Amgen today announced the presentation of new data across rare autoimmune and inflammatory diseases at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress, taking place from June 3-6 in London.
New data from the Phase 3 MITIGATE trial of UPLIZNA® (inebilizumab) provide insights into the biology of immunoglobulin G4-related disease (IgG4-RD),1 while additional analyses support its long-term safety profile and sustained results in IgG4-RD.2 Additionally, new real-world evidence on TAVNEOS® (avacopan) further support its established efficacy and safety profile with reduced steroid use in people living with anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis.3
“Patients living with rare autoimmune diseases still face significant unmet medical needs despite advances in treatment, with conditions often being difficult to diagnose and challenging to manage,” said Paul Burton, M.D., Ph.D., chief medical officer at Amgen. “The data we’re presenting at EULAR deepen our understanding of disease biology and demonstrate the strength of our portfolio of options for patients with these conditions, reflecting our commitment to advancing the science and delivering meaningful progress for patients.”
Key presentations include:
Long-term Efficacy and Safety of Inebilizumab in IgG4-Related Disease: Primary Results from Year 1 of the Open-Label Period (OLP) of the Phase 3 MITIGATE Trial
Abstract #POS0440, Poster View 1 (Poster View Presentation), Wednesday, June 3 from 3:30–4:30 p.m. BST
IgG4-RD is a chronic and debilitating condition, marked by recurrent, unpredictable flares that can potentially impact multiple organs.4,5 New Phase 3 MITIGATE data further support the longer-term clinical profile of UPLIZNA.
Key findings include:
- In the first year of the OLP, these data demonstrated sustained results and disease control with continued UPLIZNA treatment in patients with IgG4-RD.
- No patients (0%) who received UPLIZNA in the randomized controlled period (RCP) and continued with UPLIZNA in the OLP (N=56) experienced a flare, and 71.4% achieved flare-free, glucocorticoid-free complete remission at year 1 of the OLP.2
- 5.9% of patients who received placebo in the RCP and transitioned to UPLIZNA in the OLP (N=51) experienced a flare, and 41.2% achieved flare-free, glucocorticoid-free complete remission at year 1 of the OLP.2
- Safety results were consistent with the established safety profile of UPLIZNA. The most common adverse events in the OLP were COVID-19, upper respiratory tract infection, cough and influenza.2
- Across the combined RCP and OLP period, median total UPLIZNA treatment exposure was 2.2 years among participants who received ≥1 dose of inebilizumab.2
“For clinicians, a sustained reduction in flares and timely intervention are central to improving long-term outcomes,” said John Stone, M.D., M.P.H., principal investigator and a professor of medicine at Harvard Medical School and the Edward A. Fox Chair in Medicine at the Massachusetts General Hospital. “The new MITIGATE data reinforce the long-term safety and efficacy profile of UPLIZNA while advancing our understanding of how IgG4-RD progresses over time. These findings may help clinicians identify opportunities for earlier intervention and reduce avoidable flares.”
Natural History of IgG4-RD: Patterns of Organ Involvement and Flare-associated Biomarker Changes in the Phase 3 MITIGATE Trial
Abstract #OP052, Basic and Clinical Abstract Sessions: Insights in Other Diseases (Oral Abstract Presentation), Wednesday, June 3 from 4:30–4:40 p.m. BST
The first-of-its-kind natural history analysis reinforced the chronic and unpredictable nature of IgG4-RD, underscoring widespread and diverse multi-organ involvement and the need for earlier intervention and more comprehensive monitoring and risk stratification.
Key findings include:
- Dynamic patterns of organ involvement over time, including the emergence of new organ manifestations and biological signals that may precede disease flares.
- CD19+ B cells were the first biomarker to rise ahead of a flare, followed by increases in total IgG and IgG subsets within the 30-day window preceding a flare.
An additional exploratory combined analysis (Abstract #POS0089) of clinical trial RCP and OLP data in MITIGATE (N=119) showed how long-term use of UPLIZNA resulted in mostly mild immunoglobulin (Ig) reduction, with no significant association between these Ig reductions and occurrence of infections or serious infections. The incidence of infections and serious infections did not increase with each additional year of UPLIZNA treatment.
