Research article

Assessment of radiographic progression in the spines of patients with ankylosing spondylitis treated with adalimumab for up to 2 years

Désirée van der Heijde¹ , David Salonen² , Barbara N Weissman³ , Robert Landewé⁴ , Walter P Maksymowych⁵ , Hartmut Kupper⁶ , Shaila Ballal⁷ , Eric Gibson⁷ and Robert Wong⁷ for the Canadian (M03-606) study group and the ATLAS study group

¹  Department of Rheumatology, C1R, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands

²  Department of Medical Imaging, University of Toronto, 600 University Avenue, Toronto, ON M5G 1X5, Canada

³  Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA

⁴  Department of Internal Medicine/Rheumatology, Maastricht University Medical Center, PO Box 616, 6200 MD Maastricht, The Netherlands

⁵  Medicine/Rheumatic Disease Unit, University of Alberta, 562 Heritage Medical Research Building, Edmonton, AB T6G 2S2, Canada

⁶  Abbott GmbH & Co. KG, Knollstrasse 50, Ludwigshafen 67061, Germany

⁷  Formerly Abbott Laboratories, 300 Interpace Parkway B, Parsippany, NJ 07054, USA

author email corresponding author email

Arthritis Research & Therapy 2009, 11:R127doi:10.1186/ar2794

Published:	24 August 2009

Abstract

Introduction

Ankylosing spondylitis (AS) is a chronic rheumatic disease associated with spinal inflammation that subsequently leads to progression of structural damage and loss of function. The fully human anti-tumor necrosis factor (anti-TNF) antibody adalimumab reduces the signs and symptoms and improves overall quality of life in patients with active AS; these benefits have been maintained through 2 years of treatment. Our objective was to compare the progression of structural damage in the spine in patients with AS treated with adalimumab for up to 2 years versus patients who had not received TNF antagonist therapy.

Methods

Radiographs from patients with AS who received adalimumab 40 mg every other week subcutaneously were pooled from the Adalimumab Trial Evaluating Long-Term Efficacy and Safety for Ankylosing Spondylitis (ATLAS) study and a Canadian AS study (M03-606). Radiographic progression from baseline to 2 years in the spine of adalimumab-treated patients from these two studies (adalimumab cohort, n = 307) was compared with an historic anti-TNF-naïve cohort (Outcome in AS International Study [OASIS], n = 169) using the modified Stoke AS Spine Score (mSASSS) method.

Results

mSASSS results were not significantly different between the adalimumab cohort and the OASIS cohort, based on baseline and 2-year radiographs. Mean changes in mSASSS from baseline to 2 years were 0.9 for the OASIS cohort and 0.8 for the adalimumab cohort (P = 0.771), indicating similar radiographic progression in both groups. When results for patients in the OASIS cohort who met the baseline disease activity criteria for the ATLAS and Canadian studies (OASIS-Eligible cohort) were analyzed, there was no significant difference in mean change in mSASSS from baseline to 2 years between OASIS-Eligible patients and adalimumab-treated patients; the mean changes in mSASSS were 0.9 for the OASIS-Eligible cohort and 0.8 for the adalimumab cohort (P = 0.744).

Conclusions

Two years of treatment with adalimumab did not slow radiographic progression in patients with AS, as assessed by the mSASSS scoring system, when compared with radiographic data from patients naïve to TNF antagonist therapy.

Trial registration

Canadian study (M03-606) ClinicalTrials.gov identifier: NCT00195819; ATLAS study (M03-607) ClinicalTrials.gov identifier: NCT00085644.