Teplizumab use in individuals with stage 2 and stage 3 type 1 diabetes mellitus (T1DM) was associated with frequent but generally manageable adverse events (AEs), according to a meta-analysis of interventional studies presented at the AACE Annual Meeting 2026.

The meta-analysis included 8 interventional studies encompassing 575 participants with stage 2 or stage 3 T1D. MEDLINE, Embase, Cochrane CENTRAL, and clinical trial registries were searched through November 2025.

Cutaneous AEs were reported most frequently. Rash occurred in 60.40% of participants (95% confidence interval [CI], 18.43-91.15), whereas pruritus was less common. Gastrointestinal symptoms were also frequent, with abdominal pain reported more often than nausea, vomiting, or diarrhea.

Cytokine release syndrome (CRS)-related symptoms occurred in 15.75% of participants (95% CI, 2.59-56.75). Headache occurred in 33.34% (95% CI, 10.19-68.80), fever in 33.33% (95% CI, 22.30-46.54), and fatigue in 14.79% (95% CI, 8.34-24.86). Psychiatric AEs, primarily anxiety and mood changes, were reported in 27.36% of participants (95% CI, 19.73-36.60).

Infections were predominantly mild upper respiratory infections, with no consistent signal for opportunistic infections. Overall, pooled evidence suggested that teplizumab exposure in stage 2 and stage 3 T1DM was generally well tolerated. The findings provide updated safety expectations as teplizumab continues to be evaluated across earlier-stage T1DM populations.