Lymphoma Risk and Overall Safety Profile of Adalimumab in Patients With Crohn’s Disease With up to 6 Years of Follow-Up in the Pyramid Registry

Geert D’Haens, Walter Reinisch, Remo Panaccione, Jack Satsangi, Joel Petersson, Mareike Bereswill, Dilek Arikan, Eva Perotti, Anne M. Robinson, Jasmina Kalabic, Gabriela Alperovich, Roopal Thakkar, Edward Vincent Loftus, Jr

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15 Scopus citations

Abstract

OBJECTIVES: Real-world, prospective, long-term studies in Crohn’s disease (CD) characterizing adalimumab safety data and lymphoma risk were lacking. We present the final results from the PYRAMID registry, which was designed to rule out a doubling of lymphoma risk in adalimumab-treated patients with CD. Methods: Patients with moderately to severely active CD newly prescribed or currently receiving adalimumab according to local product labels were followed for up to 6 years and analyzed for adverse events (AEs). The registry exposure-adjusted observed rate of lymphoma was compared with the estimated background lymphoma rate from a sex-matched general population in the Surveillance, Epidemiology, and End Results 17 Registry database adjusted for anticipated prior or concurrent thiopurine use in a CD population. Results: A total of 5025 patients were evaluated (16680.4 PY of adalimumab registry exposure, ≈3 years/patient mean follow-up). Registry treatment-emergent AEs included 4129 serious AEs (n = 1853 [36.9%]; 24.8 E/100 PY), 792 serious infections (n = 556 [11.1%]; 4.7 E/100 PY), and 134 malignancies (n = 116 [2.3%]; 0.8 E/100 PY), including ten lymphomas. The observed lymphoma rate (0.060 E/100 PY) was lower than the estimated background rate (0.084 E/100 PY), and the upper bound of the one-sided 95% CI of the observed rate (0.102 E/100 PY) was lower than double the estimated rate (0.168 E/100 PY). Conclusions: PYRAMID is the longest prospective adalimumab study in routine clinical practice, with up to 6 years of follow-up. No new safety signals were reported. The pre-specified registry objective of ruling out a doubling of lymphoma risk with adalimumab was met.

Original languageEnglish (US)
Pages (from-to)1-11
Number of pages11
JournalAmerican Journal of Gastroenterology
DOIs
StateAccepted/In press - Jun 5 2018

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ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

D’Haens, G., Reinisch, W., Panaccione, R., Satsangi, J., Petersson, J., Bereswill, M., Arikan, D., Perotti, E., Robinson, A. M., Kalabic, J., Alperovich, G., Thakkar, R., & Loftus, Jr, E. V. (Accepted/In press). Lymphoma Risk and Overall Safety Profile of Adalimumab in Patients With Crohn’s Disease With up to 6 Years of Follow-Up in the Pyramid Registry. American Journal of Gastroenterology, 1-11. https://doi.org/10.1038/s41395-018-0098-4