The US Food and Drug Administration convened a public hearing and specialty panel on May 31st to review the potential use, safety and effectiveness of cannabidiol (CBD) products that do not contain THC.

Interleukin 17 (IL-17) inhibitors are highly effective and FDA approved for use in psoriasis, psoriatic arthritis and ankylosing spondylitis. However, many of the initial trials were done in rheumatoid arthritis (RA) where it was projected to be effective, but was not. A recent metanalysis examines how effective IL-17 inhibition was in two RA populations: biologic-naïve or tumor necrosis factor inhibitor inadequate responders (TNF-IR).

The American College of Rheumatology (ACR) Board of Directors is pleased to announce that Steven C. Echard, IOM, CAE  is the new Executive Vice President (EVP) of the American College of Rheumatology.

Dr. Jack Cush presents the news and best of rheumatology and medicine from the past week on RheumNow.com

Rituximab (Rituxan) may be an option for maintenance therapy in patients with difficult-to-treat systemic lupus erythematosus (SLE), European researchers reported.

A study of biologic-naïve patients with ankylosing spondylitis (AS) who started therapy with a tumour necrosis factor inhibitor (TNFi) shows that after 5 years only 46% are still on a TNFi and that some are able to lower the dose over time.

Upadacitinib (UPA) is an oral, selective JAK1-selective inhibitor being developed for use in rheumatoid arthritis patients; Lancet has reported the SELECT-MONOTHERAPY trial showing that UPA is safe and effective in RA patients with an inadequate response to methotrexate (MTX).

The risk of serious infectious events (SIE) with rituximab (RTX) is similar to that seen in other biologics (e.g., RA: 2% or 4.3/100PY), but with prolonged use the risk may change. Recent research says that low IgG levels, RTX induced neutropenia, prior SIE and comorbidities can significantly augment this risk.

A retrospective longitudinal single center study of 700 rheumatic and musculoskeletal diseases (RMDs) treated monitored serum immunoglobulins (at baseline and 4–6 months after each cycle), clinical outcomes and SIE over time.

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

 In August 2018, the CMS announced that Medicare Advantage (MA) plans would be allowed to utilize step therapy for Part B drugs. The American College of Rheumatology (ACR) expressed strong concerns about this proposal.

The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency issued recommendations limiting the use of Xeljanz (tofacitinib) 10 mg twice daily in patients with ulcerative colitis in the EU.

The new recommendations are temporary while PRAC undertakes a review of all available evidence on the safety and efficacy of tofacitinib. The review follows warnings of an increased risk of pulmonary embolism (PE) and death from the U.S. Food and Drug Administration based on Pfizer's large post-marketing safety study (in high risk rheumatoid arthritis patients with one or more underlying cardiovascular risk factors) wherein those receiving in tofacitinib 10 mg twice daily in study A3921133 had more PE and mortalities than comparator groups (tofacitinib 5 mg bid or adalimumab).

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

A combination risk score helped predict recurrent thrombosis -- particularly arterial -- among patients with antiphospholipid syndrome (APS), an international study found.

The FDA has published an industry guidance document to define interchangeability as regards to biosimilar use in the United States under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). 

The NY Times and 60 Minutes have reported that Connecticut, along with 43 other states, filed a mega-lawsuit accusing the generic drug makers of a massive, systematic conspiracy to bilk consumers out of billions of dollars.

JAMA Dermatology reports on a comparative cohort study of 107,707 psoriasis patients, finding a decreased risk of serious infections among users of apremilast, etanercept, and ustekinumab when compared with methotrexate.

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

A recent article in JAMA by Drs. Goodman and Brett reviews the increasing off label use of gabapentinoid drugs, originally developed as antiseizure drugs that are now increasingly prescribed for painful conditions.

Reuters reports on regulatory efforts by Canada and the US to curb the rising cost of drugs, especially expensive new medicines. 

Combining denosumab (Prolia) with a conventional disease-modifying antirheumatic drug (DMARD) such as methotrexate showed promise for slowing radiographic damage in rheumatoid arthritis (RA), a manufacturer-sponsored phase III trial called DESIRABLE found.