The second quarter of 2025 brought critical developments in rheumatology and autoimmune disease, as the FDA advanced several high-impact therapies and new data emerged to support innovative treatments. Regulatory milestones included the first-ever approval of inebilizumab for immunoglobulin G4-related disease, a landmark for this underserved patient population, and expanded indications for upadacitinib in giant cell arteritis, offering clinicians new tools for managing complex inflammatory conditions. Meanwhile, late-stage trial successes for TNX-102 SL in fibromyalgia and deucravacitinib in psoriatic arthritis hinted at promising future options for patients facing chronic pain and joint disease.
Alongside these approvals and data readouts, advances in gout and lupus therapies underscored the ongoing evolution of targeted treatment strategies, with monthly pegloticase regimens showing feasibility for uncontrolled gout and belimumab reaffirming its role in systemic lupus erythematosus. However, an expansive analysis of rheumatoid arthritis trends painted a sobering picture of rising disease burden despite progress in treatment, highlighting the need for renewed global efforts in prevention and early intervention.
Check out this Q2 2025 rheumatology month in review for a recap of HCPLive’s coverage of the top rheumatology news and research from the past few months:
New Therapies Address Unmet Needs
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.
New Data Support TNX-102 SL Efficacy Ahead of PDUFA
TNX-102 SL, a sublingual cyclobenzaprine formulation, showed significant efficacy in reducing pain and improving sleep disturbance in fibromyalgia patients in the phase 3 RESILIENT study, with benefits sustained over 14 weeks. The phase 1 PK study demonstrated that TNX-102 SL achieves higher dynamic peak cyclobenzaprine levels with reduced exposure to its active metabolite norcyclobenzaprine, which may contribute to more durable effects compared to oral formulations. If approved by its August 15, 2025 PDUFA date, TNX-102 SL could become the first new FDA-approved fibromyalgia therapy in over 15 years and a novel non-opioid analgesic option for this challenging chronic pain condition.
EULAR Data Readouts
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.
Higher Dose Pegloticase Q4W Feasible for Uncontrolled Gout
The phase 4 FORWARD trial suggests that once-monthly (Q4W) dosing of pegloticase at 16 mg or 30 mg, combined with methotrexate, can maintain serum urate control in most patients with uncontrolled gout, with 68-73% achieving sustained sUA responses through month 6. These findings indicate that less frequent pegloticase infusions could improve treatment logistics and adherence while maintaining comparable safety and efficacy to the established Q2W regimen. Importantly, infusion reaction rates were low and consistent with prior studies, supporting monthly pegloticase as a feasible alternative for patients struggling with the burden of biweekly therapy.
Belimumab Superior to Placebo in Yielding Systemic Lupus Erythematosus Responses
A meta-analysis of five Phase 3 trials has confirmed the efficacy of belimumab in systemic lupus erythematosus (SLE) using the BICLA responder index. The pooled analysis of over 3000 patients showed significantly higher BICLA response rates with belimumab versus placebo, particularly in those with high disease activity or serologic markers. The therapy was also more effective when combined with antimalarials, reinforcing its clinical utility in SLE management.
Arthritis Burden Soars Globally
Rheumatoid Arthritis Burden Has Surged Over Last 30 Years
A large AI-driven analysis of rheumatoid arthritis (RA) trends across 953 global locations revealed a 13.2% rise in RA incidence since 1990, affecting 17.9 million people in 2021, with a shift toward younger populations. While age-standardized RA mortality dropped by 32.7% since 1980, global RA-related DALYs nearly doubled, highlighting an expanding burden despite medical advances. The study also pinpointed local hotspots—like West Berkshire, UK, with the highest incidence—and demonstrated that targeted interventions, such as smoking reduction, could substantially lower RA burden, emphasizing the importance of localized strategies beyond socioeconomic status alone.