BACKGROUND: We aimed to evaluate the predictors of sustainability of biologic drugs for paediatric patients with Crohn's disease (CD). METHODS: The Czech National Prospective Registry of Biologic and Targeted Therapy of Inflammatory Bowel Disease (CREdIT) was used to identify the biologic treatment courses in paediatric patients with CD. Mixed-effects Cox models and propensity score analyses were employed to evaluate predictors of treatment sustainability. RESULTS: Among the 558 observations of 473 patients, 264 were treated with adalimumab (47%), 240 with infliximab (43%), 41 with ustekinumab (7%), and 13 with vedolizumab (2%). Multivariable analysis revealed higher discontinuation risk with infliximab compared to adalimumab (HR = 0.600, 95%CI 0.389-0.926), both overall and in first-line treatment (HR = 0.302, 95%CI 0.103-0.890). Infliximab versus adalimumab was associated with shorter time to escalation (HR = 0.094, 95%CI 0.043-0.203). Propensity-score analysis demonstrated lower sustainability of infliximab (HR = 0.563, 95%CI 1.159-2.725). The time since diagnosis to treatment initiation (HR = 0.852, 95%CI 0.781-0.926) was the most important predictor. Baseline immunosuppressive therapy prolonged sustainability with infliximab (HR = 2.899, 95%CI 1.311-6.410). CONCLUSIONS: Given the results suggesting shorter sustainability, the need for earlier intensification and thus higher drug exposure, and the greater need for immunosuppression with infliximab than with adalimumab, the choice of these drugs cannot be considered completely equitable. IMPACT: Our study identified predictors of sustainability of biologic treatment in paediatric patients with Crohn's disease, including adalimumab (versus infliximab), early initiation of biologic treatment, and normalised baseline haemoglobin levels. Infliximab treatment was associated with earlier intensification, higher drug exposure, and a greater need for immunosuppression. Parents and patients should be fully informed of the disadvantages of intravenous infliximab versus adalimumab during the decision-making process. This study emphasises the importance of not delaying the initiation of biologic therapy in paediatric patients with Crohn's disease.
- MeSH
- adalimumab * terapeutické užití MeSH
- biologické přípravky terapeutické užití MeSH
- Crohnova nemoc * farmakoterapie MeSH
- dítě MeSH
- humanizované monoklonální protilátky terapeutické užití MeSH
- infliximab * terapeutické užití MeSH
- lidé MeSH
- mladiství MeSH
- proporcionální rizikové modely MeSH
- prospektivní studie MeSH
- registrace * MeSH
- tendenční skóre MeSH
- ustekinumab terapeutické užití MeSH
- výsledek terapie MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- MeSH
- hepatitida diagnóza imunologie klasifikace virologie MeSH
- jaterní cirhóza diagnóza etiologie klasifikace patologie MeSH
- nádory jater diagnóza klasifikace MeSH
- nemoci jater * diagnóza farmakoterapie klasifikace MeSH
- nemoci jícnu diagnóza farmakoterapie klasifikace MeSH
- nemoci střev diagnóza farmakoterapie klasifikace MeSH
- nemoci trávicího systému * diagnóza farmakoterapie klasifikace MeSH
- nemoci žlučového ústrojí diagnóza farmakoterapie klasifikace MeSH
- Publikační typ
- přehledy MeSH
Článek seznamuje čtenáře se základními charakteristikami nového zástupce protilátek proti interleukinu-23 – mirikizumabu. Uvádí data z registračních klinických studií a informace zaměřené na účinnost a bezpečnost mirikizumabu a jeho specifické klinické charakteristiky v gatroenterologii.
The article introduces the reader to the basic characteristics of a new representative of antibodies against interleukin-23 – mirikizumab. It presents data from registrational clinical trials and information focusing on the efficacy and safety of mirikizumab and its specific clinical characteristics in gastroenterology.
- MeSH
- analgosedace MeSH
- antibiotická profylaxe MeSH
- gastrointestinální endoskopie klasifikace metody normy MeSH
- gastrointestinální krvácení diagnóza prevence a kontrola terapie MeSH
- gastrointestinální nemoci diagnóza prevence a kontrola terapie MeSH
- hematologické látky aplikace a dávkování MeSH
- hemostáza endoskopická metody MeSH
- kolonoskopie * klasifikace metody normy škodlivé účinky MeSH
- lidé MeSH
- předoperační péče metody MeSH
- riziko MeSH
- roztoky analýza klasifikace terapeutické užití MeSH
- terciární prevence metody MeSH
- vysazování léků MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- směrnice pro lékařskou praxi MeSH
- MeSH
- biologické přípravky aplikace a dávkování terapeutické užití MeSH
- idiopatické střevní záněty * diagnóza farmakoterapie MeSH
- injekce subkutánní MeSH
- lidé MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- úvodní články MeSH
- MeSH
- Crohnova nemoc * diagnóza MeSH
- diagnostické zobrazování metody MeSH
- kolonoskopie metody MeSH
- lidé MeSH
- magnetická rezonanční tomografie metody MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- směrnice pro lékařskou praxi 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.
