{
  "abstract": "Background Pancreatitis has been described after cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy, but large real-world pharmacovigilance data remain limited. This study evaluated whether pancreatitis is disproportionately reported with CFTR modulators in the FDA Adverse Event Reporting System (FAERS) and described associated patient characteristics, outcomes, and time to onset.Methods This pharmacovigilance disproportionality analysis used FAERS data from 2020 to 2025. After two-step deduplication, reports were screened for pancreatitis using a broad 36-term MedDRA dictionary and for exposure to four marketed CFTR modulator regimens: elexacaftor/tezacaftor/ivacaftor (ETI), ivacaftor, lumacaftor/ivacaftor, and tezacaftor/ivacaftor. Reports were classified into 2×2 contingency tables, and disproportionality was assessed using proportional reporting ratio (PRR), reporting odds ratio (ROR), chi-squared, information component (IC), and empirical Bayesian geometric mean (EBGM). Pre-specified sensitivity analyses used a narrow 8-term pancreatitis dictionary and restriction to patients with a recorded cystic fibrosis indication.Results Among 8,648,164 deduplicated FAERS reports ( IDDF2026-ABS-0334 Figure 1. Flow chart of population selection in the study), 20,008 (0.23%) involved CFTR modulators and 32,242 (0.37%) included a pancreatitis-related term. There were 248 pancreatitis reports among CFTR modulator users, representing 1.24% of CFTR modulator reports, compared with a background FAERS pancreatitis reporting rate of 0.37% (p<0.001). ETI accounted for 160 cases (64.5%), followed by ivacaftor 57 (23.0%), lumacaftor/ivacaftor 23 (9.3%), and tezacaftor/ivacaftor 20 (8.1%). For all CFTR modulators combined, disproportionality was significant: ROR 3.37 (95% CI 2.97–3.82), PRR 3.34 (2.95–3.78), χ2=405.6, EBGM 3.31 (2.91–3.73), and IC 1.73 (1.35–2.10). All individual modulators met Evans criteria, with the highest ROR seen for lumacaftor/ivacaftor at 4.07 (2.70–6.14). Group A patients had a ­median age of 18 years (IQR 12–28); 45.2% were hospitalized and 64.9% had another serious outcome. Onset data (IDDF2026-ABS-0334 Figure 2. Frequency distribution of pancreatitis onset time after CFTR modulator initiation) were available for 53 cases: median onset was 18 days (IQR 3–377), with 54.7% occurring within 30 days. Sensitivity analyses remained significant with the narrow dictionary (ROR 2.82, 95% CI 2.41–3.29) and in cystic-fibrosis-only analyses (ROR 2.07, 95% CI 1.45–2.97).Conclusions In FAERS, pancreatitis was reported disproportionately more often with CFTR modulators than with other drugs, and the signal persisted across all four regimens and in sensitivity analyses. These findings support a safety signal that warrants clinical awareness and further study.Abstract IDDF2026-ABS-0334 Figure 1Abstract IDDF2026-ABS-0334 Figure 2",
  "authors": [
    {
      "affiliations": [
        "Sheffield Teaching Hospitals NHS Foundation Trust, United Kingdom"
      ],
      "name": "Arkadeep Dhali"
    },
    {
      "affiliations": [
        "University of Nottingham, United Kingdom"
      ],
      "name": "Saikat Mandal"
    },
    {
      "affiliations": [
        "University of Nottingham, United Kingdom"
      ],
      "name": "Guruprasad Aithal"
    }
  ],
  "title": "IDDF2026-ABS-0334 Pancreatitis reporting with CFTR modulators: a faers pharmacovigilance disproportionality analysis",
  "uid": "ca206ab7-3f2a-537b-90f5-3e257174f0c2"
}