AB1524-HPR THERAPEUTIC RESULTS AND QUALITY OF LIFE CHANGES OF PATIENTS WITH RHEUMATOID ARTHRITIS IN PROSPECTIVE REAL LIFE CLINICAL SETTINGS

Abstract

BackgroundRheumatoid arthritis (RA) as a chronic inflammatory disease significantly deteriorating the physical functioning and the quality of life (QoL) of the patients. The introduction of biological therapy in its management significantly improves both the physical functioning and QoL. Many biological medicines are already available on the market claiming higher effectiveness and high cost of therapy but the difference in real clinical setting is not well studied.ObjectivesThe aim of this study is to analyze the therapeutic results of RA therapy with different biologicals and the first JAK inhibitor in real life clinical settings.MethodsТhis study was performed like a prospective, observational, longitudinal study at the biggest rheumatology clinic in Bulgaria during the period 2012 – 2020. Written informed consent was obtained by the recruited 197 patients, out of which 174 remain at the end of the observation. Patients naïve to biological therapy were assigned on the available at that moment biologic DMARDs (infliximab, etanercept, adalimumab, rituximab, golimumab, cetrolizumab, tocilizumab), and the first JAK inhibitor (tofacitinib). The clinically proven RA according ACR (1987) and / or ACR/EULAR (2010) criteria, previous therapy with DMARDs, and/or methotrexate, suitable for therapy with biological medicines or JAK inhibitors were formulated as inclusion criteria, while infectious diseases, cardiac insufficiency (NYHA III and IV grade), malignant hypertension, any neoplasms or proliferative lymph diseases within the previous 5 years were the exclusion criteria. We evaluate DAS28-CRP, HAQ and Short form 36 measured at the initiation of biological therapy, after 6, and 12 months of follow up. We analyze the changes in the two major subgroups of SF36 - physical (MCS) and mental health (PCS).Descriptive statistic, Dispersion analysis with non-parametric Kruskal-Wallis test comparing the effect of different therapies between first and third measurement was performed. Linear correlation and regression analysis (Pearson type) comparing the effect of different therapies was also performed.ResultsThe age and gender distribution were similar between the groups on bDMARDs and tsDMARD. Number of patients per therapeutic DMARD vary between 20 to 30, with prevailing part of the female and average age between 53.2 (SD 9.13) and 57.15 (SD 9.05) years. Average length of the disease is also similar between the groups with highest value of patients assigned to tocilizumab (14.13 (SD 8.38) years) and lowest for infliximab (6.4 (SD 2.92) years), respectively. All observed indicators for disease control and QoL improve after the initiation of the biological or JAK inhibitor therapy. We also analyse the effect of therapies on DAS-28, HAQ, SF-36 (PCS, MCS). Dispersion analysis for the effect of therapy measured through DAS28 between 1st and 3rd measurement shows a statically significant difference in between the average effect of therapies (P = 0.005141). The most effective is the golimumab (Median difference = 2.745), followed by rituximab (median = 2.305) and etanercept (median = 2.070). The difference in effect measured with HAQ is higher with tofacitinib (median 0,563). Followed rituximab and infliximab (median 0.500 for both). Less effective appears to be etanercept (median difference 0,250). All differences are statistically significant (p = 0,012589). Regarding the changes in the QoL measured with SF-36 MCS and PCS there is no statistically significant differences in the average effect of different therapeutic agents. The medical effect of different therapeutic agents regarding physical group of SF-36 (PCS) is similar and changes are not statistically significant. The same is valid for SF36 psychological components (MCS).ConclusionTofacitinib and bDMARDs improve both clinical results and QoL of patients with RA naïve to biological therapy. The difference between tofacitinib and bDMARDs is not statistically significant for both clinical and QoL results.Disclosure of InterestsVladimira Boyadzhieva Speakers bureau: Boehringer ingelheim, Abbvie, Roche, Konstantin Tachkov: None declared, Nikolay Stoilov Speakers bureau: Abbvie, AMGEN, Konstantin Mitov: None declared, Guenka Petrova: None declared, Rumen Stoilov Speakers bureau: Abbvie, Pfizer, Roche, Boehringer ingelheim, MSD,