The 2025 Rheumatology Year in Review Save

Jack Cush, MD

Jan 16, 2026 1:31 pm

The year 2025 presented numerous advances in rheumatology and related inflammatory and autoimmune disorders ranging from several new groundbreaking FDA approvals/indications, drug developments, game-changing guidelines and practices that will impact patient care for rheumatic diseases.

There are many approaches to identifying rheumatology’s most impactful advances. Each year RheumNow re-publishes the most read and popular articles. In 2025, our popular topics included:

Overview of the VEXAS Syndrome
Methotrexate intolerance in rheumatoid arthritis
Vitamin D for disease prevention
Glucocorticoids in SLE: how to start, how to follow, how to stop
Contraception in SLE
ERS/EULAR guidelines for CTD-related interstitial lung disease

The ACR is another a great source for rheumatology’s bests. At the 2025 Annual ACR Convergence meeting, the “Year in Review” session featured Drs. Anne Davidson (NY) and Bryant England (NE) listed their 2025 highlight advances in clinical rheumatology and rheumatology research, including:

COPA Syndrome
mRNA vaccines
CAR-T cell advances
Predicting RA risk through single cell proteomics
AI accelerated drug development
Low yield of routine lab testing in RA
Modest benefits with newly approved vagal nerve stimulation (VNS)
Promise of sonelokimab, a dual 17A/17F (IL-17A/17F nanobody inhibitor
Treatment advances in Sjogren’s disease
FDA approval of a new anti-CD20 mAb, obinutuzumab, for lupus nephritis
Upadacitinib approval in giant cell arteritis

My approach to the top dozen advances is based on studying rheumatology news and major journal articles and choosing those that I think will most affect the future of rheumatologic care. Here is my list in no particular order:

New FDA Approvals and Indications
1. In 2025 the FDA approved 46 new drugs (none in Rheumatology), compared to 55 in 2023 and 50 in 2024. Most of these were small molecules, mainly in other therapeutic areas (14 oncology treatments, 26 for orphan diseases). 2025 saw only 5 new cell and gene therapies (CGT), compared to 9 CGT approvals in 2024.
2. There were 6 novel drugs approved for tangentially related musculoskeletal or immune indications: https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals…
  1. Jascayd (nerandomilast): 10/7/2025 for idiopathic pulmonary fibrosis
  2. Rhapsido (remibrutinib): 9/30/2025 for chronic spontaneous urticaria
  3. Wayrilz (rilzabrutinib): 8/29/2025 for persistent or chronic immune thrombocytopenia.
  4. Tryptyr (acoltremon): 5/28/2025 for dry eye disease.
  5. Imaavy (nipocalimab-aahu): 4/29/2025 for myasthenia gravis.
  6. Journavx (suzetrigine): 1/30/2025 for moderate to severe acute pain.
3. New Device Indication
  1. SetPoint System: is an FDA-approved medical device, vagal nerve stimulator for use in active moderate-to-severe RA who have had inadequate responses to biologic or targeted synthetic DMARDs. Approval was based on the 52 week, 242-patient RESET-RA study demonstrating efficacy superior to sham therapy – this is unique in being a non-medicinal, minimally invasive outpatient, neuroimmune modulator that can be used for up to 10 years.
4. New FDA Indications Approved (for currently marketed products)
  1. Obinutuzumab (Gazyva) for Lupus Nephritis, approved in October 2025, based on positive phase 2 NOBILITY and phase 3 REGENCY studies. Thought to be a major advance with improvements in renal outcomes, serologies, proteinuria, and reduced steroid use.
  2. Guselkumab (Tremfya) approved in September 2025 for children (aged > 6 years) with moderate to severe plaque psoriasis or active psoriatic arthritis.
  3. Upadacitinib (Rinvoq): added ulcerative colitis (UC) as a new FDA approved indication in 2025.
  4. Gamifant (emapalumab-lzsg), an anti-IFNγ antibody, was FDA approved in June 2025 to treat Macrophage Activation Syndrome (MAS) related to Still's disease.
  5. Inebilizumab-cdon approved in December 2025 for generalized myasthenia gravis in anti-AChR or anti-MuSK antibody-positive patients (favorable twice-yearly dosing).
  6. Tonmya (sublingual cyclobenzaprine) approved in August 2025 for fibromyalgia, targeting nonrestorative sleep.
Rheumatic Drugs Expected to Lose Patent Protection Soon
1. The battle over patent protection is rife throughout the rheumatology landscape, with past examples including adalimumab and future victims being etanercept, tofacitinib, golimumab, and others.
2. Denosumab (Prolia, Xgeva) - US patent expired in February 2025, with multiple biosimilar versions being approved and launched - denosumab-bbdz, denosumab-bbgn, and denosumab-bkzt.
3. Ustekinumab (for Crohn's, Psoriasis, PsA, UC): went off patent in 2025, with several new biosimilar versions being launched, including: Wezlana. Pyzchiva, Yesintek, and Selarsdi also entered the market, with more expected throughout the year.
B-Cell Targeted Therapies Shine
1. Obinutuzumab (Gazyva): an anti-CD20 therapy, FDA approved for lupus nephritis.
2. Inebilizumab (Uplizna): a monoclonal antibody used to treat neuromyelitis optica spectrum disorder, immunoglobulin G4-related disease (IgG4-RD), and recently FDA approved for generalized myasthenia gravis (gMG).
3. Ianalumab: a B-cell deplete that blocks ADCC and BAFF, has shown promise in SLE, ITP, and other autoimmune disorders. At ACR 2025 two phase 3 trials (NEPTUNUS-1 and NEPTUNUS-2) demonstrated its efficacy in Sjögren disease.
4. Telitacicept: blocks both Blyss and APRIL and has shown efficacy in SLE trials, reinforcing a central role for B cells in lupus. https://rheumnow.com/news/telitacicept-effective-systemic-lupus-erythem….
5. Numerous B cell targeting CAR-T cell products are in development, each targeting circulating B cells, to plasmablasts to tissue resident plasma cells. Limited small reports are fueling big trials in many autoimmune indications, with real, reliable results being 3-5 years away.
Cardiometabolic and Rheumatic Benefits to DM Drugs - While GLP-1 receptor agonists have gained popularity for weight loss, both GLP-1a and SGLT2 inhibitors offer broader benefits including renal protection, reduced cardiovascular death, and improvements in rheumatic disease activity. Ongoing clinical trials are evaluating these drugs as monotherapy or combined with biologics. EULAR and ACR abstracts demonstrated benefits in knee osteoarthritis, gout, RA, PsA, and SLE. Future research must determine whether these rheumatic benefits stem from weight loss alone or reflect anti-inflammatory or disease-modifying properties. This year's examples include:
1. SGLT-2i: sodium–glucose cotransporter 2 inhibitors have shown benefits beyond glycemic control, cardioprotective and nephroprotective effects, and modest weight loss. SGLT-2i have been linked to the prevention of autoimmune rheumatic disease. A recent study also suggests they may have immunomodulatory effects and https://t.co/grsgHFQic5
2. SGLT2i vs GLP-1a in Lupus Nephritis (LN) as by TriNetX population study. GLP-1a use linked to better renal and CV outcomes in LN with less CKD progression, and acute MI https://t.co/v4LgKFDt68
3. GLP-1a: Retrospective analysis study of 2,449 RA patients on JAK inhibitors, showed that those also taking GLP-1RA had significantly (36%) lower risk of acute coronary syndromes, less (36%) risk of deep venous thrombosis, but no significant change in survival (EULAR 2025 OP0069).
4. GLP-1a: reports have shown GLP-1 drugs to be clinically effective in knee osteoarthritis, rheumatoid arthritis and psoriatic arthritis (patients with obesity as the indication for GLP-1a).
Expanding the Role of TYK-2 Inhibition
1. Deucravacitinib Efficacy in Psoriatic Arthritis. The phase 3 POETYK PsA-1 trial demonstrated that deucravacitinib significantly improved joint and skin symptoms in adults with active psoriatic arthritis, with an ACR20 response at week 16 of 54% vs. 34% on placebo. No new safety signals have been identified. This will be up for FDA approval in 2026.
2. Zasocitinib: a new TYK2 inhibitor was shown effective in a phase 2b trial, zasocitinib 30 mg and 15 mg significantly improved ACR20 responses at week 12 in patients with active psoriatic arthritis (54.2% and 53.3%, respectively, vs. 29.2% with placebo; P = .002). This is now in phase 3 trials.
3. The advantage of these oral agents is that they are part of the JAK family and may not carry the same risks or warnings as marketed JAK inhibitors. While their early use and development is for psoriatic disease, there are future trials planned in lupus, inflammatory bowel disease (IBD), Sjögren's syndrome, dermatomyositis, and uveitis.
Rheumatology Lessons Learned from the COVID-19 Pandemic
1. Five years after COVID-19 first emerged, the rheumatology community reflected on transformative lessons that will shape practice in the future.
2. Autoimmune and rheumatic disease patients (AIRD) were at higher risk for more severe outcomes when infected by COVID-19 infection.
3. Rituximab and high-dose glucocorticoids posed particular risks for severe COVID-19 outcomes.
4. There is no consistent evidence that COVID-19 infection or COVID vaccination increased the risk of, or severity of, pre-existing AIRD.
5. Biologic use was not shown to worsen COVID outcomes compared to the general population. COVID-19 vaccination was critical for protection, with unvaccinated patients facing significantly higher risks.
6. Research on “Long Covid” syndrome continues, with many patients manifesting chronic complaints analogous to fibromyalgia, with new insights into infection-triggered immune dysregulation or alterations in pain processing.
7. Emergence of the COVID related to MIS-C disorder, with important similarities and differences with Kawasaki syndrome in children and adolescents.
8. The main benefit from COVID is that we all learned we can do Telemedicine in rheumatology - an outpatient discipline rooted in pattern recognition. Yet only a minority of rheumatologists have continued to offer and practice by telemedicine. Initially liberal reimbursements for telemedicine have become more restrictive.
Nurse Practitioners and Physician Assistants - Expanding Roles and Challenges
1. The projected rheumatology workforce crisis intensified discussions about expanding and integrating advanced practice providers (APPs) into rheumatology care. While the rheumatology workforce decreases (with an aging, male rheumatologist workforce), the demand for services will increase by 138% through 2030. The influx of new rheumatologists will not meet this need. Currently the fastest growing and best paid jobs in America are nurse practitioners and physician assistants.
2. RheumNow dedicated December 2025 to APPs in rheumatology – their use, utility, impact and needs. RheumNow surveys show that only half of Rheum practices use/employ an APP, but by 2025 APPs are found in up to 78% of practices. Multiple studies have shown that APP care and outcome match their MD mentors or employers and often exceed them in multiple outcomes (e.g., achieving remission or high patient satisfaction).
3. The Challenges in APP integration in rheumatology include:
  1. Training – 92% of APPs say their rheumatology training and education was largely unstructured and “on the job”. This needs to change.
  2. Independence and practice use: still too many practices limit their APPs to outpatient follow up, certain diseases, etc. when in fact they should be trained and challenged as you would a rheumatology fellow or new hire. There are many practices and regions where APP independence is necessary and can be achieved with plans to ensure education and competence.
  3. Retention: why spend $130,000 per year on a physician assistant, train and educate them, only to lose them when they switch disciplines for better pay, better jobs and rewarding experiences. Effective training/mentoring, promoting education, open communication, practice feedback, case reviews, and a challenging case mix are the best methods to retain your APP.
  4. Education: rheumatologists/practices/divisions need to encourage and support APP education. Numerous channels exist, including RheumNow.com, RhAPP, RNS, ACR and EULAR – all having educational opportunities for APPs.
New Guidelines for Lupus (SLE)
1. On the heels of the 2024 ACR Guidelines for the Management of Lupus Nephritis, 2025 saw new lupus guideline published by EULAR and ACR.
2. October 2025 brought the release of the 2025 ACR Guideline for the Treatment of Systemic Lupus Erythematosus. This includes the management of non-Renal lupus domains (cutaneous, MSK, serositis, hematologic, neuropsychiatric, cardiac, vasculitis). While there were over 65 recommendations; all were conditional (expert opinion) and only 3 were “strong” and evidence based: a) all SLE patients should be on hydroxychloroquine; b) steroids need to be tapered; and c) refractory SLE needs to have DMARD therapy escalated.
3. 2025 EULAR updated recommendations on the management of lupus nephritis (LN). Significantly, the historic standard of care (SOC) (i.e. mycophenolate with glucocorticoids, GC) is now inferior to newer therapies, namely, voclosporin, belimumab and (just released) obinutuzumab (based on well-designed renal endpoints. EULAR recommendations also favored the need for renal biopsy to assess suspected LN. EULAR also recommend early use of quadruple therapies (GC + hydroxychloroquine + immunosuppressant [MMF or low dose Cyclophosphamide] + calcineurin inhibitor or Biologics [belimumab or obinutuzumab).
Gene Therapy for Osteoarthritis Using IL-1RA. There are now 3 novel agents being developed as intraarticular gene therapy for osteoarthritis wherein IL-1 receptor antagonist (IL-1Ra) is delivered via vector into osteoarthritic knees. Interestingly, the anti-inflammatory IL-1RA continues to be expressed long after the intraarticular therapy is delivered. These preparations come from the Mayo Clinic (sc-rAAV2.5IL-1Ra), Pacira BioSciences (PCRX-201), and Genascence (GNSC-001).
New Treatments for Interstitial Lung Disease
Collaborative Guidelines
1. In September 2025, the European Respiratory Society (ERS) and European Alliance of Associations for Rheumatology (EULAR) released their first collaborative clinical practice guidelines for connective tissue disease-associated ILD, providing evidence-based recommendations for screening, diagnosis, monitoring, and treatment across multiple CTDs (PSS, RA, IIM, Sjögren disease, SLE, and MCTD). Importantly there were aggressive recommendations on increased screening with high resolution CT scanning and clarity on when to use immunosuppressants vs newer antifibrotic therapies (nintedinib, pirfenidone, nerandomilast). The ACR and American College of Chest Physicians (CHEST) had previously released two comprehensive guidelines in 2024 that were widely implemented throughout 2025. Importantly these publications provide guidance on the use of newer antifibrotic agents.
2. FIBRONEER trials were reported in 2025. There were two Phase III trials (FIBRONEER-IPF & FIBRONEER-ILD), both of which included autoimmune patients. They showed the new, FDA approved drug, nerandomilast, when added to standard immunosuppressive therapy, both slowed FVC decline and conferred a survival benefit in autoimmune progressive ILD, the first evidence of mortality reduction with combination therapy.
AI Advances in Rheumatology and Medicine
1. The medical world is split on the excitement, potential, adoption and current utility of artificial intelligence (AI). AI is showing up in many venues that affect us – FDA, research, imaging, population planning, practice management, patient education, clinic visit documentation. My point? If you’re not part of the future, you’ll be left in the past. The only thing that survives is change. There are several new tools that are useful in-patient care:
2. MeFisto system uses AI-powered radiomics to evaluate hand motion as a means of disease activity assessment, enabling digital and accurate remote monitoring without in-person visits.
3. Large Language Models (LLMs) emerged as powerful tools for analyzing electronic health records, to identify new diagnoses (before they’ve been diagnosed), as well as recruit patients for studies or referrals, promoting earlier diagnoses and earlier treatment.
4. Automated ambient clinical documentation is either being incorporated into large system EHRs or purchased per clinic to capture patient-physician conversations and generate structured clinical notes, reducing administrative burden and physician burnout.
5. AI Challenges: include limited clinician adoption (73% of rheumatologists have never used AI in practice), the need for AI training and integration, concerns about AI accuracy and “hallucinations”, data privacy and security concerns, and costs.
Many New Guidelines in 2025
1. This includes updated clinical practice guidelines for SLE, lupus nephritis, and interstitial lung disease from multiple societies. Also new guidelines on Still’s disease (EULAR), BSR ANCA-Associated Vasculitis (GPA, MPA, EGPA), Axial Spondyloarthritis, conventional synthetic disease-modifying anti-rheumatic drugs, perioperative DMARD use, drug monitoring, JIA, systemic JIA (Still’s disease), and EULARs Guidelines on Reproductive Health.