Q3 2025 Recap: Rheumatology News and Updates

Q3 2025 was a landmark quarter for rheumatology news, with both breakthrough United States Food and Drug Administration (FDA) approvals and pivotal trial results reshaping treatment options across autoimmune and inflammatory diseases. Highlights included the long-awaited approval of TNX-102 SL, the first new fibromyalgia therapy in more than 15 years, and the green light for SetPoint Medical’s neuroimmune modulation device for rheumatoid arthritis, representing a novel, non-immunosuppressive approach. The FDA also expanded access to guselkumab for pediatric psoriasis and psoriatic arthritis (PsA), while golimumab showed promise as a steroid-sparing agent in early PsA.

On the clinical front, late-stage trial data advanced multiple pipeline therapies. Dapirolizumab pegol (DZP) significantly improved disease activity and fatigue in systemic lupus erythematosus, while deucravacitinib moved closer to approval in psoriatic arthritis following a positive FDA review. In neuromuscular disease, cemdisiran delivered strong phase 3 results in myasthenia gravis, supporting a BLA submission for 2026, and rosnilimab continued to build momentum with durable efficacy and favorable safety in rheumatoid arthritis.

Check out this Q3 2025 rheumatology month in review for a recap of HCPLive’s coverage of the top rheumatology news and research from the past few months:

1. DZP Significantly Improves Disease Activity, Fatigue in People With SLE

DZP significantly improved disease activity and fatigue in patients with moderate-to-severe SLE, with 40.9% achieving low disease activity at Week 48 compared to 19.6% on standard of care (SOC) alone (P <.0001), according to phase 3 PHOENYCS GO trial data presented at EULAR 2025.
These findings highlight DZP’s potential to achieve key treat-to-target goals such as LLDAS and DORIS remission while minimizing glucocorticoid use.

2. TYK2 Inhibitor Deucravacitinib up for FDA Review for Psoriatic Arthritis

The FDA accepted Bristol Myers Squibb’s sNDA for deucravacitinib in active PsA with a PDUFA date of March 6, 2026, based on phase 3 POETYK PsA trials showing 54.2% of patients achieved ACR20 at week 16 versus 34.1% with placebo (P <.0001). The TYK2 inhibitor also significantly improved PASI 75 response, physical function, fatigue, and radiographic progression, with no new safety signals and a low rate of serious adverse events.

3. 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.

4. 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.

4. 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.

5. 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.

6. 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.

7. 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.