OR WAIT null SECS
ACR Convergence 2025 Recap: Late-Breaking Trials to Know
A compilation of 13 trials presented as late-breaking data at ACR Convergence 2025.
The American College of Rheumatology (ACR) Convergence is widely regarded as a premier annual gathering for rheumatology, showcasing cutting-edge research, clinical advances, and discussions that can shape treatment strategies and patient care.
ACR Convergence 2025, held in Chicago, Illinois from October 25–29 and covered by HCPLive Rheumatology, featured two late-breaking sessions presenting 24 studies across a range of rheumatologic conditions.
For this article, the HCPLive Rheumatology editorial team has curated 13 of these late-breaking trials, highlighting key findings clinicians should know from the meeting.
ACR 2025: Sjögren Late-Breakers to Know
Telitacicept Improves Sjögren Symptoms Over Placebo in Phase 3 Trial
Telitacicept, a dual BAFF/APRIL inhibitor, improved systemic disease activity and patient-reported symptoms in Sjögren disease through 48 weeks.
At Week 24, ESSDAI scores fell by −4.4 with 160 mg and −3.0 with 80 mg versus −0.6 on placebo, and these improvements remained robust through Week 48. By Week 48, 73% (160 mg) and 49% (80 mg) achieved ≥3-point ESSDAI reductions compared with 16.5% on placebo, and ESSPRI improved by −2.56 and −1.74 versus −0.41.
NEPTUNUS-1 and 2: Monthly Ianalumab Significantly Improves Sjögren Disease Activity
Ianalumab, an anti–BAFF-R monoclonal antibody, demonstrated significant improvements in disease activity in patients with Sjögren disease (SjD) in the phase 3 NEPTUNUS-1 and NEPTUNUS-2 studies.
In pooled monthly dosing data, patients receiving ianalumab 300 mg monthly showed greater reductions in ESSDAI score compared with placebo (−6.5 vs −5.3; P = .0031) and improvements in Patient Global Assessment (−13.5 vs −8.7; P = .0049). Both studies also reported consistent benefits across secondary endpoints, including low systemic disease activity, oral dryness, and patient-reported outcomes, with a safety profile comparable to placebo.
ACR 2025: Lupus Late-Breakers to Know
REGENCY: Obinutuzumab’s Deep B-Cell Depletion in Kidney Supports Benefit for Lupus Nephritis
Obinutuzumab, a type 2 anti-CD20 antibody, showed profound intrarenal B-cell and plasma cell depletion in lupus nephritis in an exploratory biopsy analysis from the REGENCY trial.
At Week 76, kidney B-cells fell by a median −98.34% with obinutuzumab versus a +29.8% increase on placebo, and plasma cells dropped by 57.13% compared with a 2.74% rise on placebo. Clinically, 46.4% of patients receiving obinutuzumab plus standard therapy achieved complete renal response versus 33.1% with standard therapy alone.
Low-Dose IL-2 Rebalances Immunity in SLE, With Yuebo Jin, MD
Low-dose interleukin-2 (IL-2) demonstrated clinically meaningful improvements in systemic lupus erythematosus (SLE) in a phase 2b trial.
At 1.0 million IU, 60% of patients achieved SRI-4 response criteria compared with 23% on placebo, with additional benefits across skin, hematologic, and renal domains. Treatment also increased complement levels, reduced corticosteroid requirements, and showed lower infection rates, highlighting a favorable safety profile while restoring immune balance.
ACR 2025: Osteoarthritis Late-Breakers to Know
Apoptotic cell therapy, an investigational immunomodulatory cell-based treatment, showed promising efficacy in older adults with moderate-to-severe knee osteoarthritis in the phase 2a ENX-CL-05-001 trial.
At 3 months, patients ≥60 years achieved a 72% relative improvement in WOMAC pain (–27.82 vs –16.22; P = .03) and a 109% improvement in function (–26.45 vs –12.63; P = .007) over placebo. Benefits were even stronger in patients ≥65 years, with total WOMAC improving –27.14 vs –6.03 (P = .0004), and safety findings were mainly transient effusions occurring more often with treatment.
Two-dose adipose-derived mesenchymal stem cells (AdMSC) therapy showed superior improvements in pain, function, and cartilage structure compared with hyaluronic acid (HA) in patients with knee osteoarthritis (KOA).
At 6 months, two-dose AdMSC reduced VAS pain by 3.2 points versus 1.3 points with HA and improved KOOS function by 21.24 versus 11.31 points (P < .001). Structural benefits were also observed, with femoral cartilage thickness increasing by 0.25 mm and MRI-assessed cartilage defects improving by 9.13% in the two-dose AdMSC group, compared with cartilage thinning (−0.06 mm) and defect worsening (0.75%) with HA.
ACR 2025: Fibromyalgia Late-Breakers to Know
Gut Microbiome Modulation by Fiber Enhances RA Methotrexate Response, With Claire Daien, MD, PhD
Fiber supplementation improved clinical response rates and immune balance in rheumatoid arthritis in the randomized SUPERFIBRE trial.
By Day 30, 53.85% of patients receiving fiber achieved a EULAR response versus 21.74% on placebo (P = .04), with an odds ratio of 4.65 (P = .03) after adjustment. Among methotrexate-treated patients, mean ΔDAS28 was −1.00 with fiber compared with 0.34 with placebo (P = .011), and treatment was well tolerated with >90% compliance.
TENS With Physical Therapy Meaningfully Reduced Fibromyalgia Movement-Evoked Pain
Transcutaneous electrical nerve stimulation (TENS), a non-invasive neuromodulation approach, improved movement-evoked pain and related symptoms when added to routine physical therapy in the pragmatic FM-TIPS trial.
At Day 60, MEP was lower with PT+TENS (mean −1.1; 95% CI, −1.58 to −0.7) and 41% achieved ≥30% MEP reduction versus 13% with PT alone (P = .0001). Resting pain improvements were also greater (30% vs 21%; P = .004), with benefits across fatigue measures and no serious treatment-related adverse events.
ACR 2025: PsA Late-Breakers to Know
AgAIN: Secukinumab Outperforms Ustekinumab in Post-TNFi Psoriatic Arthritis, With Frank Behrens, MD
Secukinumab, an IL-17A–inhibiting biologic, showed superior efficacy to ustekinumab in TNFi-experienced PsA in the head-to-head AgAIN trial.
At Week 28, 57.1% of secukinumab-treated patients achieved a HAQ-DI response versus 27.0% with ustekinumab (OR 3.647; 95% CI, 1.601–8.311; P = .002). Secukinumab also delivered faster and broader improvements across joints, skin, pain, and enthesitis, while the ustekinumab group had higher discontinuation rates due to loss of efficacy.
New data on IL-17–targeting therapies, including bimekizumab, sonelokimab, and izokibep, highlight evolving treatment strategies in PsA.
Patients achieving “state zero” with bimekizumab, defined as complete resolution of swollen joints, enthesitis, and radiographic progression, experienced substantial improvements in pain, function, and quality of life.
More ACR 2025 Late-Breakers to Know
ROC-SpA: IL-17i Not Superior to Cycling TNFi Post-Failure in AxSpA
Switching to an IL-17 inhibitor did not outperform cycling to a second TNF inhibitor in axial spondyloarthritis in the phase 4 ROC-SpA trial.
At week 24, ASAS40 responses were similar between IL-17i and TNFi groups (15.2% vs 14.5%; P not significant), and no secondary endpoints showed statistical differences. Subgroup trends hinted at potential advantages for IL-17i in patients with primary nonresponse, psoriasis, HLA-B27–negative status, or low CRP, but overall disease activity improvements were comparable, with mean ASDAS reaching 2.5 in both groups.
Mepolizumab Demonstrates Benefit for End Organ Dysfunction in EGPA and HES
Mepolizumab, an anti–IL-5 biologic, demonstrated improvements across cardiac, renal, and vascular systems in patients with eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES) in a large real-world analysis.
In patients with EGPA, mepolizumab significantly improved acute kidney failure (P = .026) and chronic kidney disease stage 3 (P = .009) compared with standard-of-care therapy. Among patients with HES, mitral regurgitation (P <.001) and venous thrombosis (P = .009) were also reduced, highlighting its effectiveness in reducing end-organ dysfunction across multiple systems.
Rosnilimab: A New Era of Upstream RA Disease Control, With Jonathan Graf, MD
Rosnilimab, a novel monoclonal antibody targeting pathogenic T cells, demonstrated rapid and meaningful clinical improvements in patients with moderate to severe rheumatoid arthritis (RA) in a phase 2b trial.
At week 12, all rosnilimab dosing arms achieved significantly greater reductions in DAS28-CRP compared with placebo (–2.06 to –2.12 vs –1.69; P < .01). Improvements were also seen across ACR20/50/70 responses and CDAI low disease activity, with benefits sustained through week 28 and maintained off therapy through week 38.
