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Article: Health Innovation Manchester as AHSS - the Test of a Hypothesis.

Rigby, John / Chukwukelu, Godwin / Mendoza, Jose Pineda / Yeow, Jillian

International journal of integrated care

2021 Volume 21, Issue 3, Page(s) 5

Abstract: The ambitious and wide-ranging paper on Academic Health Science Systems ['AHSS'] [1] proposed a new model for health innovation and stimulated considerable interest. The paper made three main assumptions about AHSS: i) university-based centres should ... ...

Abstract	The ambitious and wide-ranging paper on Academic Health Science Systems ['AHSS'] [1] proposed a new model for health innovation and stimulated considerable interest. The paper made three main assumptions about AHSS: i) university-based centres should play linchpin roles in health and social care innovation; ii) medical innovation cannot be achieved without links to industry; iii) innovation occurs at the scientific end of a discovery-care continuum. But the paper had a pregnant coda for the NHS, and GM devolution in particular: the authors explicitly linked their view of the need for the integration of university-based research and health care delivery to population level approaches, suggesting that vertically integrated AHSSs should ultimately transform into integrated care organisations. When Manchester's experiment in the devolution of health and social care as a place-based approach to health and social care began in 2015, Health Innovation Manchester was created as an AHSS to support innovation in the Partnership. Five years after the start of devolution, this short paper, which is based on a longer study of Health Innovation Manchester's development [2], provides an overdue reflection on the proposition advanced just over a decade ago [1].
Language	English
Publishing date	2021-08-16
Publishing country	England
Document type	Journal Article
ISSN	1568-4156
ISSN	1568-4156
DOI	10.5334/ijic.5837
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Article: COVID-19 Vaccine Response in People with Multiple Sclerosis Treated with Dimethyl Fumarate, Diroximel Fumarate, Natalizumab, Ocrelizumab, or Interferon Beta Therapy.

Jaber, Aliya / Patel, Meera / Sylvester, Andrew / Yarussi, Mary / Kalina, J Tamar / Mendoza, Jason P / Avila, Robin L / Tremblay, Matthew A

Neurology and therapy

2023 Volume 12, Issue 2, Page(s) 687–700

Abstract: Background: Some multiple sclerosis (MS) disease-modifying therapies (DMTs) impair responses to vaccines, emphasizing the importance of understanding COVID-19 vaccine immune responses in people with MS (PwMS) receiving different DMTs.: Methods: This ... ...

Abstract	Background: Some multiple sclerosis (MS) disease-modifying therapies (DMTs) impair responses to vaccines, emphasizing the importance of understanding COVID-19 vaccine immune responses in people with MS (PwMS) receiving different DMTs. Methods: This prospective, open-label observational study enrolled 45 participants treated with natalizumab (n = 12), ocrelizumab (n = 16), fumarates (dimethyl fumarate or diroximel fumarate, n = 11), or interferon beta (n = 6); ages 18-65 years inclusive; stable on DMT for at least 6 months. Responder rates, anti-SARS-CoV-2 spike receptor-binding domain IgG (anti-RBD) geometric mean titers (GMTs), antigen-specific T cells, and vaccination-related adverse events were evaluated at baseline and 8, 24, 36, and 48 weeks after first mRNA-1273 (Moderna) dose. Results: At 8 weeks post vaccination, all natalizumab-, fumarate-, and interferon beta-treated participants generated detectable anti-RBD IgG titers, compared to only 25% of the ocrelizumab cohort. At 24 and 36 weeks post vaccination, natalizumab-, fumarate-, and interferon beta-treated participants continued to demonstrate detectable anti-RBD IgG titers, whereas participants receiving ocrelizumab did not. Anti-RBD GMTs decreased 81.5% between 8 and 24 weeks post vaccination for the non-ocrelizumab-treated participants, with no significant difference between groups. At 36 weeks post vaccination, ocrelizumab-treated participants had higher proportions of spike-specific T cells compared to other treatment groups. Vaccine-associated side effects were highest in the ocrelizumab arm for most symptoms. Conclusions: These results suggest that humoral response to mRNA-1273 COVID-19 vaccine is preserved and similar in PwMS treated with natalizumab, fumarate, and interferon beta, but muted with ocrelizumab. All DMTs had preserved T cell response, including the ocrelizumab cohort, which also had a greater risk of vaccine-related side effects.
Language	English
Publishing date	2023-02-16
Publishing country	New Zealand
Document type	Journal Article
ISSN	2193-8253
ISSN	2193-8253
DOI	10.1007/s40120-023-00448-x
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Article ; Online: Whole blood miRNAs in relapsing MS patients treated with dimethyl fumarate in the phase 4 TREMEND trial.

Elkjaer, Maria L / Lohse, Rikke M / Burton, Mark / Mendoza, Jason P / Thomassen, Mads / Sejbaek, Tobias / Illes, Zsolt

Journal of neuroimmunology

2023 Volume 381, Page(s) 578145

Abstract: We investigated the impact of dimethyl fumarate (DMF), an oral therapy for relapsing multiple sclerosis (MS), on blood microRNA (miRNA) signatures and neurofilament light (NFL) levels. DMF normalized miR-660-5p and modulated various miRNAs associated ... ...

Abstract	We investigated the impact of dimethyl fumarate (DMF), an oral therapy for relapsing multiple sclerosis (MS), on blood microRNA (miRNA) signatures and neurofilament light (NFL) levels. DMF normalized miR-660-5p and modulated various miRNAs associated with the NF-kB pathway. These alterations reached a peak 4-7 months after treatment. Notably, particular miRNAs correlated with high or low NFL levels, implying their potential role as markers of treatment efficacy. Our findings broaden the understanding of DMF's immunomodulatory effects and may aid in predicting treatment responses.
MeSH term(s)	Humans ; Dimethyl Fumarate/therapeutic use ; Immunosuppressive Agents/adverse effects ; MicroRNAs ; Multiple Sclerosis, Relapsing-Remitting/drug therapy ; Multiple Sclerosis, Relapsing-Remitting/chemically induced ; Multiple Sclerosis/chemically induced ; Recurrence
Chemical Substances	Dimethyl Fumarate (FO2303MNI2) ; Immunosuppressive Agents ; MicroRNAs ; MIRN660 microRNA, human
Language	English
Publishing date	2023-06-26
Publishing country	Netherlands
Document type	Clinical Trial, Phase IV ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	8335-5
ISSN	1872-8421 ; 0165-5728
ISSN (online)	1872-8421
ISSN	0165-5728
DOI	10.1016/j.jneuroim.2023.578145
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Article: Response to Letter to the Editor Regarding "Real-World Analysis Affirms the High Persistence and Adherence Observed with Diroximel Fumarate in Patients with Multiple Sclerosis".

Lager, Brittney / Liseno, Jacob / Božin, Ivan / England, Sarah M / Shankar, Sai L / Mendoza, Jason P / Lewin, James B

Neurology and therapy

2023 Volume 12, Issue 6, Page(s) 2199–2203

Language	English
Publishing date	2023-09-14
Publishing country	New Zealand
Document type	Letter
ISSN	2193-8253
ISSN	2193-8253
DOI	10.1007/s40120-023-00536-y
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Article: Multiple Sclerosis Patients Treated With Diroximel Fumarate in the Real-World Setting Have High Rates of Persistence and Adherence.

Liseno, Jacob / Lager, Brittney / Miller, Catherine / Shankar, Sai L / Mendoza, Jason P / Lewin, James B

Neurology and therapy

2021 Volume 10, Issue 1, Page(s) 349–360

Abstract: Introduction: Persistence to multiple sclerosis (MS) disease-modifying therapy is fundamental for maximal treatment outcomes. Diroximel fumarate (DRF) is approved in the USA for relapsing MS. Following oral administration, DRF is metabolized to ... ...

Abstract	Introduction: Persistence to multiple sclerosis (MS) disease-modifying therapy is fundamental for maximal treatment outcomes. Diroximel fumarate (DRF) is approved in the USA for relapsing MS. Following oral administration, DRF is metabolized to monomethyl fumarate, the active metabolite of dimethyl fumarate (DMF). DRF showed clinically significant improvements in gastrointestinal (GI) tolerability versus DMF in a head-to-head clinical trial; however, real-world persistence/adherence has not been assessed. We evaluated persistence/adherence in DRF-treated patients in a real-world clinical practice. Methods: This retrospective analysis of the AcariaHealth Specialty Pharmacy Program included patients initiating DRF from 4 December 2019 through 3 April 2020 and followed until data extraction (31 August 2020). Exclusion criteria included undetermined treatment status (e.g., DRF prescription transfer to a different pharmacy). Endpoints included persistence (overall proportion of patients remaining on DRF), discontinuation rate due to GI adverse events (AEs), and adherence (proportion of days covered [PDC]). GI AEs included GI-related AEs occurring at any time, or any unknown AE without details about the nature of the event if the unknown AE occurred ≤ 90 days after DRF initiation. Results: Overall, 160 patients with MS were included. Median (range) patient age was 51 (20-79) years, 80.6% (129/160) of patients were female, and 16.3% (26/160) had prior DMF treatment. Median (range) treatment duration was 7.6 (0.1-10.4) months. Estimated proportion of patients remaining persistent on DRF treatment at 8 months was 88.6% (95% confidence interval [CI] 82.5-2.7). Overall, 3.8% (6/160) of patients discontinued due to GI AEs. Mean PDC was 91.4% (95% CI 89.1-93.7). In a DMF-to-DRF switch subgroup, 92.3% (24/26) remained persistent on DRF, and 3.8% (1/26) discontinued DRF due to GI AEs. Conclusion: This real-world analysis of DRF-treated patients showed high overall persistence, low discontinuation rate due to GI AEs, and high adherence to therapy, aligning with expectations based on DRF clinical trials. Data were consistent in the DMF-to-DRF subgroup. INFOGRAPHIC.
Language	English
Publishing date	2021-04-12
Publishing country	New Zealand
Document type	Journal Article
ISSN	2193-8253
ISSN	2193-8253
DOI	10.1007/s40120-021-00242-7
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Article: Infrarenal inferior vena cava agenesis and recurrent deep vein thrombosis: a case report and literature review.

Prado, Victor E / Rey-Mendoza, Juan Pablo / Wakefield, Connor J / Aqeel, Sheeba Ba / Kumssa, Admasu

Oxford medical case reports

2021 Volume 2021, Issue 1, Page(s) omaa104

Abstract: Inferior vena cava agenesis is a rare congenital vascular defect often diagnosed as an incidental finding in asymptomatic patients. When symptoms arise, it can present with chronic venous stasis or unprovoked deep vein thrombosis (DVT). A 42-year-old man ...

Abstract	Inferior vena cava agenesis is a rare congenital vascular defect often diagnosed as an incidental finding in asymptomatic patients. When symptoms arise, it can present with chronic venous stasis or unprovoked deep vein thrombosis (DVT). A 42-year-old man with history of unprovoked right lower extremity (RLE) DVTs was admitted for swelling, pain and erythema to the RLE, concerning for new DVT. Venous Doppler ultrasound showed a chronic DVT of the right proximal femoral vein in addition to an acute DVT of the distal femoral vein. Extensive thrombophilia workup was negative and additional imaging with abdominal computed tomography scan revealed the absence of the infrarenal inferior vena cava. Patient was treated with oral anticoagulation and compression stockings and discharged with clinical improvement. At 3-month follow-up, patient was completely asymptomatic. Recurrent unprovoked DVTs in young patients require exhaustive work up including imaging studies to rule out vascular anomalies.
Language	English
Publishing date	2021-01-12
Publishing country	England
Document type	Case Reports
ZDB-ID	2766251-2
ISSN	2053-8855
ISSN	2053-8855
DOI	10.1093/omcr/omaa104
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Article: A paradox of traffic and extra cars in a city as a collective behaviour.

Prieto Curiel, Rafael / González Ramírez, Humberto / Quiñones Domínguez, Mauricio / Orjuela Mendoza, Juan Pablo

Royal Society open science

2021 Volume 8, Issue 6, Page(s) 201808

Abstract: Promoting walking or cycling and reducing cars' use is one of the city planners' main targets, contributing to a sustainable transport method. Yet, the number of vehicles worldwide is increasing as fast as the population, and motorized mobility has ... ...

Abstract	Promoting walking or cycling and reducing cars' use is one of the city planners' main targets, contributing to a sustainable transport method. Yet, the number of vehicles worldwide is increasing as fast as the population, and motorized mobility has become the primary transport method in most cities. Here, we consider modal share as an emergent behaviour of personal decisions. All individuals minimize their commuting time and reach an equilibrium under which no person is willing to change their transportation mode. In terms of the minimum travel time, the best-case scenario is used to determine the extra commuting time and the excess cars, computed as a social inefficiency. Results show that commuting times could increase up to 25% with many more vehicles than optimum. Paradoxically, all individuals trying to minimize their time could collectively reach the maximum commuting times in the extreme case, with all individuals driving during rush hour.
Language	English
Publishing date	2021-06-23
Publishing country	England
Document type	Journal Article
ZDB-ID	2787755-3
ISSN	2054-5703
ISSN	2054-5703
DOI	10.1098/rsos.201808
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Article ; Online: Only the carrot, not the stick: incorporating trust into the enforcement of regulation.

Mendoza, Juan P / Wielhouwer, Jacco L

PloS one

2015 Volume 10, Issue 2, Page(s) e0117212

Abstract: New enforcement strategies allow agents to gain the regulator's trust and consequently face a lower audit probability. Prior research suggests that, in order to prevent lower compliance, a reduction in the audit probability (the "carrot") must be ... ...

Abstract	New enforcement strategies allow agents to gain the regulator's trust and consequently face a lower audit probability. Prior research suggests that, in order to prevent lower compliance, a reduction in the audit probability (the "carrot") must be compensated with the introduction of a higher penalty for non-compliance (the "stick"). However, such carrot-and-stick strategies reflect neither the concept of trust nor the strategies observed in practice. In response to this, we define trust-based regulation as a strategy that incorporates rules that allow trust to develop, and using a generic (non-cooperative) game of tax compliance, we examine whether trust-based regulation is feasible (i.e., whether, in equilibrium, a reduction in the audit probability, without ever increasing the penalty for non-compliance, does not lead to reduced compliance). The model shows that trust-based regulation is feasible when the agent sufficiently values the future. In line with the concept of trust, this strategy is feasible when the regulator is uncertain about the agent's intentions. Moreover, the model shows that (i) introducing higher penalties makes trust-based regulation less feasible, and (ii) combining trust and forgiveness can lead to a lower audit probability for both trusted and distrusted agents. Policy recommendations often point toward increasing deterrence. This model shows that the opposite can be optimal.
MeSH term(s)	Humans ; Management Audit ; Probability ; Trust
Language	English
Publishing date	2015
Publishing country	United States
Document type	Journal Article
ISSN	1932-6203
ISSN (online)	1932-6203
DOI	10.1371/journal.pone.0117212
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Article: Real-World Analysis Affirms the High Persistence and Adherence Observed with Diroximel Fumarate in Patients with Multiple Sclerosis.

Lager, Brittney / Liseno, Jacob / Božin, Ivan / England, Sarah M / Shankar, Sai L / Mendoza, Jason P / Lewin, James B

Neurology and therapy

2022 Volume 12, Issue 1, Page(s) 145–159

Abstract: Introduction: Adherence to disease-modifying therapies is key for achieving optimal outcomes in multiple sclerosis (MS). Diroximel fumarate (DRF) is an oral fumarate approved for treatment of relapsing forms of MS. It has the same pharmacologically ... ...

Abstract	Introduction: Adherence to disease-modifying therapies is key for achieving optimal outcomes in multiple sclerosis (MS). Diroximel fumarate (DRF) is an oral fumarate approved for treatment of relapsing forms of MS. It has the same pharmacologically active metabolite as dimethyl fumarate (DMF) and similar efficacy and safety profiles, but with demonstrated fewer gastrointestinal (GI) related adverse events (AEs). There are limited data characterizing persistence and adherence to DRF in the real world. Methods: This retrospective analysis of the AcariaHealth Specialty Pharmacy Program included patients with MS initiating DRF from 1 December 2019 to 30 January 2021. This analysis evaluated persistence, measured as proportion of patients remaining on therapy; discontinuation rate due to GI AEs; and adherence measured by proportion of days covered (PDC). Results: Overall, 1143 patients were included; 433 (37.9%) patients had been treated with prior DMF and switched to DRF. Persistence was high in both groups: the estimated proportion of patients remaining on DRF at 16 months was 82.3% [95% confidence internal (CI) 77.2-86.3%], and 90.1% (95% CI 82.2-94.6%) in the DMF to DRF group. Fifty-two (4.5%) patients overall and 15 (3.5%) in the DMF switch subgroup discontinued DRF due to GI AEs. Mean PDC was 90.8% (95% CI 89.2-92.5%), and 85.4% (95% CI 83.3-87.4%) of patients achieved PDC ≥ 80% in the overall population. In the DMF to DRF group, mean PDC was 90.7% (95% CI 88.0-93.5%), and 84.8% (95% CI 81.4-88.1%) of patients achieved PDC ≥ 80%. Conclusion: In this analysis of > 1000 patients treated with DRF in real-world clinical practice, overall persistence at 16 months was high, treatment discontinuation due to GI AEs was low, and patients were highly adherent to therapy. Of 433 patients who switched from DMF to DRF, most (> 90%) were able to tolerate and persist on DRF after switching. Graphical abstract available for this article.
Language	English
Publishing date	2022-11-05
Publishing country	New Zealand
Document type	Journal Article
ISSN	2193-8253
ISSN	2193-8253
DOI	10.1007/s40120-022-00413-0
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Article ; Online: Dimethyl fumarate is associated with lower rates of infection and lower infection-related healthcare costs when compared with ocrelizumab.

Nicholas, Jacqueline A / Gudesblatt, Mark / Garabedian, Meghan / Belviso, Nicholas / Shen, Changyu / Geremakis, Caroline / Shankar, Sai L / Mendoza, Jason P / Lewin, James B

Multiple sclerosis and related disorders

2022 Volume 63, Page(s) 103921

Abstract: Background: Infections in people with multiple sclerosis (PwMS) may have a detrimental effect on disease progression, risk of hospitalization, and healthcare resource utilization (HRU). The infection risk and HRU costs may vary between disease-modifying ...

Abstract	Background: Infections in people with multiple sclerosis (PwMS) may have a detrimental effect on disease progression, risk of hospitalization, and healthcare resource utilization (HRU). The infection risk and HRU costs may vary between disease-modifying therapies (DMTs); however, the individual risks and differences associated with DMTs are not well characterized. Some DMTs may increase the risk for infections in PwMS; however, previous studies have reported an intact humoral immune response in dimethyl fumarate (DMF)-treated patients. The objective was to compare infection-related HRU and healthcare costs (HCCs) between PwMS treated with DMF or ocrelizumab (OCR). Methods: Eligible patients were identified from the Optum US claims database between April 2017 and September 2020 (DMF n = 1429; OCR n = 3170). Patients were followed from index date to first occurrence of: (1) end of study, (2) end of insurance eligibility, (3) discontinuation of index DMT, or (4) switch from index DMT to another DMT. Outcomes were annualized rate of infection encounters (defined as infection encounters [n] during follow-up window / days followed [n] × 365); annualized infection-related HCCs (defined as aggregated costs of infection encounters during follow-up window / days followed [n] × 365); location-specific infections, and overall infection-related events. Propensity score matching (PSM) 1:1 method was used; PS was calculated via logistic regression for probability of DMF treatment conditional on demographics and comorbidities. Mean differences (MD) were reported for infection encounter measures. Results: After PSM, DMF and OCR cohorts (n = 1094 in each cohort) were balanced based on baseline characteristics (standardized MD of adjusted baseline characteristics <0.1). Mean (standard deviation) follow-up was 296 (244) days for DMF patients and 297 (243) for OCR patients. DMF patients experienced lower annualized rates of overall infection encounters vs OCR patients (MD -0.51 [95% confidence interval (CI): -0.92 to -0.11], p = 0.01). When stratified by type of infection encounter, DMF patients experienced significantly lower annualized rates of outpatient (MD [95% CI]: -0.44 [-0.80 to -0.08], p = 0.02) and inpatient/hospitalization infection encounters (-0.08 [-0.14 to -0.02], p<0.01) vs OCR patients. A trend towards a shorter duration of infection-related hospitalization in the DMF vs the OCR group was observed (MD [95% CI]: -2.20 [-4.73 to 0.26] days, p = 0.08). The most common infection types in both DMT groups were urinary tract infections, sepsis, and pneumonia. DMF patients experienced lower annualized infection-related HCCs (MD [95% CI]: -$3642 [-$6380 to -$904], p < 0.01) vs OCR patients, which were driven largely by infection-related hospitalization costs (-$3639 [-$6019 to -$1259], p < 0.01). Conclusion: DMF-treated patients PS-matched with OCR patients experienced lower annualized rates of infection encounters and lower infection-related HCCs.
MeSH term(s)	Antibodies, Monoclonal, Humanized/adverse effects ; Dimethyl Fumarate/therapeutic use ; Health Care Costs ; Humans ; Multiple Sclerosis/chemically induced ; Multiple Sclerosis/complications ; Multiple Sclerosis/drug therapy ; Retrospective Studies
Chemical Substances	Antibodies, Monoclonal, Humanized ; ocrelizumab (A10SJL62JY) ; Dimethyl Fumarate (FO2303MNI2)
Language	English
Publishing date	2022-06-02
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2645330-7
ISSN	2211-0356 ; 2211-0348
ISSN (online)	2211-0356
ISSN	2211-0348
DOI	10.1016/j.msard.2022.103921
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