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Pharma/Regulatory

Avacopan for ANCA Vasculitis Goes in Front of the FDA

MedPage Today
May 07, 2021

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.

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RheumNow Podcast – Falling or Falling in Love?

May 06, 2021

Dr. Jack Cush reviews the best journal articles from the past week on RheumNow.com.

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ARTIC REWIND - Don't Half DMARD Therapy

May 06, 2021

The ARTIC-REWIND study examined rheumatoid arthritis (RA) patients in remission on conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) to see if they could "step-down" their csDMARDs theray; but  the study showed that 25% those who went on half-dose experienced disease

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Drug Monitoring Ineffective with Infliximab Treatment

May 05, 2021

The predictive value of therapeutic drug monitoring (TDM) while on biologics is debateable; gastroenterology routinely relies on TDM, while rheumatologists do not. A randomized trial compared TDM to no TDM in patients receiving infliximab for chronic immune-mediated inflammatory diseases (

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Childhood Lupus May Hamper Adult Careers

May 04, 2021

Long-term outcomes of kids with childhood-onset systemic lupus erythematosus (cSLE) are uncommon, but this cSLE cohort analysis suggests that SLE significantly impacts their future education, vocation, and employment as they reach adulthood.



A cohort of 106 cSLE (93% female, 73% White

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Results Disappoint for Fecal Transplant in Arthritis

MedPage Today
May 04, 2021

Fecal microbiota transplantation (FMT) showed disappointing results among patients with active psoriatic arthritis, a small randomized trial found.



During 26 weeks of follow-up, the risk of treatment failure was higher among patients receiving FMT compared with those given a sham

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Higher Cardiovascular Risks with Systemic Lupus Erythematosus

May 03, 2021

The Journal of the American College of Cardiology has published the results of a study showing that patients with systemic lupus erythematosus (SLE) have an increased risk of heart failure (HF) and other long-term cardiovascular outcomes. 



Data taken from Danish

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Uric Acid: A Major Player in the Metabolic Syndrome

May 03, 2021

An open source, free read from the European Journal of Internal Medicine discusses how uric acid has evolved from the toxic cause of gout and nephrolithiasis and evolved, by way of science, into a pleiotropic recidivist in the evolution of obesity, diabetes, insulin resistance, renal disease,

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RheumNow Podcast – Uppers and Downers

Apr 30, 2021

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

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ACR Updates COVID-19 Vaccine Guidance- April 2021

ACR COVID-19 Vaccine Clinical Guidance Task Force
Apr 30, 2021

The ACR COVID-19 Vaccine Clinical Guidance was originally published on February 8, 2021 and updated on March 4, 2021. On April 28, 2021, new recommendations were added regarding mycophenolate, methotrexate, acetaminophen, and NSAID timing considerations,  

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Predictors of Methotrexate Toxicity

Apr 30, 2021

A metanalysis showed that while adverse events (AEs) are common when methotrexate is used in rheumatoid arthritis or inflammatory arthritis patients, serious AEs ranged from 2.1 to 9.5% and drug discontinuations ranged from 6.7% to 15.5%, mostly due to gastrointestinal events. 

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Seven Year Delay in Diagnosing Spondyloarthritis

Apr 29, 2021

A large patient cohort study suggests that the mean diagnostic delay (DD) in European axial spondyloarthritis (axSpA) patients is 7.4 years, moreso in women and younger patients.



An online survey of 2,652 patients from 13 countries (European Map of Axial Spondyloarthritis - EMAS)

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Tofacitinib in Ankylosing Spondylitis

Apr 28, 2021

A phase III trial assessing the efficacy and safety of tofacitinib in adults with with active ankylosing spondylitis (AS) shows that JAK inhibitiion was superior to placebo in a 48 week study.



A total of 269 adult AS patients with a prior an inadequate response or intolerance to ≥2

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Psoriatic Pregnancies Pose Risks to the Mother, Not Child

Apr 27, 2021

A metanalysis of pregnancy outcomes in women with psoriasis and psoriatic arthritis finds an excess risk of adverse maternal events, but not adverse neonatal events.



This systematic review included 16 studies meeting inclusion criteria. 



Overall they found that pregnant women

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Dual IL-17 Targeting is Effective but has More Candidiasis

Apr 27, 2021

Bimekizumab (BIM) is a monoclonal antibody that targets both interleukin-17A and interleukin-17F, which as a biologic target has worked well in the management of psoriatic disease. The current issue of the NEJM has two reports wherein BIM was shown to be more effective than secukinumab and

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Little Effect with Multimodal Treatment of CMC1 Osteoarthritis

Apr 26, 2021

A randomized clinical trial of patients with CMC1 osteoarthritis shows modest benefits when a combination of conservative treatments (education, splinting, hand exercises, 1% diclofenac sodium gel) was used compared to education alone. While there were small to medium benefits with regard to

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Golimumab Effective in non-radiographic Axial Spondyloarthritis

Apr 26, 2021

The GO-AHEAD study was designed to assess the long-term efficacy and safety of golimumab (GLM) in non-radiographic axial spondyloarthritis (nr-axSpA).  After the 16-week, placebo [PBO]-controlled double-blind phase, 189/198 (95.5%) entered the long-term extension (OLE) for 36 weeks wherein

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Lupus Activity Affects Mortality

MedPage Today
Apr 23, 2021

Each one-unit increase on a disease activity score during the first year after enrollment into a systemic lupus erythematosus (SLE) cohort was associated with a significant increased risk for death and organ damage during subsequent follow-up, researchers reported.

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RheumNow Podcast – Coconspirators: RA and Lung Disease

Apr 23, 2021

Dr. Jack Cush reviews and discusses more than a dozen news and journal articles from the past week on RheumNow.com.

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Diagnostic Delay in Spondyloarthritis

Apr 22, 2021

Literature review and metanalysis of many studies suggests that significant delay to diagnosis in axial spondyloarthritis (axSpA) exist, are longer than other rheumatic diseases and have not changed over time.



From a total of 64 studies identified the reported mean delay in diagnosing

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Increased Methotrexate Liver Disease in Psoriasis

Apr 22, 2021

A Danish cohort study examined the risk of methotrexate related liver disease risk in patients with psoriasis (PsO)and psoriatic arthritis (PsA), and found that compared to rheumatoid arthritis (RA), psoriatic patients had up to a 3 fold higher risk of liver disease. 



In a population-

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BSRBR: Demyelinating Disease Following Anti-TNFα Therapy

Apr 21, 2021

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 incrased by taking TNFi therapy. 



From their large registry (n=13,489) they

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Increased Risk of COPD in ACPA+ Pre-RA Patients

Apr 21, 2021

The lung and its pathology is uniquely tied to rheumatoid arthritis (RA) and its pathogenesis.  A new study shows that elevation of anti–citrullinated protein antibodies (ACPAs) before diagnosis of RA increases the risk of developing chronic obstructive pulmonary disease (COPD) and/or asthma

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New Side Effect From mRNA COVID Vaccines?

MedPage Today
Apr 20, 2021

Herpes zoster reactivation -- a.k.a. shingles -- following COVID-19 vaccination in six patients with comorbid autoimmune/inflammatory diseases may be a new adverse event associated with the Pfizer/BioNTech mRNA vaccine, suggested a new report.



At two centers in Israel, there have been

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Raynaud and Microvascular Complications with New Migraine Meds

Apr 20, 2021

A new study of calcitonin gene-related peptide (CGRP) antagonists for migraine headaches found that a small subset manifested Raynaud phenomenon and other had microvascular complications, suggesting that CGRP antagonists should be used in caution in patients with Raynauds. 

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