Demographic and clinical evaluation of patients using biological agent at rheumatology department

Use of the anti-TNF drugs in the treatment of Connective Tissue Diseases (CTD) is still a matter of concern because of consistent side effects and safety. Since the randomized and double blind medical studies are not reflecting the daily clinical practice, most of the developed countries focus on the generation of their own local registry systems to record anti-TNF using patients. Despite the rapid spread of the usage and indication of the anti-TNF drugs in our country, still there is not a systemic registry database to record those patients. We herein attempt to analyze and compare the data of anti-TNF receiving patients diagnosed with Rheumatoid Arthritis (RA), Ankylosing Spondilitis (AS), Psoriatic Arthritis (PsA) and vasculitis in terms of drug effectiveness, treatment retention rates and safety.Totally 520 Patients diagnosed with RA, AS, PsA and vasculitis and treated with biologic agents within the Gaziantep University Rheumatology Clinic were included in the study. Of the 520 biologic receiving patients, 170 (33%) diagnosed with RA, 303 (58%) diagnosed with AS, 33 (6%) diagnosed with PsA and 14 (3%) diagnosed with vasculitis. The evaluation of the patients in biologic agent treatment process made before and after the use of drug in week 16th in terms of effectiveness, treatment retention rates and safety. Regarding the effectiveness, treatment responses of the RA patient?s were assessed in each patient after 16 months with Diseases Activity Score in 28 tender and swollen joints (DAS28), Visual Analogue Scale (VAS), and Health Assessment Questionnaire (HAQ), treatment responses of the AS patients were assessed in each patient after 16 week with Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Bath Ankylosing Spondylitis Functional Index (BASFI) and treatment responses of other patients assessed with VAS, C-Reactive protein (CRP) and erytrocyte sedimentation rate (ESR) levels.Concerning the drug retention rates, we first examined the time until drug discontinuation independently of the reason that led to drug interruption at week 36th for each biologic drug and calculated the median retention rate. In order to analyze the safety profiles of the biologic drugs, we have examined the drug discontinuation reasons including primary unresponsiveness, secondary unresponsiveness and frequency of the adverse events. After the evaluation of all patients receiving anti-TNF drugs, Adalimumab has highest drug retention rates (89 %) and concerning the side effects, there was high risk of adverse events with infliximab (4 Tuberculosis, 1 malignancy and 13 allergic reaction). The comparison of the pre-clinical data with after treatment data revealed that there was a statistically significant improvement in the diseases activity scores of the patients receiving anti-TNF drugs (p<0.05). Despite the positive and significant affect to the drug retention rates of patient?s with AS, concomitant use of DMARDs had not a significant contribution in the treatment process.Consequently, all patients receiving biologic drugs need to be evaluated beforehand concerning the risk of tuberculosis. Concomitant use of sulphasalazin in AS had not affected the clinics of the patients. All patients treated with biologic drugs must be recorded and there must be a unique local approach to these drugs in our country.Key Words: Infliximab, Etanercept, Adalimumab, Connective Tissue Diseases