: The Slovak version of the SIBDQ is a valid, reliable, and highly acceptable instrument to measure quality of life of patients with UC and CD.

• Klíčová slova
• SIBDQ,
• MeSH
• Crohnova nemoc diagnóza   psychologie   MeSH
• idiopatické střevní záněty * diagnóza   psychologie   MeSH
• klinická studie jako téma MeSH
• kvalita života * MeSH
• průzkumy a dotazníky MeSH
• reprodukovatelnost výsledků MeSH
• ukazatele zdravotního stavu * MeSH
• ulcerózní kolitida diagnóza   psychologie   MeSH

• Publikační typ
• abstrakt z konference MeSH

BACKGROUND & AIMS: Health-related quality of life (HRQoL) is impaired in patients with Inflammatory Bowel Disease (IBD). The aim was prospectively to assess and validate the pattern of HRQoL in an unselected, population-based inception cohort of IBD patients from Eastern and Western Europe. METHODS: The EpiCom inception cohort consists of 1560 IBD patients from 31 European centres covering a background population of approximately 10.1 million. Patients answered the disease specific Short Inflammatory Bowel Disease Questionnaire (SIBDQ) and generic Short Form 12 (SF-12) questionnaire at diagnosis and after one year of follow-up. RESULTS: In total, 1079 patients were included in this study. Crohn's disease (CD) patients mean SIBDQ scores improved from 45.3 to 55.3 in Eastern Europe and from 44.9 to 53.6 in Western Europe. SIBDQ scores for ulcerative colitis (UC) patients improved from 44.9 to 57.4 and from 48.8 to 55.7, respectively. UC patients needing surgery or biologicals had lower SIBDQ scores before and after compared to the rest, while biological therapy improved SIBDQ scores in CD. CD and UC patients in both regions improved all SF-12 scores. Only Eastern European UC patients achieved SF-12 summary scores equal to or above the normal population. CONCLUSION: Medical and surgical treatment improved HRQoL during the first year of disease. The majority of IBD patients in both Eastern and Western Europe reported a positive perception of disease-specific but not generic HRQoL. Biological therapy improved HRQoL in CD patients, while UC patients in need of surgery or biological therapy experienced lower perceptions of HRQoL than the rest.

• MeSH
• chirurgie trávicího traktu metody   MeSH
• dospělí MeSH
• idiopatické střevní záněty epidemiologie   psychologie   terapie   MeSH
• kvalita života * MeSH
• lidé středního věku MeSH
• lidé MeSH
• management nemoci * MeSH
• mladiství MeSH
• mladý dospělý MeSH
• morbidita trendy   MeSH
• následné studie MeSH
• prognóza MeSH
• prospektivní studie MeSH
• průzkumy a dotazníky MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• surveillance populace * MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Evropa MeSH

Úvod a ciele: Nedávno bol schválený prvý subkutánny infliximab (IFX), CTP-13, v indikácii IBD. Pilotná štúdia preukázala noninferioritu subkutánneho infliximabu voči intravenóznej forme z hľadiska účinnosti, pričom neboli pozorované žiadne neočakávané nežiaduce účinky liečby. Cieľom štúdie bolo zhodnotiť účinnosť liečby, farmakokinetiku a bezpečnosť po prechode z intravenóznej na subkutánnu liečbu infliximabom. Metódy: Táto retrospektívna kohortová štúdia zah?ňala všetkých pacientov s Crohnovou chorobou (CD) a ulceróznou kolitídou (UC) sledovaných v IBD centre, ktorí prešli z intravenózneho na subkutánny IFX medzi septembrom 2022 a septembrom 2023. Klinická aktivita ochorenia podľa HBI a pMayo, sIBDQ, fekálny kalprotektín, perzistencia liečby, bezpečnosť a farmakokinetika boli hodnotené v 24. a 56. týždni po prechode na subkutánny infliximab. Výsledky: Kohorta pozostávala z 107 pacientov (63 CD a 44 UC). Indexy kvality života a klinickej aktivity ochorenia zostali nezmenené pri CD aj UC. Fekálny kalprotektín sa významne znížil pri CD, ale nie pri UC. Pacienti, ktorým bol IV IFX podávaný v štandardnom režime, ako aj tí na intenzifikovaných režimoch, vykazovali podobné výsledky pri štandardnom SC dávkovaní. Nevyskytli sa žiadne závažné nežiaduce udalosti. Prechodné injekčné reakcie sa vyskytli u 4,7 % pacientov. Medián najnižších hladín infliximabu sa významne zvýšil po prechode na subkutánnu formu. Záver: Prechod z intravenózneho infliximabu na subkutánny je bezpečnou a účinnou možnosťou liečby pacientov so zápalovým ochorením čriev vrátane tých s aktivitou ochorenia a/alebo na intenzifikovanom intravenóznom režime infliximabu.

Background and aims: Recently, the first subcutaneous infliximab (IFX), CTP-13, was approved in the indication of IBD. Pivotal study established noninferiority of subcutaneous infliximab to intravenous formulation in terms of efficacy, with no unexpected safety signals observed. The aims of the study were to evaluate persistency of treatment, pharmacokinetics and safety following a switch from intravenous to subcutaneous infliximab treatment. Methods: This retrospective, single-centre cohort study, recruited all Crohn’s disease (CD) and ulcerative colitis (UC) patients who transitioned from intravenous to subcutaneous IFX between September 2022 and September 2023. Clinical disease activity according to HBI and pMayo, sIBDQ, faecal calprotectin, drug persistence, safety and pharmacokinetics were evaluated at week 24 and 56 after the switch to subcutaneous infliximab. Results: A number of 107 patients was included (63 CD and 44 UC). Quality of life and clinical disease activity scores remained unchanged both in CD and UC. Faecal calprotectin decreased significantly in CD but not in UC. Patients that had been on standard compared to intensified IV infliximab dosing displayed similar outcomes on standard SC dosing. No serious adverse events occurred. Transient local injection reactions were experienced by 4.7% of patients. Median infliximab trough levels significantly increased after the switch to subcutaneous formulation. Conclusion: The switch from intravenous to subcutaneous infliximab is a safe and effective option for the treatment of inflammatory bowel diseases including those with active disease and/or on intensified intravenous infliximab regime.

• MeSH
• biologické přípravky aplikace a dávkování   farmakologie   terapeutické užití   MeSH
• Crohnova nemoc * farmakoterapie   MeSH
• infliximab * aplikace a dávkování   farmakologie   terapeutické užití   MeSH
• intravenózní podání MeSH
• lidé MeSH
• retrospektivní studie MeSH
• subkutánní infuze MeSH
• ulcerózní kolitida * farmakoterapie   MeSH
• Check Tag
• lidé MeSH

Objective: To assess the effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in adults with moderate-to-severe active Crohn's disease (CD) or ulcerative colitis (UC). Methods: This multi-centre, observational cohort study was conducted at medical centres in Romania, Czech Republic, and Bulgaria. Effectiveness was measured using the Crohn's Disease Activity Index (CDAI) for CD or partial Clinical Activity Index (pCAI) for UC. Quality-of-life (QoL) was measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Safety was assessed according to treatment withdrawals and adverse events (AEs) monitoring. Analyses were performed in the safety population and were reported based on the observed case (OC) or last observation carried forward (LOCF) method. Results: Altogether, 85 patients with CD (n = 38) or UC (n = 47) received biosimilar infliximab for up to 30 weeks. Most patients (n = 68; 80.0%) had no prior exposure to infliximab. At the end of treatment, 65.8% (95% CI = 49.8-78.9) of CD patients and 55.3% (95% CI = 41.2-68.6) of UC patients showed a clinical response, and 47.4% (95% CI = 32.5-62.7) and 48.9% (95% CI = 35.3-62.8), respectively, were in remission. Statistically significant (p < 0.0001) improvements from baseline were observed in CDAI and pCAI scores (both LOCF). In the combined CD and UC population, SIBDQ was significantly improved (p < 0.0001) from baseline to end of treatment (OC). Two AEs (moderately severe infusion reactions) were judged by investigators to be definitely related to treatment, one of which led to treatment withdrawal. Conclusion: Results align with those of previous studies demonstrating the effectiveness and safety of biosimilar infliximab in CD and UC.

• Publikační typ
• časopisecké články MeSH