BACKGROUND/AIMS: Originator-adalimumab, an established treatment for patients with Crohn's disease (CD), showed no difference in efficacy or adverse events versus adalimumab biosimilar SB5 (SB5-adalimumab) over 10 weeks (W) of treatment. To understand the long-term effectiveness of SB5-adalimumab in CD, patients switched from originator-adalimumab to SB5-adalimumab were compared with patients remaining on originator-adalimumab over 104 W. METHODS: Data on patients aged ≥18 years, diagnosed with CD and treated at ISCARE, were collected prospectively from July 2018 to January 2021. Primary outcome: clinical disease activity at W52, measured by Harvey-Bradshaw index (HBI). Secondary outcomes: C-reactive protein (CRP), faecal calprotectin (FC) and adalimumab concentrations at W10, 26, 52 and 104, and treatment persistence. To ensure comparable cohorts, patients were propensity score (PS)-matched for age, gender and disease activity. RESULTS: After matching, 54 patients remained per cohort. At W52, mean (SD) HBI score was 3.2 (2.5) for originator-adalimumab and 4.0 [3.6] for SB5-adalimumab (difference [95% CI] -0.78 [-2.8, 1.3]; n = 18/cohort); no clinically meaningful differences in CRP, FC or drug concentrations were noted. Kaplan-Meier's estimates (95% CI) of remaining on treatment were originator-adalimumab: 0.870 (0.785-0.965) versus SB5-adalimumab: 0.648 (0.533-0.789) at W52 and significantly lower for SB5-adalimumab versus originator-adalimumab (p < .001) over 104 W. Local skin reaction events/pain was the main reason for treatment discontinuation in the SB5-adalimumab cohort (n = 20/54 [37%]). CONCLUSIONS: These long-term results of CD patients receiving originator-adalimumab or following nonmedical switch to SB5-adalimumab show similar therapeutic effects on clinical disease activity, biological parameters and pharmacokinetic profile in both cohorts from 52 to 104 W. A separation in persistence was observed beyond W26, mainly due to differences in local reactions at the injection site.
- MeSH
- adalimumab škodlivé účinky MeSH
- biosimilární léčivé přípravky * škodlivé účinky MeSH
- Crohnova nemoc * chemicky indukované farmakoterapie MeSH
- dospělí MeSH
- kohortové studie MeSH
- lidé MeSH
- mladiství MeSH
- tendenční skóre MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mladiství MeSH
- Publikační typ
- časopisecké články MeSH
- MeSH
- finanční podpora výzkumu jako téma MeSH
- interpretace statistických dat MeSH
- kardiovaskulární nemoci diagnóza komplikace prevence a kontrola MeSH
- koronární nemoc epidemiologie komplikace prevence a kontrola MeSH
- lidé středního věku MeSH
- lidé MeSH
- longitudinální studie MeSH
- mortalita trendy MeSH
- primární prevence metody statistika a číselné údaje trendy MeSH
- rizikové faktory MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- Publikační typ
- srovnávací studie MeSH
- MeSH
- demence ošetřování MeSH
- dospělí MeSH
- finanční podpora výzkumu jako téma MeSH
- kognitivní poruchy epidemiologie MeSH
- lidé MeSH
- senioři MeSH
- služby domácí péče statistika a číselné údaje MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Geografické názvy
- Evropa MeSH
The aim was to review the most interesting articles dealing with estimations of an individual's absolute coronary heart disease risk based on the Framingham heart study. Besides the Framingham coronary heart disease risk functions, results of validation studies of these Framingham risk functions are discussed. In general, the Framingham risk functions overestimated an individual's absolute risk in external (non-Framingham) populations with a lower occurrence of coronary heart disease compared with the Framingham population, and underestimated it in populations with a higher occurrence of coronary heart disease. Even if the calibration accuracy of the Framingham risk functions were not satisfying, the Framingham risk functions were able to rank individuals according to risk from low-risk to high-risk groups, with the discrimination ability of 60% and more.
- MeSH
- domácí ošetřování statistika a číselné údaje MeSH
- dospělí MeSH
- geriatrie statistika a číselné údaje MeSH
- lidé MeSH
- logistické modely MeSH
- retrospektivní studie MeSH
- senioři MeSH
- spotřeba léčiv MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Geografické názvy
- Evropa MeSH
- MeSH
- arterioskleróza epidemiologie patologie MeSH
- dospělí MeSH
- interpretace statistických dat MeSH
- lidé MeSH
- longitudinální studie MeSH
- rizikové faktory MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mužské pohlaví MeSH
- Geografické názvy
- Česká republika MeSH
