DDW 2017. 616. LONG-TERM SAFETY OF ADALIMUMAB IN PATIENTS WITH CROHN’S DISEASE: FINAL DATA FROM PYRAMID REGISTRY

Results: A total of 5025 pts were evaluated in this analysis (57.1% female, mean age 37.8 yrs at enrollment), representing 16680.4 PYs of ADA exposure over 6 yrs. The mean (SD) duration of ADA exposure during the registry was 1212.4 (835.4) days. A total of 2852 pts (56.8%) had prior biologic use, 1798 (35.8%) used immunomodulators (IMM), and 1463 (29.1%) used corticosteroids (CS) at registry baseline (BL). Overall, 3478 (69.2%) pts discontinued ADA or the registry. A total of 1853 pts (36.9%) reported 4129 treatment-emergent SAEs (24.8/100 PY). A total of 556 pts reported 792 treatment-emergent serious infections (SI) (4.7/100 PY). The only treatment-emergent SI reported by ≥1% of pts was perianal abscess (0.7/100 PY). The SI rate was higher for pts with concomitant medication at BL (ADA+CS, ADA+IMM, ADA+CS+IMM) vs ADA monotherapy (6.4, 4.8, 5.0 vs 4.2/100PY, respectively). A total of 116 pts experienced 134 treatment-emergent malignancy events (0.8/100 PY), of which 10 were lymphomas. No non-treatment-emergent lymphoma events were reported. The registry exposure-adjusted rate of lymphoma was 0.060/100 PY. The upper bound of the 1-sided 95% CI of this rate was 0.102/100 PYs and fell below 0.168/100 PYs (double the expected rate of 0.084/100 PYs). TEAEs leading to death were reported in 43 pts (0.3/100 PY). 

Conclusions: The registry achieved the goal of ruling out a doubling of lymphoma risk in pts with CD treated with ADA. No new safety signals were identified.

CARE™ Faculty Perspective: While immunosuppressive therapies have been associated with adverse events including infection and malignancy, this large-scale study determined that there is not a doubling of lymphoma risk for patients receiving adalimumab. The overall safety profile of adalimumab in this large registry is similar to that reported previously.