Q4 2025 Recap: Rheumatology News and Updates

The fourth quarter of 2025 delivered a steady stream of regulatory milestones and late-stage data that continue to reshape the rheumatology landscape, with particularly notable momentum in systemic lupus erythematosus (SLE) and lupus nephritis. Headlining the quarter was the United States (US) Food and Drug Administration (FDA) approval of obinutuzumab for lupus nephritis, supported by robust phase 2 and phase 3 data demonstrating meaningful improvements in renal response, serologic markers, corticosteroid reduction, and proteinuria. Additional regulatory progress, including the FDA approval of inebilizumab-cdon for generalized myasthenia gravis, underscored the growing impact of targeted B-cell–directed therapies across immune-mediated diseases.

Beyond approvals, a deep and increasingly diverse pipeline highlighted ongoing innovation in rheumatology. Phase 3 results with telitacicept and positive phase 2b data for orelabrutinib reinforced the central role of B-cell modulation in SLE, while sonelokimab advanced as a promising dual IL-17A/IL-17F therapy for psoriatic arthritis. Real-world evidence further strengthened confidence in newly approved agents, with post-approval data for obinutuzumab demonstrating durable kidney protection even in refractory lupus nephritis.

Check out this recap of what made headlines in Q4 of 2025:

FDA News

FDA Approves Obinutuzumab for Lupus Nephritis

On October 20, 2025, the FDA approved Genentech’s obinutuzumab (Gazyva) for the treatment of lupus nephritis. The decision was based on positive results from the phase 2 NOBILITY and phase 3 REGENCY studies. In REGENCY, nearly half of the participants (46.4%) on obinutuzumab in combination with standard therapy achieved a complete renal response compared to 33.1% on standard therapy alone, accompanied by clinically meaningful improvements in complement levels and reductions in anti-dsDNA, corticosteroid use, and proteinuria.

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.

A Robust Pipeline

Sonelokimab Demonstrates Psoriatic Arthritis Improvements Over Placebo

Sonelokimab met its primary endpoint in a phase 2 trial, significantly improving psoriatic arthritis signs and symptoms with higher ACR50 response rates at week 12 versus placebo. As a dual IL-17A/IL-17F–targeting nanobody, the therapy demonstrated robust joint and skin efficacy with a favorable safety profile, supporting its continued evaluation in ongoing phase 3 PsA studies.

Telitacicept Significantly Improves Lupus Response Rates Above SOC Alone

Telitacicept significantly improved clinical response rates compared with placebo when added to standard therapy in a phase 3 trial of patients with active SLE, with 67.1% of treated patients achieving a modified SRI-4 response at week 52 versus 32.7% with placebo (P <.001). Although higher rates of treatment-related adverse events were observed, the dual BAFF/APRIL inhibitor demonstrated robust efficacy that supports its potential as an important new addition to the lupus treatment landscape.

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.

Obinutuzumab Shows Durable Kidney Protection and High Remission Rates in Lupus Nephritis, with Bahtiyar Toz, MD

New real-world data presented at ACR Convergence 2025 showed obinutuzumab maintained efficacy and kidney-protective potential in a small, refractory lupus nephritis cohort, with approximately 70% of patients achieving complete or partial remission by 24 months and significant reductions in proteinuria (P <.001) despite lower baseline kidney function. The retrospective single-center analysis supports the durability and tolerability of obinutuzumab following its recent FDA approval, with stable eGFR in most responders and no new safety signals observed.

Deeper Dives

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.

Closing the Gap: Collaborating Care to Improve Outcomes in Psoriasis and Psoriatic Arthritis

Experts are calling for earlier, more coordinated detection of psoriatic arthritis, which develops in up to 30% of patients with psoriasis and is often diagnosed years too late. In this HCPLive feature, leading dermatology and rheumatology voices discuss how routine screening, shared treatment strategies, and cross-specialty collaboration can help close diagnostic gaps and prevent irreversible joint damage.