Amgen Discloses Phase 3 Sjögren’s Data Ahead of ACR Convergence 2026

Amgen on October 27, 2026 announced plans to present new data across its portfolio in rare and other serious autoimmune diseases at the American College of Rheumatology (ACR) Convergence 2026, led by late-breaking results from the Phase 3 OASIZ-301 study of dazodalibep in adults with Sjögren’s disease and moderate-to-severe systemic disease activity.

The OASIZ-301 presentation is scheduled as Late-Breaking Abstract #22 on Wednesday, November 11, 2026, from 8:45 to 9:00 a.m. ET. The underlying abstract, first published October 20, 2026, on the ACR’s meeting-abstracts site, reports that 648 patients were randomized 1:1:1 to dazodalibep 1,500 mg intravenously every four weeks (217 patients), dazodalibep 3,000 mg intravenously every 12 weeks (217 patients), or placebo (214 patients). Amgen’s announcement describes the study as enrolling approximately 621 patients.

Patients entered OASIZ-301 with an average European Alliance of Associations for Rheumatology Sjögren’s Syndrome Disease Activity Index score of 10.2. At Week 48, disease activity scores improved by a least-squares mean change from baseline of -5.6 points in patients receiving dazodalibep every four weeks (difference versus placebo, -1.8; adjusted p<0.001) and -5.2 points in those treated every 12 weeks (difference versus placebo, -1.4; adjusted p=0.010), compared with -3.8 points for placebo, the company reported. Amgen (AMGN ) said treatment effects were observed as early as four weeks and characterized the reductions as statistically significant and clinically meaningful.

The every-four-week regimen also improved the key secondary endpoint of patient-reported dryness. Patients reported greater reductions in dryness on both the EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) dryness score (least-squares mean change from baseline, -2.50 versus -1.33 for placebo; adjusted p<0.001) and the Diary for Assessing Sjögren’s Patient Reported Index (DASPRI) dryness score (-1.98 versus -1.05; adjusted p<0.001), according to the announcement. The ACR abstract states the corresponding differences versus placebo were -1.17 for ESSPRI dryness and -0.93 for DASPRI dryness.

Treatment emergent adverse events, serious adverse events, and treatment emergent adverse events leading to discontinuation occurred at similar rates across treatment groups, both the announcement and the abstract state. When Amgen reported topline results on September 22, 2026, it said the most common adverse events, defined as at least 5% incidence and reported at a higher rate than placebo, were nasopharyngitis, urinary tract infection, hypertension, and infusion-related reactions, generally mild to moderate in nature, with no imbalance in thromboembolic events or opportunistic infections across treatment arms.

According to the ACR abstract, OASIZ-301 (NCT06104124) was a 48-week, international, multicenter, randomized, double-blind, placebo-controlled study in adults aged 18 and older meeting ACR/EULAR 2016 classification criteria with an ESSDAI score of at least 5; patients with concomitant rheumatoid arthritis or systemic lupus erythematosus were eligible. The primary endpoint was change from baseline in ESSDAI at Week 48, and key secondary endpoints evaluated dryness, tender and swollen joints, fatigue, and ESSDAI5 response, defined as a decrease of at least 5 points from baseline. Safety was assessed through Week 56 for patients who did not continue into the long-term extension study.

Dazodalibep is a CD40L antagonist that disrupts interactions between T cells, glandular epithelial cells, B cells, and other antigen-presenting cells; Amgen describes it as a potential first-in-class fusion protein. The company is studying it in two Sjögren’s patient groups: those with moderate-to-severe systemic disease and those with high symptom burden and low systemic disease activity.

“For patients living with Sjögren’s disease, systemic disease activity and symptoms can have a significant impact on their health and daily lives, yet treatment options remain limited,” said Dr. Teresa K. Tarrant, MD, Associate Professor of Medicine at Duke University. “The rapid improvements in ESSDAI, as well as self-reported dryness, observed with dazodalibep are particularly encouraging.”

Amgen states there are currently no FDA-approved medicines for Sjögren’s disease, which it describes as the second most common autoimmune rheumatic disease. Beyond OASIZ-301, the company is conducting OASIZ 303, a Phase 3 study in patients with high symptom burden and low systemic disease activity that is expected to complete in the fourth quarter of 2026, and OASIZ 304, an open-label long-term extension study for eligible participants from OASIZ 301 and OASIZ 303.

Remaining ACR Convergence Slate

The broader program includes three posters from the open-label period of the Phase 3 MITIGATE trial describing the long-term safety profile and sustained efficacy of UPLIZNA (inebilizumab-cdon) in IgG4-related disease: Abstract #0177 on Sunday, November 8, 2026; Abstract #1129 on Monday, November 9, 2026; and Abstract #2107 on Tuesday, November 10, 2026, each in poster sessions running 10:30 a.m. to 12:30 p.m. ET. UPLIZNA is indicated in adults for anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder, IgG4-related disease, and anti-acetylcholine receptor or anti-muscle specific tyrosine kinase antibody-positive generalized myasthenia gravis; after two initial infusions, patients receive one dose every six months.

Two TAVNEOS (avacopan) posters will cover the effectiveness and safety of avacopan added to standard of care versus standard of care alone in ANCA-associated vasculitis (Abstract #2133) and glucocorticoid-associated conditions in patients with granulomatosis with polyangiitis and microscopic polyangiitis with prolonged moderate-to-high dose glucocorticoid use (Abstract #1156). TAVNEOS is indicated as an adjunctive treatment for adults with severe active ANCA-associated vasculitis in combination with standard therapy including glucocorticoids.

Five KRYSTEXXA (pegloticase) posters are scheduled, including a post hoc analysis of a 2.5-year open-label extension study on induction and maintenance of gout remission (Abstract #0714), real-world attainment and durability of gout remission in a U.S. practice-based rheumatology network (Abstract #0853), induction of clinical remission with pegloticase and immunomodulation in two community rheumatology practices (Abstract #2648), gout-flare patterns in the MIRROR and AGILE clinical trials (Abstract #2657), and real-world immunomodulation co-therapy use among new pegloticase users (Abstract #2653). Amgen states KRYSTEXXA was the first biologic approved by the FDA for adults with uncontrolled gout and that labeling expanded in 2022 to include co-administration with methotrexate based on results from the MIRROR randomized controlled trial.

“The data we’re presenting at ACR demonstrate the breadth of Amgen’s portfolio and pipeline across rare and other serious autoimmune diseases,” said Paul Burton, M.D., Ph.D., senior vice president and chief medical officer at Amgen.