Laura M Jacobsen, Dave Cuthbertson, Jamie Felton, Jennifer L Sherr, Kimber M Simmons, Jennifer Hosford, Heba M Ismail, Carla J Greenbaum, Diane K Wherrett, Ashley Pinckney, Srinath Sanda, Linda A DiMeglio, Lauren E Higdon, Carmella Evans-Molina
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引用次数: 0
Abstract
Objective: Long-term side effect surveillance after immunotherapy clinical trial participation in individuals with or at risk of type 1 diabetes is needed.
Research design and methods: Participants from 14 randomized controlled trials (47%) joined the Long-term Investigative Follow-up in Type 1 Diabetes TrialNet or Immune Tolerance Network Type 1 Diabetes Extension Study, and 98% answered at least one health-related outcomes question.
Results: Participants were observed for a median of 1.78 (interquartile range 0.89-4.04) years after original trial completion and, in some, up to 18 years. There were no differences in the frequency of self-reported health outcomes, including moderate to severe hypoglycemia events, hospitalizations, serious infections (including COVID-19 infection), new allergic reactions, autoimmune disease, and cancer incidence, between those receiving active and placebo therapy (n = 209-473 responses per question; P > 0.05 for all).
Conclusions: We observed no differences in self-reported health outcomes between those who received active immunotherapy versus placebo. Continued long-term follow-up of immunotherapy trial participants is essential.
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