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.

• 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

OBJECTIVE: To assess the incidence of anti-drug antibodies (ADA) in patients with rheumatoid arthritis (RA) treated with the TNF inhibitors etanercept (ETN), adalimumab (ADL), or infliximab (IFX), and determine the potential relationship with trough drug concentration, efficacy, and patient-reported outcomes. METHODS: This multi-national, non-interventional, cross-sectional study (NCT01981473) enrolled adult patients with RA treated continuously for 6-24 months with ETN, ADL, or IFX. ADA and trough drug concentrations were measured by independent assays ≤2 days before the next scheduled dose. Efficacy measurements included Disease Activity Score 28-joint count (DAS28), low disease activity (LDA), remission, and erythrocyte sedimentation rate (ESR). Targeted medical histories of injection site/infusion reactions, serum sickness, and thromboembolic events were collected. RESULTS: Baseline demographics of the 595 patients (ETN: n = 200; ADL: n = 199; IFX: n = 196) were similar across groups. The mean duration of treatment was 14.6, 13.5, and 13.1 months for ETN, ADL, and IFX, respectively. All ETN-treated patients tested negative for ADA, whereas 31.2% and 17.4% patients treated with ADL and IFX, respectively, tested positive. In ADL- or IFX-treated patients, those with ADA had significantly lower trough drug concentrations. There were negative correlations between trough drug levels and both CRP and ESR in ADL- and IFX-treated patients. DAS28-ESR LDA and remission rates were higher in patients without ADA. The rate of targeted medical events reported was low. CONCLUSION: ADA were detected in ADL- and IFX-treated but not ETN-treated patients. Patients without ADA generally showed numerically better clinical outcomes than those with ADA. TRIAL REGISTRATION: This study was registered on www.ClinicalTrials.gov (NCT01981473).

• MeSH
• adalimumab škodlivé účinky   imunologie   farmakologie   terapeutické užití   MeSH
• antirevmatika imunologie   farmakologie   terapeutické užití   MeSH
• bezpečnost MeSH
• etanercept škodlivé účinky   imunologie   farmakologie   terapeutické užití   MeSH
• infliximab škodlivé účinky   imunologie   farmakologie   terapeutické užití   MeSH
• internacionalita MeSH
• lidé středního věku MeSH
• lidé MeSH
• protilátky imunologie   MeSH
• revmatoidní artritida farmakoterapie   imunologie   MeSH
• vztah mezi dávkou a účinkem léčiva MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

Biologická léčba přípravky anti‑TNFα je velmi účinnou terapií idiopatických střevních zánětů. Klinickým problémem je častá ztráta primárně dobré odpovědi na tuto léčbu. Jednou z příčin ztráty účinnosti je nízká koncentrace léčiva v séru, na níž se může podílet tvorba protilátek proti léku. Intenzifikace léčby (navýšení dávky nebo zkrácení intervalu mezi aplikacemi) může u části pacientů obnovit původní účinnost, část pacientů má naopak prospěch ze změny přípravku anti‑TNFα a u jiných nemocných je nutno dosavadní léčbu ukončit a zahájit terapii s jiným mechanismem účinku. Monitorování koncentrací a lékových protilátek se zdá být u části pacientů přínosné při optimalizaci léčby v případě ztráty odpovědi na terapii anti‑TNFα.

Biologic therapy with anti‑TNFα agents represents a very effective treatment modality in inflammatory bowel diseases. Secondary loss of response to anti‑TNFα treatment is an important problem in clinical practice, possibly caused by low levels of the drug in serum. Development of anti‑drug antibo­dies may be responsible for low drug levels in some patients. Dose intensification (dose increase and/or shortening of application interval) may restore the primary efficacy in some patients while the others benefit from switch to another anti‑TNFα agent. In some patients, anti‑TNFα therapy has to be stopped and the treatment with other mechanism of action is required. Pharmacokinetic monitoring seems to be beneficial in optimisation of anti‑TNFα treatment in some patients with loss of response to biologic th

• Klíčová slova
• golimumab,
• MeSH
• adalimumab imunologie   terapeutické užití   MeSH
• biologická terapie MeSH
• idiopatické střevní záněty * farmakoterapie   MeSH
• infliximab imunologie   terapeutické užití   MeSH
• lidé MeSH
• monitorování léčiv MeSH
• monoklonální protilátky imunologie   terapeutické užití   MeSH
• protilátky krev   MeSH
• TNF-alfa * antagonisté a inhibitory   imunologie   MeSH
• tolerance léku * MeSH
• vztah mezi dávkou a účinkem léčiva MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• přehledy MeSH