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Pharma/Regulatory

Are Rheums Attending ACR 2020?

Oct 30, 2020

ACR 2020 (aka ACR Convergence) is just around the corner, with the opening ceremonies and lecture starting Thursday, November 5th; followed by the full meeting beginning the next morning, Friday November 6th. 



But wait.... no one's going, it's all virtual and how will this go down?

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RheumNow Podcast – ACR 20 is Coming to Town (10.30.20)

Oct 29, 2020

Dr Jack Cush overviews the RheumNow commitment, upcoming bonus coverage of ACR20 and the good news and journal reports from the past week on RheumNow.com

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Abatacept in Early Systemic Sclerosis (ASSET study)

Oct 29, 2020

An open-label extension of the ASSET trial (abatacept in diffuse cutaneous systemic sclerosis) showed continued safety with significant improvements in the modified Rodnan Skin Score (mRSS) at 12 months, suggesting abatacept (ABA) may benefit early systemic sclerosis (SSc).



ASSET was

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FDA Invites Patient Input on Systemic Sclerosis Drug Development

Oct 28, 2020

While there have been several promising new agents for systemic sclerosis, many have failed - with all noting the difficulties in appropriate outcomes and endpoints for clinical trials. With this in mind, the FDA was interested in hearing patients’ perspectives on systemic sclerosis and new drug

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Guselkumab, an IL-23 Inhibitor, Effective in Psoriatic Arthritis

Oct 28, 2020

The DISCOVER‐2 trial has shown that guselkumab, an interleukin‐23p19 was shown to be safe and effective in biologic‐naïve psoriatic arthritis (PsA) patients in a one year study.



This was a phase III trial that enrolled  biologic‐naïve PsA patients with active disease (≥5 swollen+≥5

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Fibromyalgia Therapies Show Limited Evidence of Pain and QOL Reduction

Oct 27, 2020

JAMA Internal Medicine has published a review showing that most currently approved therapies for fibromyalgia (FM) do not have high-quality evidence to support their use; with some reducing pain or improving quality of life (QOL) in the short term, but overall effect size is not impressive.

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Vedolizumab Promising in Immune-Related GI Events

Oct 27, 2020

Vedolizumab (Entyvio) was superior to infliximab (Remicade) for treating immune-mediated diarrhea and colitis (IMDC), a researcher reported.



In a retrospective study of patients with cancer, treatment with vedolizumab led to a 13% IMDC recurrence rate versus 28% with infliximab,

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Telemedicine Outcomes in RA Care

Oct 26, 2020

A new short‐term follow‐up study has shown no significant difference in outcomes and quality measures in patients with RA who were managed by telemedicine (compared to usual in-person care).

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RheumNow Podcast – Back Talk: Questions from Listeners (10.23.20)

Oct 23, 2020

Dr. Jack Cush reviews the news, journal reports, survey results and "Back Talk" questions from Rheums.

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Remdesivir FDA Approved for Hospitalized COVID-19

Oct 22, 2020

The FDA has approved Gilead Sciences Inc’s antiviral drug remdesivir for treating patients hospitalized with COVID-19, making it the first and only drug approved for the disease in the United States.



FDA approved its 1st drug to treat COVID-19 -

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Clinical Trial Boom or Bust in Severe COVID-19

Oct 20, 2020

A number of recently published clinical trials are further defining the efficacy and outcomes of tocilizumab or remdesivir in treating SARs-CoV-2 infection.



Remdesivir

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TNF Inhibitors or non-TNF Biologics - First Best Choice?

Oct 18, 2020

Prospective observational findings from the CORRONA registry of rheumatoid arthritis (RA) patients compared clinical outcomes between initial aggressive therapy using either a tumour necrosis factor inhibitor (TNFi) or a non-TNFi (biological disease-modifying antirheumatic drugs (bDMARDs) and

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RheumNow Podcast – Good Time Charlie…. (10.16.20)

Oct 15, 2020

Dr. Jack Cush sings the news and journal reports from the past week on RheumNow.com.

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Abatacept vs. Upadacitinib in Biologic Refractory Rheumatoid Arthritis

Oct 15, 2020

NEJM reports the results of the SELECT-Choice trial, a head to head study of upadacitinib (UPA) and abatacept (ABA) in biologic refractory rheumatoid arthritis (RA); 12 weeks results showed UPA was significantly more clinically effective than ABA using a DAS28-CRP remission, but ABA had fewer

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ICI Arthritis Tied to Cancer Progression

Oct 14, 2020

Cancer patients treated with immune checkpoint inhibitors (ICI) who develop severe arthritis may be at risk for progression of the malignancy, a single-center study suggested.



Almost 90% of patients treated with ICI develop immune-related adverse events, which can include pulmonary,

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@MattieRheumMD @News_CRA @statnews People are being crushed by co-pays- rheumatology patients' co-pays doubled to $1000 last year - and medical staff are wasting much time on paperwork. Plus, the @Aetna @CVSHealth merger caused prior auth meltdown in many. (Intentional?) Rebate system must go!

Angus Worthing MD AngusWorthing ( View Tweet)

Oct 14, 2020

COVID Transmission from Young to Old

Oct 13, 2020

The CDC has analyzed temporal trends in percent positivity by age group in COVID-19 hotspot counties before and after their identification as hotspots. Among 767 hotspot counties identified during June and July 2020, early increases in the percent positivity among persons aged ≤24 years were

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Tofacitinib and Thromboembolic Risk

Oct 13, 2020

Mease and colleagues have reviewed the tofacitinib drug development and clinical trial data, finding the risk of venous (VTE) and arterial thromboembolism (ATE) to be low and augmented in patients with baseline cardiovascular abd VTE risk factors and those taking higher doses of tofacitinib (

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Thrombotic Risk in Rheumatoid Arthritis Linked to Disease Activity

Oct 11, 2020

A large RA cohort study from the Swedish Rheumatology Quality Register shows a higher risk of venous thromboembolism (VTE) in rheumatoid arthritis (RA)  and that risk is linked to RA disease activity. 

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Hydroxychloroquine Shows No Benefit in Hospitalized COVID-19 Patients

Oct 09, 2020

The NEJM reports on a controlled clinical trial showing patients hospitalized with Covid-19 given hydroxychloroquine (HCQ) do not have a lower incidence of death compared to those receiving routine care.



A total of 4716 patients who were hospitalized with Covid-19 were randomly to

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RheumNow Podcast – Bad Disease & Bad Outcomes (10.9.20)

Oct 08, 2020

Dr. Jack Cush Reviews the news and journal articles from the past week on RheumNow.com.

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Biologics Beneficial in Eosinophilic Vasculitis

Oct 08, 2020

Two biologic therapies showed promise in the treatment of refractory or relapsing eosinophilic granulomatosis with polyangiitis (EGPA) in a retrospective European study.



Among 63 patients who were treated with rituximab (Rituxan), remission or partial responses at 1 year were observed

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Sustained Remission Off Therapy Unlikely in GPA

Oct 08, 2020

A French Vasculitis Study Group analysis of their granulomatosis with polyangiitis (GPA) reveals that after 10 years, only 7% of GPA patients achieved sustained remission off therapy (SROT) and have never relapsed.

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IL-1 Inhibition Alters Arthroplasty Rates

Oct 07, 2020

A subanalysis of the CANTOS trial suggests that inhibition of interleukin-1β (IL-1β) can reduce rates of incident hip or knee replacement (THR/TKR) surgeries.

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