EULAR Annual Meeting in London, UK | 2026 | News | Updates | iPharmaCenter
- Badari Andukuri
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JOHNSON AND JOHNSON
Nipocalimab Shows Stronger Phase 2 Signal in Autoantibody-High Sjögren’s Disease
Nipocalimab is attracting attention at EULAR 2026 as a potential new option for patients with Sjögren’s disease who have a high autoantibody burden. Fresh Phase 2 data from the DAHLIAS study suggest that the patients with the most pronounced serologic activity may be the ones who gain the greatest clinical benefit.
Signal in patients with high autoantibody and IgG levels
DAHLIAS enrolled adults with moderate to severe Sjögren’s disease who received nipocalimab or placebo on top of standard treatment while investigators tracked systemic activity with ClinESSDAI and detailed biomarker profiles.
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In a post hoc analysis, participants who started with elevated disease related autoantibodies and higher IgG levels had stronger responses on nipocalimab, with a reported response rate of 62.5 percent in this subgroup compared with 51.9 percent in the overall nipocalimab treated cohort.
Clinical improvement was reported across the study population, but the larger effect in patients with the highest baseline autoantibody and IgG levels points to a link between immunologic load and treatment benefit.
Earlier DAHLIAS results already showed that nipocalimab produced a statistically significant reduction in ClinESSDAI scores at week 24 compared with placebo, indicating that the impact extends beyond biomarker shifts to measurable changes in systemic disease activity.
Nipocalimab Shows Stronger Phase 2 Signal in Autoantibody‑High Sjögren’s Disease
Mechanism and biomarker changes
Nipocalimab is a monoclonal antibody that targets the neonatal Fc receptor, a key regulator of IgG recycling, and is intended to lower circulating IgG and pathogenic autoantibodies while limiting broader immune suppression.
Nipocalimab Delivers 58.2% SRI‑4 Response vs 36.1% in Autoantibody‑Positive SLE
Johnson & Johnson presented Phase 2 results for nipocalimab in systemic lupus erythematosus, adding to the growing interest in FcRn blockade as a more targeted way to manage an autoantibody-driven disease.
In the JASMINE study, nipocalimab met the primary endpoint at 24 weeks. At that time, 53.5% of patients receiving nipocalimab plus background medication achieved an SRI-4 response, compared with 46.7% in the placebo group plus background therapy. The treatment effect also held through week 52, when 53.6% of patients in the nipocalimab group achieved an SRI-4 response compared with 39.7% in the placebo group plus background therapy.
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The signal was stronger in the predefined autoantibody-positive subgroup, which represents about 80% of people living with SLE. In this group, 58.2% of patients on nipocalimab achieved an SRI-4 response at week 52 versus 36.1% on placebo. Low disease activity, measured by LLDAS, was reached by 38.9% of patients on nipocalimab compared with 18.0% on placebo in the same subgroup.
Across the full study population, 37.5% of patients receiving nipocalimab 15 mg/kg achieved LLDAS at week 52, versus 20.5% with placebo. That pattern suggests the benefit may be more pronounced in patients whose disease is clearly driven by autoantibodies.
Nipocalimab is designed to block the neonatal Fc receptor, which helps reduce pathogenic IgG autoantibodies while aiming to preserve broader immune function. That makes it an appealing concept in SLE, where long-term disease control often depends on therapies that go beyond conventional steroid-based suppression.
Safety findings were in line with earlier experience, and no new safety concerns were reported. The most common adverse events were nasopharyngitis, headache, urinary tract infection and nausea.
UCB
Bimzelx Leads in Head-to-Head PsA Trial, Surpassing Skyrizi at Week 16
Bimzelx (bimekizumab) has demonstrated greater efficacy than Skyrizi (risankizumab) in treating psoriatic arthritis, based on Week 16 results from the BE BOLD trial.
What is the efficacy comparison of Bimzelx vs Skyrizi in psoriatic arthritis?
At Week 16, 49.1% of patients treated with bimekizumab achieved the ACR50 primary endpoint, compared with 38.4% of those receiving risankizumab, confirming statistically significant superiority in joint response outcomes.
This marks the first instance where an approved biologic has shown clear superiority in ACR50 results in a head-to-head psoriatic arthritis study.
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Secondary outcomes generally favored bimekizumab, although not all reached statistical significance.
Minimal disease activity (MDA) at Week 16 was achieved by 43.0% of patients on bimekizumab versus 39.9% on risankizumab. Because the statistical testing hierarchy stopped at this endpoint, subsequent secondary outcomes were evaluated descriptively.
Early response was also more pronounced with bimekizumab. By Week 4, 19.9% of patients achieved ACR50 compared with 7.2% in the risankizumab group, indicating faster onset of joint improvement.
In terms of skin outcomes, complete clearance (PASI100) at Week 16 was observed in 53.4% of patients treated with bimekizumab and 46.6% of those receiving risankizumab.
Additionally, combined ACR50 and PASI100 responses were higher with bimekizumab (33.5% vs 24.4%).
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Further exploratory measures also supported bimekizumab’s efficacy. Low disease activity based on DAPSA (score ≤14) was achieved by 65.3% of patients in the bimekizumab group compared with 54.7% in the risankizumab group.
The safety profiles of both treatments were broadly similar. Treatment-emergent adverse events occurred in 57.0% of patients receiving bimekizumab and 52.0% of those on risankizumab.
The BE BOLD study is a randomized, double-blind, active-controlled trial involving 553 adults with active psoriatic arthritis. Participants included both biologic-naïve patients and those who had previously received one TNF inhibitor with inadequate response or intolerance.
Dapirolizumab Pegol Signals Steroid-Sparing Potential in Phase 3 SLE Trial
Dapirolizumab pegol is drawing attention at EULAR 2026 with Phase 3 data suggesting it may help keep systemic lupus erythematosus (SLE) under control while allowing patients to come down on steroids, a long‑standing challenge in routine care.
Steroid sparing and disease control
In the PHOENYCS GO trial, adding dapirolizumab pegol to background standard therapy was linked to more consistent disease control at lower glucocorticoid doses over 48 weeks than placebo plus standard care.
The signal was particularly clear in patients who entered the study on more than 7.5 mg/day of prednisone (or equivalent): a greater share of those on dapirolizumab pegol were able to taper to 7.5 mg/day or less and stay there through week 48 while still meeting predefined response criteria.
Post hoc analyses suggested that, compared with placebo, a higher proportion of patients on the dapirolizumab pegol arm both maintained reduced steroid doses and met composite endpoints such as BICLA and SRI‑4, or avoided moderate to severe BILAG‑defined flares over the 48‑week period. Although exploratory, these observations reinforce the idea that steroid reduction did not simply come at the expense of losing disease control.
Why this matters in SLE
SLE is a chronic multisystem autoimmune disease in which patients cycle between flare and remission, with the skin, joints, kidneys and other organs at risk over time. Repeated flares and sustained inflammatory activity contribute to irreversible organ damage, morbidity and premature mortality, while long‑term glucocorticoid use is itself linked to fractures, cardiovascular disease, infections and other cumulative toxicities.
Against that backdrop, the PHOENYCS GO data position dapirolizumab pegol as a potential tool for achieving a familiar clinical goal: fewer flares, steadier disease control, and steroids pushed down to safer doses whenever possible. Whether these findings translate into routine use will depend on results from ongoing confirmatory work, including the PHOENYCS FLY Phase 3 trial and future regulatory decisions.
NOVARTIS
Novartis’ Cosentyx Meets Phase III Endpoints in PMR, Cuts Steroid Use
New data from Novartis place Cosentyx (secukinumab) in focus as a potential treatment option for polymyalgia rheumatica (PMR), with Phase III results showing improved disease control and reduced steroid burden compared with placebo.
In the REPLENISH trial, sustained remission at 52 weeks was achieved in 41.2% of patients receiving secukinumab 300 mg and 40.6% of those on the 150 mg dose, compared with 20.4% in the placebo group.
The consistency across both dose arms suggests a robust treatment effect in maintaining disease control over one year.
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Steroid reduction remains a central challenge in PMR management, and the study data point to a clear advantage with secukinumab. Patients in the active treatment groups required lower cumulative glucocorticoid doses over the study period than those receiving placebo, reinforcing its potential as a steroid-sparing therapy.
The trial also showed that patients treated with secukinumab experienced a longer duration before needing additional or rescue treatment, indicating more sustained disease stability.
REPLENISH was designed as a global, randomized, double-blind Phase III study evaluating two dose levels of secukinumab against placebo, all given alongside a standardized 24-week steroid taper. The primary goal was to assess sustained remission at one year, with secondary measures including depth of remission, cumulative steroid exposure, and time to treatment escalation.
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PMR is a chronic inflammatory condition affecting adults over the age of 50, typically presenting with pain and stiffness in the shoulders, neck, and hips. Current treatment strategies rely heavily on glucocorticoids, making therapies that can maintain remission while reducing steroid use an area of significant clinical interest.
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