Overall, the study found dazodalibep was generally safe and well tolerated, with limited serious adverse events. Larger clinical trials are warranted to further determine effectiveness and safety.
“As reported in another abstract from EULAR 2023, a 20-week course of dazodalibep infusions also reduced the signs and symptoms of extraglandular involvement in those patients with Sjogren’s [disease] with at least moderately active systemic disease, as defined by an ESSDAI of ≥5,” says E. William St.Clair, MD, the lead investigator in this study and chief of the Division of Rheumatology and Immunology, Duke University School of Medicine, Durham, N.C.6 “Taken together, these results provide evidence that dazodalibep therapy for Sjögren’s [disease] has an acceptable balance of efficacy and safety for controlling systemic disease activity, as well as reducing symptoms of dryness, fatigue and pain.”
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- St. Clair EW, Alecios I, Rees W, et al. Dazodalibep (VIB4920/HZN4920) in Sjögren’s subjects with an unacceptable symptom burden: Safety and efficacy from a phase 2, randomized, double-blind study [abstract LB0003]. Ann Rheum Dis. 2023;82:201.
- Sandoval-Flores MG, Chan-Campos I, Hernández-Molina G. Factors influencing the EULAR Sjögren’s Syndrome Patient-Reported Index in primary Sjögren’s syndrome. Clin Exp Rheumatol. 2021 Nov–Dec;39 Suppl 133(6):153–158.
- Disease & conditions: Sjögren’s syndrome. American College of Rheumatology. 2023 Feb. (Updated by Kristen Lee, MD, and reviewed by the Sjögren’s Foundation and the American College of Rheumatology Committee on Communications and Marketing.)
- A study to evaluate the efficacy and safety of vib4920 in participants with Sjögren’s syndrome (SS) [NCT04129164]. ClinicalTrials.gov. 2023 May 21.
- EyeWiki: Dry eye syndromes questionnaire. American Academy of Ophthalmology. 2023 Mar 12.
- St. Clair EW, Wang L, Alevizos I, et al. Efficacy and safety of dazodalibep (VIB4920/HZN4920) in subjects with Sjögren’s sydrome: A phase 2, randomized, double-blind, placebo-controlled, proof of concept study [abstract OP0143]. Ann Rheum Dis. 2023;82:201.
