7 Rheumatology Headlines You Missed in September 2025

September 2025 brought a wave of impactful developments in rheumatology, spanning FDA approvals, trial data, and real-world insights. Among the key highlights was the FDA’s decision to approve guselkumab for pediatric patients with psoriasis and psoriatic arthritis, expanding treatment options for children with these conditions. Data from the KEEPsAKE and SLEek trials reinforced the long-term durability of risankizumab in psoriatic arthritis and upadacitinib in systemic lupus erythematosus, while golimumab showed a potential steroid-sparing effect in early PsA.

Emerging therapies also gained traction, with tigulixostat demonstrating superior urate-lowering efficacy over febuxostat in gout and TNX-102 SL confirming benefits that supported its recent fibromyalgia approval. In addition, a real-world study highlighted GLP-1 receptor agonists as promising tools to improve both disease activity and cardiometabolic health in patients with rheumatoid arthritis, reflecting a growing focus on therapies that target overlapping inflammatory and metabolic pathways.

Check out this September 2025 rheumatology month in review for a recap of HCPLive’s coverage of the top news and research from the past few weeks:

1. Adding Golimumab to Treatment Regimen Reduced Rescue Corticosteroid Use in People With Early PsA

A randomized trial of 84 treatment-naïve patients with early psoriatic arthritis found that adding golimumab to methotrexate did not significantly improve Psoriatic Arthritis Disease Activity Score at 24 weeks compared with methotrexate alone. Patients in the placebo plus methotrexate group required more rescue corticosteroids (49% vs 21%), highlighting a potential steroid-sparing effect of golimumab. Safety was comparable between groups, with no unexpected adverse events reported.

2. 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.

3. Tigulixostat Proves Superiority to Febuxostat in Patients with Gout and Hyperuricemia

A phase 2 trial of tigulixostat, a novel xanthine oxidase inhibitor from Innovent Biologics, showed substantially greater urate-lowering efficacy than febuxostat in patients with gout and hyperuricemia. By week 16, 86% of patients on tigulixostat 200 mg achieved serum urate <360 µmol/L versus 18% with febuxostat, with dose-dependent benefits observed across all treatment groups. The therapy was well-tolerated with no signal of renal toxicity, supporting advancement to phase 3 trials later in 2025.

4. GLP-1 RA Use Improves Disease Activity, Cardiovascular Risk in Rheumatoid Arthritis

A retrospective study of patients with rheumatoid arthritis and overweight or obesity found that GLP-1 receptor agonists were associated with improvements in disease activity, pain, and cardiometabolic risk factors. Compared with controls, patients receiving semaglutide or tirzepatide had greater reductions in RA activity scores, weight, cholesterol, HbA1c, and inflammatory markers, though discontinuation rates were notable due to gastrointestinal side effects and insurance issues.

5. 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.

6. Upadacitinib Alone and With Elsubrutinib Continue to Yield SLE Responses in Long-Term Data

A long-term extension of the phase 2 SLEek trial showed that upadacitinib monotherapy and the upadacitinib/elsubrutinib combination maintained or improved efficacy in systemic lupus erythematosus through 104 weeks. Patients on active therapy achieved sustained responses across multiple endpoints, including SRI-4, BICLA, and LLDAS, with continued reductions in glucocorticoid use and flare frequency. Safety findings were consistent with prior data, with no new safety signals observed.

7. Risankizumab Shows Durable GRAPPA Improvements for PsA

A post hoc analysis of the phase 3 KEEPsAKE trials showed that risankizumab provided durable improvement across all GRAPPA-defined domains of psoriatic arthritis through 100 weeks. Patients experienced sustained benefits in joint, skin, nail, enthesitis, dactylitis, and axial disease outcomes, with most showing no radiographic progression at week 100. Rates of new-onset or flare of inflammatory bowel disease and uveitis were low, and about two-thirds of patients achieved low disease activity or remission by 2 years.