Subcutaneous infliximab in Crohn's disease patients with previous immunogenic failure of intravenous infliximab.

PURPOSE: Immunogenicity is a major reason for secondary loss of response to infliximab (IFX). Recent work suggested potentially lower immunogenicity of subcutaneous (SC) compared to intravenous (IV) IFX. However, it is unknown whether re-exposure to IFX SC after secondary loss of response and immunogenicity to its intravenous formulation is safe and effective. METHODS: In a retrospective cohort study conducted at two medical centers, patients with clinically (Harvey-Bradshaw Index ≥ 5) and/or biochemically (fecal calprotectin > 250 µg/g) active Crohn's disease (CD) and previous immunogenic failure of IFX IV underwent exposure to IFX SC. Harvey-Bradshaw Index, fecal calprotectin, IFX serum concentration, and anti-drug antibodies were assessed until month 12. RESULTS: Twenty CD patients were included. The majority of patients (90%) had previous treatment with three or more biologics. Fifteen (75%) and ten (50%) of 20 patients continued IFX SC treatment until months 6 and 12, respectively. No immediate hypersensitivity reactions were observed. Two patients discontinued IFX SC treatment because of delayed hypersensitivity at week 2 and week 4. IFX serum concentrations increased from baseline to month 12, while anti-drug antibody levels decreased. Combined clinical and biochemical remission at month 12 was observed in seven of 20 patients (35%). CONCLUSION: Subcutaneous infliximab treatment of Crohn's disease patients with previous immunogenic failure of intravenous infliximab was well tolerated and effective in a cohort of patients with refractory Crohn's disease.

Technical assessment of resolution of handheld ultrasound devices and clinical implications.

PURPOSE: Since handheld ultrasound devices are becoming increasingly ubiquitous, objective criteria to determine image quality are needed. We therefore conducted a comparison of objective quality measures and clinical performance. MATERIAL AND METHODS: A comparison of handheld devices (Butterfly IQ+, Clarius HD, Clarius HD3, Philips Lumify, GE VScan Air) and workstations (GE Logiq E10, Toshiba Aplio 500) was performed using a phantom. As a comparison, clinical investigations were performed by two experienced ultrasonographers by measuring the resolution of anatomical structures in the liver, pancreas, and intestine in ten subjects. RESULTS: Axial full width at half maximum resolution (FWHM) of 100µm phantom pins at depths between one and twelve cm ranged from 0.6-1.9mm without correlation to pin depth. Lateral FWHM resolution ranged from 1.3-8.7mm and was positively correlated with depth (r=0.6). Axial and lateral resolution differed between devices (p<0.001) with the lowest median lateral resolution observed in the E10 (5.4mm) and the lowest axial resolution (1.6mm) for the IQ+ device. Although devices showed no significant differences in most clinical applications, ultrasonographers were able to differentiate a median of two additional layers in the wall of the sigmoid colon and one additional structure in segmental portal fields (p<0.05) using cartwheel devices. CONCLUSION: While handheld devices showed superior or similar performance in the phantom and routine measurements, workstations still provided superior clinical imaging and resolution of anatomical substructures, indicating a lack of objective measurements to evaluate clinical ultrasound devices.