Long-term Effectiveness of Adalimumab in Crohnʼs Disease: Observational Data from the PYRAMID Registry

Abstract

Purpose: Adalimumab (ADA), an anti-tumor necrosis factor agent, is approved for the treatment of moderately to severely active Crohn's disease (CD). Methods: We assessed long-term effectiveness of ADA in patients enrolled in an observational study initiated in 2007, PYRAMID. ADA was prescribed according to local product labels, and patients were followed for 6 years. Effectiveness measures assessed include Physician's Global Assessment (PGA, composite of Harvey-Bradshaw Index and a rectal bleeding score), Short Inflammatory Bowel Disease Questionnaire (SIBDQ), and four components of the Work Productivity and Activity Impairment Questionnaire (WPAI): absenteeism, presenteeism, total work productivity impairment (TWPI), and total activity impairment (TAI). These effectiveness analyses are interim in nature, and results are summarized with descriptive statistics for patients who were naïve to adalimumab therapy at the time of study enrollment. Results: As of December 1, 2012, 5,061 patients have been enrolled. Forty-one percent (2095/5061) of patients were ADA-naïve at the time of enrollment. Mean age of ADA-naive patients was 37 years, mean CD duration was 10 years, 58% were women, and 96% were white. Mean scores for PGA improved from baseline to years 1, 2, 3, and 4 for new ADA users. Clinically meaningful improvements in mean scores for SIBDQ and WPAI (absenteeism, presenteeism, TWPI, and TAI) were maintained over 4 years (Table).Table: Table. Efficacy measures for ADA-naïve patientsConclusion: In this worldwide observational study of ADA use in routine clinical practice, clinically meaningful improvements in disease activity, work productivity, and activity impairment were seen in patients with CD 1 year after initiation of ADA therapy. These improvements were maintained over a 4-year assessment period. Disclosure - EV Loftus Jr: Financial support for research: AbbVie, Amgen, Braintree, Bristol-Myers Squibb, Genentech, GlaxoSmithKline, Janssen Biotech, Millenium-Takeda, Pfizer, Santarus, Shire, UCB. Consultancy: AbbVie, Cubist, Elan, Eisai, Given, Hospira, Ironwood, Janssen Biotech, UCB. G D'Haens: Study Investigator and Consultant - AbbVie; CME events/Educational Grants - AbbVie. W Reinisch: Consultant/Advisory Committee - AbbVie, Aesca, Centocor, Genentech, Novartis, Schering-Plough, UCB. Consultant/Speaker - Ferring. J Satsangi: None. R Panaccione: Advisory Board - AbbVie, Amgen, Aptalis, AstraZeneca, Baxter, Bristol-Myers Squibb, Centocor, Eisai, Ferring, Elan, GlaxoSmithKline, Janssen, Merck, Pfi zer, Schering-Plough, Shire, UCB, Warner Chilcott; Consultant - AbbVie, Amgen, Aptalis, AstraZeneca, Baxter, Bristol-Myers Squibb, Centocor, Eisai, Elan, Ferring, GlaxoSmithKline, Jansen, Merck, Pfizer, Schering-Plough, Shire, UCB, Warner Chilcott; Research/Educational Support - AbbVie, Bristol-Myers Squibb, Centocor, Elan, Ferring, Janssen, Millennium, Schering-Plough, Proctor & Gamble; Speaker - AbbVie, AstraZeneca, Centocor, Elan, Janssen, Prometheus, Schering-Plough, Shire, Warner Chilcott. R Thakkar, S Eichner, M Castillo, N Kan-Dobrosky, PM Mulani, J Chao, M Skup: Employee & Shareholder - AbbVie.