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The RheumNow Week in Review – 18 August 2017
The RheumNow Week in Review discusses the past week's news, journal articles and highlights from RheumNow.com.
Read ArticleTherapeutic Update: 5 Questions on Sirukumab FDA Hearing
Drs. Cush and Gibofsky answer 5 questions about the August 2, 2017 FDA Arthritis Advisory Committee meeting that reviewed the NDA for sirukumab use in rheumatoid arthritis. The panel voted against (1-12) the approval of sirukumab.
Read ArticleFDA Arthritis Advisory Panel Endorses Tofacitinib Approval for Psoriatic Arthritis
On Thursday, August 3, the FDA Arthritis Advisory Committee (AAC) met to consider tofacitinib for use in patients with psoriatic arthritis. The panel voted 10-1 in favor of approval.
Read ArticleThe RheumNow Week in Review – 4 August 2017
Dr. Jack Cush reviews new FDA decisions on sirukumab and tofacitinib as well as other news items from the past week on RheumNow.com.
Read ArticleArthritis Advisory Panel Votes Down Sirukumab
On Wednesday, August 2, the FDA convened the Arthritis Advisory Committee (AAC) to evaluate the safety and efficacy of Janssen’s anti-IL-6 monoclonal antibody, sirukumab.
Read ArticleNo Increase in Malformations with Etanercept Use During Pregnancy
While there are several reports detailing uncontrolled, observational results of biologic use during pregnancy, most are hampered by low numbers, incomplete data and too small a sample to make reliable judgements regarding the teratogenicity. A company sponsored claims data analysis has shown that etanercept exposure during pregnancy was not associated with an increase in major congenital malformations (MCMs).
Read ArticleAugust 2nd AAC Meeting: FDA Concerns Over Sirukumab Deaths
On August 2, the US Food and Drug Administration (FDA) will convene a hearing of the Arthritis Advisory Committee (AAC) to review the safety of the novel IL-6 inhibitor, sirukumab, being developed by Janssen (Johnson & Johnson).
Read ArticleNEJM: Actemra Effective in Giant Cell Arteritis
On May 22, Genentech received FDA approval for the use of subcutaneous (sc) tocilizumab (TCZ) in patients with giant cell arteritis (GCA) – also known as temporal arteritis.
Read ArticleDenosumab Increases Trabecular Bone
Bone mineral density (BMD) measurement vie DEXA scan commonly used to assess bone density and fracture risk in postmenopausal osteoporosis provides us with approximate assessment of bone health while lacking sensitivity in vertebral fracture risk prediction.
Read ArticleBiosimilar Pricing Wars Have Begun
Despite the approval of four anti-TNF biosimilars in 12 months, their introduction into the U.S. market has been slow and - until now - with paultry discounts compared to their introduction throughout Europe, where discounts averaged 50% and were as high as 70% (compared to the price of Remicade).
Read ArticleBaricitinib Derailed by FDA Review
Eli Lilly and Co disclosed today that upon further discussions with the US Food and Drug Administration (FDA) there would be a delay in further regulatory decisions regarding baricitinib, a JAK inhibitor, that is being developed for use in rheumatoid arthritis (RA).
Read ArticleBenlysta FDA Approved for Sub-Q Use in Lupus
The US Food and Drug Administration (FDA) has approved a new subcutaneous formulation of Benlysta (belimumab) for use in active, autoantibody‑positive Systemic Lupus Erythematosus (SLE) patients.
Read ArticleRheumatologists and Patients Concerns over Biosimilars - RheumNow “Live Vote” Results
The RheumNow “Live Vote” on the use, uptake and safety of biosimilars contrasts rheumatologist and patient views. Despite FDA approval and looming introduction, there is considerable concern, knowledge gaps and hesitancy regarding their uptake in the US. The survey's primary question demonstrates that less than one-third of US rheumatologists are prepared to adopt biosimilars when they are available.
Read ArticleThe RheumNow Week in Review – 21 July 2017
Dr. Jack Cush reviews the news from the past week on RheumNow.com:
Read ArticleObesity Impairs TNF Inhibitor Responses in Axial Spondyloarthritis
Investigators with the Swiss Clinical Quality Management (SCQM) program have studied the effects of obesity on patients with axial spondyloarthritis (axSpA) and, specifically, their response to tumor necrosis factor inhibitors (TNFi).
Read ArticleCurbside Consults - July 2017
Curbside Consults are cases submitted by our rheumatology colleagues as challenging therapeutic or safety issues. Answers are based on experience, with added evidence from the medical literature and published guidelines. Here are four new cases.
Read ArticleWithdrawal of TNF Inibitors Fails in Most RA Patients
The 12 month POET study analyzed 817 rheumatoid arthritis (RA) patients who achieved remission or low disease activity (LDAS) for ≥6 months and then randomized 2:1 to stopping or continuing their TNF inhibitor.
Read ArticleManaging Secondary Non-Response to Rituximab in Lupus
Rituximab, a chimeric anti-CD20 monoclonal antibody, has been effectively used in the treatment of multiple autoimmune disorders for over two decades. But the response to rituximab has been shown to not be as effective in SLE as it is in RA.
Read ArticleLinkage Between Gut and Joint Immunity in Rheumatoid Arthritis
Pianta, et al have published their findings in the Journal of Clinical Investigation showing that two novel autoantigens, GNS and FLNA, are highly expressed in synovium and share a sequence homology with gut microbesa; thereby providing a potential link between gut mucosal and joint immunity in rheumatoid arthritis.
Read ArticleBreastfeeding Rates Lower in Lupus
It is a common practice for rheumatologists to discuss medication-related teratogenicity and disease implications in case of pregnancy. Yet, discussion of breastfeeding are often omitted.
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