- Fecal Incontinence
|Adalimumab Effectiveness Up to Six Years in Adalimumab-naïve Patients with Crohn
Loftus EV Jr1, Reinisch W2, Panaccione R3, Berg S4, Alperovich G5, Bereswill M6, Kalabic J6, Petersson J7, Thakkar R7, Robinson AM7, D'Haens G8. Inflamm Bowel Dis. 2019 Feb 8. doi: 10.1093/ibd/izz008. [Epub ahead of print]
1 Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
2 Department of Internal Medicine III, Division Gastroenterology and Hepatology, Medical University Vienna, Vienna, Austria.
3 Division of Gastroenterology, Department of Medicine, University of Calgary, Calgary, Alberta, Canada.
4 AbbVie AB, Solna, Sweden.
5 AbbVie Spain S.L.U., Madrid, Spain.
6 AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.
7 AbbVie Inc., North Chicago, Illinois, USA.
8 Academic Medical Center, Amsterdam, Netherlands.
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 InflammatoryBowel 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 diseaseduration <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 diseaseoutcomes and remission rates for up to 6 years. No new safety signals were observed.