1256 The Journal of Rheumatology 2009; 36:6; doi:10.3899/jrheum.081033 Personal non-commercial use only. The Journal of Rheumatology Copyright © 2009. All rights reserved. Etanercept in the Longterm Treatment of Patients With Ankylosing Spondylitis BEN DIJKMANS, PAUL EMERY, MARKKU HAKALA, MARJATTA LEIRISALO-REPO, EMILIO MARTIN MOLA, LAURENCE PAOLOZZI, CARLO SALVARANI, RAIMON SANMARTI, JEAN SIBILIA, JOACHIM SIEPER, FILIPVan Den BOSCH, DÉSIRÉE van der HEIJDE, SJEF van der LINDEN, and JOSEPHWAJDULA ABSTRACT. Objective. To evaluate the 2-year efficacy and safety of etanercept in patients with ankylosing spondylitis (AS). Methods. A 96-week open-label extension study, which followed a 12-week double-blind place- bo-controlled trial, was designed to provide longterm efficacy and safety data, including radio- graphic outcomes, for patients treated with etanercept 25 mg twice weekly (NCT00421980). In all, 81 patients were enrolled (96% of the participants from the double-blind study). Key efficacy meas- ures included improvement using theAssessment inAnkylosing Spondylitis 20% (ASAS20) criteria, the Bath Ankylosing Spondylitis Functional Index (BASFI), and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Radiographic progression was evaluated using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) method. Paired t tests were used to test with- in-group changes from baseline. Results. The percentage of responders, by ASAS20 criteria, remained relatively constant in patients who received etanercept during the 12-week double-blind study (60% at Week 0 and 83% at Week 96 of the open-label extension); more patients from the placebo group became responders after being switched to etanercept (23% and 74%, respectively). A similar trend was also observed using the ASAS40 and ASAS5/6 criteria, the BASFI, and the BASDAI. Most patients had no change from baseline in mSASSS values. Etanercept was well tolerated; the most frequent adverse events were injection site reactions (n = 30; 37.0%) and headache (n = 18; 22.2%), and the most frequent infec- tions were upper respiratory tract infections (n = 43; 53.1%) and flu syndrome (n = 22; 27.2%). Conclusion. For 2 years, etanercept was clinically effective and well tolerated, with no unexpected safety findings. (First Release May 1 2009; J Rheumatol 2009;36:1256–64; doi:10.3899/ jrheum.081033) Key IndexingTerms: ANKYLOSING SPONDYLITIS ASSESSMENT INANKYLOSING SPONDYLITIS 20 MODIFIED STOKE ANKYLOSING SPONDYLITIS SPINE SCORE ETANERCEPT From Universitair Ziekenhuis Gent, Gent, Belgium; Helsinki University Central Hospital, Helsinki, Finland; Rheumatism Foundation Hospital, Heinola, Finland; Hôpital Hautepierre, Strasbourg, France; Hôpital Lapeyronie, Montpellier, France; University Hospital Benjamin Franklin, Berlin, Germany; University Hospital Erlangen-Nuremberg, Erlangen, Germany; Arcispedale S. Maria Nuova, Reggio Emilia, Italy; Academisch Ziekenhuis, Maastricht,The Netherlands; Department of Rheumatology, VU University Medical Center,Amsterdam,The Netherlands; Department of Rheumatology, Leiden University Medical Center, Leiden,The Netherlands; Hospital Clinic i Provincial, Barcelona, Spain; Hospital La Paz, Madrid, Spain; Leeds General Infirmary, Leeds, UK; Royal National Hospital for Rheumatic Diseases, Bath, UK; Medical Research, andWyeth Pharmaceutical, Collegeville, Pennsylvania, USA. Supported by a grant fromWyeth Research, Collegeville, Pennsylvania, USA, and Amgen Inc., Thousand Oaks, California, USA. B.A.C. Dijkmans, MD, PhD, Department of Rheumatology,VU University Medical Center, and Jan van Breemen Institute,Amsterdam; P. Emery, MA, MD, FRCP, LeedsTeaching HospitalTrust and Leeds University; M. Hakala, MD, Rheumatism Foundation Hospital and Department of Musculoskeletal Medicine and Rehabilitation, Medical School, University ofTampere,Tampere, Finland; M. Leirisalo-Repo, MD, PhD, Helsinki University Central Hospital; E. Martin Mola, MD, PhD, Hospital La Paz, Madrid, Spain; L. Paolozzi, MD, Research and Development,Wyeth Research, Paris, France; C. Salvarani, MD,Arcispedale S. Maria Nuova; R. Sanmarti, MD, Hospital Clinic i Provincial; J. Sibilia, MD, PhD, Hôpital Hautepierre; J. Sieper, MD, University Hospital Benjamin Franklin; F.Van Den Bosch, MD, PhD, UZ Gent; D. van der Heijde, MD, PhD, Leiden University Medical Center; S. van der Linden, MD, Academisch Ziekenhuis Maastricht; J.Wajdula, PhD, Clinical Research and Development,Wyeth Research, Collegeville, PA. Address reprint requests to Dr. J.Wajdula, Medical Research,Wyeth Pharmaceuticals, 500Arcola Road, Collegeville, PA 19426, USA. E-mail: wajdulj@wyeth.com Accepted for publication December 31, 2008. Ankylosing spondylitis (AS) is a chronic rheumatic disease characterized by inflammatory back pain due to sacroiliitis and spondylitis that affects young adults. Joint damage, including erosions, syndesmophytes, and ankylosis, can result in severe longterm functional impairment leading to a compromised quality of life. Tumor necrosis factor-α (TNF-α) antagonists such as etanercept are remarkably effective at relieving pain and stiffness 1-4 and improving mobility and quality of life in AS 5,6 . In 2 double-blind studies 2,3 significantly more patients receiving etanercept responded to therapy than did those receiving placebo. In both studies, the difference between the etanercept and placebo groups was seen as early as 2 weeks after the start of therapy and was sustained www.jrheum.org Downloaded on June 23, 2022 from