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2019 was a year marked by major advances, hallmark research, and big news items affecting rheumatology. Herein you will find our top 10 list, formulated by what I think rheumatologists should know and what will likely change their standards and practice in 2020 and beyond.
- New Drugs. In 2019 the FDA approved 49 new drugs (last year= 59). For the rheumatologist, this included: Nintedanib (for PSS-ILD), Rinvoq (for RA), Evenity/romosuzumab (for postmenopausal osteoporosis, and Skyrizi/risankisumab (IL-23 inhibitor for psoriasis). Also notable were new indications for previously approved agents, including Otezla for Behcets, Benlysta for pediatric SLE, Benlysta as a subcutaneous injection, Xeljanz and Stelara for ulcerative colitis, Taltz for ankylosing spondylitis and axial Spondyloarthritis and Cimzia for nonradiographic axial spondylitis. Adding to our list of 11 biosimilars in the rheumatology space are 4 new biosimilars: Avsola (infliximab), Abrilada and Hadlima (adalimumab biosimilars), Enticovo (etanercept) and Ruxience (rituximab biosimilar approved only for GPA/MPA, but not RA).
- Women in Rheumatology. For those not paying attention, the number of women in rheumatology fellowship is greater than the number of male fellows (> 60 % of those entering rheumatology fellowships are women). This trend is showing up in practice and at medical schools, but there is still a shortage of women leadership roles and as speakers and teachers at national meetings. Is this from a lack of opportunity or a lack of initiative? Nevertheless, the impact of this change will be great and substantial for our patients and our discipline. Remember the famed dance duo Fred Astaire and Ginger Rogers? He was the acclaimed star, but it was Ginger Rogers who did the same dance, except she did it backwards and in heels.
- Vagal Nerve Stimulation in RA. Dr. Mark Genovese presented results of a study using an implanted vagal nerve neurostimulator to manage inflammatory RA; the rationale being that vagal nerve stimulation can induce a cholinergic reflex that down regulates inflammatory cytokine (e.g., TNF) production for 24-48 hrs. post stimulation. A total of 14 patients were tested, and those who received sham or qid stimulation had no response but those receiving daily vagal stimulation had improvement in clinical parameters IL-1, IL-6, IL-17, IL-23 and TNF levels. The logistics of implantation and device safety are still a concern as there was one vocal cord paralysis and one Horner’s syndrome in those tested.
- Treating Gout via the Gut. A novel study from Poland presented the results of using ALLN-346, a recombinant urate degrading enzyme, given pigs with hyperuricemia and shown to lower uric acid (SUA) levels. The rationale being that up to one-third of the body’s urate is excreted in the intestines, and even more with renal impairment. This orally administered agent is not absorbed and thus should have no side effects. This is a novel way of lowering SUA and reduce the overall urate burden in those with hyperuricemia and gout.
- New Approaches for Lupus. While there were 2 large, conflicting results from the anifrolumab (anti-alpha interferon) trials in SLE (http://bit.ly/37QnJtE), there were other studies that may change the lupus landscape in the future. This includes the use of ustekinumab in SLE – presumeably working thru IL-12 inhibitory effects (http://bit.ly/2tERzTi ), Tyk2 inhibition (now in clinical trials) and even low dose IL-2 treatment in SLE (http://bit.ly/2Fy3pRU).
- Low Dose Prednisone Excels. There were 2 trials presented this year at the 2019 Annual ACR meeting showing the efficacy of prednisone 10 mg qd in patients with hand OA. However after 6 weeks prednisone was withdrawn and the pain and symptoms recurred. Another novel trial compared SLE patients who either maintained their low dose prednisone or withdrew prednisone and not surprisingly there were fewer flares for those maintained on prednisone 5 mg qd.
- EMRs are Killing Medicine. Despite the push, incentives and forcible change to EMRs or more expensive institutional EMRs (EHRs), there is a growing number of reports (https://t.co/PttGYvgCue) showing that these patient care machines are not benefitting patients, as much as the administrators and tend to promote inefficiency. More importantly, they are significantly impairing the physician patient relationship and have become one of the leading causes of physician burnout. The NY Times ran a recent opinion piece outlining this problem and calling for both nurses and physicians to unite in finding a better, smarter alternative.
- Limitations of SI MRI. The sensitivity of MRI in detecting early sacroiliitis has been viewed as an important tool in patient assessment. Features of sacroiliac (SI) joint synovitis, bone marrow edema, enthesitis have all been used to help diagnosed a new range of Spondyloarthritis conditions. Yet there are sobering reports that abnormal SI findings are often seen outside of the SpA population. Studies have shown that MRI done in normal adult volunteers reveals findings of SI joint bone marrow edema (BME) in 17%, Vertebra BME in 27% and fatty lesions in 81% of those studied. Another Danish study showed that sacroiliac bone marrow edema is nonspecific, seen in 3-39% of non-spondyloarthritis individuals and that only SI erosions and ankylosis were specific for axial Spondyloarthritis.
- The Venous-Thrombo-Embolic Scare. Before 2018, there were 2 JAK inhibitors (tofacitinib, ruxoltinib) and not risk of VTE (DVT or pulmonary emboli). Baricitinib was approved in 2018 with a boxed warning about the risk of VTE. In 2019, a new JAK inhibitor, Upadacitinib, was approved with a similar warning about VTE risk. But then in 2019, the results of a long-term safety study (in high risk individuals) comparing tofacitinib against adalimumab found an increased risk of VTE events and cardiac death in RA patients taking high dose tofacitinib (10 mg bid). The net result was that tofacitinib joined the other JAK inhibitors in having a boxed warning for VTE events. Complicating matters even more, the European regulatory agency is now considering even more stringent restriction on who should not take tofacitinib (and other JAK inhibitors) because of this new safety trial data. The bottom line is that RA patients have a small increased risk of VTE (up to 5-6 per 1000 patients) and that there is some, inconsistent evidence that JAK inhibitor therapy may increase this by 1-2 more cases per 1000. Rheumatologists have been warned that if your patient has a prior history of DVT or PE, that it may be wise to choose another drug. Also, don’t use the high (Unapproved) dose of tofacitinib (10 mg bid).
- RheumNow Live. Of course we are biased, but RheumNow Live could be the best and new rheumatology review meeting you might attend. Launched last March 2019, this 2 day meeting held over the weekend in Fort Worth, TX was attended by over 170 rheumatologists and was streamed over the internet to over 400 additional viewers. Distinguished by being held in unique Fort Worth, with a world class faculty, shorter lectures, longer Q&A and panel discussions and thought provoking TED-like talks. The next RNL will be March 13-15, 2020. Registration is now open.