H1 2025 Recap: 7 Rheumatology Updates to Know

The first half of 2025 marked a dynamic period in pulmonology, with major FDA milestones, promising trial readouts, and continued momentum in precision medicine for respiratory conditions. Most notably, the FDA granted landmark approval to mepolizumab as the first biologic for eosinophilic COPD, signaling a shift toward more targeted treatment for a challenging COPD phenotype. Other regulatory progress included FDA acceptance of a gene therapy BLA for recurrent respiratory papillomatosis, an ultrarare disease with no approved treatments, and encouraging steps toward new therapies for pulmonary arterial hypertension and progressive pulmonary fibrosis.

Meanwhile, clinical pipelines produced a mix of breakthroughs and setbacks. Positive results for TPIP and brensocatib suggested new hope for patients with PAH and bronchiectasis—2 historically underserved populations. Nerandomilast also showed statistically significant benefit in progressive pulmonary fibrosis, potentially expanding options for this debilitating disease. However, tezepelumab failed to meet its endpoint in a COPD trial, underscoring the complexity of inflammation-driven phenotypes.

Check out this H1 2025 rheumatology month in review for a recap of HCPLive’s coverage of the top rheumatology news and research from the past few months:

New Approvals for Rare Diseases

FDA Approves Inebilizumab (Uplizna) as First IgG4-RD Therapy for Adults
The FDA has approved inebilizumab-cdon (Uplizna) as the first treatment for adults with immunoglobulin G4-related disease (IgG4-RD), addressing a significant unmet need in this rare autoimmune condition. This approval offers a new therapeutic option for patients previously reliant on less targeted treatments.​

FDA Approves Upadacitinib, Expanding Treatment for Adults With Giant Cell Arteritis
Upadacitinib has received FDA approval for treating adults with giant cell arteritis, providing a new option for managing this inflammatory vascular disease. This expands the therapeutic arsenal for clinicians dealing with this challenging condition.​

High-Impact Data Readouts

SAP-001 Demonstrates “Best in Class” Data for Gout With Hyperuricemia Refractory to SOC XOI Therapy

SAP-001, a novel urate-lowering agent, demonstrated best-in-class efficacy in a Phase 2b trial, with a majority of patients achieving target serum uric acid levels by Month 3. The treatment showed potential for addressing hyperuricemia refractory to standard xanthine oxidase inhibitor (XOI) therapy.

REGENCY: Obinutuzumab Proves Efficacy in Lupus Nephritis
Use of obinutuzumab (Gazya/Gazyvaro) was superior to standard of care therapy alone for achieving a complete renal response in patients with active lupus nephritis, according to results from the phase 3 REGENCY trial.

Rosnilimab Demonstrates Historic Responses for Rheumatoid Arthritis

Rosnilimab has demonstrated historic American College of Rheumatology (ACR) and clinical disease activity index (CDAI) low disease activity (LDA) responses in patients with rheumatoid arthritis (RA) in new findings from a phase 2b trial.

New Data Support TNX-102 SL Efficacy Ahead of PDUFA

TNX-102 SL, a sublingual cyclobenzaprine formulation, showed significant efficacy in reducing pain and improving sleep disturbance in fibromyalgia patients in the phase 3 RESILIENT study, with benefits sustained over 14 weeks. The phase 1 PK study demonstrated that TNX-102 SL achieves higher dynamic peak cyclobenzaprine levels with reduced exposure to its active metabolite norcyclobenzaprine, which may contribute to more durable effects compared to oral formulations. If approved by its August 15, 2025 PDUFA date, TNX-102 SL could become the first new FDA-approved fibromyalgia therapy in over 15 years and a novel non-opioid analgesic option for this challenging chronic pain condition.

Phase 3 Deucravacitinib Trial Meets ACR20 End Point in PsA

The phase 3 POETYK PsA-1 trial demonstrated that deucravacitinib significantly improved joint and skin symptoms in adults with active psoriatic arthritis, meeting its primary endpoint with 54.2% of treated patients achieving ACR20 response at week 16 versus 34.1% on placebo. Key secondary endpoints were also met, including significant improvements in skin clearance, physical function, and quality of life measures, alongside evidence of inhibited radiographic progression. The safety profile of deucravacitinib was consistent with previous studies, with no new safety signals identified, supporting its potential as an oral, first-in-class TYK2 inhibitor for psoriatic arthritis management.