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This annual appraisal of hallmark moments, news and research articles from 2018 are gleaned from that published in RheumNow during the last year and filtered by other news sources and literature review. The top 10 list herein is rooted in what rheumatologists should know and what will likely change their standards and practice in the future, if not 2019.
- New Drugs. It seems like every year the FDA again sets a record in drug approvals and this year tops their history with 59 newly approved drugs. The drugs affecting rheumatology and inflammatory diseases include baricitinib (Olumiant) for RA, fostamatinib (Tavalisse) for chronic ITP, and tildrakizumab (Ilumya) for moderate-to-severe plaque psoriasis. While many of the other new agents qualify as orphan drugs, the FDA has been scrutinized by the Government Accountability Office for the proliferation of new orphan drug approvals; felt by some as being abused and allowing either a shortcut to market or an unneeded pathway to expand the market with an already approved drug. https://buff.ly/2R3sEUp
- Immune related Adverse Events (irAEs) with Immune Checkpoint Inhibitors. The growth of new highly effective, checkpoint inhibitor agents for use in malignancy has given rise to a new syndrome of immune-related adverse events (irAE) that include a wide spectrum of autoimmune inflammatory musculoskeletal syndromes. Although uncommon, patients presenting with irAEs have been seen by nearly half of US rheumatologists. Moreover it appears that irAEs are even more common in patients with pre-existing autoimmune disease. https://t.co/aNHIE86B8r https://buff.ly/2F3hAzr
- Erelzi v. Enbrel Goes to Court. There are currently 6 FDA approved biosimilars in the US market – 3 infliximab biosimilars (Inflectra, Renflexis, Cyltezo, and Ixifi), 2 adalimumab biosimilars (Amjevita, Cyltezo) and one etanercept biosimilar – Erelzi. Despite these approvals, biosimilars have yet to change the biologic economics, use or outcomes in rheumatology. Many of these companies have been involved with legal wrangling’s to extend their exclusivity via patent litigation or patent deals with competitor biosimilars. Sandoz’s Erelzi was FDA approved in 2016, but 2 years later hasn't been launched commercially. Sandoz has been in court with Amgen to challenge Amgen’s patents protecting Enbrel until 2029. A decision by the New Jersey district court on these patent issues is expected in (early?) 2019. https://buff.ly/2xguFQu
- Opioid Overdose Crisis. The tragedy continues to stay at the top of this annual list, this year for the 4th year in a row. The numbers underlying this are truly tragic. As such pain management will become more scrutinized, regulated and possibly require mandatory education. More importantly, a few, deserved pain patients are being victimized by the stain and fear of narcotic use.
- The USA has the highest per capita rate of opioid use in the world.
- U.S. drug overdose deaths exceeded 72,000 or ~ 200 deaths per day; lead by heroin, fentanyl, other opioids, methamphetamine and cocaine. https://t.co/jfayrQbt5d
- Gabapentin is the 10th most prescribed drug in USA; 22% of opioid abusers abuse this drug and in some states it accounts for a high number (4-41%) of overdose deaths. https://t.co/UVOB9Kif6S.