2023 Rheumatology Year in Review Save

2023 was a year of growth and new horizons while returning to operational and practice standards (in care and education) established before the pandemic.  Below is my top 10 list (in no particular order) of 2023 advances, game-changers, and developments that changed, or will soon change, rheumatologic practices.

1. FDA Regulatory Actions: in 2023 the FDA approved nearly 50% more novel drugs (compared to 2022), with 55 new approvals in 2023 (up from 37 in 2022 and 51 in 2021) and not far from its peak of 59 new drugs in 2018. This included:
   • Newly Approved Entities:
     • Bimekizumab (Bimzelx; for use in psoriasis – not yet approved for PsA)
   • New FDA indications (of previously approved Rheum Drugs: including:
     • Intravenous use of secukinumab (Cosentyx; in adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). 
     • Sarilumab (Kevzara; for use in PMR)
     • Secukinumab (Cosentyx; for use in severe hidradenitis suppurativa)
     • Canakinumab (Ilaris; for use in Gout Flares)
     • Abatacept (Orencia; for juvenile psoriatic arthritis (JPsA)
     • Upadacitinib (Rinvoq for severe Crohn's Disease in adults)
     • Colchicine (for use in Cardiovascular prevention)  
     • Infliximab-dyyb (Zymfentra – this is the subcutaneous version of the IV drug Inflectra – indications include Crohns and ulcerative colitis only)
     • And a multitude of new biosimilars for use in rheumatology (see below)
2. Biosimilar breakout: While several versions of infliximab have been approved and commercially available in the USA, the number of biosimilars dramatically increased in 2023; thereby making biosimilars a more relevant and available option for rheumatologists.  This expansion was led by either the approval or introduction of nine new adalimumab biosimilars; many of these were FDA approved prior to 2023 but their market availability was delayed based on legal settlements between AbbVie and the biosimilar manufacturers. In addition, other new biosimilars for tocilizumab, ustekinumab and rituximab appeared on the market. Biosimilar sales are expected to be $129 billion in next 5 yrs, with estimated savings of $181 billion https://t.co/HMOYaSaIBQL New biosimilars include:
   • Wezlana (ustekinumab-auub) October 2023
   • Tofidence (tocilizumab-bavi) September 2023
   • Yuflyma (adalimumab-aaty) May 2023   
   • Idacio (adalimumab-aacf) December 2022
   • Abrilada (adalimumab-afzb) November 2019
   • Hadlima (adalimumab-bwwd) July 2019 
   • Hulio (adalimumab-fkjp) July 2020
   • Hyrimoz (adalimumab-adaz) October 2018
   • Cyltezo (adalimumab-adbm) August 2017
   • Amjevita (adalimumab -atto) September 2016
   • Yusimry (adalimumab-aqvh) December 2021
3. Polymyalgia spotlight: with FDA approval of sarilumab for refractory PMR, there was considerable buzz, education and discussion about a new, steroid-sparing, approach to PMR patients with an inadequate response to steroids.  RheumNow hosted a month-long campaign (sponsored by Sanofi) on PMR education and treatment that had over 50,000 engagements.   
4. CAR–T Therapy: the use of CAR-T cell therapy in SLE was first introduced 2 years ago by Dr. Georg Schett and colleagues and since, there has been repeat reports on a small but grown cohort of horribly refractory SLE patient who have been in remission for nearly 2 years and have not had to restart their immunosuppressive, biologic or steroid drugs.  Heretofore, CAR-T cell therapies have largely been used in oncology with nearly six of these being FDA approved. As such there are many companies who are investing and developing CAR-T cell therapies for use in rheumatic diseases like SLE, inflammatory myositis, systemic sclerosis and rheumatoid arthritis.  With expanded development the cost of such therapy should dramatically decrease. Nonetheless, The CAR-T cell therapy market was nearly $4 billion in 2023 and is expected to be greater than an $85 billion market in the next 10 years.  
5. Artificial intelligence in medicine: AI has been in development for decades, but it wasn’t until the public availability of Chat-GPT in November of 2022, did the use and applicability of AI take modern society by storm.  Information about the integration of AI and natural language processing (Chat-GPT) is growing exponentially, especially in medicine where AI is being used in diagnostics, medical practice, EMR documentation, medical decision making, drug development, time and practice management and medical education. If you’re AI perturbed or a disbeliever, be prepared to be anchored in the analogue past, as you will certainly not be apart of a digitally integrated, digitally predominant future practice of medicine.
6. Virtual Learning: more and more rheumatologists are opting to attend national and regional conferences when given the opportunity to attend virtually.  Stemming from forced virtual attendance back in 2020 and 2021, many continue to go (stay?) virtual when given the option, presumably because of time, cost, and travel advantage while still claiming the educational impact.  Surveys show that many clinicians do want to attend meetings onsite, largely because they value face-to-face interaction with faculty and peers. Nonetheless, virtual adoption for medical education is here to stay.
7. Diabetes Drugs: Numerous reports have appeared in the medical literature and at national congresses about the mortality benefits of both GLP-1 agonists and SGLT2 Inhibitors when given as cotherapy (diabetes as the primary use indication) in general in autoimmune patients, and more specifically in patients with gout, lupus, osteoarthritis, and psoriasis.  SGLT2 inhibitors have become mainstay cotherapy in patients with CHF and chronic renal disorders; might they evolve into the same role in select rheumatologic disorders?
8. Growth of Autoimmune disease:  In the last few years there have been many epidemiologic reports on the global burden of arthritis – a fact that is well know and at the same time ominous to rheumatologist, as we face the realities of a growing public health problem and a very limited MSK workforce.  These facts became even more uncomfortable with a recently Lancet paper declaring that 10% of the population will have an autoimmune disease.  Prior population-based studies suggested that the frequency of autoimmune disease was 1/31 in 1997 and in 2005 the risk was 1/12 in women and 1/20 in men (total: 23.5 million) in the USA.  The Lance report shows the frequency of 19 autoimmune conditions to be 10.2% (13.1% in women and 7.4% in men).  A plan to deal with this growing challenge is sorely needed.  
9. Outcomes in Women: A growing number of research reports and clinical trials have clearly documented the poorly understood fact in rheumatology disease, women do worse. Specifically, women with rheumatic disease have more frequently affected, and have worse outcomes and poorer responses to conventional and advance therapies when compared to men. The reasons for this are multifactorial, not well understood and are currently without a logical plan to offset the differences observed.
10. Difficult to Treat: In 2021 EULAR published its definition for difficult-to-treat RA (D2T-RA) and since there is a growing list of research and publications attempting to tackle this problem among RA patients.  In 2023 we began to see this “difficult-to-treat” concept extend to other disorders such as lupus, spondyloarthritis and psoriatic arthritis.  These approaches go beyond past discussions of the treat to target approach and now are defining those in the D2T category and what approaches or options should be explored.  Look for more D2T research in 2024.  

Honorable mention: there are many items, topics and news bits that are often tossed about in rheumatology circles. And while these are popular and potentially cool, my view is that they are floundering, going nowhere have yet to fulfill a need or promise inherently predicted.  Thus, my disappointments include:

• Biomarkers (there are none of note or realistic value)
• Personalized medicine (hard to achieve, when most marketed and developed are “me-too” or “me-three” drugs)
• Long Covid (a real problem, but I’ve not yet seen an explanation other than fibromyalgia as the root cause of these symptoms) 
• Both “steroid-sparing” therapies and “steroid toxicity” research is increasingly presented (but have rheumatologists curtailed their use of corticosteroids?)