Romanian Society of Pharmaceutical Sciences
 

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EMERGING DISPROPORTIONALITY SIGNALS OF ADVERSE EVENTS FOR TEPLIZUMAB IN REAL-WORLD USE FOR DELAYING TYPE-1 DIABETES ONSET: A FAERS-BASED PHARMACOVIGILANCE ANALYSIS

BILAL JAWED 1,2, AZFAR ATHAR ISHAQUI 3, KHALID ORAYJ 3, SALMAN ASHFAQ AHMAD 4*, MUHAMMAD IMRAN 4, ADNAN IQBAL 5, STEFANO MARTINOTTI ¹

¹ Unit of Clinical Pathology and Microbiology, Miulli Generale Hospital, LUM University, 70021 Acquaviva delle Fonti, Italy
2 Center of Advanced Studies and Technology, Department of Innovative Technology in Medicine and Dentistry, G. d’Annunzio University, 66100 Chieti, Italy
3 Department of Clinical Pharmacy, College of Pharmacy, King Khalid University, Abha 62583, Saudi Arabia.
4 Faculty of Pharmacy, Iqra University, Karachi 75850, Pakistan
5 Department of Pharmacology, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi 75270, Pakistan

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Teplizumab, approved by the FDA in 2022 to delay the onset of type 1 diabetes, requires ongoing safety monitoring. This study analyzes its adverse event profile using the FDA Adverse Event Reporting System (FAERS) to identify both known and new safety signals. We extracted reports from the FAERS database for the first quarter of 2023 through the fourth quarter of 2024, in which Teplizumab was listed as the primary suspect drug. We categorized adverse events using MedDRA by Preferred Terms and System Organ Classes (SOCs). Disproportionality analysis was performed to detect significant safety signals. 279 reports for Teplizumab were found, involving 1,015 adverse events. Strong disproportionality signals appeared in several SOCs, especially Gastrointestinal Disorders (such as nausea with Reporting Odds Ratio, ROR: 5.887; vomiting with ROR: 5.278), Skin and Subcutaneous Tissue Disorders (rash with ROR: 9.089; pruritic rash with ROR: 25.857), and General Disorders (fatigue with ROR: 4.289; pyrexia with ROR: 8.556; chills with ROR: 9.776). Newly identified safety signals included hyperglycemia (ROR: 9.677), increased glycosylated hemoglobin (ROR: 7.952), and influenza-like illness (ROR: 10.047), none of which were previously highlighted in FDA labeling. Headache (ROR: 5.487) and cytokine release syndrome (ROR: 12.590) were also notably linked to Teplizumab use. This analysis confirms known risks and identifies new potential adverse events linked to Teplizumab. The results indicate that gastrointestinal, skin-related, and general disorders may be more common in clinical practice than previously recognized. The emergence of signals such as hyperglycemia and influenza-like illness underscores the need for further research and clinical vigilance.