Received Research Grants Research Articles

Efficacy of a novel self-assembling peptide gel for hemostasis in refractory neoplastic bleeding.

Video 1Outline of how self-assembling peptide gel can be used exvivo.

High Hospital-related Costs at the End-of-life in Patients With Multiple Myeloma: A Single-center Study.

High Hospital-related Costs at the End-of-life in Patients With Multiple Myeloma: A Single-center Study.

Hypnotic prescriptions in Japan may be shifting from benzodiazepine receptor agonists to other types of hypnotics, melatonin receptor agonists, and orexin receptor antagonists.

Hypnotic prescriptions in Japan may be shifting from benzodiazepine receptor agonists to other types of hypnotics, melatonin receptor agonists, and orexin receptor antagonists.

LBA02-09 EMBARK: A Phase 3 Randomized Study of Enzalutamide or Placebo Plus Leuprolide Acetate and Enzalutamide Monotherapy in High-risk Biochemically Recurrent Prostate Cancer

LBA02-09 EMBARK: A Phase 3 Randomized Study of Enzalutamide or Placebo Plus Leuprolide Acetate and Enzalutamide Monotherapy in High-risk Biochemically Recurrent Prostate Cancer

Place of care and costs associated with acute episodes and remission in schizophrenia.

BACKGROUND: Schizophrenia imposes significant economic burden on patients, families, caregivers, and society. To our knowledge, place of care and associated costs of acute schizophrenia episodes have not been well characterized. OBJECTIVE: To describe the care settings and costs associated with likely acute episodes and untreated remission periods among patients with schizophrenia. METHODS: Adults with schizophrenia were identified using the IBM MarketScan Commercial and Medicare Supplemental databases (2009-2018); claims for capitated benefits plans were excluded. Acute episode index date was defined as at least 1 inpatient schizophrenia claim or outpatient schizophrenia claim (frequency of claim dependent on visit type, such as hospitalization, emergency department, private practice, clinic, urgent care, or laboratory). Mental health-related medical costs (health plan+patient) associated with acute episodes were collected over a 2-month follow-up period and stratified by setting (inpatient vs outpatient); acute episode data were reported in subgroups of patients without or with prior clozapine use, as an indication of disease severity. Remission index date was defined as at least 1 outpatient claim with a schizophrenia diagnosis with no acute episode and no oral or injectable antipsychotic therapy. Remission costs were assessed over a 3-month period. All data were analyzed descriptively. RESULTS: A total of 14,824 patients with schizophrenia met criteria for an acute episode (12,896 [87.0%] without prior clozapine use; 1,427 [9.6%] with prior clozapine use). Most acute episodes were treated in an outpatient setting (all patients, 76.3%; without prior clozapine use, 74.5%; with prior clozapine use, 87.1%). When treated inpatient, mean (SD) episode medical costs were $17,045 ($28,101) for all patients, $16,060 ($22,786) for those without prior clozapine use, and $22,827 ($55,860) for those with prior clozapine use. When treated outpatient, mean (SD) medical costs for acute episodes were $2,478 ($6,961) for all patients, $2,609 ($7,068) for those without prior clozapine use, and $1,770 ($6,560) for those with prior clozapine use. For all patients with acute episodes, regardless of clozapine use, patient-incurred out-of-pocket costs were approximately 30% of total medical costs. For an untreated period of remission, 6,950 patients with schizophrenia met criteria. Total medical costs were $2,399 for these patients over a 3-month period. CONCLUSIONS: The majority of acute schizophrenia episodes were treated in the outpatient setting. For episodes that required inpatient care, inpatient episodes were approximately 7 times more costly than episodes treated in outpatient-only settings. For acute episodes and remission periods, health plans covered most costs; however, there were additional patient-incurred out-of-pocket costs. DISCLOSURES: All authors met the International Committee of Medical Journal Editors authorship criteria. Neither honoraria nor payments were made for authorship. Dr McIntyre has received research grant support from CIHR/GACD/National Natural Science Foundation of China (NSFC) and the Milken Institute; speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, AbbVie, Atai Life Sciences. Dr McIntyre is a CEO of Braxia Scientific Corp. Mr Doan, Dr Amari, and Mr Mercer are employees of Genesis Research, which was funded to perform the study. Ms Higa, Dr Gillard, and Dr Harrington were employees of AbbVie at the time of the study and may hold stock. This study was sponsored by AbbVie.

E087 Reduced joint synovitis assessment versus the global EULAR OMERACT synovitis score (GLOESS) to predict the response to secukinumab in patients with active psoriatic arthritis and inadequate response to conventional disease-modifying anti-rheumatic drugs: exploratory results from the ULTIMATE trial

Abstract Background/Aims The combined use of Power Doppler and B-mode ultrasound (PDUS) allows visualisation of morphological and pathophysiological changes of the synovium. ULTIMATE (NCT02662985) was the first large, randomised, double-blind, placebo-controlled PDUS phase IIIb study in psoriatic arthritis (PsA) to demonstrate that the validated Global OMERACT EULAR Synovitis Score (GLOESS), an ultrasound score at patient level, could detect the early and continuous decrease in synovitis in a multicentre setting using different ultrasound devices and examiners. Since the ultrasound assessment for GLOESS is time-consuming owing to the number of joints assessed, we investigated the ability of various reduced joint sets to predict GLOESS. Methods ULTIMATE was a 52-week study of secukinumab with a 12-week, double-blind, placebo-controlled period followed by a 12-week, open-label treatment period and 6-month open-label extension period. GLOESS for 24 paired joints was calculated, with a resultant potential score ranging from 0 to 144. Based on their composite PDUS scores, highly correlated joint clusters were identified with a Spearman’s rank correlation matrix and a Clustered Image Map. Representative joints were then selected from each group by various approaches (best correlation, model optimisation, etc.) yielding several joint combinations. For these reduced joint sets, GLOESS was predicted with linear models based on data from 60% of randomly selected patients from ULTIMATE. The remaining 40% of patient data were used for model validation and diagnostics. Results Five models were established with reduced pairs of joint sets (9-13 pairs) for PDUS-detected synovitis. The joints included in each linear model are summarised in the Table. All five reduced joint set models demonstrated scores very close to full 48 joint GLOESS (R2 ∼0.95); models 1-3 (based on 9 joint pairs) were less accurate at predicting GLOESS than models 4 and 5 (based on 13 and 12 joint pairs, respectively) for the secukinumab cohort in the open-label part (data to be shown in poster). Conclusion All models of reduced joint sets for PDUS-detected synovitis predicted GLOESS well. The next steps will be to document responsiveness and ability to discriminate between active and placebo treatment. Disclosure P.G. Conaghan: Consultancies; P.G.C. has received consultancy fees from AbbVie, AstraZeneca, BMS, Eli Lilly, Galapagos, Janssen, Merck, Novartis and Pfizer, Stryker and UCB. Member of speakers’ bureau; P.G.C. has received speakers bureau fees from AbbVie, Novartis and Pfizer. M. D'agostino: Consultancies; M.A.D'A. has received consultancy fees from AbbVie, BMS, Celgene, Eli Lilly, Janssen, Novartis, Roche, Sanofi, and UCB. Member of speakers’ bureau; M.A.D'A. has received speakers bureau fees from AbbVie, BMS, Celgene, Eli Lilly, Janssen, Novartis, Roche, Sanofi and UCB. M. Boers: Consultancies; M.B. has received consultancy fees from Novartis. E. Naredo: Honoraria; E.N. has received honoraria for clinical trials from AbbVie, BMS and Novartis. Member of speakers’ bureau; E.N. has received speakers bureau fees from AbbVie, BMS, Celgene GmbH, Janssen, Lilly, Novartis, Pfizer, Roche and UCB. Grants/research support; E.N. has received research grants from Eli Lilly. P. Mandl: Member of speakers’ bureau; P.M. has received speakers bureau fees from AbbVie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Roche and UCB. Grants/research support; P.M. has received grant/research support from AbbVie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Roche and UCB. P. Carron: Consultancies; P.C. has received consultancy fees from AbbVie, Bristol Myers Squibb, Celgene Corporation, Eli Lilly, Gilead, Merck Sharp Dohme, Novartis, Pfizer and UCB. Member of speakers’ bureau; P.C. has received speakers bureau fees from AbbVie, Bristol Myers Squibb, Celgene Corporation, Eli Lilly, Gilead, Merck Sharp Dohme, Novartis, Pfizer and UCB. Grants/research support; P.C. has received grant/research support from Merck Sharp Dohme, Pfizer and UCB. M. Backhaus: Consultancies; M.B. has received consultancy fees from BMS, Galapagos, Jonsson, MSD, Novartis, Pfizer, Roche and UCB. Member of speakers’ bureau; M.B. has received speakers bureau fees from BMS, Galapagos, Jonsson, MSD, Novartis, Pfizer, Roche and UCB. Grants/research support; M.B. has received grant/research support from BMS, Galapagos, Jonsson, MSD, Novartis, Pfizer, Roche and UCB. A. López-Rodríguez: Consultancies; A.L.R. has received consultancy fees from Eli Lilly, GSK, Janssen, Novartis, Roche and UCB. Member of speakers’ bureau; A.L.R. has received speakers bureau fees from Eli Lilly, GSK, Janssen, Novartis, Roche and UCB. P. Hanova: Consultancies; P.H. has received consultancy fees from Novartis. P. Goyanka: Other; P.G. is an employee of Novartis. B.G. Sahoo: Other; B.G.S. is an employee of Novartis. C. Gaillez: Shareholder/stock ownership; C.G. is a shareholder of Novartis and BMS. Other; C.G. is an employee of Novartis. W. Bao: Shareholder/stock ownership; W.B. is a shareholder of Novartis. Other; W.B. is an employee of Novartis.

P171 Bimekizumab in bDMARD-naïve patients with active psoriatic arthritis: improvements in PsARC over 24 weeks in the Phase 3 BE OPTIMAL trial

Abstract Background/Aims Bimekizumab (BKZ) is a humanised monoclonal IgG1 antibody that acts by selectively inhibiting IL-17F in addition to IL-17A and has demonstrated clinical efficacy vs placebo (PBO) in both joint and skin outcomes in patients with active psoriatic arthritis (PsA). We report interim 24-week (wk) PsARC response rates along with HRQoL estimates in bDMARD-naïve patients with active PsA from the phase 3, pivotal BE OPTIMAL trial (NCT03895203). Methods BE OPTIMAL is a randomised multicentre, double-blind, PBO-controlled to wk 16, followed by 36-wks maintenance phase, active reference, parallel-group, phase 3 study. Patients were randomised (2:3:1) to receive PBO, BKZ 160 mg every 4 weeks (Q4W), or active reference (adalimumab [ADA]) 40 mg every 2 weeks (Q2W). At wk 16, patients receiving PBO were switched to BKZ 160 mg Q4W; other patients remained on their original dose. We report PsARC to wk 16 and wk 24, and the association of PsARC response with HRQoL-related outcomes for the randomised set. Data are reported as non-responder imputation (NRI) and observed cases. Results 852 patients were randomised at the baseline (PBO: 281; BKZ: 431; ADA: 140). Baseline characteristics were comparable between the three groups (mean age: 48.7 yrs; BMI: 29.20 kg/m2; disease duration: 5.9 yrs and 46.8% were males). At wk 16, PsARC response (NRI) was achieved by: PBO, 40.2%; BKZ, 80.3% and ADA, 82.1%. At wk 24, PsARC response increased in those PBO patients switched to BKZ: PBO/BKZ, 76.2%; BKZ, 77.3% and ADA, 80.0% (Table). Clinically meaningful improvement in HAQ-DI and SF-36 physical component summary (PCS), and improvements in FACIT-Fatigue were achieved from baseline among PsARC responders compared to non-responders (Table). Over the course of 24 weeks, safety was consistent with previous BKZ studies and no new safety signals were observed. Conclusion BKZ in bDMARD-naïve PsA patients demonstrated rapid and clinically relevant improvements in musculoskeletal outcomes compared to PBO at wk 16 and patients who switched to BKZ from PBO at wk 16 have a similar response rate at wk 24. Patients with PsARC response had numerically greater improvements in HRQoL-related outcomes. No new safety signals were observed. Disclosure I. McInnes: Grants/research support; IM has received grants/research support from Astra Zeneca, Abbvie, BMS, Compugen, Cabaletta, EveloBio, Eli Lilly, GSK, Janssen, Novartis, Moonlake, Novartis, Sanofi, UCB Pharma, XinThera. B. Ink: Shareholder/stock ownership; BI is a shareholder of AbbVie, GlaxoSmithKline and UCB Pharma. R. Bajracharya: Other; RB is an employee of UCB Pharma. V. Taieb: Other; VT is employee of UCB Pharma. W.R. Tillett: Other; WRT has received Research Grant, consulting or speaker fees from Abbvie, Amgen, Eli Lilly, Janssen, GSK, MSD, Novartis, OVA Pharma, Pfizer and UCB Pharma.

P090 Protocol for the two-cohort, open-label, single-arm EMERALD study of emapalumab, an anti-interferon gamma monoclonal antibody, in patients with macrophage activation syndrome in rheumatic diseases

Abstract Background/Aims Macrophage activation syndrome (MAS), a form of secondary haemophagocytic lymphohistiocytosis, is a severe, life-threatening complication of rheumatic diseases such as Still’s disease (systemic juvenile idiopathic arthritis or adult-onset Still’s disease) and systemic lupus erythematosus (SLE). Interferon gamma has been implicated in the underlying pathology of both conditions. Standard first-line treatment for MAS is high-dose glucocorticoids (GCs); however, additional treatments are used without a standardised approach in patients who are treatment-refractory. When 9 patients with an inadequate response to high-dose GCs were administered emapalumab in a pilot study (NCT03311854), interferon gamma was rapidly neutralised and MAS was controlled. Emapalumab also had a favourable safety profile. A new study (EMERALD) is currently enrolling patients with MAS in Still’s disease and SLE to further evaluate the efficacy and safety of emapalumab. Methods The open-label, single arm, multicentre, phase 2/3 interventional EMERALD study (NCT05001737) is enrolling paediatric and adult subjects with MAS and an inadequate response to high-dose GCs into two cohorts: MAS in Still’s disease (n = 25) and MAS in SLE (n = 16). Each cohort is a single-arm study comprising two phases: an optional run-in phase and an interventional phase. Key eligibility criteria vary by cohort and phase (Table). During the run-in phase, patients are treated with high-dose GCs and followed until MAS remission or inadequate response, or for a maximum of 12 weeks. Patients enrolled in the interventional phase are treated with intravenous emapalumab (initial dose 6 mg/kg, subsequent doses 3 mg/kg) for 4 weeks or until protocol-defined complete response (CR), then followed up for 1 year. Results The primary endpoint of the study is protocol-defined CR at Week 8 after first emapalumab administration. Secondary efficacy endpoints include GC tapering, survival, time to first CR, overall response (CR and partial response), time to first overall response, MAS recurrence, pharmacokinetic/pharmacodynamic profile of emapalumab and patient-reported outcomes. Safety endpoints include assessments of adverse events, abnormal laboratory parameters and anti-drug antibodies. Conclusion The ongoing EMERALD study is designed to address the unmet need for new efficacious and safe therapies for the treatment of MAS. Disclosure P. Brogan: Consultancies; P.B. has acted as a consultant for Sobi, Novartis, Roche and UCB. A. Grom: Consultancies; A.G. has acted as a consultant for Novartis, AB2 Bio, Novimmune and Sobi. R. Kanceva: Corporate appointments; R.K. is an employee of Sobi. F. De Benedetti: Consultancies; F.D.B. has acted as a consultant for AbbVie, Sobi, Pfizer, Roche, Sanofi, Novartis and Novimmune. Grants/research support; F.D.B has received research grants from AbbVie, Sobi, Pfizer, Roche, Sanofi, Novartis and Novimmune.

P131 Time to Discontinuation and Effectiveness with Baricitinib in Rheumatoid Arthritis: 12-Month European Data from a Multinational, Prospective, Observational Study

Abstract Background/Aims RA-BE-REAL is a 3-year, multinational, prospective, observational study of adult patients with rheumatoid arthritis (RA) evaluating time-to-discontinuation of initial RA treatment. Baricitinib (BARI), an oral selective JAK1/2 inhibitor, is approved for the treatment of adults with moderate-to-severe active RA. This analysis reports time-to-discontinuation and effectiveness in patients with RA enrolled in Europe following 12M of either BARI, a biologic (b) disease-modifying anti-rheumatic drug (DMARD) or any other targeted synthetic (ts)DMARD, after starting that treatment for the first time. Methods Two cohorts were assessed: patients in cohort A initiated treatment with BARI (2-mg or 4-mg as monotherapy or in combination with any csDMARD) while patients in cohort B initiated any bDMARD (tumour necrosis factor inhibitors [TNFi] or non-TNFi bDMARD) or any other tsDMARD for the first time. Treatment initiation and changes were at the discretion of patient or physician. Time-to-discontinuation for patients in both cohorts were analysed in both bDMARD-naïve and -experienced patients. Response rates for remission and low disease activity (LDA) were determined using the Clinical Disease Activity Index at 12M. Steroid use was collected for both cohorts. This pre-specified interim analysis reports descriptive 12M data using summary statistics, without any inferential testing. Results At 12M, a similar percentage of patients discontinued 2-mg (25.4%) and 4-mg (26.9%) BARI whether as monotherapy (24.7%) or as combination therapy with any csDMARD (28.8%). In cohort B, 42.2%, 44.7%, and 52.3% of patients using TNFi, non-TNFi, and any other tsDMARD, respectively, discontinued treatment at 12M. In both cohorts, patients naïve to b/tsDMARD were least likely to discontinue treatment while those who had more than two previous b/tsDMARD treatments were most likely to discontinue. The most common reasons for discontinuation were primary non-response (Cohort A: 6.3%; Cohort B: TNFi: 8.3%, non-TNFi: 10.6%, any other tsDMARD: 10.6%) and adverse events (Cohort A: 6.3%; Cohort B: TNFi: 5.1%, non-TNFi: 7.5%, any other tsDMARD: 13.6%). At 12M, remission rates were 21.8%, 18.0%, 4.0%, and 18.2% for those on monotherapy treatment with BARI, TNFi, non-TNFi, and any other tsDMARD, respectively. For combination therapy, remission rates were 26.2%, 19.0%, 15.9%, and 13.6% for BARI, TNFi, non-TNFi, and any other tsDMARD treated patients, respectively. At 12M, 31.8% and 36.0% of patients in cohort A and B, respectively, reported ongoing steroid use, a reduction of 25.9% and 18.0%, respectively, from baseline. Conclusion Despite an older and more bDMARD experienced population, discontinuation rates were lower while remission was higher for those treated with BARI than those in cohort B. Discontinuation rate was consistent irrespective of BARI dose or if used in monotherapy or combination therapy. Discontinuation rates increased with number of previous b/tsDMARD in both cohorts, with numerically lower discontinuation rates at 12M for patients treated with BARI. Disclosure R. Alten: Grants/research support; R. A. has been a consultant for and/or received grant/research support from: AbbVie, Bristol Myers Squibb, Eli Lilly and Company, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB. G.R. Burmester: Consultancies; G. R. B. has been a consultant for and/or received honoraria as a speaker for: AbbVie, Eli Lilly and Company, Galapagos, Gilead, Janssen, MSD, Pfizer, Roche, and UCB. M. Matucci-Cerinic: Corporate appointments; M. M-C. has been an officer or board member for: Biogen. Consultancies; M. M-C. has been a consultant for: Behring, Chemomab, Janssen, and Pfizer. Honoraria; M. M-C. has received honoraria as a speaker for: Eli Lilly and Company, and Sandoz. Grants/research support; M. M-C. has received grant/research support from: Merck, and MSD. A. Ostor: Consultancies; A. O. has been an advisor, review panel member, and/or consultant for: Abbot, AbbVie, Bristol Myers Squibb, Eli Lilly and Company, Gilead, Janssen, Novartis, Paradigm, Pfizer, Roche, and UCB. L. Zaremba-Pechmann: Other; L. Z-P. is a contractor for: HaaPACS GmbH. T. Treuer: Shareholder/stock ownership; T. T. is an employee and shareholder of: Eli Lilly and Company. K. Ng: Shareholder/stock ownership; K. J. N. is an employee and shareholder of: Eli Lilly and Company. J. Gerwien: Shareholder/stock ownership; J. G. is an employee and shareholder of: Eli Lilly and Company. K.A. Gibson: Consultancies; K. A. G. has been a consultant for: Janssen, and Novartis. Shareholder/stock ownership; K. A. G. is an employee and shareholder of: Eli Lilly and Company. Honoraria; K. A. G. has received honoraria as a speaker for: UCB. Grants/research support; K. A. G. has received grant/research support from: Novartis. B. Fautrel: Grants/research support; B. F. has received research grants from AbbVie, Lilly, MSD and Pfizer, and consultancy fees from AbbVie, Amgen, Biogen, BMS, Celltrion, Fresenius Kabi, Galapagos, Gilead, Janssen, Lilly, Medac, MSD, NORDIC Pharma, Novartis, Pfizer, Roche, Sandoz, Sanofi-Genzyme, SOBI, UCB, Viatris. T. Sheeran (Non-Author Presenter): None.

P194 Bimekizumab is associated with improvement in quality of life in patients across the full spectrum of axial spondyloarthritis at week 16: results from two phase 3 studies

Abstract Background/Aims Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A and has demonstrated rapid and clinically meaningful improvements in disease activity (ASAS40, primary outcome measure) in patients across the full spectrum of axial spondyloarthritis (axSpA; active non-radiographic axSpA [nr-axSpA; BE MOBILE 1, NCT03928704] and ankylosing spondylitis [AS] / radiographic axSpA [r-axSpA; BE MOBILE 2, NCT03928743]). Here we report results related to HRQoL instruments (EQ-5D-3L, ASQoL and SF-36) from the two ongoing phase 3 studies at week (wk) 16. Methods BE MOBILE 1 and 2 were conducted in parallel with similar study designs: 16-wk double-blind placebo-controlled period followed by a 36-wk maintenance period. Patients were randomised (1:1 in BE MOBILE 1 and 2:1 in BE MOBILE 2) to BKZ 160 mg Q4W or placebo (PBO). All patients received BKZ 160 mg Q4W from wk16. We report change from baseline (CfB) in the overall EQ-5D-3L utility index, ASQoL and SF-36 Physical component Summary (PCS) scores at wk16 compared to PBO. Missing data is imputed using multiple imputation. Results Overall, 240/254 (94.5%; nr-axSpA) and 313/332 (94.3%; r-axSpA) patients completed the studies up to wk24. Both studies met their primary and all ranked secondary endpoints at wk16. In both studies, BKZ treatment resulted in improved health status as measured with the EQ-5D-3L utility score versus PBO. This improvement at wk16 was consistent across both tumour necrosis factor inhibitor (TNFi)-naive and TNFi-inadequate responders (IR) patients. Significantly greater improvements were also observed with BKZ compared to PBO in ASQoL and SF-36 PCS in both studies (p < 0.001, all comparisons) at wk16 (Table). At wk16, a higher proportion of BKZ- versus PBO-treated patients achieved ≥5-point improvement in SF-36 PCS (nr-axSpA: 64.8% vs 41.3% and r-axSpA: 63.8% vs 49.5%) and ≥4-point improvement in ASQoL (nr-axSpA: 58.6% vs 33.3% and r-axSpA: 57.5% vs 45.0%), respectively. Conclusion Dual inhibition of IL-17A and IL-17F with BKZ improved quality of life measured by EQ-5D-3L, ASQoL and SF-36 PCS scores compared with PBO in patients across the full spectrum of axSpA. Disclosure N. McKay: Member of speakers’ bureau; NM has received Speaker' bureau from Gilead. Other; NM has received travel fees from UCB Pharma and Gilead. A. Bennett: Honoraria; AB has received teaching honorarium from Abbvie Ltd, Pfizer, UCB Pharma, Novartis and Biogen. Grants/research support; AB has received research grants from Pfizer. Other; AB has received advisory board fees from Abbvie Ltd, Pfizer, UCB Pharma, MSD, Novartis and Eli Lilly. N. Goodson: Honoraria; NG has received honoraria from UCB Pharma and Novartis. C. Fleurinck: Other; CF is an employee of UCB Pharma. C. de la Loge: Consultancies; CdlL is a consultant to UCB Pharma, Brussels, Belgium. U. Massow: Other; UM is an employee of UCB Pharma. V. Taieb: Other; VT is employee of UCB Pharma. H. Marzo-Ortega: Grants/research support; HMO has received grants/research support from Janssen, Novartis and UCB Pharma. Other; HMO has received honoraria and/or consultancy and/or speaker fees from Abbvie, Biogen, Celgene, Janssen, Eli-Lilly, Moonlake, Novartis, Pfizer and UCB Pharma. K. Gaffney: Consultancies; KG has received honoraria or consultancy fees from Novartis, AbbVie, UCB Pharma, Eli Lilly and Pfizer. Shareholder/stock ownership; KG is a shareholder of Rheumatology Events. Member of speakers’ bureau; KG has paticipated in speaker's bureau for Novartis, UCB Pharma, AbbVie and Eli Lilly. Grants/research support; KG has received grants/research support from NASS, Versus Arthritis, AbbVie, Pfizer, UCB Pharma, Norvartis, Eli Lilly, Cellgene, Celltrion, Janssen, Gilead and Biogen. Other; KG has received meeting expenses from AbbVie, Eli Lilly, Roche, Novartis, Pfizer and UCB Pharma.

The NDIS at ten years: designing an equitable scheme for the next decade.

The NDIS at ten years: designing an equitable scheme for the next decade.

Health disparity in use of novel agents for first-line therapy in Black and White patients with chronic lymphocytic leukemia in the Department of Veterans Affairs.

BACKGROUND: Novel agents (NAs) (ibrutinib, idelalisib, and venetoclax) were first introduced in 2013 as therapeutic options to treat chronic lymphocytic leukemia (CLL). OBJECTIVES: To determine if the uptake of NAs for first-line treatment was similar in Black and White patients with CLL treated in the Department of Veterans Affairs (VA). METHODS: We conducted a retrospective cohort study including adults with CLL managed in the VA from October 1, 2013, to September 30, 2017. Descriptive statistics were used to summarize demographic data, and appropriate bivariable statistical tests were used to compare NA use, baseline characteristics, health outcomes, and complications. A multivariable logistic regression model was used to identify factors associated with uptake of NAs. The study included 565 patients; 86% were White and 14% were Black. Black patients were younger than White patients (median age [66 vs 69 years; P < 0.01]) but had similar median baseline Charlson comorbidity scores (4 vs 5). RESULTS: Overall, Black patients were less likely to receive NAs than White patients (14% vs 26%; P = 0.02). The gap narrowed over the study period: 4% vs 17% (2014), 13% vs 25% (2015), 17% vs 33% (2016), and 31% vs 33% (2017). Black race (P = 0.02) and fiscal year (P < 0.01) were the only variables significantly associated with NA use in the multivariable model. Health outcomes and most complications were similar for Black and White patients despite the difference in prescribing patterns. CONCLUSIONS: This is the first study to identify a potential health disparity with respect to use of NAs among Black and White patients with CLL treated in the VA. Fortunately, health outcomes and most complications were similar for Black and White patients despite the difference in prescribing patterns. DISCLOSURES: Funding for the study was provided by AstraZeneca as a research grant to the Foundation for Advancing Veterans' Health Research (FAVHR), a non-profit entity within the Audie L. Murphy Veterans Hospital, San Antonio, TX. Drs Nooruddin and Frei have received research grants (paid to FAVHR) from AstraZeneca in the last 3 years. Ms Ryan is an employee of AstraZeneca. The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs, the National Institutes of Health, or the authors' affiliated institutions.

Influence of anti-interleukin (IL)-5/anti-IL-5 receptor-α treatment on work productivity in patients with severe eosinophilic asthma.

This retrospective study shows that treatment with anti-eosinophilic antibodies in patients with severe eosinophilic asthma is associated with an increase in work productivity and a decrease in missed days at work https://bit.ly/3IIPppR.

A119 DEVELOPMENT AND EVALUATION OF LOW-COST GEL POLYPS FOR POLYPECTOMY SKILLS TRAINING IN NOVICE ENDOSCOPISTS

Abstract Background Polypectomy is an essential skill for endoscopists to acquire. As polyps are encountered ad hoc during colonoscopies, exposure to polypectomy in clinical training may vary. There is a need to deliver a curriculum that standardizes exposure to polypectomy while remaining cost-effective for endoscopy programs worldwide. Purpose To develop low-cost simulated polyps that can be incorporated into endoscopic training programs, and to evaluate their perceived realism and useability for polypectomy training. Method We designed 3D molds based on the Paris classification, a validated rubric for polyp morphology. The polyps are depicted in Figure 1. Using low-cost materials, we created gel-based polyps compatible with physical colonic simulators. Current versions of the polyps were finalized based on visual realism and durability. Expert (performed &amp;gt;1000 procedures) and novice (&amp;lt;25 procedures) endoscopists were invited to perform simulated polypectomies and evaluate the realism of the polyps. Using a 7-point Likert scale (“strongly disagree” to “strongly agree”), we administered a survey adapted from the Direct Observed Polypectomy Skills (DOPyS) checklist to evaluate the polyps on practicality of design and useability for training. Additionally, the simulator’s resemblance to human polypectomy was assessed through a scale with 1 indicating “low resemblance” and 7 indicating “high resemblance”. The ease of identifying morphology was also evaluated, with 1 indicating “difficult” and 7 indicating “easy”. Result(s) The survey was completed by 11 expert endoscopists and 10 novices. The median score submitted by experts on the polyps’ useability in training the technique for mobilization of the polyp was 7 (IQR 6-7). Experts rated the simulator’s practicality in teaching cold snare or electrocautery techniques with a median score of 6 (IQR 6-7). Lastly, the ability of the simulator to develop skills in identifying and treating the residual polyp was assessed by expert endoscopists, giving it a median score of 6 (IQR 6-7). The simulators were tested on similarity to human polypectomy, with the median score of expert groups being 5 (IQR 5-6), and novice groups being 6 (IQR 6-6). Both groups were asked to rate if morphology could be identified using the simulator; the median score of expert groups being 6 (IQR 6-7), and 6.5 for novice endoscopists (IQR 5-7). Image Conclusion(s) The development of simulated polyps with differing morphologies using low-cost and common materials with high realism is feasible. These polyps may potentially be integrated into different endoscopic training programs. Please acknowledge all funding agencies by checking the applicable boxes below None Disclosure of Interest A. Zhao: None Declared, N. Gimpaya: None Declared, J. Lisondra: None Declared, R. Fujiyoshi: None Declared, Y. Fujiyoshi: None Declared, R. Khan Grant / Research support from: Rishad Khan has received research grants from AbbVie (2018) and Ferring Pharmaceuticals (2019) and research funding from Pendopharm (2019). , D. Tham: None Declared, M. Scaffidi: None Declared, R. Bansal: None Declared, C. Walsh: None Declared, S. Grover Shareholder of: Samir C. Grover has equity in Volo Healthcare., Grant / Research support from: Samir C. Grover has received research grants and personal fees from AbbVie and Ferring Pharmaceuticals, personal fees from Takeda, education grants from Janssen.

Letter in reply: aletter to the editor commenting on the recent publication by AY Avidan and CA Kushida.

Letter in reply: aletter to the editor commenting on the recent publication by AY Avidan and CA Kushida.

TDM Is Alive and Kicking!

*Univ Rennes, CHU Rennes, Inserm, EHESP; †INSERM, Centre d'Investigation Clinique 1414, Rennes, France; and ‡Erasmus MC Transplant Institute, Rotterdam, the Netherlands. Correspondence: Florian Lemaitre, Department of Pharmacology, Rennes University Hospital, Hôpital Pontchaillou, 2, rue Henri Le Guilloux, 35033 Rennes, Cedex (e-mail: [email protected]). F. Lemaitre has received research grants (paid to the institution) from Astellas Pharma, Chiesi Pharma, and Sandoz and has received fees to attend meetings from Pfizer and Chiesi Pharma. During the last three years, D.A. Hesselink has received lecture and consulting fees from Astellas Pharma, Chiesi Pharma, Medincell, Novartis Pharma, and Sangamo Therapeutics. He received grant support from Astellas Pharma and Chiesi Pharma (paid to his institution). D.A. Hesselink does not have employment or stock ownership at any of these companies, nor does he have patents or patent applications.

Past, Present, and Future of Language Assessment: An Interview with Dr. Hossein Farhady

Professor Hossein Farhady is an outstanding English Language Teaching (ELT) scholar in the field of applied linguistics, in general, and aspects of language testing and assessment, in particular with the English as a Foreign Language (EFL) and English as a Second Language (ESL). He has been teaching various courses on language testing and assessment, research methods, and English for Specific Purposes (ESP) at MA and Ph.D. programs for the last four decades in Iran, the USA, Canada, Armenia, and Turkey. He has also been a prolific writer, publishing papers and books in prestigious international journals and publishing houses and presented numerous speeches and papers at national and international seminars and conferences. Moreover, he has supervised more than 80 MA theses and Ph.D. dissertations. His widely used book about research methodology for applied linguistics commonly known as “Hatch and Farhady” (1982) has served as the basic textbook at both undergraduate and graduate levels since the early 1980s. He has, additionally, been a curriculum developer and test developer in Iran and other parts of the world. He worked as a senior scholar and project manager for several organizations such as Ordinate and Lidget Green Corporations in California, Avant Assessment, and Second Language Testing, INC., in Rockville, Maryland. He has also received research grants and awards from organizations such as Pearson, Educational Testing Service (ETS), and International Language Testing Association (ILTA) in scoring and validating language tests. Currently, he is a faculty member at the English Language Teaching (ELT) Department at Yeditepe University in Istanbul, Turkey.

Spontaneous tensor fascia lata abscess caused by Parvimonas micra presenting as lateral hip pain.

Dear Editor, Parvimonas micra is a gram-positive obligate anaerobic bacterial species and known flora of the human oral cavity, respiratory system, gastrointestinal tract, and the female genitourinary tract.[1,2] It was originally identified in 1933 as Peptostreptococcus micros, underwent a reclassification in 1999 to Micromonas micros and ultimately was reclassified as P. micra in 2006.[1,3]Parvimonas micra has been implemented as an infectious organism in case reports of spondylodiscitis, vertebral osteomyelitis, iliopsoas abscess, hepatic abscess, endocarditis, empyema, meningitis, brain abscess and septic arthritis.[1–3] Although multiple areas of infection by P. micra have been described, tensor fascia lata infection has not been described.[4] A patient with no significant past medical history presented to our outpatient multidisciplinary pain center complaining of left hip pain. He was seen in the emergency department the day prior. X-ray of the hip was performed which did not reveal any acute pathology. His pain had been present for one week and had been worsening in intensity. He did not describe any radiation of the pain to the lower legs and denied any recent trauma to the area. He described swelling and fullness of the hip worsened with movement and relieved by rest. His physical examination was only positive for tenderness of palpation over the left greater trochanter. Due to a presumed diagnosis of greater trochanteric bursitis, conservative measures were pursued. He was prescribed naproxen 500 mg twice a day as needed, tizanidine 2 mg three times per day as needed, topical EMLA to the painful area. He was also instructed to start physical therapy and was provided a referral for the same. He was discharged from the emergency department after this visit. Nearly two weeks later, the patient presented to the emergency department with left thigh erythema and swelling. His laboratory work was significant for ESR of 115 and CRP of 16, white counts were 8.2. On exam, in the ED, he was afebrile and physical exam was positive for erythema, tenderness to palpation over the left thigh. Several pustules overlying the area along with areas of induration and fluctuance were noted. A CT with contrast of the left hip was performed which demonstrated a 20 × 10 × 6.5 cm rim enhancing fluid collection in the proximal lateral left thigh/gluteal region abutting and extending along the fascia lata of the thigh, dissecting into the substance of the tensor fasciae lata muscle and extending into the deep subcutaneous tissues [Figure 1]. The patient was started on broad-spectrum IV antibiotics and scheduled for incision and drainage in the operating room by general surgery. Drains were placed and the wound closed by secondary intention. Cultures from the operating room (anaerobic- tissue and abscess) yielded P. micra. Repeat blood cultures were negative at 5 days. The patient was kept on vancomycin and piperacillin/tazobactam for 3 days and transitioned to oral trimethoprim and sulfamethoxazole at discharge.Figure 1: Coronal view of left thigh CT demonstrating abscessThis case represents an unusual occurrence of P. micra abscess requiring prompt recognition of the abscess and prudent microbial identification. Financial support and sponsorship Nil. Conflicts of interest Dr. Shaparin reports the following disclosures outside the submitted manuscript; he was a consultant for Averitas Pharma and AcelRx Pharmaceuticals and has received research grant funding from Grunenthal and Heron Therapeutics. Dr. Koushik has served as a consultant for AcelRx Pharmaceuticals.

Gynecologic Surgical Training: Current and Future Perspectives

Gynecologic Surgical Training: Current and Future Perspectives

ISPAD Clinical Practice Consensus Guidelines 2022: Diabetes technologies: Insulin delivery.

J.L.S. reports having received speaker honoraria from Eli Lilly, Insulet, Medtronic, and Zealand and serves on advisory boards of Bigfoot Biomedical, Cecelia Health, Insulet Corporation, Medtronic Diabetes, JDRF T1D Fund, and Vertex. She has been a consultant for Insulet and Medtronic. J.L.S.'s institution received research grant support from JDRF, Medtronic, Insulet, and NIDDK. M.S. reports research grant support, paid to her institution, from Tandem Diabetes Care, Insulet, Medtronic, JDRF, and NIDDK. T.S. has no conflict to disclose. L.R. reports speaker fees from Sanofi, Pfizer, NovoNordisk. T.B. reports speaker fees, consulting honoraria or research support from AstraZeneca, Ascensia, DexCom, Medtronic, NovoNordisk, Roche, Sanofi, and Ypsomed. Since 2021, he is member of the Expert group for medical devices of the European Medicines Agency. A.G. received speaker honoraria from Ypsomed. A.G.'s institution received research support from the European Commission (H2020 program). J.V. has no conflict to disclose. M.E.H. receives research grant support from NIDDK, JDRF, and The Leona M. and Harry B. Helmsley Charitable Trust. C.B. has been a consultant for Insulet. L.A.D. reports that in the last 3 years she has consulted for Vertex and served on a Mannkind, Merck, and Abata adivosry board. She has also recieved research support to her instiution from Caladrius, Lilly, Mannkind, Medtronic, Provention, and Zealand. The peer review history for this article is available at https://publons.com/publon/10.1111/pedi.13421. JLS reviewed the literature, drafted sections of the guidelines, oversaw completion of the first draft of the guidelines, and edited the manuscript. MS, TD, LR, TB, AG, JV, MEH and CB reviewed the literature, provided drafts of sections and edited the manuscript. LAD outlined the guidelines, reviewed the literature, edited the manuscript, and served as the senior author. The authors gratefully acknowledge the editorial assistance of Dr. Leena Priyambada. Data sharing not applicable to this article as no datasets were generated or analysed during the current study.