The first quarter of 2025 has delivered significant advancements across the rheumatology landscape, with regulatory milestones, breakthrough clinical trial results, and emerging therapies offering new hope for patients with autoimmune and inflammatory conditions.
Regulatory Milestones Expand Treatment Options
The FDA has maintained a brisk pace of approvals and designations in early 2025, potentially transforming care for several rheumatologic conditions.
On March 3, Celltrion secured FDA approval for its denosumab biosimilars, marketed as Vegzelma and Vegzelma SC. These represent the first U.S.-approved alternatives to reference products Prolia and Xgeva, covering indications including osteoporosis and bone metastases. The approval is expected to expand access to these critical bone loss therapies through improved affordability.
For patients with systemic lupus erythematosus (SLE), the FDA granted Fast Track designation to two promising cellular therapies. On February 5, Descartes-08, an autologous RNA CAR-T cell therapy targeting CD8+ cells, received the designation for both generalized myasthenia gravis and SLE. Similarly, Adicet Bio's ADI-001, a CD20-targeting therapy, earned Fast Track status for refractory SLE with extrarenal involvement. These designations reflect growing interest in adaptive cell therapy approaches for severe, treatment-resistant autoimmune diseases.
In the gout treatment arena, XORTX announced a Type B meeting with the FDA scheduled for March 19 to review its XRx-026 program, a novel oral formulation of oxypurinol. The therapy could provide an alternative for patients intolerant to current standard treatments allopurinol or febuxostat.
Additionally, on January 27, the FDA accepted a Biologics License Application for AVT04, a proposed biosimilar to golimumab, intended for treating inflammatory conditions including rheumatoid arthritis and psoriatic arthritis.
Breakthrough Clinical Data Transforms Treatment Paradigms
Lupus Nephritis: Obinutuzumab Shows Superior Efficacy
The phase 3 REGENCY trial delivered landmark results for patients with lupus nephritis, demonstrating that obinutuzumab (Gazya/Gazyvaro) added to standard of care therapy significantly improved complete renal response rates compared to standard therapy alone.
"The positive REGENCY study results confirmed the findings of an earlier trial that administration of obinutuzumab, a therapy which targets B cells, benefitted patients with lupus nephritis more than standard treatment alone," said Richard Furie, MD, Chief of the Division of Rheumatology at Northwell Health and the Marilyn and Barry Rubenstein Chair in Rheumatology.
Dr. Furie has emphasized the emerging role of B cell–depleting therapies in lupus nephritis, noting that recent trial data support further exploration of dual B cell–targeting strategies in difficult-to-treat cases.
Rheumatoid Arthritis: Rosnilimab Sets New Efficacy Benchmarks
Rosnilimab has demonstrated what researchers describe as "historic" American College of Rheumatology (ACR) and clinical disease activity index (CDAI) low disease activity responses in patients with rheumatoid arthritis, according to new findings from a phase 2b trial.
"Rosnilimab's efficacy data paired with a favorable safety and tolerability profile present a promising new option for people living with RA," said Paul Emery, MD, Versus Arthritis professor of rheumatology at the University of Leeds and Leeds Biomedical Research Centre, UK.
Gout: Novel Urate-Lowering Agent Shows Promise
SAP-001, a novel urate-lowering agent, demonstrated "best-in-class" efficacy in a Phase 2b trial for patients with hyperuricemia refractory to standard xanthine oxidase inhibitor (XOI) therapy. The majority of patients achieved target serum uric acid levels by Month 3, offering hope for patients with limited treatment options.
This development comes as researchers continue to refine gout diagnosis methods. A team led by Lishan Xiao from the Department of Ultrasound at the Affiliated Hospital of Qingdao University has developed an interpretable machine learning model for predicting gout, establishing a foundation for future applications in supporting diagnosis.
However, another study led by Tristan Pascart, MD, PhD, from Lille Catholic University found that dual-energy computed tomography (DECT) was unable to detect genuine monosodium urate crystal deposits in kidneys and renal artery walls, cautioning against overreliance on this imaging modality for detecting gout nephropathy.
Fibromyalgia: Non-Pharmacological Approaches Show Promise
A clinical study demonstrated that M1-repetitive transcranial magnetic stimulation (rTMS) significantly reduced fibromyalgia pain for up to eight weeks, with sustained functional improvements lasting 16 weeks. The findings support rTMS as a noninvasive neuromodulatory option for fibromyalgia management.
Additional research has identified potential biomarkers and risk factors for fibromyalgia. A study found that copper and iron are associated with fibromyalgia risk, while separate research demonstrated that perceived stress was positively correlated with symptom burden in people with fibromyalgia syndrome, even when not correlated with endocrinological stress indicators.
Expanding Biologic Options for Psoriatic Arthritis
The POETYK PsA-2 trial showed that deucravacitinib, a selective TYK2 inhibitor, led to significant symptom improvement and quality-of-life benefits in patients with active psoriatic arthritis. Efficacy was observed even in those with prior inadequate response to TNF inhibitors.
Philip Mease, MD, has highlighted the expanding array of biologic options for psoriatic arthritis, emphasizing IL-17 and IL-23 inhibitors as important alternatives to TNF inhibitors, particularly in patients with skin-dominant disease or axial involvement. He underscores the value of personalized treatment selection based on disease domain and prior therapeutic response.
Looking Forward: Implications for Clinical Practice
The first quarter of 2025 has set a rapid pace for innovation in rheumatology, with advances spanning from novel biologics and cellular therapies to improved diagnostic approaches and non-pharmacological interventions.
These developments suggest a shift toward more personalized treatment strategies, with an expanding toolkit allowing clinicians to better match therapies to individual patient characteristics, disease manifestations, and prior treatment responses.
As these new therapies move toward broader clinical implementation, the rheumatology community anticipates further refinement of treatment algorithms and potentially improved outcomes for patients with historically difficult-to-treat conditions.
