Recent Publications by CFE Educators

OBJECTIVE

Assess long-term safety, tolerability and efficacy of bimekizumab in ankylosing spondylitis (radiographic axial spondyloarthritis (r-axSpA)).

METHODS

Patients with active r-axSpA completing the dose-ranging 48-week randomised controlled trial could enrol in the open-label extension, where patients received bimekizumab 160 mg every 4 weeks. Safety (exposure-adjusted incidence rates/100 patient-years (EAIRs)) and efficacy outcomes (binary: non-responder imputation (NRI) and observed case (OC); continuous: multiple imputation (MI)) are presented through 256 weeks.

RESULTS

From Weeks 0-256, 289/303 (95.4%) patients had ≥1 treatment-emergent adverse event (TEAE); most frequent were nasopharyngitis (21.8%) and upper respiratory tract infection (14.5%). The EAIR of fungal infections was 7.4 ( infections: 2.6; oral candidiasis: 2.2); none systemic. EAIR of serious infections was 1.4; no active tuberculosis was reported. Active inflammatory bowel disease and anterior uveitis EAIRs were 0.8 and 0.7, respectively. 202/303 (66.7%) patients completed Week 256. 42 (13.9%) patients discontinued treatment due to TEAEs.Efficacy at Week 48 was maintained for 5 years. At Week 256, NRI analysis showed 49.7% (OC: 73.1%) and 41.6% (OC: 71.1%) of patients achieved Assessment of SpondyloArthritis International Society 40% (ASAS40) response and Axial Spondyloarthritis Disease Activity Score (ASDAS) low disease activity, respectively. Mean (SE; MI) ASDAS improved from 3.9 (0.1) at baseline to 2.1 (0.1) at Week 48, which was maintained to Week 256. Improvements in pain, fatigue, physical function and health-related quality of life were sustained.

CONCLUSIONS

The safety profile of bimekizumab after 5 years of treatment remained consistent with previous reports, with no new safety signals identified. 5-year efficacy was sustained in this r-axSpA population following robust disease control achieved at Week 48.

TRIAL REGISTRATION NUMBERS

NCT02963506; NCT03355573.

PURPOSE

Many trainees lack competence in performing cold snare polypectomy (CSP), and longer observation periods using assessment tools, such as the Cold Snare Polypectomy Assessment Tool (CSPAT), may be required. However, these tools are not commonly used in busy academic endoscopy practices. This study evaluates the concordance between trainee self-assessment of CSP with expert assessment and assesses factors associated with concordance.

METHOD

Consecutive CSPs performed by gastroenterology trainees from 2 institutions were video recorded and rated by 8 blinded experts from 4 different academic institutions in the United States and Singapore using the CSPAT from August 2017 to February 2020. Trainees self-assessed competence for each CSP immediately after the procedure. Concordance between trainee and trainer was reported as percentage of agreement in competence (score of 3 or 4) or not yet competent (score of 1 or 2).

RESULTS

Twenty-two trainees performed 765 colonoscopies with 2,267 CSPs. Concordance was found between expert and trainee assessment of competence for 1,380 CSPs (60.9%; 95% CI, 58.8%-62.9%; weighted κ = 0.12; 95% CI, 0.08-0.16). Trainees underassessed competence for 541 CSPs (23.9%; 95% CI, 22.1%-25.7%) and overassessed competence for 326 CSPs (15.3%; 95% CI, 13.8%-16.8%). Career plan of private practice general gastroenterology (adjusted odds ratio, 0.40; 95% CI, 0.17-0.92) and lower colonoscopy volume before study (adjusted odds ratio, 0.35; 95% CI, 0.22-0.62) were independently associated with lower likelihood of concordance between expert and trainee assessment of competence. Structured feedback was not associated with concordance, and there was no change as trainees gained experience; however, feedback decreased the proportion of overassessments.

CONCLUSIONS

There is poor concordance between trainee self-assessment and trainer assessment of CSP. Self-assessment can be used as an initial part of competency assessment, which should then be reconciled with external assessments to improve concordance in assessments.

Lung tumors can be obscured in x-rays, preventing accurate and robust localization. To improve lung conspicuity for image-guided procedures, we isolate the lungs in the anterior-posterior (AP) x-rays using a lung extraction network (LeX-net) that virtually removes overlapping thoracic structures, including ribs, diaphragm, liver, heart, and trachea.73 965 thoracic 3DCTs and 106 thoracic 4DCTs were included. The 3D lung volume was extracted using an open-source lung volume segmentation model. AP digitally reconstructed radiographs (DRRs) of the full anatomy CT and extracted lungs were computed as the input and reference to train a network (LeX-net) to generate lung-extracted DRRs (LeX-net DRRs) from full anatomy DRRs, which adopted a Swin-UNet model with conditional GAN. Subsequently, the trained LeX-net on 3DCT was applied to 4DCT-derived DRRs. Lung tumor tracking was then performed on DRRs using a template-matching method on a holdoff 4DCT test set of 79 patients whose gross tumor volumes were smaller than 20 cm.. LeX-net successfully isolated the lungs in DRRs, achieving an SSIM of 0.9581 ± 0.0151 and a PSNR of 30.78 ± 2.50 on the testing set of 3DCT-derived DRRs. Its performance declined slightly when applied to the 4DCT but maintained useable lung-only 2D views. On the challenging test set including cases of organ overlap, high tumor mobility, and small tumor size, the individual tumor tracking error for LeX-net DRRs was 0.97 ± 0.86 mm, significantly lower than that of 3.13 ± 5.82 mm using the full anatomy DRRs. LeX-net improved success rates of using 5 mm, 3 mm, and 1 mm tracking windows from 88.1%, 80.0%, and 58.7% to 98.1%, 94.2%, and 73.8%, respectively.. LeX-net removes overlapping anatomies and enhances visualization of the lungs in x-rays. The model trained using 3DCTs is generalizable to 4DCT-derived DRRs, achieving significantly improved tumor tracking outcome.