Journal of Natural Sciences Research www.iiste.org ISSN 2224-3186 (Paper) ISSN 2225-0921 (Online) Vol.3, No.14, 2013 124 Etanercept is Effective and Relatively Safe in a Sample of Iraqi Patients with Ankylosing Spondylitis Mohammed H. Al-Osami*, Faiq I.Gorial*, Mays R. Albeer**, Majid H.Hussein*** *Rheumatology Unit, Department of Medicine, College of Medicine, Baghdad University, Baghdad, Iraq **Department of Radiology, College of Medicine, Baghdad University, Baghdad, Iraq *Baghdad Teaching Hospital, Rheumatology Unit, Baghdad, Iraq Abstract Objective: To evaluate the efficacy and safety of etanercept in a sample of Iraqi patients with ankylosing spondylitis patients. Patients and methods: A single center open labeled prospective study conducted on 74 patients with ankylosing spondylitis diagnosed according to modified New York criteria of ankylosing spondylitis. Patients received etanercept 25mg twice weekly and were assessed at baseline, at month1, 3, and 6 thereafter. Disease activity was evaluated by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and functional status by Bath Ankylosing Spondylitis Function Index (BASFI) at each visit. Safety assessments included adverse events and laboratory tests. Results: Mean age of patients was 35.2 ± 10 years, males represented 92% of the cases, and the mean disease duration was 9.29 ± 7.1 years. A significant decrease in BASFI and BASDAI was found after 1month,3 months, and 6 months compared to baseline( p<0.001). Multiple logistic regression analysis revealed no significant association between age of patients, disease duration, HLA-B27, family history of psoriasis or inflammatory bowel disease, nonsteroidal anti-inflammatory drugs intake, and duration of smoking with the changes in BASDAI and BASF of the patients. Drug related adverse effects included three patients developed injection site reaction, 10 patients upper respiratory tract infections, and no serious infections occurred Conclusion: Etanercept was effective and relatively safe in treatment of ankylosing spondylitis patients. Further investigation of longer term treatment with etanercept is warranted to further define its therapeutic utility. Keywords: Ankylosing spondylitis; Etanercept; Efficacy; Safety; BASDAI, BASFI 1. Introduction Ankylosing spondylitis (AS) is a chronic inflammatory rheumatic disease characterized by inflammatory backpain, peripheral arthritis, enthesitis, and extraarticular features such as uveitis and inflammatory bowel disease(IBD) [Braun and Sieper , 2007].The disease has a relatively early onset, presenting at a mean age of 26 years, and occurs somewhat more frequently in men than in women [Feldtkeller et al, 2003]. Disease progression may result in loss of mobility and function, and therefore patients can experience a heavy disease burden, with pain and stiffness, loss of physical function, and severe impairment in quality of life [Davis et al, 2005; Zink et al, 2000]. Therapeutic options for patients suffering from AS have been limited over the last decades. There is no evidence that disease modifying anti-rheumatic drugs (DMARDs) work in axial manifestations of [Roychowdhury et al, 2002; Braun et al, 2006]. Tumour necrosis factor (TNF) blockers have greatly improved the condition of patients with active inflammatory spinal disease [Heiberg et al, 2005]. The short-term efficacy and safety of the recombinant 75-kd tumour necrosis factor (TNF) receptor IgG1 fusion protein etanercept (Enbrel) has been demonstrated in clinical studies of patients with active AS [Brandt et al, 2003; Gorman et al, 2002; Davis et al, 2004; Brandt et al, 2005 ]. This study was designed to assess the efficacy and safety of etanercept in a sample of Iraqi patients with ankylosing spondylitis 2. Patients and Methods 2.1 Study design This was a single center, single group open labelled prospective study conducted at Rheumatology Unit in Baghdad Teaching Hospital from the 1 st of January to the 1 st of August, 2013.Patients received etanercept 25 mg twice weekly and evaluated at baseline and after 1month, 3 months, and 6 months for its efficacy and safety. Informed consent was obtained from all participants and this study was approved by the ethical committee of Baghdad University, College of Medicine -Medical Department. 2.2 Sample selection Patients were included in the study if they had proved diagnosis of AS according to modified New York criteria of ankylosing spondylitis [Vander Linden et al, 1984] regardless the age or gender. Patients were excluded from