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Article ; Online: Overview of FDA Drug Approval and Labeling.

Clarridge, Katherine E / Chin, Stacy J / Stone, Kelly D

The journal of allergy and clinical immunology. In practice

2022 Volume 10, Issue 12, Page(s) 3051–3056

Abstract: The U.S. Food and Drug Administration (FDA) regulates a variety of products, including medical, food, and tobacco products. Prior to the creation of the FDA, there were few protections to the public around the contents and sale of food and ... ...

Abstract	The U.S. Food and Drug Administration (FDA) regulates a variety of products, including medical, food, and tobacco products. Prior to the creation of the FDA, there were few protections to the public around the contents and sale of food and pharmaceuticals. Over time, legislation was passed and amended that ensured drugs and biologics undergo extensive review by multidisciplinary teams to provide assurance that marketed products are safe and effective for their intended use. The FDA-approved drug labeling is the primary tool for communicating essential information regarding the safe and effective use of a drug product. As such, providers should be familiar with the format of the prescribing information because it is a valuable source of information, particularly prior to prescribing a new drug for the first time. Although there are clinical circumstances in which off-label drug use may be warranted, prescribing drugs off-label involves a context of use that has not undergone the FDA's rigorous evaluation of the benefit-risk assessment.
Language	English
Publishing date	2022-12-07
Publishing country	United States
Document type	Journal Article
ZDB-ID	2843237-X
ISSN	2213-2201 ; 2213-2198
ISSN (online)	2213-2201
ISSN	2213-2198
DOI	10.1016/j.jaip.2022.09.005
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Zs.A 7086: Show issues

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Article ; Online: Frequency and predictors of complication clustering within 30 days of spinal fusion surgery: a study of children with neuromuscular scoliosis.

Rajkumar, Sujay / Iyer, Rajiv R / Stone, Lauren / Kelly, Michael P / Plonsker, Jillian / Brandel, Michael / Gonda, David D / Mazur, Marcus D / Ikeda, Daniel S / Lucas, Donald J / Choi, Pamela M / Ravindra, Vijay M

Spine deformity

2024 Volume 12, Issue 3, Page(s) 727–738

Abstract: Purpose: There is limited information on the clustering or co-occurrence of complications after spinal fusion surgery for neuromuscular disease in children. We aimed to identify the frequency and predictive factors of co-occurring perioperative ... ...

Abstract	Purpose: There is limited information on the clustering or co-occurrence of complications after spinal fusion surgery for neuromuscular disease in children. We aimed to identify the frequency and predictive factors of co-occurring perioperative complications in these children. Methods: In this retrospective database cohort study, we identified children (ages 10-18 years) with neuromuscular scoliosis who underwent elective spinal fusion in 2012-2020 from the National Surgical Quality Improvement Program-Pediatric database. The rates of co-occurring complications within 30 days were calculated, and associated factors were identified by logistic regression analysis. Correlation between a number of complications and outcomes was assessed. Results: Approximately 11% (709/6677 children with neuromuscular scoliosis undergoing spinal fusion had co-occurring complications: 7% experienced two complications and 4% experienced ≥ 3. The most common complication was bleeding/transfusion (80%), which most frequently co-occurred with pneumonia (24%) and reintubation (18%). Surgical time ≥ 400 min (odds ratio (OR) 1.49 [95% confidence interval (CI) 1.25-1.75]), fusion ≥ 13 levels (1.42 [1.13-1.79]), and pelvic fixation (OR 1.21 [1.01, 1.44]) were identified as procedural factors that independently predicted concurrent complications. Clinical risk factors for co-occurring complications included an American Society of Anesthesiologist physical status classification ≥ 3 (1.73 [1.27-2.37]), structural pulmonary/airway abnormalities (1.24 [1.01-1.52]), impaired cognitive status (1.80 [1.41-2.30]), seizure disorder (1.36 [1.12-1.67]), hematologic disorder (1.40 [1.03-1.91], preoperative nutritional support (1.34 [1.08-1.72]), and congenital malformations (1.20 [1.01-1.44]). Preoperative tracheostomy was protective against concurrent complications (0.62 [0.43-0.89]). Significant correlations were found between number of complications and length of stay, non-home discharge, readmissions, and death. Conclusion: Longer surgical time (≥ 400 min), fusion ≥ 13 levels and pelvic fixation are surgical risk factors independently associated with co-occurring complications, which were associated with poorer patient outcomes. Recognizing identified nonmodifiable risk factors might also be important for preoperative planning and risk stratification of children with neuromuscular scoliosis requiring spinal fusion. Level of evidence: Level IV evidence.
MeSH term(s)	Humans ; Spinal Fusion/adverse effects ; Scoliosis/surgery ; Child ; Adolescent ; Female ; Male ; Retrospective Studies ; Postoperative Complications/epidemiology ; Postoperative Complications/etiology ; Neuromuscular Diseases/complications ; Neuromuscular Diseases/epidemiology ; Risk Factors ; Time Factors ; Operative Time ; Pneumonia/epidemiology ; Pneumonia/etiology
Language	English
Publishing date	2024-02-09
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2717704-X
ISSN	2212-1358 ; 2212-134X ; 2212-1358
ISSN (online)	2212-1358 ; 2212-134X
ISSN	2212-1358
DOI	10.1007/s43390-023-00813-8
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Article ; Online: SRS-22r Self-Image After Surgery for Adolescent Idiopathic Scoliosis at 10-year Follow-up.

Stone, Lauren E / Upasani, Vidyadhar V / Pahys, Joshua M / Fletcher, Nicholas D / George, Stephen G / Shah, Suken A / Bastrom, Tracey P / Bartley, Carrie E / Lenke, Lawrence G / Newton, Peter O / Kelly, Michael P

Spine

2023 Volume 48, Issue 10, Page(s) 683–687

Abstract: Study design: Retrospective cohort.: Objective: To examine SRS-Self Image scores at up to 10 years after surgery for adolescent idiopathic scoliosis (AIS).: Summary of background data: Self-image is complex with implications for surgical and ... ...

Abstract	Study design: Retrospective cohort. Objective: To examine SRS-Self Image scores at up to 10 years after surgery for adolescent idiopathic scoliosis (AIS). Summary of background data: Self-image is complex with implications for surgical and patient-reported outcomes after AIS surgery. Surgically modifiable factors that impact self-image are inconsistently reported in the literature with few longer-term reports. We examined the rate and durability of self-image improvement. Materials and methods: An AIS registry was queried for patients with up to 10 years of follow-up after AIS surgery. A mixed effects model estimated change in SRS-22 Self Image from baseline to 6 weeks, 1 year, 2 years, 5 years, and 10 years. All enrolled patients contributed data to the mixed effects models. A sub-analysis of patients with 1-year and 10-year follow-up evaluated worsening/static/improved SRS-22 Self Image scores examined stability of scores over that timeline. Baseline demographic data and 1-year deformity magnitude data were compared between groups using parametric and nonparametric tests as appropriate. Results: Data from 4608 patients contributed data to the longitudinal model; 162 had 1-year and 10-year data. Mean SRS-Self Image improvement at 10-year follow-up was 1.0 (95% CI: 0.9-1.1) point. No significant changes in Self-Image domain scores were estimated from 1-year to 10-year (all P >0.05) postoperative. Forty (25%) patients had SRS-Self Image worsening from 1 year to 10 years, 36 (22%) improved, and 86 (53%) were unchanged. Patients who worsened over 10 years had lower SRS-Self Image at baseline than those unchanged at enrollment (3.3 vs. 3.7, P =0.007). Neither radiographic parameters nor SRS-Mental Health were different at baseline for the enrolled patients. Conclusion: Ten years after surgery, 75% of patients reported similar or better SRS-Self Image scores than one year after surgery. Nearly 25% of patients reported worsening self-image at 10 years. Patients who worsened had lower baseline SRS-Self Image scores, without radiographic or mental health differences at baseline or follow-up.
MeSH term(s)	Humans ; Adolescent ; Follow-Up Studies ; Retrospective Studies ; Scoliosis/diagnostic imaging ; Scoliosis/surgery ; Scoliosis/psychology ; Quality of Life ; Kyphosis
Language	English
Publishing date	2023-03-13
Publishing country	United States
Document type	Journal Article
ZDB-ID	752024-4
ISSN	1528-1159 ; 0362-2436
ISSN (online)	1528-1159
ISSN	0362-2436
DOI	10.1097/BRS.0000000000004620
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Zs.A 1305: Show issues

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Article ; Online: Measuring HIV Acquisitions Among Partners of Key Populations: Estimates From HIV Transmission Dynamic Models.

Silhol, Romain / Anderson, Rebecca L / Stevens, Oliver / Stannah, James / Booton, Ross D / Baral, Stefan / Dimitrov, Dobromir / Mitchell, Kate M / Donnell, Deborah / Bershteyn, Anna / Brown, Tim / Kelly, Sherrie L / Kim, Hae-Young / Johnson, Leigh F / Maheu-Giroux, Mathieu / Martin-Hughes, Rowan / Mishra, Sharmistha / Peerapatanapokin, Wiwat / Stone, Jack /

Stover, John / Teng, Yu / Vickerman, Peter / Garcia, Sonia Arias / Korenromp, Eline / Imai-Eaton, Jeffrey W / Boily, Marie-Claude

Journal of acquired immune deficiency syndromes (1999)

2024 Volume 95, Issue 1S, Page(s) e59–e69

Abstract: Background: Key populations (KPs), including female sex workers (FSWs), gay men and other men who have sex with men (MSM), people who inject drugs (PWID), and transgender women (TGW) experience disproportionate risks of HIV acquisition. The UNAIDS ... ...

Abstract	Background: Key populations (KPs), including female sex workers (FSWs), gay men and other men who have sex with men (MSM), people who inject drugs (PWID), and transgender women (TGW) experience disproportionate risks of HIV acquisition. The UNAIDS Global AIDS 2022 Update reported that one-quarter of all new HIV infections occurred among their non-KP sexual partners. However, this fraction relied on heuristics regarding the ratio of new infections that KPs transmitted to their non-KP partners to the new infections acquired among KPs (herein referred to as "infection ratios"). We recalculated these ratios using dynamic transmission models. Setting: One hundred seventy-eight settings (106 countries). Methods: Infection ratios for FSW, MSM, PWID, TGW, and clients of FSW were estimated from 12 models for 2020. Results: Median model estimates of infection ratios were 0.7 (interquartile range: 0.5-1.0; n = 172 estimates) and 1.2 (0.8-1.8; n = 127) for acquisitions from FSW clients and transmissions from FSW to all their non-KP partners, respectively, which were comparable with the previous UNAIDS assumptions (0.2-1.5 across regions). Model estimates for female partners of MSM were 0.5 (0.2-0.8; n = 20) and 0.3 (0.2-0.4; n = 10) for partners of PWID across settings in Eastern and Southern Africa, lower than the corresponding UNAIDS assumptions (0.9 and 0.8, respectively). The few available model estimates for TGW were higher [5.1 (1.2-7.0; n = 8)] than the UNAIDS assumptions (0.1-0.3). Model estimates for non-FSW partners of FSW clients in Western and Central Africa were high (1.7; 1.0-2.3; n = 29). Conclusions: Ratios of new infections among non-KP partners relative to KP were high, confirming the importance of better addressing prevention and treatment needs among KP as central to reducing overall HIV incidence.
MeSH term(s)	Male ; Humans ; Female ; HIV Infections/epidemiology ; Homosexuality, Male ; Sex Workers ; Sexual and Gender Minorities ; Substance Abuse, Intravenous
Language	English
Publishing date	2024-01-04
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
ZDB-ID	645053-2
ISSN	1944-7884 ; 1077-9450 ; 0897-5965 ; 0894-9255 ; 1525-4135
ISSN (online)	1944-7884 ; 1077-9450
ISSN	0897-5965 ; 0894-9255 ; 1525-4135
DOI	10.1097/QAI.0000000000003334
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Zs.A 2442: Show issues

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Article ; Online: ABBV-184: A Novel Survivin-specific TCR/CD3 Bispecific T-cell Engager is Active against Both Solid Tumor and Hematologic Malignancies.

Chervin, Adam S / Stone, Jennifer D / Konieczna, Iwona / Calabrese, Kelly M / Wang, Ningyan / Haribhai, Dipica / Dong, Feng / White, Michael K / Rodriguez, Luis E / Bukofzer, Gail T / Ellis, Paul A / Cosgrove, Cormac / Hecquet, Claudie / Clarin, Jerry D / Palma, Joann P / Reilly, Edward B

Molecular cancer therapeutics

2023 Volume 22, Issue 8, Page(s) 903–912

Abstract: CD3 bispecific T-cell engagers (TCE), comprised of a tumor-targeting domain linked to a CD3 binding domain, function by bridging target-positive tumors and CD3-expressing effector T cells enabling redirected T cell-mediated killing of tumor cells. ... ...

Abstract	CD3 bispecific T-cell engagers (TCE), comprised of a tumor-targeting domain linked to a CD3 binding domain, function by bridging target-positive tumors and CD3-expressing effector T cells enabling redirected T cell-mediated killing of tumor cells. Although the majority of CD3 bispecific molecules in clinical development incorporate tumor-targeting antibody-based binding domains, many tumor-associated antigens derive from intracellular proteins and are not accessible to targeting via antibody. Intracellular proteins processed into short peptide fragments and presented on the cell surface by MHC proteins are recognized by T-cell receptors (TCR) on the surface of T cells. Here we describe the generation and preclinical evaluation of ABBV-184, a novel TCR/anti-CD3 bispecific composed of a highly selective soluble TCR that binds a peptide derived from the oncogene survivin (BIRC5) bound to the class I MHC allele human leukocyte antigen (HLA)-A*02:01 expressed on tumor cells, linked to a specific binder to the CD3 receptor on T cells. ABBV-184 drives an optimal distance between T cell and target cell thereby enabling sensitive recognition of low-density peptide/MHC targets. Consistent with the expression profile of survivin across a broad range of both hematologic and solid tumors, treatment of acute myeloid leukemia (AML) and non-small cell lung cancer (NSCLC) cell lines with ABBV-184 results in T-cell activation, proliferation, and potent redirected cytotoxicity of HLA-A2-positive target cell lines, both in vitro and in vivo, including patient-derived AML samples. These results indicate that ABBV-184 is an attractive clinical candidate for the treatment of patients with AML and NSCLC.
MeSH term(s)	Humans ; T-Lymphocytes ; Carcinoma, Non-Small-Cell Lung/metabolism ; Survivin/metabolism ; Lung Neoplasms/metabolism ; Receptors, Antigen, T-Cell ; CD3 Complex ; Leukemia, Myeloid, Acute/pathology ; Hematologic Neoplasms/metabolism ; Antibodies, Bispecific/pharmacology ; Antibodies, Bispecific/therapeutic use
Chemical Substances	Survivin ; Receptors, Antigen, T-Cell ; CD3 Complex ; Antibodies, Bispecific
Language	English
Publishing date	2023-06-09
Publishing country	United States
Document type	Journal Article
ZDB-ID	2063563-1
ISSN	1538-8514 ; 1535-7163
ISSN (online)	1538-8514
ISSN	1535-7163
DOI	10.1158/1535-7163.MCT-22-0770
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Zs.A 5750: Show issues

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Article ; Online: A surge in serum mucosal cytokines associated with seroconversion in children at risk for type 1 diabetes.

Journal of diabetes investigation

2023 Volume 14, Issue 9, Page(s) 1092–1100

Abstract: Aims/introduction: Autoantibodies to pancreatic islet antigens identify young children at high risk of type 1 diabetes. On a background of genetic susceptibility, islet autoimmunity is thought to be driven by environmental factors, of which enteric ... ...

Abstract	Aims/introduction: Autoantibodies to pancreatic islet antigens identify young children at high risk of type 1 diabetes. On a background of genetic susceptibility, islet autoimmunity is thought to be driven by environmental factors, of which enteric viruses are prime candidates. We sought evidence for enteric pathology in children genetically at-risk for type 1 diabetes followed from birth who had developed islet autoantibodies ("seroconverted"), by measuring mucosa-associated cytokines in their sera. Materials and methods: Sera were collected 3 monthly from birth from children with a first-degree type 1 diabetes relative, in the Environmental Determinants of Islet Autoimmunity (ENDIA) study. Children who seroconverted were matched for sex, age, and sample availability with seronegative children. Luminex xMap technology was used to measure serum cytokines. Results: Of eight children who seroconverted, for whom serum samples were available at least 6 months before and after seroconversion, the serum concentrations of mucosa-associated cytokines IL-21, IL-22, IL-25, and IL-10, the Th17-related cytokines IL-17F and IL-23, as well as IL-33, IFN-γ, and IL-4, peaked from a low baseline in seven around the time of seroconversion and in one preceding seroconversion. These changes were not detected in eight sex- and age-matched seronegative controls, or in a separate cohort of 11 unmatched seronegative children. Conclusions: In a cohort of children at risk for type 1 diabetes followed from birth, a transient, systemic increase in mucosa-associated cytokines around the time of seroconversion lends support to the view that mucosal infection, e.g., by an enteric virus, may drive the development of islet autoimmunity.
MeSH term(s)	Child ; Humans ; Infant ; Child, Preschool ; Diabetes Mellitus, Type 1 ; Cytokines ; Seroconversion ; Autoimmunity ; Autoantibodies ; Islets of Langerhans
Chemical Substances	Cytokines ; Autoantibodies
Language	English
Publishing date	2023-06-13
Publishing country	Japan
Document type	Journal Article
ZDB-ID	2625840-7
ISSN	2040-1124 ; 2040-1116
ISSN (online)	2040-1124
ISSN	2040-1116
DOI	10.1111/jdi.14031
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Zs.A 6920: Show issues

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Article ; Online: The Road to Achieving the European Commission's Chemicals Strategy for Nanomaterial Sustainability-A PATROLS Perspective on New Approach Methodologies.

Doak, Shareen H / Clift, Martin J D / Costa, Anna / Delmaar, Christiaan / Gosens, Ilse / Halappanavar, Sabina / Kelly, Sean / Pejinenburg, Willie J G M / Rothen-Rutishauser, Barbara / Schins, Roel P F / Stone, Vicki / Tran, Lang / Vijver, Martina G / Vogel, Ulla / Wohlleben, Wendel / Cassee, Flemming R

Small (Weinheim an der Bergstrasse, Germany)

2022 Volume 18, Issue 17, Page(s) e2200231

Abstract: The European Green Deal outlines ambitions to build a more sustainable, climate neutral, and circular economy by 2050. To achieve this, the European Commission has published the Chemicals Strategy for Sustainability: Towards a Toxic-Free Environment, ... ...

Abstract	The European Green Deal outlines ambitions to build a more sustainable, climate neutral, and circular economy by 2050. To achieve this, the European Commission has published the Chemicals Strategy for Sustainability: Towards a Toxic-Free Environment, which provides targets for innovation to better protect human and environmental health, including challenges posed by hazardous chemicals and animal testing. The European project PATROLS (Physiologically Anchored Tools for Realistic nanOmateriaL hazard aSsessment) has addressed multiple aspects of the Chemicals Strategy for Sustainability by establishing a battery of new approach methodologies, including physiologically anchored human and environmental hazard assessment tools to evaluate the safety of engineered nanomaterials. PATROLS has delivered and improved innovative tools to support regulatory decision-making processes. These tools also support the need for reducing regulated vertebrate animal testing; when used at an early stage of the innovation pipeline, the PATROLS tools facilitate the safe and sustainable development of new nano-enabled products before they reach the market.
MeSH term(s)	Animals ; Environmental Health ; European Union ; Nanostructures ; Risk Assessment
Language	English
Publishing date	2022-03-24
Publishing country	Germany
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2168935-0
ISSN	1613-6829 ; 1613-6810
ISSN (online)	1613-6829
ISSN	1613-6810
DOI	10.1002/smll.202200231
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Article ; Online: Cervical Disc Arthroplasty: Current Evidence and Real-World Application.

Nunley, Pierce D / Coric, Domagoj / Frank, Kelly A / Stone, Marcus B

Neurosurgery

2017 Volume 83, Issue 6, Page(s) 1087–1106

Abstract: Cervical total disc replacement (cTDR) is still considered a developing technology, with widespread clinical use beginning in the early 2000s. Despite being relatively new to the marketplace, the literature surrounding cTDR is abundant. We conducted a ... ...

Abstract	Cervical total disc replacement (cTDR) is still considered a developing technology, with widespread clinical use beginning in the early 2000s. Despite being relatively new to the marketplace, the literature surrounding cTDR is abundant. We conducted a thorough review of literature published in the United States (US) and outside the US to report the current global state of cTDR research and clinical use. Search criteria were restricted to publications with a clinical patient population, excluding finite element analyses, biomechanical studies, cadaver studies, surgical technique-specific papers, and case studies. US publications mostly encompass the results of the highly controlled Food and Drug Administration Investigational Device Exemption trials. The predominantly level I evidence in the US literature supports the use of cTDR at 1 and 2 surgical levels when compared to anterior cervical discectomy and fusion. In general, the outside the US studies typically have smaller patient populations, are rarely controlled, and include broader surgical indications. Though these studies are of lower levels of evidence, they serve to advance patient indications in the use of cTDR. Complications such as secondary surgery, heterotopic ossification, and adjacent segment degeneration also remain a focus of studies. Other external challenges facing cTDR technology include regulatory restrictions and health economics, both of which are beginning to be addressed. Combined, the evidence for cTDR is robust supporting a variety of clinical indications.
MeSH term(s)	Cervical Vertebrae/surgery ; Humans ; Intervertebral Disc Degeneration/surgery ; Total Disc Replacement/methods ; United States
Language	English
Publishing date	2017-12-24
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	135446-2
ISSN	1524-4040 ; 0148-396X
ISSN (online)	1524-4040
ISSN	0148-396X
DOI	10.1093/neuros/nyx579
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Zs.A 1424: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Evaluation of the safety, efficacy, and mechanism of action of obexelimab for the treatment of patients with IgG4-related disease: an open-label, single-arm, single centre, phase 2 pilot trial.

Perugino, Cory A / Wallace, Zachary S / Zack, Debra J / Quinn, Shauna M / Poma, Allen / Fernandes, Ana D / Foster, Paul / DeMattos, Steve / Burington, Bart / Liu, Hang / Allard-Chamard, Hugues / Smith, Nathan / Kai, Xin / Xing, Kelly / Pillai, Shiv / Stone, John H

The Lancet. Rheumatology

2023 Volume 5, Issue 8, Page(s) e442–e450

Abstract: Background: Obexelimab is a bifunctional, non-cytolytic, humanised monoclonal antibody that binds CD19 and Fc gamma receptor IIb to inhibit B cells, plasmablasts, and CD19-expressing plasma cells. We aimed to evaluate the safety, clinical efficacy, and ... ...

Abstract	Background: Obexelimab is a bifunctional, non-cytolytic, humanised monoclonal antibody that binds CD19 and Fc gamma receptor IIb to inhibit B cells, plasmablasts, and CD19-expressing plasma cells. We aimed to evaluate the safety, clinical efficacy, and pharmacodynamic effects of obexelimab in patients with active IgG4-related disease. Methods: We conducted an open-label, single-arm, single centre, phase 2 pilot trial at the Massachusetts General Hospital in Boston, MA, USA. Eligible patients were aged 18-80 years and had active IgG4-related disease confirmed by an IgG4-related disease responder index score of 3 or more. Patients received 5 mg/kg of obexelimab intravenously every 2 weeks for 24 weeks. Patients on glucocorticoids at baseline were expected to discontinue usage within 2 months following enrolment. The primary endpoint was the proportion of patients with a decrease of 2 or more from baseline in the IgG4-related disease responder index at day 169 (ie, primary responders). Patients who achieved a decrease of 2 or more at any visit were designated as responders. Adverse events were graded on a scale of 1-5 (ie, mild, moderate, severe, life-threatening, or death) according to the Common Terminology Criteria for Adverse Events grading scale (version 4.3). Exploratory analyses were quantification of B-cell CD19 receptor occupancy, plasmablast, total B-cell and CD4 Findings: Between Feb 24, 2016, and Dec 21, 2016, we enrolled 15 patients. The median age was 63 years (IQR 52-65). Ten (67%) of 15 patients were male, five (33%) were female, and 12 (80%) were White. At baseline, 12 (80%) of 15 patients had an elevated median serum IgG4 concentration of 220 mg/dL (IQR 124-441), and the median IgG4-related disease responder index score was 12 (IQR 7-13). 12 (80%) of 15 patients achieved the primary endpoint (ie, primary responders), 14 (93%) were defined as responders. Reductions from baseline in serum B cells and plasmablasts were observed following treatment with obexelimab. However, in most patients with follow-up data, serum B cells recovered to 75% of baseline concentrations within 42 days of the final obexelimab dose. 13 (87%) of 15 patients reported adverse events, one of which (an infusion reaction) resulted in treatment discontinuation. Interpretation: All patients except for one had clinical responses to obexelimab treatment. Both reductions in circulating B cells without evidence of apoptosis during obexelimab treatment and their rapid rebound after treatment discontinuation suggest that obexelimab might lead to B-cell sequestration in lymphoid organs or the bone marrow. These results support the continued development of obexelimab for the treatment of IgG4-related disease. Funding: Xencor, Zenas BioPharma, National Institute of Arthritis and Musculoskeletal and Skin Diseases, and National Institute of Allergy and Infectious Diseases.
MeSH term(s)	Humans ; Female ; Male ; Middle Aged ; Immunoglobulin G4-Related Disease ; Pilot Projects ; Antibodies, Monoclonal ; B-Lymphocytes ; Plasma Cells ; Adaptor Proteins, Signal Transducing ; Antigens, CD19 ; Antineoplastic Agents
Chemical Substances	Antibodies, Monoclonal ; Adaptor Proteins, Signal Transducing ; Antigens, CD19 ; Antineoplastic Agents
Language	English
Publishing date	2023-07-24
Publishing country	England
Document type	Clinical Trial, Phase II ; Journal Article
ISSN	2665-9913
ISSN (online)	2665-9913
DOI	10.1016/S2665-9913(23)00157-1
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Article ; Online: How Does Mission Ground Time Impact on Population Coverage of Aeromedical Retrieval Systems?

Smedley, Weston Andrew / Killian, John / Stone, Kelly Lorraine / Stephens, Shannon W / Griffin, Russell L / Cox, Daniel B / Kerby, Jeffrey D / Jansen, Jan O

The Journal of surgical research

2020 Volume 258, Page(s) 362–369

Abstract: Background: Aeromedical retrieval is an essential component of contemporary emergency care systems. However, in many locations, ground emergency medical services are dispatched to the scene of an incident first to assess the patient and then call for a ... ...

Abstract	Background: Aeromedical retrieval is an essential component of contemporary emergency care systems. However, in many locations, ground emergency medical services are dispatched to the scene of an incident first to assess the patient and then call for a helicopter if needed. The time to definitive care therefore includes the helicopter's flight to the scene, flight to the trauma center, and nonflying time. Mission ground time (MGT) includes the time required to get the helicopter airborne, as well as time spent at the scene, packaging and loading the casualty into the aircraft. Estimates of MGT typically vary from 10 to 30 min. The impact of MGT duration on population coverage-the number of residents that could be taken to a trauma center within a set time-is not known. The aim of this study was to compare population coverage for different durations of MGT in a single state. Methods: Coverage was calculated using elliptical coverage areas ("isochrones") based on the location of helicopter bases and Level I and Level II trauma centers. The calculations were performed using Microsoft Excel, assuming a cruising speed of 133 knots (246 km/h), and mapped using arcGIS. The access time threshold was set at 60 min, and we evaluated MGTs of 10, 15, 20, 25, and 30 min. Results: MGT has a marked impact on population coverage. The effect is, furthermore, not linear. When considering the state's three Level I trauma centers, decreasing MGT from 30 to 10 min increased population coverage from 61.2% to 84.2%. When also considering Level II centers, decreasing MGT from 30 min to 10 min increased coverage by 20%. Conclusions: Elliptical isochrones, with allowance for MGT, provide realistic estimates of population coverage. MGT significantly impacts the proportion of the population that can be taken to a Level I and/or Level II Trauma Center within a set time. The impact is not linear, reflecting the uneven distribution of the population. Consideration should be given to minimizing MGT to preserve the benefits of aeromedical retrieval.
MeSH term(s)	Air Ambulances/statistics & numerical data ; Alabama ; Humans ; Rural Population ; Spatial Analysis ; Time Factors ; Trauma Centers ; Urban Population
Language	English
Publishing date	2020-10-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	80170-7
ISSN	1095-8673 ; 0022-4804
ISSN (online)	1095-8673
ISSN	0022-4804
DOI	10.1016/j.jss.2020.08.080
Database	MEDical Literature Analysis and Retrieval System OnLINE

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