Long-term safety of adalimumab in clinical trials in adult patients with Crohn's disease or ulcerative colitis

J. F. Colombel*, W. J. Sandborn, W. Reinisch, L. Peyrin-Biroulet, R. Panaccione, P. Rutgeerts, S. B. Hanauer, S. Ghosh, G. Van Assche, A. M. Robinson, W. Lau, J. F. Maa, B. Huang, B. Pappalardo, H. Read

*Corresponding author for this work

Research output: Contribution to journalArticle

17 Scopus citations

Abstract

Background: Adalimumab is used to treat moderate to severe Crohn's disease (CD) and ulcerative colitis (UC) when conventional therapies fail. Aim: To update long-term adalimumab safety from CD and UC trials; the previous report was CD only, 3160 patients/3402 patient-years (PYs). Methods: Treatment-emergent adverse events (AEs; first dose to 70 days after last dose/December 31, 2015) in adults in phase 2/3 and 3/3b trials and open-label extensions were coded using Medical Dictionary for Regulatory Activities (MedDRA-v18.1). Rates were assessed as events/100 (E/100 PYs). Results: The database (16 trials; CD, N = 3606; UC, N = 1739) represented 4145 and 3397 PYs of exposure, respectively. For CD, incidences of any AEs with adalimumab were 60.8%-65.1%, depending on dose, and 71.5% with placebo; for UC, the incidences were 53.5%-54.8% and 56.1%, respectively. Rates of any AEs (CD, 605 E/100 PYs; UC, 361 E/100 PYs), serious AEs (CD, 36.1 E/100 PYs; UC, 18.9 E/100 PYs), and malignancies (CD, 1.2 E/100 PYs; UC, 1.0 E/100 PYs) were similar between current and prior analyses. Apparent rate of opportunistic infections was lowered to 0.3 and 0.2 E/100 PYs for CD and UC, respectively, by recent MedDRA changes excluding oral candidiasis and tuberculosis. Standardised incidence ratios for malignancies were similar to the general population (CD, 1.45 [95% CI, 0.90-2.22]; UC, 1.36 [95% CI, 0.84-2.07]). Demyelinating disorders were uncommon (CD, 0.1 E/100 PYs; UC, <0.1 E/100 PYs). Conclusions: Patients with moderately to severely active Crohn’s disease or ulcerative colitis continued to experience acceptable safety with adalimumab, without new safety signals.

Original languageEnglish (US)
Pages (from-to)219-228
Number of pages10
JournalAlimentary Pharmacology and Therapeutics
Volume47
Issue number2
DOIs
StatePublished - Jan 2018

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology
  • Pharmacology (medical)

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    Colombel, J. F., Sandborn, W. J., Reinisch, W., Peyrin-Biroulet, L., Panaccione, R., Rutgeerts, P., Hanauer, S. B., Ghosh, S., Van Assche, G., Robinson, A. M., Lau, W., Maa, J. F., Huang, B., Pappalardo, B., & Read, H. (2018). Long-term safety of adalimumab in clinical trials in adult patients with Crohn's disease or ulcerative colitis. Alimentary Pharmacology and Therapeutics, 47(2), 219-228. https://doi.org/10.1111/apt.14420