Lebrikizumab Provides Rapid Clinical Responses Across All Eczema Area and Severity Index Body Regions and Clinical Signs in Adolescents and Adults with Moderate-to-Severe Atopic Dermatitis.

INTRODUCTION: Atopic dermatitis (AD) affects multiple areas of the body, some of which may be more refractory to treatment. We evaluated improvements in the Eczema Area and Severity Index (EASI) by body region and clinical signs for each body region in lebrikizumab-treated patients with moderate-to-severe AD. METHODS: ADvocate 1 and ADvocate 2 compared lebrikizumab 250 mg as monotherapy every 2 weeks versus placebo for 16 weeks. Efficacy measures included EASI, which rates the extent and severity of four clinical signs (erythema, edema/papulation, excoriation, lichenification) in four body regions (head/neck, upper extremities, trunk, lower extremities). Analyses are post hoc. RESULTS: Mean baseline EASI, body region EASI subscores, and the severity of clinical signs were consistent across both studies (EASI ranging from 16.0 to 72.0). At week 16 in both studies, patients treated with lebrikizumab showed significantly greater percent improvement in EASI across all body regions versus placebo (p ≤ 0.001), with improvements as early as week 2. In ADvocate 1, all clinical signs significantly improved across all body regions at week 16 with lebrikizumab (51.4-71.6% improvement) versus placebo (23.1-43.5%, p ≤ 0.001), with significant improvements as early as week 2 for all signs. Significant improvements for all clinical signs at week 16 were also seen in ADvocate 2 for lebrikizumab (53.5-75.6%) versus placebo (28.5-41.2%, p ≤ 0.001) and as early as week 2 for all body regions and signs except head/neck erythema and lower extremity erythema, edema/papulation, and lichenification, which showed significant improvement by week 4. CONCLUSIONS: Lebrikizumab as monotherapy consistently and rapidly reduced the extent of involvement and severity of AD in all EASI clinical signs and body regions, including the head and neck region and clinical sign of lichenification, compared with placebo. TRIAL REGISTRATION: ClinicalTrials.gov identifier: ADvocate 1 (NCT04146363) and ADvocate 2 (NCT04178967).

Rapid and sustained improvements in itch and quality of life with upadacitinib plus topical corticosteroids in adults and adolescents with atopic dermatitis: 52-week outcomes from the phase 3 AD Up study.

Purpose: Atopic dermatitis (AD) adversely impacts quality of life (QoL). We evaluated the effect of upadacitinib, an oral selective Janus kinase inhibitor approved for moderate-to-severe AD, plus topical corticosteroids (+TCS) on patient-reported outcomes (PROs) over 52 weeks.Materials and methods: In the phase 3 AD Up study (NCT03568318), adults and adolescents with moderate-to-severe AD were randomized 1:1:1 to once-daily upadacitinib 15 mg, 30 mg, or placebo + TCS. Itch, skin pain/symptoms, sleep, QoL, daily activities, emotional state, mental health, and patient impressions of disease severity/improvement/treatment satisfaction were assessed.Results: This analysis included 901 patients. Within 1-2 weeks, PRO improvements were greater with both upadacitinib doses than with placebo (p <.05). Improvements increased through weeks 4-8; rates were generally maintained through week 52. At week 52, the proportion of patients with clinically meaningful improvements in itch (Worst Pruritus Numerical Rating Scale improvement ≥4), skin pain (AD Symptom Scale Skin Pain improvement ≥4), sleep (AD Impact Scale [ADerm-IS] Sleep improvement ≥12), daily activities (ADerm-IS Daily Activities improvement ≥14), and emotional state (ADerm-IS Emotional State improvement ≥11) ranged from 62.1%-77.7% with upadacitinib 15 mg + TCS and 71.3%-83.6% with upadacitinib 30 mg + TCS.Conclusions: Upadacitinib + TCS results in rapid, sustained improvements in burdensome AD symptoms and QoL.

The Efficacy and Safety of Bimekizumab for Plaque Psoriasis: An Expert Consensus Panel.

INTRODUCTION: Psoriasis is a chronic inflammatory condition affecting the skin, joints, and several other organ systems with significant disease burden. Bimekizumab is the first monoclonal antibody targeting both interleukin (IL)-17A and interleukin-17F and has demonstrated efficacy for treating moderate to severe psoriasis. Limited guidelines exist for incorporating this drug into clinical practice. The purpose of this study was for a panel of experts in psoriasis management to synthesize current literature and provide consensus statements with guidance on use of bimekizumab. METHODS: A comprehensive literature search of PubMed, Scopus, and Google Scholar was completed for English-language original research articles on the use of bimekizumab for moderate to severe psoriasis and psoriatic arthritis. A panel of nine dermatologists with significant expertise in treatment of psoriasis gathered to review the articles and create consensus statements on this new medication. A modified Delphi process was used to approve each statement and a strength of recommendation was assigned using Strength of Recommendation Taxonomy criteria. RESULTS: The literature search produced 102 articles that met criteria. A thorough screening of the studies for relevance to the research question resulted in 19 articles. These were distributed to all panelists for review prior to a roundtable discussion. The panel unanimously voted to adopt 14 consensus statements and recommendations, 12 of which were given a strength of "A", one of which was given a strength of "B", and one of which was given a strength of "C". CONCLUSION: Bimekizumab results in rapid and long-lasting clinical improvement for patients with moderate to severe plaque psoriasis and psoriatic arthritis. It has demonstrated superior efficacy when compared to several other biologics. The safety profile is consistent with other biologics, except for an increased incidence of oropharyngeal candidiasis.

Radiology trainee retirement programs: Options and participation.

BACKGROUND: Financial security and retirement planning are essential for all medical professionals including radiology residents. Given the available discretionary income during residency it is crucial to have insights into investment. We aimed to assess the prevalence of retirement plans offered to radiology residents, the available choices, and their degree of participation. METHODS: Two surveys were created using Qualtrics platform, one targeting program directors and another one oriented to radiology residents with items focused on demographic, financial status, offered plans, and participation. Analysis was performed using chi square whenever appropriate using Qualtrics platform. P values less than 0.05 were considered statistically significant. RESULTS: 199 radiology residents (72.6% attending university-based programs) responded to the survey. 83.7% participated in retirement plans; university-based programs had the highest rate of offering plans; 82.8% vs 70% and 53.8% for university, community and hybrid programs respectively. The most frequently offered retirement plan was a 403(b). Most of the residents (94.3%) started investment in the retirement program as early as PGY1 and PGY2. A considerable proportion of programs lacked formal training on retirement plans; however, residents emphasized the significance of financial education during their residency. CONCLUSION: Radiology residents are more likely to participate in a retirement plan if it is offered by their program. Providing proper guidance by incorporating financial education into radiology residency curricula can optimize residents' decision making and economical planning, leading to a more secure financial future.

Brain magnetic resonance imaging radiomics features associated with hepatic encephalopathy in adult cirrhotic patients.

PURPOSE: Hepatic encephalopathy (HE) is a potential complication of cirrhosis. Magnetic resonance imaging (MRI) may demonstrate hyperintense T1 signal in the globi pallidi. The purpose of this study was to evaluate the performance of MRI-based radiomic features for diagnosing and grading chronic HE in adult patients affected by cirrhosis. METHODS: Adult patients with and without cirrhosis underwent brain MRI with identical imaging protocol on a 3T scanner. Patients without history of chronic liver disease were the control population. HE grading was based on underlying liver disease, severity of clinical manifestation, and number of encephalopathic episodes. Texture analysis was performed on axial T1-weighted images on bilateral lentiform nuclei at the level of the foramina of Monro. Diagnostic performance of texture analysis for the diagnosis and grading of HE was assessed by calculating the area under the receiver operating characteristics (AUROC) with 95% confidence interval (CI). RESULTS: The final study population consisted of 124 patients, 70 cirrhotic patients, and 54 non-cirrhotic controls. Thirty-eight patients had history of HE with 22 having an HE grade > 1. The radiomic features predicted the presence of HE with an AUROC of 0.82 (95% CI: 0.73, 0.90; P < .0001; 82% sensitivity, 66% specificity). Radiomic features predicted grade 1 HE (AUROC 0.75; 95% CI: 0.61, 0.89; P < .0001; 94% sensitivity, 60% specificity) and grade ≥ 2 HE (AUROC 0.82; 95% CI: 0.71, 0.93; P < .0001, 95% sensitivity, 57% specificity). CONCLUSION: In cirrhotic patients, MR radiomic is effective in predicting the presence of chronic HE and in grading its severity.

Disease response and patient-reported outcomes among initiators of ixekizumab.

OBJECTIVES: There is limited real-world evidence on using ixekizumab in psoriasis patients. Therefore, we characterized patients with psoriasis initiating ixekizumab and report 6-month changes in disease and patient-reported outcomes. METHODS: Adult patients with psoriasis who initiated ixekizumab and completed a 6-month follow-up visit were enrolled from the Corrona Psoriasis Registry. Disease characteristics and outcomes were assessed at ixekizumab initiation. Outcomes included the mean 6-month change in Psoriasis Area and Severity Index (PASI), body surface area (BSA), Investigator Global Assessment (IGA), and IGA*BSA. RESULTS: From baseline to follow-up in all patients (n = 136), means decreased for IGA*BSA (-45.5) and BSA (-12.4), and a higher % achieved an absolute PASI ≤ 5 (84.6%), BSA 0-3 (72.1%), and IGA 0/1 (50.7%). Within stratified groups, means decreased for PASI <12 for IGA*BSA (-21.1) and BSA (-6.3); PASI≥12 for IGA*BSA (-94.8) and BSA (-24.6); weight <100 kg for IGA*BSA (-45.1) and BSA (-12.4); weight ≥100 kg for IGA*BSA (-46.2) and BSA (-12.3); concomitant PsA for IGA*BSA (-56.0) and BSA (-15.3); and in no concomitant PsA for IGA*BSA (-36.9) and BSA (-10.0). CONCLUSIONS: We provide real-world evidence on the benefits of ixekizumab for treating psoriasis, regardless of baseline disease severity, weight, or concomitant PsA.

Assessing the change in disease severity based on depressive symptoms in real-world psoriasis patients.

Aim: To evaluate whether the presence of a history of depression hinders psoriasis response to systemic therapies and to delineate baseline characteristics of patients whose depressive symptoms improved on systemic treatment. Methods: We studied patients within the Corrona® Psoriasis Registry, a prospective, multicenter observational disease-based registry, that were enrolled through September 2018, comparing changes from enrollment to 12-month visit. Results: There was a statistically significant improvement in all disease characteristics and most patient-reported outcomes in patients reporting a history of depression and in those that did not while there was no statistically significant difference in the degree of change comparing these two cohorts. Patients who noted improvement in depressive symptoms had more severe baseline disease characteristics and reported overall worse baseline patient-reported outcomes. Conclusions: History of depression does not portend a differential response to systemic treatment. Patients with improvement in depressive symptoms had worse baseline characteristics.

MOGAD: How It Differs From and Resembles Other Neuroinflammatory Disorders.

Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) is a distinct CNS inflammatory disease with symptoms and imaging findings that overlap other neuroinflammatory disorders. We highlight the imaging characteristics of MOGAD and contrast them with neuromyelitis optica spectrum disorder (NMOSD) and multiple sclerosis (MS). Intracranial features that suggest MOGAD include childhood acute disseminated encephalomyelitis pattern with diffuse signal abnormality in the cortical gray matter, subcortical white matter, deep white matter, and deep gray matter on T2-weighted and FLAIR images; few bilateral T2-hyperintense fluffy and poorly demarcated lesions; pontine or thalamic involvement (or both); and cerebellar peduncle lesions in children. Intraorbitally, one sees edematous, enlarged, tortuous optic nerve or nerves; bilateral long-segment T2 hyperintensity of anterior segments of the optic nerve; sparing of the optic chiasm and retrochiasmatic pathways; and perioptic nerve sheath and surrounding orbital fat enhancement. Spinal involvement is seen as longitudinally extensive transverse myelitis with a sagittal T2-hyperintense intramedullary spinal line, the axial "H" spinal cord sign (central cord gray matter T2 hyperintensity), and conus medullaris involvement. Early accurate diagnosis of MOGAD is important because prognosis and treatment differ from those for NMOSD and MS.

Traumatic lumbar spine fractures: Transverse process fractures dominate.

PURPOSE: With motor vehicle collisions (MVC) predominating as a source of trauma now, we sought to 1) reassess the types of traumatic lumbar spine fractures, 2) highlight the coincidence of transverse process fractures (TPF) with visceral injuries and 3) emphasize the difference in management between compression fracture (CF) and TPF. METHODS: We retrospectively reviewed the reports of lumbar spine and abdominopelvic CT scans from 2017 and 2018 to classify the types of spine fractures, their mechanism of injury, treatment and coexistence of abdominopelvic injuries. RESULTS: 2.2% of patients had posttraumatic lumbar spine fractures (113/5229), including 58 patients (51.3%) with isolated TPF and 42 (37.2%) with isolated CF; 13 patients had mixed types. TPF accounted for 70% of all fractures (195/277) as opposed to 24% for CF (67/277). MVC was responsible for 60.3% (35/58) of TPF but falls accounted for 73.8% (31/42) of CF. The odds ratio of having isolated TPF from MVC was 4.1[1.8-9.0] versus CF after a fall from standing was 4.5[2.0-10.5]. Of patients with both visceral injuries and lumbar spine fractures, 75% (27/36) had isolated TPF (odds ratio of visceral injury with TPF was 4.4[1.8-10.7]). No TPF were treated with an intervention, however 77% (40/52) of CF were addressed surgically or with braces. CONCLUSION: TPF are the most common lumbar spine fractures and are often associated with MVC. There is a high association between TPF and abdominopelvic visceral injury requiring radiologists' attentiveness even though the TPF is not directly addressed.

Musculoskeletal Radiology Reports: Overlooked or Valuable?

The electronic medical record (EMR) can reveal preferences of clinicians regarding imaging services. We sought to evaluate viewing habits for reports and images of musculoskeletal (MSK) studies by ordering clinicians. We hypothesized that MSK reports are important to clinical management, especially for advanced imaging modalities. We tracked the image and report access of all MSK studies ordered in September 2016 over 8 months using logs of the EMR (Epic Systems, Verona, WI), and by an independent analysis of the institutional PACS (Picture Archiving and Communication Systems) (Carestream Health, Rochester, NY). The time stamps were extracted for when images and reports were viewed. We categorized MSK studies by modality and provider department. We also compared the rates of viewing reports and images among different modalities and departments using the chi-square test. Of the 8143 viewed MSK studies, 7842 (96.3%) reports (with/without images) and 3916 (48.1%) imaging data (with/without reports) were viewed. Viewing reports alone occurred in 4227 (51.9%) studies. CT and MRI reports alone views occurred more often in comparison to radiographs ([482/706; 68.3%] for CT and [981/1713; 57.3%] for MRI vs. [2764/5724; 48.3%] for radiography, p < 0.001). Orthopedists ordered the highest number of MSK studies and viewed reports 99.2% (3216/3242) of the time, including a 54.6% (1770/3242) rate of viewing reports alone and a 44.6% (1446/3242) rate of viewing both reports and images. They viewed images without reports in 0.8% (27/3242) of cases. MSK reports were viewed significantly more frequently than the images across all modalities and all relevant specialties.

Clinical Access and Utilization of Reports and Images in Neuroradiology.

BACKGROUND: The radiology report serves as the primary means of communication between radiologist and clinician. However, the value clinicians place on imaging and reports is variable, with many images of studies or their reports never being viewed. This has implications on the perceived value of the radiologist in the imaging chain. We hypothesized that neurologists, neurosurgeons, and otolaryngologists would view neuroradiology images most frequently and neuroradiology reports least frequently of all medical specialties. MATERIALS AND METHODS: Ordering data were collected on all neuroradiology studies over a 1-month period. Imaging study date and time stamps were obtained for (1) when imaging study orders were placed, (2) when the patient underwent the imaging study, (3) when the imaging studies were viewed, and (4) when the radiology reports were accessed and by whom. Each data point included provider names, locations, departments, and level of training. RESULTS: There were 7,438 imaging neuroradiology studies ordered. Overall, 85.7% (6,372) of reports and 53.2% (3,956) of imaging studies were viewed and 13.1% (977) of studies had neither images nor reports viewed. Inpatient neurosurgeons and neurologists viewed both imaging and reports significantly more than primary care specialties (P < .001). In the outpatient setting, this trend stayed true for neurosurgeons though was not true for neurologists (P < .001). Outpatient study imaging and reports were both viewed the least (48.6%), and inpatient study reports were viewed the most (95.2%; P < .001). CONCLUSION: Viewing of imaging and reports varies with neurosurgeons viewing neuroradiology studies more than all other medical specialties. Overall, the reports were viewed significantly more than the images, suggesting that the radiologist and his or her interpretation are more valuable than the study's images. The radiologists' value, as measured by reports viewed, was maximal with obstetricians and gynecologists and psychiatry clinicians.

Clinical trials: Kids are not just little people.

Clinical trials are the backbone of modern evidence-based medicine. They are the vital bridge between research-based discovery and cutting edge patient care. Randomized, controlled clinical trials are the gold standard of medical research, providing a method for evaluation and discovery of novel therapies that improve and even save lives. Despite an increase in the number of pediatric and adult clinical trials over recent decades, this growth has not been equal among these populations. The volume of clinical trials involving children lags substantially behind their adult counterparts. Children are not simply little adults. As a result, extrapolating results from adult clinical trials to the treatment of children may be inappropriate and, possibly, harmful. In this review, we discuss the intricacies of performing clinical trials in all patients and stress the unique distinguishing characteristics of pediatric clinical trials.