7 Rheumatology Headlines You Missed in August 2025

In August 2025, rheumatology advanced with major FDA approvals and designations spanning fibromyalgia, rheumatoid arthritis, and lupus. The FDA approved Tonmya as the first new fibromyalgia therapy in 15 years, offering a sublingual, non-opioid approach that targets nonrestorative sleep to improve pain and fatigue. For rheumatoid arthritis (RA), the agency approved SetPoint Medical’s SetPoint System, the first neuroimmune modulation device that leverages vagus nerve stimulation to reduce inflammation. The FDA also granted Breakthrough Device Designation to Santerus AG’s NucleoCapture, an extracorporeal therapy designed to remove cfDNA and NETs from plasma in patients with severe, treatment-refractory systemic lupus erythematosus.

Late-phase trial results highlighted further momentum across autoimmune and inflammatory diseases. Regeneron’s cemdisiran achieved significant efficacy in the phase 3 NIMBLE trial for myasthenia gravis, while rosnilimab maintained durable responses in RA with immune-restorative effects. Novartis’ ianalumab met primary endpoints in two phase 3 trials for Sjögren disease, showing significant activity reduction and a favorable safety profile. In polymyalgia rheumatica, sarilumab demonstrated meaningful improvements in physical and mental health scores, quality of life, and fatigue compared with placebo.

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

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

The FDA has 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.

2. 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.

3. NucleoCapture Gets FDA Breakthrough Designation for Systemic Lupus Erythematosus

The FDA has granted Breakthrough Device Designation to Santerus AG’s NucleoCapture technology for severe, treatment-refractory systemic lupus erythematosus, recognizing its potential to address a critical unmet need. The extracorporeal device selectively removes cfDNA and NETs from plasma, offering a non-immunosuppressive approach now advancing toward pivotal trials.

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. Ianalumab Improves Sjögren Disease Activity in 2 Phase 3 Trials

The phase 3 NEPTUNUS-1 and NEPTUNUS-2 trials showed that ianalumab significantly reduced disease activity in patients with Sjögren disease with active extraglandular involvement, supporting Novartis’ upcoming BLA submission. The therapy, which combines B-cell depletion with BAFF-R signaling blockade, also demonstrated a favorable safety profile, marking a major advance for this population with limited treatment options.

7. Phase 3 Trial Confirms Sarilumab Improves Polymyalgia Rheumatica Outcomes

New data from a phase 3 trial confirm that sarilumab, combined with a short glucocorticoid taper, significantly improved patient-reported outcomes in polymyalgia rheumatica compared with placebo. Benefits included better physical and mental health scores, quality of life measures, and reduced fatigue, reinforcing sarilumab’s role as the first biologic option for this patient population.