Background: PYRAMID was an international multi-center non-interventional postmarketing registry assessing long-term safety and effectiveness of Humira® (adalimumab [ADA]) as used in routine clinical practice. Patients with and without prior ADA experience were allowed to enroll. This analysis evaluates the long-term effectiveness of ADA in ADA-naïve, i.e., patients who had not received ADA before the registry enrollment, adult patients with moderate to severe Crohn's disease (CD) who were treated according to the local product label.
Methods: All patients entering the registry were followed for up to 6 years. Effectiveness of ADA was measured using Physician's Global Assessment (PGA; [a composite of Harvey Bradshaw Index and rectal bleeding score]), Short Inflammatory Bowel Disease Questionnaire (SIBDQ), and 4 components of the Work Productivity and Activity Impairment questionnaire (WPAI), including absenteeism, presenteeism, overall work impairment, and activity impairment. Effectiveness measures, captured in all patients who received at least 1 dose of ADA in the registry and had at least 1 post-enrollment measurement, were summarized descriptively by the number of observations that were not missing at each registry visit; data were used as observed.
Results: Among 5025 patients evaluated in the registry, 2657 patients (52.9%) were ADA-naïve. Of them, 1531 patients (57.6%) were female; mean age 37.7 years at enrollment. Mean±SD ADA exposure for the ADA-naïve subgroup during the registry was 1179.6±837.3 days. A total of 1413 patients (53.2%) had prior exposure to anti-TNF biologics; 1039 (39.1%) and 914 patients (34.4%) used immunomodulators and corticosteroids, respectively, at enrollment. Mean change from enrollment (baseline) in effectiveness measures for patients with CD is shown in the table. Mean PGA and SIBDQ scores as well as WPAI domain scores improved in ADA-naïve patients from enrollment to as early as 1 year and sustained for up to 6 years (table). No new safety signals were identified.
Conclusions: At 1 year after entering the international postmarketing registry of ADA use in routine clinical practice, clinically meaningful improvements in disease activity, work productivity, and activity impairment were achieved in ADA-naïve patients with moderately to severely active CD. These improvements were maintained for up to 6 years of the registry.