Horizon Therapeutics plc (Nasdaq: HZNP) announced that its Phase 2 trial evaluating dazodalibep for the treatment of Sjögren’s syndrome met the primary endpoint in patients with moderate-to-high systemic disease activity as defined by the European Alliance of Associations for Rheumatology (EULAR) Sjögren’s Syndrome Disease Activity Index (ESSDAI) score of ≥ 5. At Week 24, patients treated with dazodalibep achieved a 6.3-point reduction in their ESSDAI score and patients treated with placebo achieved a 4.1-point reduction, resulting in a statistically significant least squares mean difference of 2.2 points (p=0.017).

In addition to the primary endpoint, numerical improvements were seen in key secondary, exploratory, and post-hoc analyses. These included measures of dryness, which is an important symptom for patients living with Sjögren’s syndrome as it impacts chewing, swallowing and dentition. Fatigue as measured by Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) and physical functioning measured using the 36-Item Short Form Health Survey (SF-36) showed numerical improvements, as did the number of tender and swollen joints. In addition, a post-hoc responder analysis of patients achieving high levels of improvement on ESSDAI favored dazodalibep over placebo. The trial was only powered for the primary endpoint.

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