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.

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.

• Authors: Geert DʼHaens, Walter Reinisch, Remo Panaccione, Jack Satsangi, Joel Petersson, Mareike Bereswill, Dilek Arikan, Eva Perotti, Anne M Robinson, Jasmina Kalabic, Gabriela Alperovich, Roopal Thakkar, Edward V Loftus
• Journal: The American journal of gastroenterology (Am J Gastroenterol) Vol. 113 Issue 6 Pg. 872-882 (06 2018) ISSN: 1572-0241 [Electronic] United States
• PMID: 29867173 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Observational Study, Research Support, Non-U.S. Gov't)

Chemical References

• Immunosuppressive Agents
• Adalimumab

Topics

• Adalimumab (adverse effects)
• Adult
• Cardiovascular Diseases (epidemiology, immunology)
• Crohn Disease (drug therapy, immunology, mortality)
• Female
• Follow-Up Studies
• Humans
• Immunosuppressive Agents (adverse effects)
• Infections (epidemiology, immunology)
• Injection Site Reaction (epidemiology, immunology)
• Lymphoma (epidemiology, immunology)
• Male
• Middle Aged
• Prospective Studies
• Registries (statistics & numerical data)
• Skin Diseases (epidemiology, immunology)
• Survival Rate