PYRAMID Registry: Long-term Safety of Adalimumab by Age in Patients With Crohnʼs Disease

Abstract

Introduction: The global post-marketing observational registry PYRAMID assessed the long-term safety and effectiveness of adalimumab (ADA) as used in routine clinical practice in patients (pts) with moderate to severe Crohn's disease (CD). Methods: Enrolled Pts were newly prescribed or currently receiving ADA according to local product label; pts were followed up to 6 yrs. This analysis assessed the long-term safety of ADA by age subgroups (< 40, 40-59, and ≥60 yrs) at registry enrolment (baseline [BL]). Registry treatment-emergent (TE) adverse events (AEs), (any event with onset on/after first dose of ADA in the registry up to 70 days after last ADA injection) are reported as events per 100 patient-yrs (PY). Results: 5025 pts in the registry received at least one dose of ADA and included in the analysis; at BL, 2981 pts (59.3%) were < 40 yrs (female, 57.1%; median age, 29.0 yrs; median CD duration, 7.0 yrs), 1717 pts (34.2%) were 40-59 yrs (female, 57.8%; median age, 47.0 yrs; median CD duration, 13.0 yrs) and 327 pts (6.5%) were ≥60 yrs (female, 52.9%; median age, 64.0 yrs; median CD duration, 13.5 yrs). Of those ≥60 yrs at BL, 23/327 (7.0%) were ≥75 yrs. Cumulative registry ADA exposure by BL age groups was 9681.1 PY (< 40 yrs), 6009.3 PY (40-59 yrs) and 990.0 PY (≥60 yrs). Approximately 46-52% of pts were receiving ADA monotherapy (without immunomodulators or corticosteroids) at BL across age groups. Rates of any registry TEAEs, including serious AEs and AEs of special interest, by age groups at BL are shown in Table 1. Similar rates of registry TE serious infections and opportunistic infections were observed across younger age groups, but numerically higher in the ≥60 yrs group. Rates of any registry TE malignancies and non-melanoma skin cancer were significantly higher in older pts (≥60 yrs at BL). There was no event of lymphoma reported in aged ≥60 yrs at BL group; however, during the follow-up in the registry, 3 pts classified in the 40-59 yrs at BL age group were diagnosed with lymphoma when they were ≥60 yrs. No pts in the ≥60 yrs group reported active/latent tuberculosis.Table: Table. Cumulative incidence of registry treatment-emergent adverse events (TEAEs)Conclusion: Long-term treatment with ADA was well tolerated in pts with moderate to severe CD, irrespective of patient age. Rate of exposure-adjusted registry TEAEs (per 100 PY) was generally higher in older (≥60 yrs) compared to younger pts (< 60 yrs); however, no new safety signals were identified in this age group.