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Pharma/Regulatory

JAK Inhibitor Misses Endpoint in Safety Study. Now What?

MedPage Today
Jan 27, 2021

Pfizer announced results Wednesday from its FDA-mandated postmarketing safety study of tofacitinib (Xeljanz), and they don't bode well for the drug and possibly others in its class.



Compared with patients taking tumor necrosis factor (TNF) inhibitors, those assigned to tofacitinib (5

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Urate Lowering Therapy During Acute Gout

Jan 26, 2021

Acute gout has its well defined protocols, and most state that urate lowering therapy (ULT) should be continued; but does ULT affect outcomes in an acute gout attack?

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Protective Effects of Colchicine in Non-Hospitalized COVID-19

Jan 25, 2021

A press release from Montreal Heart Institute announced that the COLCORONA clinical trial provided evidence of the protective effect of colchicine; demonstrating a 21% reduced risk of death or hospitalizations in patients with COVID-19 compared to placebo. COLCORONA trial was a contact-less,

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Voclosporin FDA Approved for Lupus Nephritis

Jan 24, 2021

On January 22nd, the FDA approved voclosporin (Lupkynis) for use in adults with active lupus nephritis; voclosporin is a calcineurin-inhibitor immunosuppressant indicated for use in combination with a background immunosuppressive therapy. FDA approval was based on data from the pivotal AURORA

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RheumNow Podcast – Don’t Hold the Benlysta, Take the Vaccine (1.22.2021)

Jan 22, 2021

Dr. Jack Cush reviews the news and journal articles from the past week on RheumNow.com, with more than a dozen items to discuss on this week's podcast.

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NEJM: Early Combo Monoclonal Antibody Therapy in COVID-19

Jan 21, 2021

NEJM has published the interim analysis of the REGN-COV2 trial, wherein an antibody cocktail reduced viral loads with less clinical consequences. 



Recent data suggest that high viral loads are associated with greater risk for COVID-19 complications and death. A combination of two

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Combo Anti-Spike Protein Antibody for Mild to Moderate COVID-19

Jan 21, 2021

JAMA has published the BLAZE-1 study, showing significant SARS-CoV-2 viral load reduction at day 11 and less COVID-19 progression when combination anti-spike monoclonal antibody therapy (bamlanivimab and etesevimab) was given to mild to moderate, non-hospitalized COVID-19 patients.

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Low Risk of TB with Secukinumab

Jan 20, 2021

JAMA Dermatology has reported on a longitudinal cohort study of 12,319 secukinumab (SEC) treated patients (psoriasis, psoriatic arthritis, or ankylosing spondylitis); no new cases of active tuberculosis (TB) and very few cases of latent tuberculosis infection (LTBI) were found. 

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Mortality Risk in Rheumatoid Lung Patients

Jan 20, 2021

A Medicare claims analysis of rheumatoid arthritis (RA) patients showed that RA-associated interstitial lung disease (RA-ILD) was seen in nearly 5% of patients and was found to increase mortality risks, including respiratory and cancer mortality not explained by other factors.



Sparks

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Dr. Janet Woodcock has been appointed the interim head of the FDA. President Biden has yet to nominate a new FDA commissioner. Dr. Woodcock is a rheumatologist and current Director of CDER at the FDA .https://t.co/Wk0auZ2pn1

Dr. John Cush RheumNow ( View Tweet)

Jan 20, 2021

Factors Predictive of SLE Flare After HCQ Taper/Discontinuation

MedPage Today
Jan 19, 2021

The benefits of hydroxychloroquine in lupus are many, but if you were to withdraw HCQ? A recent study of five Canadian cohorts, suggests that certain baseline variables, including age, race, and steroid use,  were predictive of flare in patients with SLE who tapered or discontinued treatment

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Copay Assistance Programs Help Patients but Confuse Them Too

MedPage Today
Jan 15, 2021

"If you're having trouble paying for your medications, Drug Company X may be able to help."



You may have heard sentences like this at the end of pharmaceutical ads on television, and some clinicians may wonder what exactly the companies do to help their patients. The help usually

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2020 Rheumatology Year in Review

Jan 14, 2021

2020 was historic, memorable and game-changing. Under the cloud of COVID-19, there were many significant and memorable advances and setbacks for the rheumatology world. In our accounting of most read articles for 2020, (not surprisingly) 17/20 were COVID-related. Below, are our top news items

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ProDERM Study: IVIG in Dermatomyositis

Jan 13, 2021

The ProDERM study design and outcomes are previewed in Medicine; and as promised the results were revealed at ACR Convergence in November 2020 showing that IVIg is safe, effective and superior to placebo i(PBO) in patients with dermatomyositis (DM).

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Long Term Safety and Efficacy of Tacrolimus in Lupus Nephritis

Jan 13, 2021

Takeuchi et al has published their large experience with long-term tacrolimus use in lupus nephritis patients showing its real-world safety and efficacy.



This oopen-label, observational, cohort study from 275 sites in Japan, included 1355 systemic lupus erythematosus (SLE) patients

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Delays in Diagnosis of Axial Spondyloarthritis

Jan 12, 2021

The diagnosis of axial spondyloarthritis (and anklylosing spondylitis) (axSpA) is often delayed and usually not diagnosed by rheumatologists; a recent metanalysis shows that longer delays were attributable to lower education levels, younger age at onset and absence of extra-articular

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Hydroxychloroquine Shortage During COVID-19

Jan 12, 2021

According to a recent report in Annals of Rheumatic Disease, public enthusiasm for hydroxychloroquine (HCQ) created significant access issues for rheumatic patients in the early phases of the COVID-19 pandemic.



Despite public, political and quasi research evidence supporting

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Corticosteroid Use Hikes CV Risks in Rheumatic Patients

Jan 11, 2021

UK Clinical Practice Research Datalink population study shows that patients with immune-mediated inflammatory diseases, such as RA, PMR, GCA and IBD, have an augmented risk of CV outcomes with glucocorticoid use; even lower doses had a near doubling of their underlying CVD risk.

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RheumNow Podcast – Lights, Camera, Zoom (1.8.2021)

Jan 08, 2021

Dr. Jack Cush reviews the news, journal articles and favorite blogs from this past week on RheumNow.com.

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Rhapsody Study: IL-1 Inhibition in Recurrent Pericarditis

Jan 06, 2021

Recurrent pericarditis is a rare, probable autoinflammatory disorder mediated by interleukin-1 (IL-1); and is often refractory to glucocorticoids and colchicine. A novel trial of IV rilonacept, an IL-1 α and IL-1β cytokine trap, resulted in rapid resolution of recurrent pericarditis and to a

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EULAR Guidance on Patient Adherence to Meds

Jan 06, 2021

Non-adherence may be the single most untold risk to suboptimal outcomes in the care of musculoskeletal disease.  It has been estimated that 30-80% of patients with rheumatic and musculoskeletal diseases (RMDs) are nonadherent to prescribed regimens.  EULAR has commissioned a task force to

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Spinal Benefits Seen With Cosentyx in PsA

MedPage Today
Jan 05, 2021

Secukinumab (Cosentyx) was effective for axial manifestations of psoriatic arthritis in a 52-week multicenter phase III study, investigators reported.



The primary endpoint of a 20% response on the criteria of the Assessment of Spondyloarthritis International Society (ASAS20) at week

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Plaquenil Does Not Protect Lupus Patients from COVID-19 (Best of 2020)

Dec 31, 2020

Annals of Rheumatic Disease reports on an analysis of lupus (SLE) patients that shows COVID-19 infection rates were similar between those lupus patients who were taking hydroxychloroquine (HCQ) and those not taking HCQ. 

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Update on Polymyalgia Rheumatica and Giant Cell Arteritis (Best of 2020)

Dec 31, 2020

JAMA has published a clinical update of recent studies on GCA. While PET/CT scanning are novel means of demonstrating activity, they have not changed the diagnostic approach to GCA or PMR and although there are no new proven treatment strategies for PMR beyond glucocorticoids, the FDA has

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ACR 2020 Reproductive Guidelines - Medication Use with Pregnancy (Best of 2020)

Dec 30, 2020

The ACR has published guidelines to manage reproductive health issues in rheumatic disease (RMD) patients before, during and after pregnancy. In this second excerpt from their guidelines articles, we present recommendations (and good clinical practice statements) for paternal rheumatology

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