Abstract
Abstract Background/Aims Tumor necrosis factor (TNF) blocking therapies like etanercept (ETN) have revolutionized the management of ankylosing spondylitis (AS). Clinical trials suggest that Etanercept exhibits beneficial effects in terms of improving disease severity of AS patients. Etanercept has also been shown to have a good safety profile as compared to other TNF inhibitors in terms of risk of tuberculosis (TB) which seems to be an important aspect especially in India, considering the high prevalence of TB here. Despite having an established efficacy and safety profile, data regarding patient profile of AS patients who are prescribed etanercept is not clear. Methods This retrospective, multicentric, cross sectional, data collection form based observational study was planned to evaluate the patient profile of AS patients who are prescribed etanercept in India. Results Retrospective data of 423 AS patients was collected across 48 centers in India. Mean age of AS patients prescribed ETN was 53.26±8.60 years. 84.63% patients were males while the remaining 15.37% were females. To some extent, this can be attributed to the epidemiology of AS which is seen more commonly in males. Average height and weight of the patients were 68.30±7.11 kg and 166.75±3.98 cm respectively. Mean Body mass index (BMI) of the patient group was 24.59±2.66 kg/m2. 6.38% patients were obese while 21.27% patients were in the overweight category. Most of the patients had a medication history of taking some or other non-steroidal anti-inflammatory drug (NSAID) (95.98%). Other drugs which were previously consumed by the patients included sulfasalazine (74.47%), methotrexate (26.95%), steroids (13.95%). 11.11% of patients had a previous medication history of biologic medications including infliximab (6.86%), adalimumab (2.84%), secukinumab (0.95%) and golimumab (0.47%). Most common comorbid disorder reported in the patient group was hypertension (15.60%). Other comorbidities were diabetes mellitus (7.32%), inflammatory bowel disorder (4.3%) and psoriasis (1.65%). Erythrocyte sedimentation rate (ESR) was done in 29.74% of the patients with a mean value of 20.42 ±10.35 mm/hr. C-reactive protein (CRP) was done in 25.76% patients with a mean value of 10.82±4.27 mg/L was reported.HLA-B27 antigen testing was done only for 13.23% patients. Among patients who were subjected to HLA-B27 testing, 78.57% were HLA-B27 positive while the remaining 21.43% patients were HLA-B27 negative. 95.03% of the patients were prescribed ETN dose of 50mg/week through subcutaneous route while 4.97% of patients received ETN dose of 25mg twice weekly. Sulfasalazine was prescribed in 78.72% of these patients and was the most commonly co-prescribed drug along with ETN. Other commonly co-prescribed medications included NSAIDS (32.62%), methotrexate (28.37%) and steroids (5.67%). Conclusion Etanercept is commonly used in patients not responding to NSAIDS & sulfasalazine. It is even used in patients who have been on biologics previously. Disclosure A.B. Jain: Corporate appointments; Medical Advisor to Intas Pharmaceuticals Ltd, India. S. Warudkar: Corporate appointments; Medical Advisor to Intas Pharmaceuticals Ltd, India. N. Dave: Corporate appointments; Medical Advisor to Intas Pharmaceuticals Ltd, India. A. Chaturvedi: Corporate appointments; Medical Advisor to Intas Pharmaceuticals Ltd, India.
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