August 2nd AAC Meeting: FDA Concerns Over Sirukumab Deaths

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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).

NEJM: Actemra Effective in Giant Cell Arteritis

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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.

Denosumab Increases Trabecular Bone

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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.

Biosimilar Pricing Wars Have Begun

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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).

Baricitinib Derailed by FDA Review

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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).  

Benlysta FDA Approved for Sub-Q Use in Lupus

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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.

Rheumatologists and Patients Concerns over Biosimilars - RheumNow “Live Vote” Results

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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.

Obesity Impairs TNF Inhibitor Responses in Axial Spondyloarthritis

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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).

Curbside Consults - July 2017

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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. 

Withdrawal of TNF Inibitors Fails in Most RA Patients

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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.

Managing Secondary Non-Response to Rituximab in Lupus

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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. 

Linkage Between Gut and Joint Immunity in Rheumatoid Arthritis

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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. 

Breastfeeding Rates Lower in Lupus

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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.

Tildrakizumab, an IL-23 Inhibitor, is Successful in Plaque Psoriasis

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Therapeutic options for cutaneous psoriasis (and psoriatic arthritis as well) are rapidly expanding.  Lancet has published the impressive results of two phase III trials of tildrakizumab, a IgG1 antibody against interleukin 23 p19, in patients with active chronic plaque psoriasis.

ACR/AAHKS Guidelines on Perioperative Management

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The American College of Rheumatology has partnered with the American Association of Hip and Knee Surgeons to develop consensus-based guidelines for perioperative management of antirheumatic therapies for patients with rheumatic diseases who plan to undergo total joint replacement.

EULAR 2017 – Day 3 Highlights

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Friday was a mega-day in Madrid as this day all the late-breaking abstracts were presented, in addition to the bulk of high-impact podium presentations in several areas.

Here are the major presentations from several clinical areas.

Lancet Launches EULAR 2017 and "A Platinum Age of Rheumatology"

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The current Lancet edition for 10 June 2017 is a rheumatology rich collection.