American College of Rheumatology (ACR) Convergence | Chicago | 2025 | iPharmaCenter

Bristol Myers Squibb

Bristol Myers Squibb Unveils Promising Sotyktu Results for Psoriatic Arthritis and Lupus at ACR Conference

Bristol Myers Squibb has unveiled new data from late-breaking clinical studies highlighting the promise of Sotyktu (deucravacitinib) in treating both psoriatic arthritis (PsA) and systemic lupus erythematosus (SLE). These findings, from the pivotal Phase 3 POETYK PsA-1 trial and integrated Phase 2 PAISLEY-SLE and long-term extension studies.

Psoriatic Arthritis Results:

The Phase 3 POETYK PsA-1 trial enrolled adults with active psoriatic arthritis who had not received prior biologic DMARD therapy. Sotyktu demonstrated meaningful clinical improvement, sustained through 52 weeks. At Week 16, 54.2% of patients taking Sotyktu achieved a 20% improvement (ACR20 response), compared to 34.1% in the placebo group. These benefits further increased and remained stable at Week 52 for those on continuous Sotyktu (63.1%), and similarly in patients who switched from placebo to Sotyktu after 16 weeks (60.8%).

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Sotyktu also slowed the progression of joint damage, as measured by radiographic scores, when compared to placebo. A significant proportion of patients (over 73% in the continuous-treatment group) saw no progression in joint damage out to Week 52. Additionally, the therapy improved multiple disease activity measures and patient-reported symptoms, with comparable trends seen in more stringent response criteria (ACR50 and ACR70).

Systemic Lupus Erythematosus Results:

In patients with moderate-to-severe SLE, integrated analyses of the PAISLEY-SLE and its long-term extension demonstrated that Sotyktu maintained efficacy and safety for up to four years. The drug helped patients sustain disease control across multiple composite endpoints—including SLE Responder Index-4, BICLA, and measures for low disease activity and cutaneous symptoms.

Long-term safety results remained stable, with adverse event and discontinuation rates consistent across dosing regimens.

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Bristol Myers Squibb Reports Promising Early Data for CAR T Therapy in Autoimmune Disease

Bristol Myers Squibb (BMS) today revealed encouraging results from its Phase 1 Breakfree-1 study of the investigational BMS-986353 (also known as CC-97540) CD19 NEX-T CAR T-cell therapy in three difficult-to-treat autoimmune conditions.

Key Findings

• The study included 71 treated patients across three disease cohorts: Systemic sclerosis (SSc), Systemic lupus erythematosus (SLE) and Idiopathic inflammatory myopathies (IIM).

• A striking 94 % of evaluable patients were able to stop chronic immunosuppressive therapy at the time of analysis.

• In the SSc cohort (26 treated, 19 evaluable), patients with SSc-interstitial lung disease saw a median 10 % increase in forced vital capacity (pFVC) at six months, a result rarely seen with other therapies.

• In the SLE cohort (32 patients treated, 26 evaluable at the selected dose), almost all efficacy-evaluable patients experienced symptom resolution, and 92 % remained off SLE-specific immunosuppressants at evaluation.

• In the IIM cohort (13 treated, 11 evaluable), 91 % reached a moderate or major response, with muscle strength improving by ~17 % at 3 months and ~22 % at 6 months.

• The safety profile was consistent with expectations for CAR T therapies: most adverse events occurred shortly after infusion and were low-grade and resolved quickly.

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UCB

New Three-Year Data for Bimzelx Signal Long-Term Control in Psoriatic Arthritis and Axial Spondyloarthritis

UCB today unveiled compelling three-year results from Phase 3 trials and open-label extensions of its dual IL-17A/IL-17F inhibitor Bimzelx (bimekizumab) in adults with active psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), including non-radiographic (nr-axSpA) and ankylosing spondylitis (AS) forms.

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Key findings at a glance

• In patients with PsA, improvements achieved at one year in core domains—including peripheral arthritis, dactylitis, enthesitis, skin psoriasis and nail psoriasis—were maintained at year three.

• Among axSpA patients (nr-axSpA and AS), half of those who reached the stringent Ankylosing Spondylitis Disease Activity Score (ASDAS) low disease activity (< 2.1) by week 16 never lost that status at any assessed visit over 3 years.

• Real-world observational data show early improvements in quality-of-life measures: some benefits were seen as early as Week 2, and further gains observed by Week 24 in both PsA and axSpA patients.

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NOVARTIS

Novartis’ Ianalumab Shows Strong Efficacy in Sjögren’s Disease Phase III Trials

Novartis announced promising Phase III results for its investigational therapy ianalumab, marking the first time a drug has demonstrated both reduced disease activity and patient burden in Sjögren’s disease.

The twin NEPTUNUS-1 and NEPTUNUS-2 trials met their primary endpoints, showing significant reductions in disease activity along with broad clinical benefits and a favorable safety profile.

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Across both studies, ianalumab 300 mg administered monthly produced meaningful improvements in disease activity and quality of life. Reductions in disease severity were observed as early as Week 16 and were maintained through Week 52, as measured by the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI).

The NEPTUNUS program included data from 219 clinical sites across 35 countries, enrolling patients with active, systemic manifestations of the disease. Participants receiving ianalumab achieved statistically significant improvements in ESSDAI scores compared to placebo at Week 48, confirming sustained treatment benefits over one year.

Consistent Gains Across Secondary Measures

Patients treated with ianalumab demonstrated improvements in several physician- and patient-reported outcomes, including:

• A higher proportion achieving low disease activity by ESSDAI criteria

• Better scores on Physician Global Assessment and Patient Global Assessment

• Noticeable reduction in overall disease burden from Week 8 onward

• Reported improvements in dryness, pain, and fatigue as measured by patient diaries and standardized indices

• Enhanced salivary flow rates and reduced oral dryness in patients with measurable baseline secretion

While some patient-reported outcomes reached numerical rather than statistical significance, trends were consistently in favor of ianalumab across both studies and pooled analyses.