2024 Rheumatology Year in Review Save

2024 was a year of surprising new growth in technology, with the expansion of new therapeutic options for many patients and clinicians.  While these many advances offer new hope, they are countered by disappointments and gapping unmet needs in rheumatology. Below is my top 10 list (in no particular order) of 2024 developments and desires that may change rheumatologic practices.

New FDA Approved Drugs in 2024

• In 2024, the FDA (CDER) approved 50 new drugs never before marketed. None were approved for rheumatology. Most were for orphan disorders, cancer and there were two gene therapies, Casgevy and Lyfgenia, for the treatment of sickle cell disease.

New Rheumatologic Indications

• Several previously FDA approved drugs were granted new indications for use; this included:
  • Bimekizumab – previously approved in 2023 for use in plaque psoriasis, the FDA approved bimekizumab-bkzx (Bimzelx) for the treatment psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), and ankylosing spondylitis (AS).
• Upadacitinib's (Rinvoq) - was approved for use in active polyarticular juvenile idiopathic arthritis (pJIA) and pediatric (2 to < 18 years) with PsA not responding to tumor necrosis factor (TNF) blockers. A weight-based oral solution (Rinvoq LQ) was also approved.
• Biosimilars - In 2024 the FDA approved 19 new biosimilars; this; included 6 ustekinumab (Stelara) biosimilars (Selarsdi - ustekinumab-aekn; Pyzchiva - ustekinumab-ttwe; Otulfi - ustekinumab-aauz; Imuldosa - ustekinumab-srlf; Yesintek - ustekinumab-kfce; Stequeyma - ustekinumab-stba) and one adalimumab (Humira) biosimilar (Simlandi - adalimumab-ryvk), bringing the glut of adalimumab biosimilars to a total of 11, plus the originator Humira. Three tocilizumab biosimilars have been FDA approved - Tofidence (tocilizumab-bavi) in 2023, Tyenne (tocilizumab-aazg) in 2024, and Avtozma (tocilizumab-anoh) in 2025.  There are currently 69 FDA approved biosimilars in the USA, 30 being used in rheumatology. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information

Treatment Advances in 2024

• A notable area of drug development in rheumatology is the targeting of the neonatal Fc receptor (FcRn). Nipocalimab, an anti-FcRn monoclonal antibody, received breakthrough therapy designation from the FDA for the treatment of moderate-to-severe Sjögren's disease, highlighting the potential of FcRn inhibitors in managing autoimmune conditions.

GLP-1 agonists Expanding into Rheumatologic Diseases

• Glucagon-like peptide-1 receptor agonists (GLP-1 agonists – These agents are in the headlines and have expanded their use in renal and cardiovascular disorders but are also showing efficacy and health benefits (beyond weight loss) in rheumatologic conditions. Notably these agents have been reported at national congresses and major journals as benefiting patients with knee osteoarthritis, gout, rheumatoid arthritis (RA), psoriatic arthritis (PsA), lupus (SLE), and lupus nephritis.      The bulk of such research has been using either semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound). It is still unclear if the mortality and disease activity benefits are solely related to weight loss, as there are suggestions of systemic and anti-inflammatory benefits as well.

AI in rheumatology

• The dramatic introduction and growth of artificial intelligence has been realized by many is beginning to change clinical practice, patient management, clinical research and drug development.  While most are still wary of AI’s benefits, veracity, reliability and potential for misuse or over-reliance, recent JAMA polling suggests that, in just the last year, physicians are increasingly recognizing AI’s benefits and advantages, including a near doubling of AI use in physician practices (66% in 2024 vs. 38% in 2023). More physicians are using AI for visit documentation, discharge summaries and care plans, and medical research and care summaries.  AI is already being used in radiology and dermatology to diagnose based on digital images.
• Research using AI and machine learning algorithms are now capable of predicting disease onset or flares, optimizing certain treatment, interpreting laboratory data and analyzing large datasets to identify novel therapeutic targets.

Biomarkers for Rheumatic Diseases

• Biomarker research is active, but slow in yielding clinically applicable and predictive value to patients and clinicians.  Various technologies have been employed including multi-omics, genetic, epigenetic and SNP genetics and urinary biomarkers in several diseases. Most encouraging has been the work on urinary biomarkers (IL-16, CD163, etc.) from the Hopkins Lupus clinics showing their superiority over current measures in the early detection of lupus nephritis flares and correlations with lupus renal damage.
• While there are advances in molecular biomarkers for OA, more data, and validation studies are needed. Biomarkers that correlate with imaging and structural damage may not be as valuable as correlations with clinical status.

Wider Cannabis Use - Without Guidelines but with Concerns

A NY Times survey has shown that daily consumption of marijuana among young adults has nearly doubled in the last decade. Fueled by legalization and mainstream acceptance of cannabis (THC and CBD), the enthusiasm for use and potential benefits may be at odds with uncertain risks. Cannabis claims are reminiscent of holistic and nutraceutical claims – more about sales than reliable data. Recent research of people with RA using cannabis found benefits on mortality, depression, chronic pain, and anxiety. But a growing number of reports suggest that cannabis use may be tied to increased opioid use, nicotine dependence, and alcohol use. Moreover, studies show potential associations with new-onset arrhythmias, hepatotoxicity, and increased mortality in those hospitalized for cannabis use disorder (CUD). Unfortunately there are no objective guidelines for the use of cannabis in rheumatic patients or those with chronic pain.

New Rules on Glucocorticoids Use

• Steroid use continues to be the topic of discussion throughout rheumatology. They are mainstay therapy for RA, SLE, PMR, vasculitis and gout.  High dose glucocorticoids are advocated as initial therapy in lupus nephritis, cerebritis and life-threatening organ involvement.  Decades of over-reliance have led to ACR and EULAR guidelines tempering steroid use to the lowest dose and shortest duration. Yet numerous expert forums have advocated for limitation or withdrawal of steroid use, especially in light of the clear and present danger of cardiovascular and serious infectious adverse events.  This has become more realistic with the introduction of new “steroid-sparing” regimens such as the IL-6 inhibitors, avacopan, IVIG and newer targeted therapies (e.g. mepolizumab) whose success is usually affirmed by their ability to limit the cumulative exposure to glucocorticoids. "Treat-to-target" success should be achieved without steroids and all glucocorticoid prescriptions should have an expiration or stop date at the start of any systemic therapeutic plan.

Heartbreak of Osteoarthritis

• Disappointment abounds when it comes to the treatment of osteoarthritis and pain. Common analgesics (acetaminophen, NSAIDs, weak narcotics, tramadol) have little proven value in chronic care. As such these are usually avoided. The opioid crisis has discouraged the use of more aggressive narcotics, leaving the most needful in the lurch.  Several classes of drug development have failed to yield new hope, most recently evidenced by the lack of success with nerve growth factor inhibitors. Lastly the concept of disease modification (DMOADs) in OA is a mere aspiration, rather than a promise or reality.  Relief eventually arrives with the surgeon and arthroplasty!  Rheumatologists need to lead a call to action. The trial designs exist. The endpoints are clear. Yet there is anemic and uncommitted interest in drug development for the most common worldwide musculoskeletal problem. This is shameful and heartbreaking for too many.

 Innovative Trends in Patient Monitoring and Care Delivery

• Combined specialty clinics (e.g., Rheum-Derm; Cardio-Rheum; GI-Rheum) offer unique expertise, research options and potential treatment advances.
• Remote healthcare and monitoring options exist using validated patient-reported outcome measures along with telemedicine and nurse or APP-run outpatient programs.
• Integration of wearable technology with clinical data improving disease activity assessment
• Expansion of multidisciplinary care models incorporating specialized pharmacists, advanced practice providers, and mental health professionals.