On January 16, 2026, Novartis announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its investigational therapy ianalumab (VAY736) for the treatment of Sjögren’s disease, the second most prevalent rheumatic autoimmune disease affecting approximately 0.25% of the population. Sjögren’s is a chronic, progressive, systemic condition characterized by mucosal dryness, fatigue, joint pain, and increased risk of lymphoma, often leading to significant quality-of-life impairment and frequently remaining undiagnosed or misdiagnosed. Currently, no approved targeted therapies exist, leaving patients with limited symptomatic management options.
The TOGETHER-PsA trial (NCT06588296) is a 52-week, randomized, multicenter, assessor-blinded, open-label Phase 3b study evaluating the efficacy and safety of concomitant subcutaneous ixekizumab (Taltz, an IL-17A inhibitor) and tirzepatide (Zepbound, a dual GIP/GLP-1 receptor agonist) compared to ixekizumab monotherapy in 271 adults with active psoriatic arthritis (PsA) and obesity (BMI ≥30 kg/m²) or overweight (BMI 27-29.9 kg/m² with ≥1 weight-related comorbidity). Participants had high baseline disease burden (mean DAPSA score 58.65, HAQ-DI 1.3) and mean BMI 37.6 kg/m²; over 60% had prior advanced therapy exposure. Both arms included lifestyle counseling for reduced-calorie diet and physical activity.
The Phase 2 DAHLIAS study (NCT04968912), a multicenter, randomized, placebo-controlled, double-blind trial, evaluated nipocalimab—an investigational monoclonal antibody targeting the neonatal Fc receptor (FcRn)—in adults aged 18–75 with moderate-to-severe primary Sjögren’s disease (SjD) seropositive for anti-Ro60 and/or anti-Ro52 IgG autoantibodies. A total of 163 participants were randomized 1:1:1 to receive intravenous nipocalimab 5 mg/kg, 15 mg/kg, or placebo every 2 weeks through Week 22, alongside standard-of-care therapy. The primary endpoint was the change from baseline in the Clinical EULAR Sjögren’s Syndrome Disease Activity Index (ClinESSDAI) score at Week 24, a composite measure assessing 11 systemic domains including constitutional symptoms, lymphadenopathy, glandular swelling, articular, cutaneous, respiratory, renal, muscular, peripheral/central nervous system, and hematological involvement.
Regeneron Pharmaceuticals reported positive topline results from the Phase 3 NIMBLE trial evaluating investigational cemdisiran, an siRNA targeting complement factor 5 (C5), as monotherapy for adults with generalized myasthenia gravis (gMG). The trial, involving patients with anti-acetylcholine receptor antibodies, randomized participants to receive cemdisiran (600 mg subcutaneously every 12 weeks), a cemdisiran-pozelimab combination (200 mg each every 4 weeks), or placebo.
