The American College of Rheumatology (ACR) has released an official position statement supporting the role of telemedicine as a tool with the potential to increase access and improve care for patients with rheumatic diseases. It also highlights the significant barriers and opportunities presented to patients and rheumatology professionals.

An FDA advisory panel will consider whether to recommend approval of an oral C5a inhibitor for antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, with agency staff raising questions over the "clinical meaningfulness" of key study data.

Members of an FDA advisory panel were sharply divided as to whether avacopan, an oral small molecule inhibitor of the C5a receptor, was sufficiently safe and effective for treating antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.

As to whether the efficacy data supported approval of the drug, the FDA's Arthritis Advisory Committee was split 9 to 9; on whether the safety data were sufficient, the vote was 10 in favor and 8 against; and on whether the benefit-risk profile supported approval, again the vote was 10 in favor and 8 against.

Petri and colleagues have published that measuring hydroxychloroquine (HCQ) blood levels can be useful in systemic lupus erythematosus (SLE), as low levels are associated with an increased thrombotic risk in SLE.

In total cohort of 739 SLE patients, HCQ levels were serially quantified by EDTA whole blood by liquid chromatography–tandem mass spectrometry.

Last month, psoriasis patients covered by Cigna received a curious letter from the insurance giant's pharmacy management division. They could receive a $500 debit card from Cigna, with just one string attached: they would have to switch to a different medication, one preferred by the insurer. Shortly thereafter, the patients' treating physicians received a letter containing the same message.

Lancet has published the results of the AURORA-1 trial, wherein the calcineurin inhibitor, voclosporin, was tested in a placebo controlled trial of lupus nephritis and shown to be effective at inducing a complete renal response.

Sparks and colleagues have published a matched cohort analysis demonstrating risk factors that may augment the risk of rheumatoid arthritis (RA)-associated interstitial lung disease (ILD), especially the combination of obesity, high CRP, high MD-HAQ and >30 pack-year smoking history. 

This nested case-control study compared incident RA-ILD to RA non-ILD controls and examined clinical, laboratory and lifestyle factors that may predict RA-ILD.

This included 84 RA-ILD and 233 matched non-ILD RA control patients. 

NSAIDs do not affect COVID outcomes; here we are nearly 16 months into the pandemic, and this is the common sense conclusion of a recent trial published in Lancet Rheumatology.

Early in the pandemic there was an unfounded directive from the French government suggesting that non-steroidal anti-inflammatory drugs (NSAIDs) should be avoided in COVID-19 infected patients as they may contribute to increased disease severity.  Yet a search for evidence failed to provide support to this contention.

The U.S. Centers for Disease Control and Prevention (CDC) today updated COVID guidance such that fully vaccinated people do not need to wear masks outdoors, can avoid wearing them indoors in most places, and in most places will not need to physically distance. CDC believes these changes will encourage more Americans to get vaccinated.

This new guidance is based on a sharp reduction in cases accompanying the growing number of US adults who have been vaccinated.

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Dr. Jack Cush reviews the news and journal articles from the past week on RheumNow.com - a website for rheumatologists, by rheumatologists.

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1. CDC study from 33 sites, 25 states showed vaccine efficacy (against Sx COVID) in HCP was 82% with ONEdose (Pfizer, Moderna) and 94% for TWO doses (same as RCTs). The efficacy of only 1 dose (of a 2 dose COVID vax) is likely to be 70- 82%. https://t.co/uQhUmjSsRd

RheumNow Live (RNL) for 2021 was held March 20 - 21 in Fort Worth, TX, and now all can partake in the meeting - by video, podcast or by signing up for Tuesday Nite Rheumatology (TNR).

RNL has finished its 3rd year as a hybrid meeting, with the live meeting streamed to hundreds at home, who are watching and interacting on the same content viewed by those in attendance in Fort Worth. 

Analysis of patients receiving anti–tumor necrosis factor α (TNFi) therapy in the British Society for Rheumatology Biologics Register (BSRBR) shows that the risk of demyelination is rare but is marginally increased by taking TNFi therapy. 

From their large registry (n=13,489) they identified a cohort 35 patients who developed demyelinating events.  Most (71%) were women, with a mean age of 44 years, and the median disease duration of 8 years.  These events largely occurred in RA(71%), ankylosing spondylitis (14%), and 5% WITH psoriatic arthritis.

Anifrolumab has been studied in two large phase 3 trials in systemic lupus erythematosus (SLE) patients; pooled data from both the TULIP-1 and TULIP-2 trials were used to show that anifrolumab reduces flares in patients with moderate to severe SLE. 

Anifrolumab is a human monoclonal antibody to type I interferon receptor subunit and is being developed to treat active SLE patients.

Tildrakizumab, a monoclonal antibody targeting interleukin-23p19 studied in adults with psoriatic arthritis (PsA), was found to be superior to placebo and well tolerated without reports of uveitis, systemic fungal infections, inflammatory bowel disease, major cardiac events or death. 

Erosive hand osteoarthritis (EHOA) was studied as part of the Osteoarthritis Initiative, and shown to increase with advanced age and female sex, with developmental findings to suggest that EHOA as a disorder of skeletal frailty.

The Osteoarthritis Initiative is a longitudinal study of OA patients followed clinical and with radiographs from baseline and 48‐months. EHOA was defined as Kellgren‐Lawrence (KL) grade≥2 changes in in at least one interphalangeal joint on two different fingers and central erosion in at least one joint.

A French registry analysis compared the risk of diverticulitis and gastrointestinal perforation (GIP) in rheumatoid arthritis (RA) patients treated with biologics and found a greater risk of both in patients receiving tocilizumab (TCZ) compared with those on rituximab (RTX) or abatacept (ABA). It appears the increased risk with TCZ related to the increased risk of diverticulitis with TCZ.

After propensity score matching of treatment groups, the risk of diverticulitis or GIP was calculated.

Patients with psoriasis or psoriatic arthritis who were being treated with ustekinumab (Stelara) had lower rates of serious hospitalized infections than patients receiving other biologics or small molecule therapies, a study utilizing data from two commercial claims databases found.

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

1. Metanalysis (11 RCTs, 19 registries) of Pulm arterial HTN assoc. w/ CTD (w/ 1,267 & 4,008 CTD-PAH pts), showed Investigational Rxs reduced morbidity/mortality by 36%. CTD-PAH survival was lower (62 vs 72%) @3yrs, but improved after 2010 (73 vs 65%) https://t.co/0BkO70AQfi

House lawmakers on both sides of the aisle pummeled AbbVie CEO Richard Gonzalez for raising the price of two widely used drugs and for the company's "legally questionable" tactics to head off competition from biosimilars, despite pulling in healthy profits.

Much of Tuesday's House Committee on Oversight and Reform hearing centered around two issues: the risks and benefits of Medicare price negotiation and potential abuse of the patent system.

Analysis of data from the COVID-19 Global Rheumatology Alliance shows that rheumatic diseases infected with COVID-19 had a greater risk of death with age, comorbidities, high disease activity and few specific therapies.

Rheumatic disease adults with a confirmed or presumptive COVID-19 diagnosis (from 24 March to 1 July 2020) were included in this analysis of risk factors associated with COVID-19-related death.

Among a total of 3729 patients (mean age 57 years), 390 (10.5%) died.

Independent factors associated with COVID-19-related death included:

It has been postulated that TH1 and TH17 pathways are implicated in the pathogenesis of giant cell arteritis (GCA); this is supported by new research showing that interleukin 12 (IL-12) and interleukin 23 (IL-23) may stimulate inflammatory and proliferative pathways relevant to the pathogenesis of GCA.

Temporal artery biopsy (TABs) explants and peripheral blood mononuclear cells (PBMC) were studied in culture and for gene expression. 

A study of the IL-23 risankizumab in active ankylosing spondylitis (AS) patients failed to show efficacy and did not meet primary efficacy endpoints in a 6-month trial.

Risankizumab (RIZ) is a new, humanised anti-IL-23 monoclonal antibody that targets the p19 subunit of interleukin-23 (IL-23). It was studied in a 24-week trial involving 159 biologic-naïve, active AS patients. The primary outcome was a 40% improvement in Assessment in Spondylo Arthritis International Society (ASAS40) at week 12.