In this interview, Dr. Alevizos described the major takeaways from his team’s findings on this drug for Sjögren's Syndrome.
In this HCPLive interview, Ilias Alevizos, DMD, PhD, the executive director of clinical development for Amgen, discussed his team’s findings on dazodalibep for Sjögren's Syndrome.
The findings were presented at the annual American College of Rheumatology 2023 Convergence meeting in San Diego, California.
“So the dazodalibep in Sjögren's syndrome is a phase 2 trial,” Alevizos said. “It's now completed. We previously presented primary endpoint results, which was at day 169. We examined 2 different Sjögren's populations. I will call population 1, patients with moderate to severe systemic disease activity and population 2 is composed of patients primarily with high symptomatic burden.”
Alevizos explained that for these patients, it is usually dryness, pain, and fatigue, but low systemic disease activity.
“So the primary endpoint, as I mentioned, was at Day 169,” he said. “But at that point, it was a crossover. So participants on the dazodalibep switch onto placebo and participants on placebo switch to dazodalibep.”
He explained that the study contiunued for 6 more months after that.
“In this current ACR, we present the results of the stage 2 after the crossover,” Alevizos said. “But let’s go back a little bit and discuss, as you asked about the primary endpoint on what we observed previously. So for the primary endpoint for population 1, the patients with moderate to high systemic disease activity, the primary endpoint was ESSDAI, which is Systemic Disease Activity Index. It's the most commonly used for Sjögren's studies. It's composed of 12 different domains.”
In this population, Alevizos’s team observed a statistically significant and clinically meaningful difference by day 169, which was more than 2 points over placebo.
“For population 2, the primary endpoint was called ESSPRI, which is a patient reported index composed of 3 different scales, rating pain, dryness and fatigue,” Alevizos said. “So we are very happy to say that this is the first study that has met both primary endpoints for 2 distinct populations.”
To learn more about Alevizos’s team’s findings, view the full interview segment posted above.
The quotes contained in this summary article were edited for clarity.