Alan Baer

Nov 22, 2024 | healio.com | Justin Cooper |Shenaz Bagha |Alan Baer |Robert Landewé

You've successfully added Sjögren’s Syndrome to your alerts. You will receive an email when new content is published. Click Here to Manage Email Alerts We were unable to process your request. Please try again later. If you continue to have this issue please contact [email protected]. “Ankylosing spondylitis”? “Sjögren’s syndrome”?

Jun 5, 2024 | nature.com | Alan Baer |Wan-Fai Ng |Chiara Baldini |Teresa K Tarrant |Athena Papas |Valérie Devauchelle-Pensec | +8 more

Sjögren’s disease (SjD) is a chronic, systemic autoimmune disease with no approved disease-modifying therapies. Dazodalibep (DAZ), a novel nonantibody fusion protein, is a CD40 ligand antagonist that blocks costimulatory signals between T and B cells and antigen-presenting cells, and therefore may suppress the wide spectrum of cellular and humoral responses that drive autoimmunity in SjD. This study was a phase 2, randomized, double-blinded, placebo (PBO)-controlled trial of DAZ with a crossover stage in two distinct populations of participants with SjD. Population 1 had moderate-to-severe systemic disease activity and population 2 had an unacceptable symptom burden and limited systemic organ involvement. All participants had a diagnosis of SjD, with 21.6% and 10.1% having an associated connective tissue disease (rheumatoid arthritis or systemic lupus erythematosus) in populations 1 and 2, respectively. The remaining participants would be considered as having primary Sjögren’s syndrome. The primary endpoint for population 1 (n = 74) was the change from baseline in the European League Against Rheumatism Sjögren’s Syndrome Disease Activity Index at day 169. The primary endpoint for population 2 (n = 109) was the change from baseline in the European League Against Rheumatism Sjögren’s Syndrome Patient Reported Index at day 169. The primary endpoints (least squares mean ± standard error) were achieved with statistical significance for both population 1 (DAZ, −6.3 ± 0.6; PBO, −4.1 ± 0.6; P = 0.0167) and population 2 (DAZ, −1.8 ± 0.2; PBO, −0.5 ± 0.2; P = 0.0002). DAZ was generally safe and well tolerated. Among the most frequently reported adverse events were COVID-19, diarrhea, headache, nasopharyngitis, upper respiratory tract infection, arthralgia, constipation and urinary tract infection. In summary, DAZ appears to be a potential new therapy for SjD and its efficacy implies an important role for the CD40/CD40 ligand pathway in its pathogenesis. ClinicalTrials.gov identifier: NCT04129164 . In a phase 2 trial of dazodalibep, a CD40 ligand, with a crossover stage in two distinct populations of patients with Sjögren’s disease, the compound was well tolerated and led to significantly improved disease activity.

Mar 20, 2023 | onlinelibrary.wiley.com | Michael Brennan |Alan Baer

Corresponding Author Michael T. Brennan Department of Oral Medicine/Oral & Maxillofacial Surgery, Atrium Health Carolinas Medical Center, Charlotte, North Carolina, USA Department of Otolaryngology/Head and Neck Surgery, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA Correspondence Michael T. Brennan, Department of Oral Medicine/Oral & Maxillofacial Surgery, Atrium Health Carolinas Medical Center, 1000 Blythe Blvd, Charlotte, NC 28203, USA.