Adalimumab Effectiveness Up to Six Years in Adalimumab-naïve Patients with Crohn's Disease: Results of the PYRAMID Registry

Abstract

Background: PYRAMID was an international multicenter, noninterventional, postmarketing registry assessing long-term safety and effectiveness of adalimumab (Humira), as used in routine clinical practice.

Methods: Adult patients with moderately to severely active Crohn's disease with or without prior adalimumab experience were enrolled in the registry and followed for up to 6 years. Effectiveness measurements included the Physician's Global Assessment (PGA, a composite of Harvey Bradshaw Index [HBI] and rectal bleeding score), clinical remission (HBI < 5), Short Inflammatory Bowel Disease Questionnaire (SIBDQ), and Work Productivity and Activity Impairment (WPAI) questionnaire. Data were reported for adalimumab-naïve patients and analyzed by baseline immunomodulator use and disease duration.

Results: This study evaluated 2057 adalimumab-naïve patients. Mean PGA improved from 7.5 (baseline) to 3.9 (year 1) and 3.3 (year 6). The proportion of patients in HBI remission increased from 29% (573 of 1969; baseline) to 68% (900 of 1331; year 1) and 75% (625 of 831; year 6). Patients stratified by baseline immunomodulator use had similar HBI remission rates; patients with disease duration <2 years achieved numerically higher HBI remission rates than patients with longer disease duration. Patient-reported SIBDQ and WPAI scores improved at year 1; all WPAI subscore improvements were clinically meaningful (≥7% point change) at year 1 and maintained through year 6. Serious infections were reported in 11.1% of patients; incidence rates of malignancies, lymphoma, and demyelinating disorders were low.

Conclusion: Adalimumab therapy, as used in routine clinical practice, improved physician-reported and patient-reported disease outcomes and remission rates for up to 6 years. No new safety signals were observed.

Keywords: clinical practice; disease activity; long-term effectiveness; long-term safety; work productivity.

FIGURE 1.

Patient disposition for adalimumab-naïve patients enrolled in the PYRAMID registry.

FIGURE 2.

Mean change from baseline in PGA scores (with 95% CI) of patients in the registry. PGA was calculated at all registry visits starting at study enrollment. Assessment of current disease activity included general well-being, abdominal pain, diarrhea, blood in stool, abdominal mass, and Crohn’s disease–related complications. PGA = Physician Global Assessment.

FIGURE 3.

Mean change from baseline in HBI (with 95% CI). (A) All patients, (B) patients stratified by immunomodulator use at enrollment, (C) patients stratified by disease duration at enrollment. HBI, Harvey-Bradshaw Index.

FIGURE 4.

HBI remission. (A) All patients, (B) patients stratified by immunomodulator use at enrollment, (C) patients stratified by disease duration at enrollment. Remission was defined as HBI <5. HBI, Harvey-Bradshaw Index.

FIGURE 5.

Mean change from baseline in patient-reported SIBDQ scores (with 95% CI). Total SIBDQ score ranged from 10 (poor health-related quality of life) to 70 (optimum health-related quality of life). Dashed line indicates a 9-point change in total SIBDQ score (Irvine et al, 1996). SIBDQ, Short Inflammatory Bowel Disease Questionnaire.

FIGURE 6.

Mean change from baseline in patient-reported WPAI scores (with 95% CI). Effects of patients’ Crohn’s disease on their ability to work and perform regular activities during the previous 7 days were evaluated. Dashed line indicates a 7% point change in WPAI score, representing the minimum clinically important difference. WPAI, work productivity and activity impairment.