Spotlighting Dazodalibep Ahead Of Phase III Data In Sjogren’s

Research evidence excerpt

Spotlighting Dazodalibep Ahead Of Phase III Data In Sjogren’s

that present with a high symptom

burden despite low systemic activity (per available literature). The ESSPRI (EULAR Sjogren’s

Syndrome Patient Reported Index) was co-developed with the ESSDAI to address this gap. The

ESSPRI consists of three domains (i.e., dryness, fatigue, and pain) that are scored by the patient

on a 0-10 scale (0 being no symptoms and 10 being maximally severe).

A word on dazodalibep’s Phase III study design, Phase II data, and the potential regulatory

pathway to an approval. AMGN’s Phase III studies are in patients with moderate-to-severe

systemic disease activity and in patients with moderate-to-severe symptomatic burden with low

systemic disease activity. The former group is including patients with an ESSDAI score at least 5,

while the latter group is including patients with ESSDAI of less than 5 and ESSPRI of at least 5.

Notably, to our knowledge AMGN, is the only company with a drug in development for Sjogren’s

syndrome that is running its pivotal studies in this manner.

In the AMGN Phase II study (which used the same inclusion criteria as above), 74 patients with

moderate-to-severe systemic disease activity (Population 1) were randomized 1:1 to dazodalibep

or placebo, and 109 patients with low systemic disease activity with high symptom burden

(Population 2) were randomized 1:1 to dazodalibep or placebo. Both studies met their respective

primary endpoints at week 24, with Population 1 showing a placebo-adjusted reduction from

baseline ESSDAI of 2.2 (p=0.0167) and Population 2 showing a placebo-adjusted reduction from

baseline ESSPRI of 1.3 (p=0.0002). Notably, change from baseline ESSPRI in Population 1 was

not statistically significant.