About 287,470 results

Lower bevacizumab doses, agents with less systemic exposure may be safer options for ROP

Feb 3rd, 2022 - WAIKOLOA, Hawaii — Systemic effects of anti-VEGF in retinopathy of prematurity have not been ruled out, so it may be wise to use bevacizumab in lower doses or switch to agents with less systemic exposure, according to one presenter. “The BEAT-ROP study demonstrated a beneficial effect for bevacizumab vs. laser in the treatment of zone I, stage 3+ ROP. But one thing I didn’t like was the complet...

Natural History and Development of Spondyloarthritis

Sep 28th, 2022 - The purpose of this protocol is to study the natural history of spondyloarthritis (SpA) in children and adults. Spondyloarthritis encompasses a spectrum of immune-mediated inflammatory diseases that exhibit overlapping features, but differ from other types of inflammatory arthritis in genetic predisposition, pathogenesis, and outcome. Ankylosing spondylitis (AS), the most common form of SpA, fr...

A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens

Sep 9th, 2022 - The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected...

2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis.
Arthritis & Rheumatology (Hoboken, N.J.); Fraenkel L, Bathon JM et. al.

Jun 9th, 2021 - To develop updated guidelines for the pharmacologic management of rheumatoid arthritis. We developed clinically relevant population, intervention, comparator, and outcomes (PICO) questions. After conducting a systematic literature review, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to rate the certainty of evidence. A voting panel comprising c...

2019 Update of the American College of Rheumatology/Spondylitis Association of America/...
Arthritis & Rheumatology (Hoboken, N.J.); Ward MM, Deodhar A et. al.

Aug 23rd, 2019 - To update evidence-based recommendations for the treatment of patients with ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (SpA). We conducted updated systematic literature reviews for 20 clinical questions on pharmacologic treatment addressed in the 2015 guidelines, and for 26 new questions on pharmacologic treatment, treat-to-target strategy, and use of imaging. New q...

In Utero Exposure to Hydroxychloroquine Does Not Associate with Ocular Toxicity as Assessed by Optical Coherence Tomography Five Years After Birth
Peter Izmirly, Mala Masson, Michael Marmor et. al.

Nov 14th, 2022 - Background/Purpose: The preventive approach to congenital heart block with hydroxychloroquine (HCQ) [PATCH] study supported the efficacy of HCQ to reduce the recurrence rate of cardiac disease. This study considered whether the drug had any effects upon the retinal development of these children, examined 5 years later. Methods: Mothers in the PATCH study were treated with HCQ 400mg daily from 1...

Belimumab Disrupts Memory B-Cell Trafficking in Patients with Systemic Lupus Erythematosus
Eline J. Arends, Mihaela Zlei, Christopher M. Tipton et. al.

Nov 14th, 2022 - Background/Purpose: Belimumab (BEL), a recombinant human monoclonal antibody directed against B-cell activating factor (BAFF), is the first approved biological agent for patients (pts) with active systemic lupus erythematosus (SLE) and lupus nephritis (LN). BEL inhibits primary humoral immune responses by depleting naïve B cells that are dependent on BAFF for their survival while secondary humo...

Association of Ultra-processed Food Intake with Risk of Systemic Lupus Erythematosus in Women
Sinara Laurini Rossato, Chun-Han Lo, Medha Barbhaiya et. al.

Nov 14th, 2022 - Background/Purpose: Antioxidants and vitamins present in unprocessed foods may protect against development of systemic lupus erythematosus (SLE) whereas ultra-processed foods (UPFs) remove these nutrients, adding stabilizers and emulsifiers, and may thus increase SLE risk. We assessed the association of UPF intake and SLE incidence in two cohorts of women with more than 20 years of follow-up. M...

Long-term Renal Survival of Patients with LN by Renal Response Status in the Toronto Lupus Cohort
Murray Urowitz, Mary E. Georgiou, Jiandong Su et. al.

Nov 14th, 2022 - Background/Purpose: Approximately 40% of adult patients with SLE develop LN, which can lead to end-stage kidney disease (ESKD).1 Renal response is used in clinical trials as a measure of treatment efficacy in patients with LN; however, there are various definitions of renal response and limited evidence to support whether it accurately predicts long-term renal outcomes. A study using data from ...

AUR200: An Improved BAFF/APRIL Inhibitor with Increased Potency and Safety for the Treatment of B Cell-Mediated Diseases
Shawn Morales, Jennifer Cross and Robert Huizinga, Aurinia Pharmaceuticals et. al.

Nov 14th, 2022 - Background/Purpose: AUR200 targets both B cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL), which are key mediators in the pathogenesis of B cell-mediated autoimmune diseases. Dual blockade of BAFF and APRIL is proposed to be more effective than targeting either molecule alone. AUR200 is a potent recombinant IgG4 Fc fusion protein containing a modified B cell maturation...

SRI-4 and BICLA: How Well Do They Agree Across Trials of Active Systemic Lupus Erythematosus?
Alfredo Aguirre, Mimi Kim, Kosalaram Goteti et. al.

Nov 14th, 2022 - Background/Purpose: The Systemic Lupus Erythematosus Responder Index 4 (SRI-4) and the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) are currently the most common primary endpoints in systemic lupus erythematosus (SLE) randomized-controlled trials (RCTs). However, discordance between SRI-4 and BICLA effect sizes in studies has engendered skepticism about ...

Towards a Novel Clinician-Reported Outcome Measure for SLE – Outcomes of an International Consensus Process
Kathryn Connelly, Laura Eades, Rachel Koelmeyer et. al.

Nov 14th, 2022 - Background/Purpose: Most late-phase randomised controlled trials (RCTs) of novel drugs for systemic lupus erythematosus (SLE) have failed to meet their primary endpoint or shown contradictory efficacy results(1). While many factors contribute to RCT failure, how best to measure treatment benefit remains a challenge(1). For product approval, regulators require evidence of clinical benefit, defin...

Impact of Time to Remission, Flares and Exposure to Immunosuppressives on the Development of Advanced Chronic Kidney Disease (Stage IV or Worse) in Lupus Nephritis
Dafna Gladman, KONSTANTINOS TSELIOS, Jiandong Su3 and Murray Urowitz et. al.

Nov 14th, 2022 - Background/Purpose: Lupus nephritis (LN) affects up to 40% of patients with SLE and leads to end stage kidney disease (ESKD) in 17-33% after 10 years. The prevalence of chronic kidney disease stage IV (estimated glomerular filtration rate, eGFR=15-29ml/min/1.73m2) is not known; however, approximately two thirds of such patients will progress to ESKD after 6 years on average.1 Objective: To dete...

Sjögren’s Disease and Mitochondrial Function
Biji T Kurien, Pharaoh Gavin, Joshua Cavett et. al.

Nov 14th, 2022 - Background/Purpose: Sjögren’s disease (SjD) is a chronic inflammatory, autoimmune disorder with reduced lacrimal/salivary gland secretion resulting in keratoconjunctivitis sicca and xerostomia, respectively. Also, SjD patients have increased rates of metabolic syndrome and experience significant fatigue. Metabolic syndrome and fatigue are associated with chronic low-level inflammation. Our prev...

Serum and Tear Autoantibodies from nor Mice as Potential Diagnostic Indicators of Local and Systemic Inflammation in Sjögren’s Syndrome
Shruti Singh Kakan, Yaping Ju, Maria Edman2 and Sarah Hamm-Alvarez et. al.

Nov 14th, 2022 - Background/Purpose: Sjögren’s Syndrome (SS) is an autoimmune disease characterized by infiltration of lymphocytes into lacrimal (LG) and salivary (SG) glands and their concurrent loss of tear and saliva production, respectively, as well as the development of systemic symptoms. Diagnosis of SS takes ~3 years, due in part to manifestation of symptoms that overlap with other autoimmune diseases. R...

Immunological Differences Between PsA Patients Who Are Tumor Necrosis Factor Inhibitor-Naïve and Who Have Inadequate Response to Tumor Necrosis Factor Inhibitors
Stefan Siebert, Laura Coates, Georg Schett et. al.

Nov 14th, 2022 - Background/Purpose: A better understanding of the immunological differences between psoriatic arthritis (PsA) patients (pts) who are tumor necrosis factor inhibitor (TNFi)-naïve and who have inadequate response to TNFi (TNFi-IR) may guide treatment choices. In DISCOVER-1, benefit of the IL-23p19 subunit inhibitor guselkumab (GUS) every-four-weeks (Q4W) and Q8W over placebo (PBO) in improving Ps...

Long-term Efficacy of Guselkumab in Fatigue and Identification of Early Treatment Targets: Post Hoc Analysis Through 2 Years of a Phase 3, Randomized, Double-blind, Placebo-controlled Study Conduct...
Dafna Gladman, Michael Starr, Roberto Ranza et. al.

Nov 14th, 2022 - Background/Purpose: The IL-23p19-subunit inhibitor guselkumab (GUS) demonstrated clinically meaningful improvements in fatigue through one year of treatment1 independent of its effects on ACR20 and MDA achievement2. In this post hoc analysis, the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) scale was used to: (a) evaluate the long-term effect of GUS in maintaining improv...

Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of 11 Phase 2/3 Clinical Studies in Psoriasis and Psoriatic Arthritis
Bruce Strober, Laura Coates, Jenny Yu et. al.

Nov 14th, 2022 - Background/Purpose: Guselkumab (GUS) is a fully human monoclonal antibody that selectively binds to the p19 subunit of interleukin-23, inhibiting its function. GUS has been shown to have a favorable safety profile across Phase 2 and 3 studies conducted in adults with moderate to severe plaque psoriasis (PsO) and with active psoriatic arthritis (PsA). In this integrated analysis, safety data fro...

Association of Renal Biopsy NIH Activity and Chronicity Scores with Clinical Outcomes in a Cohort of Patients with Lupus Nephritis
David Kellner, Jonathan Zuckerman, Jennifer Grossman2 and Maureen McMahon et. al.

Nov 14th, 2022 - Background/Purpose: Renal biopsy has long been the gold standard for diagnosis of lupus nephritis (LN), and pathologic features on biopsy are commonly used to guide clinical management. The National Institutes of Health (NIH) activity index (AI) and chronicity index (CI) were developed as a semi-quantitative grading system of pathologic features to allow for more reliable monitoring of LN disea...

Changes in Serum Cytokines by Week 24 Correlate with Long-Term Efficacy of Guselkumab Through Two Years in Bio-Naïve Adults with PsA
Stefan Siebert, Georg Schett, Siba P. Raychaudhuri et. al.

Nov 14th, 2022 - Background/Purpose: The IL-23p19 inhibitor guselkumab has shown robust efficacy vs placebo (PBO) in the phase 3 DISCOVER-1 and DISCOVER-2 studies of adults with active PsA,1,2 with continuous overall clinical improvement observed through 2 years of DISCOVER-2.3 Guselkumab has previously been shown to significantly reduce levels of inflammatory biomarkers associated with PsA over 24 weeks.4 We a...