Abstract
Background
Infliximab (IFX) biosimilars CT-P13 and SB2 have comparable efficacy, safety, and immunogenicity to the originator Remicade (RMC). However, concerns about cross-switching patients ...between the 3 brands were raised in the absence of cross reactivity data between them. We aimed to determine whether antibodies to infliximab (ATI) in inflammatory bowel disease (IBD) patients cross-react with RMC, CT-P13, and SB2.
Methods
Based on previous ATI status, samples from 34 patients participating in the BIOSIM01 study (13 RMC, 9 CT-P13, and 12 switchers) were selected. Patients were treated with either RMC only, or CT-P13 only, or with RMC switched to CT-P13. Additionally, 28 IFX-naïve patients were assayed as controls. In total, 180 samples were analyzed. ATI trough levels were measured in parallel with 3 different bridging Enzyme Linked Immunosorbent Assays constructed using the 3 drugs. Spearman′s coefficient and percentages of agreement were used to study the correlation between each assay.
Results
In total, 76 samples out of 152 IFX-treated patient samples were ATI-positive (30 RMC, 14 CT-P13, and 32 switchers). All resulted ATI-positive when either CT-P13 or SB2 bridging assays were used. The overall percentage of agreement was 100% when compared either with CT-P13 or SB2 assays. No significant differences were found among ATI levels and coefficients (Spearman's 0.98 to 1.0, P < 0.0001).
Conclusions
ATI of RMC-treated, CT-P13-treated or RMC to CT-P13 switched patients show full cross-reactivity with CT-P13 and SB2. Findings suggest that immunodominant epitopes in the reference and CT-P13 drugs are equally present in SB2. Data support full interchangeability between biosimilars in regard to immunogenicity.
ObjectivesThe aim of this study was to determine whether antibodies to infliximab (IFX) in Remicade-treated patients cross-react with the biosimilar CT-P13.Methods250 consecutive patients with ...rheumatic diseases under Remicade and 77 controls were retrospectively selected for the study. Anti-IFX antibodies at drug through levels were measured in parallel with three different bridging ELISA assays: Promonitor-ANTI-IFX kit, which uses Remicade to detect antibodies, and two more assays that use either Inflectra or Remsima with the same format. Correlation and association between each assay was studied.Results50.4% of patients were tested positive with Promonitor-ANTI-IFX. All were antibodies to IFX (ATI)-positive when either Inflectra or Remsima assays were used. In all comparisons positive and negative percentage agreements were 100%, and correlation coefficients were ≥0.995. No differences between rheumatoid arthritis and spondyloarthritis, or between concomitant immunosuppressives, were observed.ConclusionsAnti-IFX antibodies of Remicade-treated patients cross-react with either Inflectra or Remsima. Although additional epitopes may be present in the biosimilar, results suggest that epitopes influencing the immune response to IFX are also present in the biosimilar. Antibody-positive patients treated with Remicade should not be switched to the biosimilar, since antibodies will interact with the new drug and potentially lead to loss of response. This finding supports the utility for therapeutic drug monitoring before a switching strategy is considered.
Speciation of respirable particles is becoming increasingly important from an epidemiological and analytical point of view to determine the potential effects of air pollution on human health. For ...this reason, current laws and analytical sampling methods focus on particle size, as it turns out to be the main factor for the greater or lesser penetration into the airways. In this sense, particles of less than 10 μm in diameter (<10 μm), referred to as PM10, are the particles that have a higher capacity for access to the respiratory tract and, therefore, more significant effect on them. In this sense, one of the most important factors that have a key role in the PM10 atmospheric pollution effect is the dispersion effect with the direct influence of natural effects such as wind, rain, topography apart from others. In this work, PM10 data extracted from the Basque Government environmental stations (19 sampling points) in the Biscay province (Basque Country, north of Spain) were combined with the results obtained from the use of self-made passive samplers (SMPS) in the same sampling points areas and subsequently, the sample analysis with a non-invasive elemental technique (Scanning Electron Microscope coupled to Energy Dispersive X-ray Spectrometry) was carried out. Thanks to this methodology, it was possible to determine a wide variety of metals in PM10 such as Al, Fe, Cr, Ni, Pb, Zn, Ti, etc. Most of them present as oxides and others as part of natural aggregations such as quartz, aluminosilicates, phosphates etc.
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•PM10 data extracted from the Basque Government environmental stations (19 different sampling points) was studied.•Spatial distributions of the Annual PM10 average concentration were constructed by 3D kriging.•Self-made passive sampler (SMPS) was successfully used for the HEs elemental speciation.•Metal oxides, phosphates, silicates, chromates etc. Forming metal clusters were identified by SEM-EDS.
Machu Picchu is an archaeological Inca sanctuary from the 15th century, located 2430 m above the sea level in the Cusco Region, Peru. In 1983, it was declared World Heritage Site by UNESCO. The ...surroundings and soils from the entire archaeological site are carefully preserved together with its grass parks. Due to the importance of the archaeological city and its surroundings, the Decentralized Culture Directorate of Cusco-PAN Machu Picchu decided to carry out a careful monitoring study in order to determine the ecological status of the soils. In this work, elemental and molecular characterization of 17 soils collected along the entire park was performed by means of X-ray Diffraction (XRD) and Inductively Coupled Plasma Mass Spectrometry (ICP-MS) after acidic digestion assisted by microwave energy. Thanks to the combination of these analytical techniques, it was possible to obtain the mineral composition and metal concentrations of all soils from these 17 sampling points. Finally, different statistical treatments were carried out in order to confirm the ecological status of the different sampling points from Machu Picchu archaeological site concluding that soils are not impacted.
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•Machu Picchu archaeological park’s granitic soil samples were analyzed.•Analytical strategy based on the combination of XRD and ICP-MS was carried out.•Environmental quality standards for agricultural soil of Peru are not exceeded.•NWAC indexes and CFs were calculated.•In general terms, the contamination degree of the soil from the archaeological site is low.
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