Medicine and Health Sciences Commons^™

African League Against Rheumatism (Aflar) Preliminary Recommendations On The Management Of Rheumatic Diseases During The Covid-19 Pandemic, Richard Oluyinka Akintayo, Rachid Bahiri, Yasser El Miedany, Hakeem Olaosebikan, Asgar Ali Kalla, Adewale Olukayode Adebajo, Angela Migowa, Samy Slimani, Ouma Devi Koussougbo, Ben Abdelghani Kawther

Paediatrics and Child Health, East Africa

Objectives: To develop recommendations for the management of rheumatic and musculoskeletal diseases (RMDs) during the COVID-19 pandemic.

Method: A task force comprising of 25 rheumatologists from the 5 regions of the continent was formed and operated through a hub-and-spoke model with a central working committee (CWC) and 4 subgroups. The subgroups championed separate scopes of the clinical questions and formulated preliminary statements of recommendations which were processed centrally in the CWC. The CWC and each subgroup met by several virtual meetings, and two rounds of voting were conducted on the drafted statements of recommendations. Votes were online-delivered and …

Physical Activity For Rheumatoid Arthritis Patients: Benchmark Study, Lauren Nicholson

MSN Capstone Projects

Rheumatoid arthritis (RA) is an autoimmune inflammatory condition that affects the joints; without proper treatment and management, RA leads to the destruction of joint function. The standard of care for RA includes medications such as biologic therapy and disease-modifying anti-rheumatic drugs. An often-overlooked area of disease management is the implementation of exercise programs for patients with RA. Exercise is known to decrease systemic inflammation, symptoms of depression, and combat fatigue – all common symptoms reported by patients with RA.

Standard of care for patients with RA does not currently include lifestyle management factors such as diet, exercise, and cessation of …

Assessing The Effect Of Interventions For Axial Spondyloarthritis According To The Endorsed Asas/Omeract Core Outcome Set: A Meta-Research Study Of Trials Included In Cochrane Reviews., Rikke A Andreasen, Lars E Kristensen, Xenofon Baraliakos, Vibeke Strand, Philip Mease, Maarten De Wit, Torkell Ellingsen, Inger Marie J Hansen, Jamie Kirkham, George A Wells, Peter Tugwell, Lara Maxwell, Maarten Boers, Kenneth Egstrup, Robin Christensen

Articles, Abstracts, and Reports

The Assessment of SpondyloArthritis international Society (ASAS) has defined core sets for (i) symptom-modifying anti-rheumatic drugs (SM-ARD), (ii) clinical record keeping, and (iii) disease-controlling anti-rheumatic therapy (DC-ART). These include the following domains for all three core sets: "physical function," "pain," "spinal mobility," "spinal stiffness," and "patient's global assessment" (PGA). The core set for clinical record keeping further includes the domains "peripheral joints/entheses" and "acute phase reactants," and the core set for DC-ART further includes the domains "fatigue" and "spine radiographs/hip radiographs." The Outcome Measures in Rheumatology (OMERACT) endorsed the core sets in 1998.Using empirical evidence from axSpA trials, we investigated …

Long-Term Safety And Tolerability Of Apremilast Versus Placebo In Psoriatic Arthritis: A Pooled Safety Analysis Of Three Phase Iii, Randomized, Controlled Trials., Philip Mease, Dafna D Gladman, Juan J Gomez-Reino, Stephen Hall, Arthur Kavanaugh, Eric Lespessailles, Georg Schett, Maria Paris, Nikolay Delev, Lichen Teng, Jürgen Wollenhaupt

Articles, Abstracts, and Reports

OBJECTIVE: Psoriatic arthritis (PsA) requires long-term treatment, yet safety concerns and monitoring requirements make maintenance a challenge. This analysis of pooled Psoriatic Arthritis Long-term Assessment of Clinical Efficacy (PALACE) 1, 2, and 3 data describes 3-year apremilast safety and tolerability in PsA.

METHODS: Patients with active PsA were randomized (1:1:1) to placebo, apremilast 30 mg twice daily, or apremilast 20 mg twice daily. Placebo patients were re-randomized to apremilast 30 mg twice daily or 20 mg twice daily at week 16 (early escape) or 24. Double-blind treatment continued to week 52; patients could continue apremilast during an open-label, long-term treatment …

Assessment And Treatment Of Down Syndrome-Associated Arthritis: A Survey Of Pediatric Rheumatologists., Anna Nicek, Nasreen Talib, Daniel Lovell, Chelsey Smith, Mara L. Becker, Jordan T. Jones

Manuscripts, Articles, Book Chapters and Other Papers

Background: Inflammatory arthritis in children with Down syndrome (DS) was first described in 1984 and is now termed Down syndrome-associated arthritis (DA). Studies have shown that DA is under-recognized with a 19-month average delay in diagnosis. Additionally, most patients present with polyarticular, rheumatoid factor (RF) and anti-nuclear antibody (ANA) negative disease. Current therapies for juvenile idiopathic arthritis (JIA) have been used, but appear to be poorly tolerated, more toxic and less effective in patients with DA. There is currently no standardized approach to the assessment or management of DA. The objective of this study was to describe provider perspectives toward …

Characterization Of Patients With Axial Spondyloarthritis By Enthesitis Presence: Data From The Corrona Psoriatic Arthritis/Spondyloarthritis Registry., Philip Mease, Mei Liu, Sabrina Rebello, Winnie Hua, Robert R Mclean, Esther Yi, Yujin Park, Alexis Ogdie

Articles, Abstracts, and Reports

OBJECTIVE: To compare the characteristics of patients with axial spondyloarthritis (axSpA) who had enthesitis versus those without enthesitis.

METHODS: This study included adult patients with axSpA enrolled in the Corrona Psoriatic Arthritis/Spondyloarthritis Registry (March 2013 to August 2018). Enthesitis was assessed at enrollment via the Spondyloarthritis Research Consortium of Canada Enthesitis Index. Characteristics were compared between patients with and without enthesitis using t tests or Wilcoxon rank-sum tests for continuous variables and χ

RESULTS: Of 477 patients with axSpA, 121 (25.4%) had enthesitis (mean, 3.9 sites) at enrollment. Higher proportions of patients with enthesitis were female and had nonradiographic axSpA …

Secukinumab Provides Sustained Low Rates Of Radiographic Progression In Psoriatic Arthritis: 52-Week Results From A Phase 3 Study, Future 5., Désirée Van Der Heijde, Philip Mease, Robert B M Landewé, Proton Rahman, Hasan Tahir, Atul Singhal, Elke Boettcher, Sandra Navarra, Xuan Zhu, Gregory Ligozio, Aimee Readie, Shephard Mpofu, Luminita Pricop

Articles, Abstracts, and Reports

OBJECTIVE: To evaluate the effect of secukinumab on radiographic progression through 52 weeks in patients with PsA from the FUTURE 5 study.

METHODS: Patients with active PsA, stratified by prior anti-TNF use (naïve or inadequate response), were randomized to s.c. secukinumab 300 mg load (300 mg), 150 mg load (150 mg), 150 mg no load regimens or placebo at baseline, at weeks 1, 2 and 3 and every 4 weeks starting at week 4. Radiographic progression was assessed by change in van der Heijde-modified total Sharp score (vdH-mTSS; mean of two readers). Statistical analysis used a linear mixed-effects model (random …

Inhibition Of Radiographic Progression Across Levels Of Composite Index-Defined Disease Activity In Patients With Active Psoriatic Arthritis Treated With Intravenous Golimumab: Results From A Phase-3, Double-Blind, Placebo-Controlled Trial., Philip Mease, M Elaine Husni, Shelly Kafka, Soumya D Chakravarty, Diane D Harrison, Kim Hung Lo, Stephen Xu, Elizabeth C Hsia, Arthur Kavanaugh

Articles, Abstracts, and Reports

BACKGROUND: In the GO-VIBRANT trial of intravenous golimumab in psoriatic arthritis (PsA), golimumab significantly inhibited radiographic progression. In post hoc analyses, we evaluated changes in total PsA-modified Sharp/van der Heijde scores (SHS) across levels of composite index-defined disease activity following treatment.

METHODS: In this phase-3, double-blind, placebo-controlled trial, 480 bio-naïve patients with active PsA randomly received intravenous golimumab 2 mg/kg (N = 241; week 0, week 4, every 8 weeks [q8w]) or placebo (N = 239; week 0, week 4, week 12, week 20) followed by golimumab (week 24, week 28, q8w) through week 52. Week 24 and week 52 …

Preface To The Psoriatic Arthritis Supplement., Philip Mease

Articles, Abstracts, and Reports

No abstract provided.

Enthesitis In Psoriatic Arthritis (Part 3): Clinical Assessment And Management., Philip Mease

Articles, Abstracts, and Reports

Enthesitis is a common clinical feature of PsA, which is characterized by inflammation at the site of insertion of tendons, ligaments and joint capsule fibres into bone. Enthesitis is relatively unique to the spondyloarthritides, setting this group of diseases apart from other rheumatological conditions. The pathophysiological underpinnings of this clinical domain, and the imaging assessment of it, are described in accompanying articles in this supplement. The focus of this article is on the assessment of enthesitis by physical examination, the impact of enthesitis on function and quality of life, the impact of concomitant FM on clinical assessment, and the evidence …

Acthar Gel (Repository Corticotropin Injection) For Persistently Active Sle: Study Design And Baseline Characteristics From A Multicentre, Randomised, Double-Blind, Placebo-Controlled Trial, A. D. Askanase, E. Zhao, J. Zhu, E. Connolly-Strong, R. A. Furie

Journal Articles

© 2020 Author(s). Objective SLE is a chronic inflammatory autoimmune disease characterised by the excessive production of autoantibodies, immune complexes and proinflammatory cytokines. Repository corticotropin injection (RCI) is a naturally sourced complex mixture of adrenocorticotropic hormone analogues and other pituitary peptides. RCI is approved by the US Food and Drug Administration for use during an exacerbation or as maintenance therapy in select cases of SLE. This paper discusses the design and baseline characteristics of a multicentre, double-blind, randomised, placebo-controlled, 24-week clinical trial evaluating the effect of RCI in reducing disease activity for patients with persistently active SLE despite moderate-dose corticosteroid …

Cell-Bound Complement Activation Products Associate With Lupus Severity In Sle., C. Arriens, R. V. Alexander, S. Narain, A. Saxena, C. E. Collins, D. J. Wallace, E. Massarotti, J. Conklin, R. A. Furie, T. Dervieux, +11 Additional Authors

Journal Articles

OBJECTIVES: To evaluate the association between lupus severity and cell-bound complement activation products (CB-CAPs) or low complement proteins C3 and C4.

METHODS: All subjects (n=495) fulfilled the American College of Rheumatology (ACR) classification criteria for SLE. Abnormal CB-CAPs (erythrocyte-bound C4d or B-lymphocyte-bound C4d levels >99th percentile of healthy) and complement proteins C3 and C4 were determined using flow cytometry and turbidimetry, respectively. Lupus severity was estimated using the Lupus Severity Index (LSI). Statistical analysis consisted of multivariable linear regression and groups comparisons.

RESULTS: Abnormal CB-CAPs were more prevalent than low complement values irrespective of LSI levels (62% vs 38%, respectively, …

Clinical Mortality In A Large Covid-19 Cohort: Observational Study., M. Jarrett, S. Schultz, J. Lyall, J. Wang, L. Stier, M. De Geronimo, K. Nelson

Journal Articles

BACKGROUND: Northwell Health, an integrated health system in New York, has treated more than 15,000 inpatients with COVID-19 at the US epicenter of the SARS-CoV-2 pandemic.

OBJECTIVE: We describe the demographic characteristics of patients who died of COVID-19, observation of frequent rapid response team/cardiac arrest (RRT/CA) calls for non-intensive care unit (ICU) patients, and factors that contributed to RRT/CA calls.

METHODS: A team of registered nurses reviewed the medical records of inpatients who tested positive for SARS-CoV-2 via polymerase chain reaction before or on admission and who died between March 13 (first Northwell Health inpatient expiration) and April 30, 2020, …

Comparative Survival Analysis Of Immunomodulatory Therapy For Coronavirus Disease 2019 Cytokine Storm., S. Narain, D. G. Stefanov, A. S. Chau, A. G. Weber, G. Marder, B. Kaplan, P. Malhotra, O. Bloom, A. Liu, M. M. Lesser, N. Hajizadeh, Northwell Covid-19 Research Consortium

Journal Articles

BACKGROUND:Cytokine storm is a marker of coronavirus disease 2019 (COVID-19) illness severity and increased mortality. Immunomodulatory treatments have been repurposed to improve mortality outcomes. RESEARCH QUESTION:Do immunomodulatory therapies improve survival in patients with COVID-19 cytokine storm (CCS)? STUDY DESIGN AND METHODS:We conducted a retrospective analysis of electronic health records across the Northwell Health system. COVID-19 patients hospitalized between March 1, 2020, and April 24, 2020, were included. CCS was defined by inflammatory markers: ferritin, > 700 ng/mL; C-reactive protein (CRP), > 30 mg/dL; or lactate dehydrogenase (LDH), > 300 U/L. Patients were subdivided into six groups: no immunomodulatory treatment (standard of care) and …

A Head-To-Head Comparison Of The Efficacy And Safety Of Ixekizumab And Adalimumab In Biological-Naïve Patients With Active Psoriatic Arthritis: 24-Week Results Of A Randomised, Open-Label, Blinded-Assessor Trial., Philip Mease, Josef S Smolen, Frank Behrens, Peter Nash, Soyi Liu Leage, Lingnan Li, Hasan Tahir, Melinda Gooderham, Eswar Krishnan, Hong Liu-Seifert, Paul Emery, Sreekumar G Pillai, Philip S Helliwell

Articles, Abstracts, and Reports

OBJECTIVES: To compare efficacy and safety of ixekizumab (IXE) to adalimumab (ADA) in biological disease-modifying antirheumatic drug-naïve patients with both active psoriatic arthritis (PsA) and skin disease and inadequate response to conventional synthetic disease-modifying antirheumatic drug (csDMARDs).

METHODS: Patients with active PsA were randomised (1:1) to approved dosing of IXE or ADA in an open-label, head-to-head, blinded assessor clinical trial. The primary objective was to evaluate whether IXE was superior to ADA at week 24 for simultaneous achievement of a ≥50% improvement from baseline in the American College of Rheumatology criteria (ACR50) and a 100% improvement from baseline in the …

Secukinumab Provides Sustained Improvements In The Signs And Symptoms Of Psoriatic Arthritis: Final 5-Year Results From The Phase 3 Future 1 Study., Philip Mease, Arthur Kavanaugh, Andreas Reimold, Hasan Tahir, Juergen Rech, Stephen Hall, Piet Geusens, Pascale Pellet, Eumorphia Maria Delicha, Luminita Pricop, Shephard Mpofu

Articles, Abstracts, and Reports

OBJECTIVE: To report the 5-year efficacy and safety of secukinumab in the treatment of patients with psoriatic arthritis (PsA) in the FUTURE 1 study (NCT01392326).

METHODS: Following the 2-year core trial, eligible patients receiving subcutaneous secukinumab entered a 3-year extension phase. Results are presented for key efficacy endpoints for the secukinumab 150-mg group (n = 236), including patients who escalated from 150 to 300 mg (approved doses) starting at week 156. Safety is reported for all patients (n = 587) who received 1 dose or more of study treatment.

RESULTS: Overall, 81.8%% (193 of 236) of patients in the secukinumab …

Unmet Need In Rheumatology: Reports From The Targeted Therapies Meeting 2019., Kevin L Winthrop, Michael E Weinblatt, Joan Bathon, Gerd R Burmester, Philip Mease, Leslie Crofford, Vivian Bykerk, Maxime Dougados, James Todd Rosenbaum, Xavier Mariette, Joachim Sieper, Fritz Melchers, Bruce N Cronstein, Ferry C Breedveld, Joachim Kalden, Josef S Smolen, Daniel Furst

Articles, Abstracts, and Reports

OBJECTIVES: To detail the greatest areas of unmet scientific and clinical needs in rheumatology.

METHODS: The 21st annual international Advances in Targeted Therapies meeting brought together more than 100 leading basic scientists and clinical researchers in rheumatology, immunology, epidemiology, molecular biology and other specialties. During the meeting, breakout sessions were convened, consisting of 5 disease-specific groups with 20-30 experts assigned to each group based on expertise. Specific groups included: rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, systemic lupus erythematosus and other systemic autoimmune rheumatic diseases. In each group, experts were asked to identify unmet clinical and translational research needs in general …

An Investigation Of Infectious Etiologies Of Sporadic Inclusion Body Myositis, Tyler Kennedy, Michele Meltzer, Md

Phase 1

Introduction: Sporadic inclusion body myositis (sIBM) is a rare, debilitating disease that can significantly lower one’s quality of life. Unfortunately, there are no current effective treatments, as the underlying causes are still unknown. We hypothesize that preceding infections do not cause sporadic inclusion body myositis.

Methods: The study investigated patients with a diagnosis of inclusion body myositis, with a concurrent or previously documented infection. Men represented a larger proportion of the population as they have an increased preponderance of those affected. The primary objective was to discern which infection, if any, could induce the inflammatory and degenerative changes in muscle …

Secukinumab Efficacy On Resolution Of Enthesitis In Psoriatic Arthritis: Pooled Analysis Of Two Phase 3 Studies., Laura C Coates, Johan K Wallman, Dennis Mcgonagle, Georg A Schett, Iain B Mcinnes, Philip Mease, Lawrence Rasouliyan, Erhard Quebe-Fehling, Darren L Asquith, Andreas E R Fasth, Luminita Pricop, Corine Gaillez

Articles, Abstracts, and Reports

BACKGROUND: Enthesitis is one of the psoriatic arthritis (PsA) domains. Patients with enthesitis are associated with worse outcomes than those without enthesitis. The effect of secukinumab on the resolution of enthesitis in patients with PsA was explored using pooled data from the FUTURE 2 and 3 studies.

METHOD: Assessments of enthesitis through week 104 used the Leeds Enthesitis Index. These post hoc analyses included resolution of enthesitis count (EC = 0), median time to first resolution of enthesitis (Kaplan-Meϊer estimate), and shift analysis (as observed) of baseline EC (1, 2, or 3-6) to full resolution (FR), stable (similar or reduction …

Secukinumab Efficacy On Resolution Of Enthesitis In Psoriatic Arthritis: Pooled Analysis Of Two Phase 3 Studies., Laura C Coates, Johan K Wallman, Dennis Mcgonagle, Georg A Schett, Iain B Mcinnes, Philip Mease, Lawrence Rasouliyan, Erhard Quebe-Fehling, Darren L Asquith, Andreas E R Fasth, Luminita Pricop, Corine Gaillez

Articles, Abstracts, and Reports

BACKGROUND: Enthesitis is one of the psoriatic arthritis (PsA) domains. Patients with enthesitis are associated with worse outcomes than those without enthesitis. The effect of secukinumab on the resolution of enthesitis in patients with PsA was explored using pooled data from the FUTURE 2 and 3 studies.

METHOD: Assessments of enthesitis through week 104 used the Leeds Enthesitis Index. These post hoc analyses included resolution of enthesitis count (EC = 0), median time to first resolution of enthesitis (Kaplan-Meϊer estimate), and shift analysis (as observed) of baseline EC (1, 2, or 3-6) to full resolution (FR), stable (similar or reduction …

Assessing Physical Activity And Sleep In Axial Spondyloarthritis: Measuring The Gap., Atul Deodhar, Lianne S Gensler, Marina Magrey, Jessica A Walsh, Adam Winseck, Daniel Grant, Philip Mease

Articles, Abstracts, and Reports

Patients with axial spondyloarthritis (axSpA) frequently report pain, stiffness, fatigue, and sleep problems, which may lead to impaired physical activity. The majority of reported-on measures evaluating physical activity and sleep disturbance in axSpA are self-reported questionnaires, which can be impacted by patient recall (reporting bias). One objective measure, polysomnography, has been employed to evaluate sleep in patients with axSpA; however, it is an intrusive measure and cannot be used over the long term. More convenient objective measures are therefore needed to allow for the long-term assessment of both sleep and physical activity in patients' daily lives. Wearable technology that utilizes …

Practice-Based Education Program To Increase Vaccination Rate In Patients On Immunotherapeutic Agents, Andrea M. Soliman Do, Soorya N. Aggarwal Do, Kyle Kreitman Do, Kourtney Erickson Do, Abdul Aleem Md, Marie S. O'Brien Do

Department of Medicine

No abstract provided.

Pain, Functional Disability, And Their Association In Juvenile Fibromyalgia Compared To Other Pediatric Rheumatic Diseases., Mark Connelly, Jennifer E Weiss, Carra Registry Investigators

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Severe pain and impairments in functioning are commonly reported for youth with juvenile fibromyalgia. The prevalence and impact of pain in other diseases commonly managed in pediatric rheumatology comparatively have been rarely systematically studied. The objective of the current study was to determine the extent to which high levels of pain and functional limitations, and the strength of their association, are unique to youth with juvenile primary fibromyalgia syndrome/JPFS) relative to other pediatric rheumatic diseases.

METHODS: Using data from 7753 patients enrolled in the multinational Childhood Arthritis and Rheumatology Research Alliance (CARRA) Legacy Registry, we compared the levels and …

Dry Eyes, Dry Mouth, And Amyloidosis – A Case Report, Andrea M. Soliman Do, Grace Guerrier Md, Carolyn Casey Do, Shereen M F Gheith Md, Phd

Department of Medicine

No abstract provided.

Screening And Treating Hyperlipidemia In Patients On Tofacitinib, Tocilizumab, Sarilumab, And Baricitinib, William Torelli Do, Thomas A. Quinn Do, Kourtney Erickson Do, Andrea M. Soliman Do, Attiya Harit Ms, James Ross Md, Facp

Department of Medicine

No abstract provided.

Case Report: Too Thick To Test, William Torelli Do, Rebecca Sharim Md

Department of Medicine

No abstract provided.

Rapidly Progressive Rheumatoid Lung Disease, Alaynna C. Kears Do, Nathan Brewster Do, Andrea M. Soliman Do, Stacey Smith Md, Facp, James Ross Md, Facp

Department of Medicine

No abstract provided.

Don’T Be Blind To The Diagnosis: An Intriguing Case Of Monocular Blindness, Kourtney Erickson Do, Kaitlyn L. Buzard Do, Daniel Tseytlin Do, Carolyn Casey Do, Eugene Alexandrin Md

Department of Medicine

No abstract provided.

Efficacy And Safety Of Intravenous Golimumab Plus Methotrexate In Patients With Rheumatoid Arthritis Aged < 65 Years And Those ≥ 65 Years Of Age., John Tesser, Shelly Kafka, Raphael J. Dehoratius, Stephen Xu, Elizabeth C Hsia, Anthony Turkiewicz

Department of Pharmacology and Experimental Therapeutics Faculty Papers

OBJECTIVE: To evaluate the safety and efficacy of intravenous golimumab + methotrexate (MTX) in patients with active rheumatoid arthritis (RA) aged < 65 years and those ≥ 65 years who were enrolled in the GO-FURTHER study.

METHODS: In the phase III, double-blind, randomized, placebo-controlled GO-FURTHER trial, patients with active RA were randomized to intravenous (IV) golimumab 2 mg/kg + MTX or placebo + MTX at weeks 0 and 4, then every 8 weeks thereafter (with crossover to golimumab at week 16 [early escape] or week 24 [per-protocol]). The final golimumab infusion was at week 100. Assessments included American College of Rheumatology (ACR) 20/50/70 response criteria. Efficacy and adverse events (AEs) were monitored through 2 years. …

Demographic, Clinical, And Treatment Characteristics Of The Juvenile Primary Fibromyalgia Syndrome Cohort Enrolled In The Childhood Arthritis And Rheumatology Research Alliance Legacy Registry., Jennifer E. Weiss, Kenneth N. Schikler, Alexis D. Boneparth, Mark Connelly, Carra Registry Investigators

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: To describe the demographic, clinical, and treatment characteristics of youth diagnosed with juvenile primary fibromyalgia syndrome (JPFS) who are seen in pediatric rheumatology clinics.

METHODS: Information on demographics, symptoms, functioning, and treatments recommended and tried were obtained on patients with JPFS as part of a multi-site patient registry (the Childhood Arthritis and Rheumatology Research Alliance Legacy Registry). Data were summarized using descriptive statistics. In a subset of patients completing registry follow-up visits, changes in symptoms, pain, and functioning were evaluated using growth modeling.

RESULTS: Of the 201 patients with JPFS enrolled in the registry, most were Caucasian/White (85%), non-Hispanic …