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.

Dr. Jack Cush reviews new FDA decisions on sirukumab and tofacitinib as well as other news items from the past week on RheumNow.com. 

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.

Comorbidity is a serious consequence or confounder in patients with inflammatory diseases. This has been well described in both psoriatic and rheumatoid disease.

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).

In March 2017, an outbreak of 41 cases of septic arthritis associated with intra-articular injections administered at an single outpatient practice occurred in New Jersey. A public health investigation identified multiple breaches of recommended infection prevention practices during the preparation and administration of PBP products. The intraarticular injections were done using fluoroscopic visualization. The CDC has reported the results of its investigation.

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).

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

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).

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).  

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.

HIV infection and AIDs has been associated with numerous complications, presumably resulting from impaired immunity from infection.  Sporadic cases and small cohorts of patients with rheumatic and autoimmune syndromes have been described but epidemiology data on the prevalence is scarce.

It does not come as a surprise to anyone anymore that Acute Coronary Syndrome (ACS) is one of the major causes of morbidity and preterm mortality in RA. What we don’t know is what measures need to be taken to modify the risk and how effective such measures are.

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. 

Dr. Jack Cush reviews highlights from the past week on RheumNow.com:

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.

Among older patients using medium to high doses of the anti-inflammatory steroid prednisolone, treatment with the osteoporosis drug alendronate was associated with a significantly lower risk of hip fracture, according to a study published by JAMA.

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. 

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.

Saturday was a day of big posters and special seminars at EULAR in Madrid.  In the morning, I passed on an interesting session on nailfold capillaroscopy led by Dr. M Cutolo and went to a JIA outcomes session.