Safety of teplizumab in patients with high-risk for diabetes mellitus type 1: A systematic review
Open accessAbstract
BACKGROUND The incidence of diabetes mellitus type 1 (DM1) has been rising worldwide because of improvements in diagnostic techniques and improved access to care in countries with lower socioeconomic status. A new anti-CD4 antibody, Tep-lizumab, has been shown to delay the progression of DM1 and is the only medication approved for this indication. However, more information is needed about the safety profile of this drug. AIM To identify the odds ratios (OR) of systems-based adverse effects for Teplizumab when compared to Placebo. METHODS An extensive systematic review was conducted from the inception of the medication until December 31, 2023. All clinical trials and studies that evaluated Teplizumab vs placebo were included in the initial review. The study protocol was designed using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines guidelines and was registered in PROSPERO (ID: CRD42024496169). Crude OR were generated using RevMan Software version 5.4. RESULTS After screening and review, 5 studies were selected to determine the risk of adverse effects of teplizumab compared to placebo. A total of 561 patients were included in the study population. Total adverse effects and system-based adverse effects were studied and reported. We determined that patients receiving Teplizumab had a higher risk of developing gastrointestinal (GI) (OR = 1.60, 95%CI: 1.01-2.52, P = 0.04), dermatological (OR = 6.33, 95%CI: 4.05-9.88, P < 0.00001) and hematological adverse effects (OR = 19.03, 95%CI: 11.09-32.66, P < 0.00001). These patients were also significantly likely to have active Epstein-Barr Virus infection (OR = 3.16, 95%CI: 1.51-6.64, P < 0.002). While our data showed that patients receiving Teplizumab did have a higher incidence of total adverse effects vs placebo, this finding did not reach statistical significance (OR = 2.25, 95%CI: 0.80-6.29, P = 0.12). CONCLUSION Our systematic review suggests that Teplizumab patients are at risk for significant adverse effects, primarily related to GI, dermatological, and hematological systems. The total adverse effect data is limited as study populations are small. More studies should be conducted on this medication to better inform the target population of potential adverse effects.
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A safety systematic review of five studies involving 561 participants identified increased risks for adverse events related to gastrointestinal systems (OR 1.6), dermatological systems (OR 6.3), and haematological systems (OR 19.0).
“A safety systematic review of five studies involving 561 participants identified increased risks for adverse events related to gastrointestinal systems (odds ratio [OR] 1•6), dermatological systems (OR 6•3), and haematological systems (OR 19•0).44”
From The future of type 1 diabetes therapy (2025) · cites this paper as [44]
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- Authors
- Buddhavarapu, V., Dhillon, G., Grewal, H., Sharma, P., Kashyap, R., & Surani, S.
- Affiliations
- Banner Health (US)
- University of Maryland Baltimore Washington Medical Center (US)
- Sacred Heart Hospital (US)
- Mayo Clinic (US)
- ORCID
- Venue
- World Journal of Diabetes
- Publisher
- Baishideng Publishing Group Inc.
- Published
- 2024-08-15
- Volume
- 15
- Issue
- 8
- Pages
- 1793-1801
- ISSN
- 1948-9358 (ISSN-L)
- PMC
- PMC11346092
- OpenAlex
- W4400969404
- Cited by
- 11
- References
- 29
- Citations by year
- 2026: 3 · 2025: 6 · 2024: 2
- FWCI
- 0.76
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Licence
- cc-by-nc
- Locations
- World Journal of Diabetes (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- teplizumab, type 1 diabetes, anti-CD4 antibody, drug safety, adverse drug reactions, gastrointestinal adverse effects, cutaneous adverse events, hematologic adverse events, Epstein-Barr virus infection, high-risk patients, placebo comparison, autoimmune disease prevention, immunomodulatory therapy, drug-induced liver injury, drug-induced thrombocytopenia
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