Rheumatology in 2025: Year in Review

Rheumatology in 2025 was marked by an unusually dense stretch of regulatory decisions and late-stage data that expanded treatment options across autoimmune, inflammatory, and neuromuscular diseases. From rare conditions like IgG4-related disease and myasthenia gravis to high-burden disorders such as rheumatoid arthritis, lupus nephritis, psoriatic disease, and fibromyalgia, the FDA approved multiple first-in-class or indication-expanding therapies that addressed long-standing gaps in care. Several of these decisions reflected a broader shift toward targeted immune modulation, non–immune-suppressive approaches, and mechanism-driven innovation.

Beyond approvals, pivotal trial readouts in 2025 reshaped expectations for emerging agents across rheumatology. Phase 2 and 3 data supported durable efficacy for novel biologics and oral therapies in rheumatoid arthritis and psoriatic arthritis, reinforced the renal benefits of B-cell depletion in lupus nephritis, and strengthened the evidence base behind newly approved fibromyalgia treatments.

At the same time, feature reporting and expert discussions highlighted the limits of pharmacology alone and the growing importance of integrated, multidisciplinary care. Clinicians emphasized earlier diagnosis, cross-specialty collaboration, and realistic expectations for new therapies, particularly in complex, heterogeneous diseases. Taken together, the top rheumatology news of 2025 reflects both meaningful progress and a clearer understanding of where innovation must go next to translate advances into sustained improvements in patient outcomes.

FDA News

FDA Approves Inebilizumab (Uplizna) as First IgG4-RD Therapy for Adults
The FDA has approved inebilizumab-cdon (Uplizna) as the first treatment for adults with immunoglobulin G4-related disease (IgG4-RD), addressing a significant unmet need in this rare autoimmune condition. This approval offers a new therapeutic option for patients previously reliant on less targeted treatments.​

FDA Approves Upadacitinib, Expanding Treatment for Adults With Giant Cell Arteritis
Upadacitinib has received FDA approval for treating adults with giant cell arteritis, providing a new option for managing this inflammatory vascular disease. This expands the therapeutic arsenal for clinicians dealing with this challenging condition.​

FDA Approves TNX-102 SL, First New Fibromyalgia Therapy in 15 Years

On August 15, the FDA approved TNX-102 SL (Tonmya), the first new fibromyalgia therapy in more than 15 years, offering a novel sublingual, non-opioid approach that targets nonrestorative sleep to improve pain and other core symptoms. Approval was based on the phase 3 RESILIENT trial, where the drug showed significant pain reduction as early as week 1 along with improvements in sleep and fatigue.

FDA Approves Neuroimmune Modulation Therapy for Rheumatoid Arthritis

The FDA has approved SetPoint Medical’s SetPoint System, the first neuroimmune modulation device for rheumatoid arthritis, offering a novel implantable therapy that stimulates the vagus nerve to reduce inflammation without immune suppression. In the pivotal RESET-RA trial, the device significantly improved ACR20 response rates at 12 weeks, with benefits sustained through 12 months and a favorable safety profile.

FDA Approves Guselkumab (Tremfya) for Pediatric Plaque Psoriasis, Psoriatic Arthritis

On September 29, 2025, the FDA approved guselkumab (Tremfya) for children aged ≥6 years and weighing ≥40 kg with moderate to severe plaque psoriasis or active psoriatic arthritis, making it the first IL-23 inhibitor approved for these pediatric indications. The decision was supported by the phase 3 PROTOSTAR trial, where guselkumab significantly improved skin clearance compared with placebo, and by extrapolated data from adult PsO and PsA studies. This expands guselkumab’s use beyond its prior adult approvals and provides a new treatment option for children with these immune-mediated diseases.

FDA Approves Obinutuzumab for Lupus Nephritis

On October 20, 2025, the FDA approved Genentech’s obinutuzumab (Gazyva) for the treatment of lupus nephritis. The decision was based on positive results from the phase 2 NOBILITY and phase 3 REGENCY studies. In REGENCY, nearly half of the participants (46.4%) on obinutuzumab in combination with standard therapy achieved a complete renal response compared to 33.1% on standard therapy alone, accompanied by clinically meaningful improvements in complement levels and reductions in anti-dsDNA, corticosteroid use, and proteinuria.

Trial Updates and New Guidelines

Rosnilimab Continues Best-in-Disease Profile Responses for Rheumatoid Arthritis

Updated 6-month data from the phase 2b RENOIR trial showed rosnilimab sustained strong efficacy in moderate-to-severe rheumatoid arthritis, with durable responses and deepening disease activity improvements over time. The PD-1–targeting therapy demonstrated efficacy on par with JAK inhibitors but with a favorable safety profile and immune-restorative effects, supporting its potential as a long-term treatment option.

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.

Phase 3 Deucravacitinib Trial Meets ACR20 End Point in PsA

The phase 3 POETYK PsA-1 trial demonstrated that deucravacitinib significantly improved joint and skin symptoms in adults with active psoriatic arthritis, meeting its primary endpoint with 54.2% of treated patients achieving ACR20 response at week 16 versus 34.1% on placebo. Key secondary endpoints were also met, including significant improvements in skin clearance, physical function, and quality of life measures, alongside evidence of inhibited radiographic progression. The safety profile of deucravacitinib was consistent with previous studies, with no new safety signals identified, supporting its potential as an oral, first-in-class TYK2 inhibitor for psoriatic arthritis management.

Positive Cemdisiran Phase 3 Data Paves Way for Myasthenia Gravis BLA Submission

Regeneron’s cemdisiran met primary and secondary endpoints in the phase 3 NIMBLE trial for generalized myasthenia gravis, showing significant improvements in patient-reported and physician-assessed outcomes over placebo. The siRNA therapy, given quarterly, demonstrated robust efficacy with manageable safety, positioning it for a planned BLA submission in early 2026.

TNX-102 SL Data Supports Recent Fibromyalgia Approval

New phase 3 data from the RESILIENT and RELIEF trials, presented at PAINWEEK 2025, confirmed that TNX-102 SL (Tonmya) significantly reduced pain in fibromyalgia compared with placebo, supporting its recent FDA approval as the first new treatment for the condition in over 15 years. At Week 14 in RESILIENT, patients receiving TNX-102 SL had a mean weekly pain score of 4.1 versus 4.7 with placebo, with all six secondary endpoints also met. The therapy was well-tolerated, with low discontinuation rates and no unexpected safety signals.

Feature Content/Podcasts

Reframing Fibromyalgia Care in 2025: Restricted Impact of TNX-102 SL’s Approval

The FDA approval of TNX-102 SL in August 2025 marked the first new fibromyalgia drug approval in more than 15 years, introducing a sleep-targeted, non-opioid approach aimed at addressing nonrestorative sleep as a core driver of symptoms. Clinicians view the therapy as a meaningful but incremental advance that may benefit selected patients when integrated into multimodal care, rather than a standalone solution for this complex, heterogeneous condition.

Closing the Gap: Collaborating Care to Improve Outcomes in Psoriasis and Psoriatic Arthritis

Experts are calling for earlier, more coordinated detection of psoriatic arthritis, which develops in up to 30% of patients with psoriasis and is often diagnosed years too late. In this HCPLive feature, leading dermatology and rheumatology voices discuss how routine screening, shared treatment strategies, and cross-specialty collaboration can help close diagnostic gaps and prevent irreversible joint damage.