Q1 2025 Recap: Rheumatology News and Updates

Rheumatology continues to advance, propelled by innovation in autoimmune therapies, targeted biologics, and personalized treatment strategies. Recent progress has spanned high-impact conditions like lupus, rheumatoid arthritis, and gout, with novel agents and alternative mechanisms offering new hope for patients with limited options.

Q1 2025 was no different—bringing key developments in regulatory decisions, pipeline breakthroughs, and clinical trial readouts. From biosimilar approvals and fast-track designations to phase 3 efficacy data and expert insights, the field is gaining traction across both established and emerging treatment fronts. HCPLive Rheumatology has compiled the major updates that defined the first quarter of the year.

In our recap, we spotlight 4 regulatory updates from the US Food and Drug Administration (FDA) and other government entities, our 5 most popular trial announcement articles, and 2 key insights from top experts featured within our coverage.

Q1 2025 Regulatory Updates in Rheumatology

FDA Accepts BLA for Golimumab Biosimilar for Inflammatory Conditions

On January 27, the FDA accepted a Biologics License Application for AVT04, a proposed biosimilar to golimumab, intended for the treatment of multiple inflammatory diseases including rheumatoid arthritis and psoriatic arthritis. The submission is supported by analytical, preclinical, and clinical data demonstrating similarity in efficacy, safety, and immunogenicity.

Oxypurinol Formulation for Gout Treatment

ON March 19, XORTX announced that it would have a Type B meeting with the FDA to review chemistry, manufacturing, pharmacology, toxicology and clinical evidence regarding its XRx-026 program, a novel oral formulation of oxypurinol,for the treatment of gout. Researchers suggest it could offer an alternative for patients intolerant to allopurinol or febuxostat.

FDA Approves Celltrion’s Denosumab Biosimilars

On March 3, the FDA approved Celltrion's denosumab biosimilars, branded as Vegzelma and Vegzelma SC, for all indications held by the reference products Prolia and Xgeva, including osteoporosis and bone metastases. The biosimilars represent the first denosumab alternatives approved in the U.S., potentially expanding access to bone loss therapies.

FDA Fast-Tracks CAR-T Therapy for Lupus

On February 5, the FDA granted Fast Track designation to Descartes-08, an autologous RNA CAR-T cell therapy targeting CD8+ cells, for the treatment of generalized myasthenia gravis and systemic lupus erythematosus. The decision reflects growing interest in adaptive cell therapy approaches for severe, treatment-resistant autoimmune diseases.

Q1 2025 Trial Announcements in Rheumatology

SAP-001 Demonstrates “Best in Class” Data for Gout With Hyperuricemia Refractory to SOC XOI Therapy

SAP-001, a novel urate-lowering agent, demonstrated best-in-class efficacy in a Phase 2b trial, with a majority of patients achieving target serum uric acid levels by Month 3. The treatment showed potential for addressing hyperuricemia refractory to standard xanthine oxidase inhibitor (XOI) therapy.

REGENCY: Obinutuzumab Proves Efficacy in Lupus Nephritis
Use of obinutuzumab (Gazya/Gazyvaro) was superior to standard of care therapy alone for achieving a complete renal response in patients with active lupus nephritis, according to results from the phase 3 REGENCY trial.

Rosnilimab Demonstrates Historic Responses for Rheumatoid Arthritis

Rosnilimab has demonstrated historic American College of Rheumatology (ACR) and clinical disease activity index (CDAI) low disease activity (LDA) responses in patients with rheumatoid arthritis (RA) in new findings from a phase 2b trial.
TMS Reduces Pain, Yields Functional Improvements in Women With Fibromyalgia

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.

Deucravacitinib Improves PsA Symptoms and Quality of Life in POETYK PsA-2
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.

Q1 2025 Expert Perspectives in Rheumatology

The Evolving Biologic Landscape for PsA Care, with Philip Mease, MD

Mease reviews the expanding array of biologic options for psoriatic arthritis, highlighting IL-17 and IL-23 inhibitors as important alternatives to TNF inhibitors, particularly in patients with skin-dominant disease or axial involvement. He emphasizes the value of personalized treatment selection based on disease domain and prior therapeutic response.

Identifying B-cell Depleting Agents for Lupus Nephritis, with Richard Furie, MD

Furie discusses the emerging role of B cell–depleting therapies in lupus nephritis, with particular focus on agents like obinutuzumab and their potential to induce durable renal responses. He notes that recent trial data support further exploration of dual B cell–targeting strategies in difficult-to-treat cases.