5 Rheumatology Headlines You Missed in December 2025

December 2025 delivered a diverse set of advances across rheumatology, spanning autoimmune neuromuscular disease, systemic lupus erythematosus (SLE), osteoarthritis, and chronic pain syndromes. Regulatory momentum was highlighted by the FDA approval of inebilizumab-cdon for generalized myasthenia gravis, while late-stage clinical data for orelabrutinib and retatrutide underscored continued progress toward more targeted, mechanism-driven therapies across inflammatory and metabolic–musculoskeletal disease.

At the same time, emerging nonpharmacologic and symptom-focused strategies gained visibility, particularly in fibromyalgia, where both neuromodulation with transcutaneous auricular vagus nerve stimulation and the recent approval of TNX-102 SL reflect a broader shift toward multimodal care.

Check out this December 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 Inebilizumab-cdon (Uplizna) for Generalized Myasthenia Gravis

On December 11, 2025, the FDA approved inebilizumab-cdon for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-AChR or anti-MuSK antibody positive, expanding treatment options with a targeted therapy. Supported by data from the phase 3 MINT trial, the CD19-targeting monoclonal antibody demonstrated durable improvements in disease activity with a twice-yearly maintenance dosing schedule following initial loading.

2. Orelabrutinib Achieves Primary Endpoint in Phase 2b SLE Trial

Orelabrutinib met its primary endpoint in a phase 2b, randomized, placebo-controlled trial, with significantly more patients with SLE achieving an SRI-4 response at week 48 with the 75 mg once-daily dose compared with placebo (57.1% vs 34.4%; P <.05), alongside improvements in SRI-6 and BICLA responses. The CNS-penetrant BTK inhibitor was generally well tolerated and has now received regulatory approval to advance into a phase 3 registrational trial, supporting its potential as a novel targeted therapy for SLE.

3. TRIUMPH-4: Retatrutide Delivers Weight Loss, Knee Osteoarthritis Pain Relief

Eli Lilly announced positive topline results from the phase 3 TRIUMPH-4 trial showing that investigational retatrutide 9 mg and 12 mg met all primary and key secondary endpoints in adults with obesity or overweight and knee osteoarthritis, significantly improving body weight, pain, and physical function at 68 weeks. The first-in-class GIP/GLP-1/glucagon triple agonist delivered up to nearly 29% average weight loss alongside substantial reductions in WOMAC pain scores, supporting its potential as a novel therapeutic option for obesity complicated by osteoarthritis.

4. taVNS Reduces Pain, Improves Mood in Fibromyalgia Patients

A recent study found that both left-sided and bilateral transcutaneous auricular vagus nerve stimulation (taVNS) significantly reduced pain and improved mood and functional outcomes in patients with fibromyalgia, with no meaningful differences in autonomic safety between approaches. The findings support taVNS as a safe, noninvasive adjunctive option for fibromyalgia management, though larger studies are needed to determine whether one stimulation strategy offers superior clinical benefit.

5. 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.