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FDA Invites Patient Input on Systemic Sclerosis Drug Development

Jack Cush, MD

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 development, and held a virtual meeting on 10/13/20.

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Immune Necrotizing Myopathy

Jack Cush, MD

A full read review of immune-mediated necrotizing myopathy is portrayed as a distinct subtype of inflammatory myopathies first described in 2004.

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RheumNow Podcast – Good Time Charlie…. (10.16.20)

Jack Cush, MD

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

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RheumNow Podcast – Bad Disease & Bad Outcomes (10.9.20)

Jack Cush, MD

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

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RheumNow Podcast – Function Follows Form (10.2.20)

Jack Cush, MD

Dr. Jack Cush reviews the news and journal articles from the past week on RheumNow.com. Regulatory approvals, update on global rheumatology alliance, smoking and psoriasis, gabapentin let down and defining difficult RA.

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Slow Lung Decline Typical in Systemic Sclerosis

RheumNow

The interstitial lung disease that develops in a subset of patients with systemic sclerosis tends to be heterogeneous, with the majority of patients experiencing a slow pattern of decline in lung function, analysis of outcomes in the European Scleroderma Trials and Research (EUSTAR) database foun

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Novel Biologic Promising in Mid-Stage Scleroderma Trial

RheumNow

The anti-interleukin agent romilkimab showed significant benefits on skin fibrosis among patients with systemic sclerosis in a phase II trial, researchers reported.

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RheumNow Podcast – Cardiovascular Risk in Psoriatic Disease (9.25.20)

Jack Cush, MD

Dr. Jack Cush reviews the news and Journal articles from the past week on RheumNow.com.

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Romilkimab Effective in Early Diffuse Systemic Sclerosis

Jack Cush, MD

A phase II study of patients with early diffuse systemic sclerosis (SSc) has demonstrated improvement in SSc skin outcomes by targeting T cells and fibrosis with the bispecific monoclonal antibody romilkimab (RMK).

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Review of 127 pts w/ diagnostic criteria for palindromic rheumatism - Most affected JTS were wrist, knee, MCP; 34% later developed CTD (28% RA, 2% lupus 3% other CTD). Progression predicted by +RF (HR 2.9), PIP (HR 2.4), Wrist (HR 2.5) & female (HR 2.2)

Dr. John Cush RheumNow ( View Tweet)

259 SLE patients followed an 80% were in lupus low disease activity state (LLDAS); 82% in remission; 19% w/ active dz. 56 pst in subjective Low activity (SLQ<6) compared to SLAQ>6, latter had more arthritis, fibromyalgia and took steroids https://t.co/IdeSNlaEOG

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Dr. John Cush RheumNow ( View Tweet)

Observational study of 123 Spanish rheumatic dz pts w/ COVID-19, finds 54 hospitalized. Admitted pts were 69.7 yrs, and 22% died. Admission was assoc w/ older age, autoimmune dz (vs inflammatory arthritis; OR: 3.55), but not DMARD Rx. https://t.co/UWNyhOKbvF

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Dr. John Cush RheumNow ( View Tweet)

The RheumNow Podcast is up - Bad Disease & Bad Outcomes. COVID consequences, TNFi Switching in SpA, psychosis in lupus? Watch it here> https://t.co/ced3cKg5eB or listent to podcast on iTunes> https://t.co/FHJv01AAbC or SoundCloud> https://t.co/e4nWr3wECz

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Dr. John Cush RheumNow ( View Tweet)

Lockdown worsening; UK survey 678 patients musculoskeletal diseases pts in late April 2020 shows 53% worsening of Sx; 1/3 had clinic/hosp access probs problems & most (88%) had no probs w/ getting meds; but 44% needed others to help them get meds. https://t.co/3efmTdHhQx

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Dr. John Cush RheumNow ( View Tweet)

Among 4766 mental health pts admited for Psychosis; 19% ANA tested and only 135 had a positive ANA >=1:160. (15% of those tested). Only 4 met 2019 ACR/EULAR criteria for SLE, and 2/4 met criteria for NPSLE. NPSLE prevalence was 1.5% in ANA+ psychosis Pts. https://t.co/c5C1VQaQAI

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Dr. John Cush RheumNow ( View Tweet)

"Prednisone >30 mg/day for > 4 weeks, patients should be on PJP prophylaxis." Image shows when to start/stop PJP prophylaxis Dr. Kevin Winthrop on Risks/Prevention of OI @UTSWRheum Grand Rounds @rheumnow https://t.co/nXuWYRxbgy
k dao KDAO2011 ( View Tweet)
RheumNow Podcast is up! COVID effects on Rheum; drug approvals, Difficult RA, SLE complement & remission. Watch it here> https://t.co/490T6k1ytk or listen to the podcast on iTunes> https://t.co/FHJv01AAbC OR on souncloud> https://t.co/dAJ0827c3B

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Dr. John Cush RheumNow ( View Tweet)

Predictors of Remission in SLE? metanalysis of 17270 SLE pts; 42-88% achieved remission x 1 yr, & 21-70% for 5 yrs. Remission assoc w/ older age , lower Dz activity & No major organ involvement; positive serologies negatively associated w/ remission https://t.co/2aoGgnY6kw

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Dr. John Cush RheumNow ( View Tweet)

Complement assoc. studied by Petri & Durcan in 2399 SLE pts. 55% had low C3 (pesistently low 4%); 47% low C4 (3% persistently low). Low C4 is weak marker clinical & serological Dz. Low C3 linked w/ renal & serological Dz, Low C3/C4 linked to ACL, CVA, DVT https://t.co/KgF7HNEYu8

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Dr. John Cush RheumNow ( View Tweet)

6.6% Risk of Late-onset Neutropenia (ANC<1000) in a single center study of 738 Rx w/ Rituximab (107 LON in 71 patients). Incidence was 7.2/100PYs. Higher risk w/ SLE or CTX Rx. 40% had Sxs, Fever 31%, sepsis in 8.5%. Rechallenge in 87% & 21% recurrent LON https://t.co/XXFV1lH9jS

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Dr. John Cush RheumNow ( View Tweet)

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