THU0141 A Non-Interventional Clinical Study Evaluating The Use of Golimumab in Patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PSA), and Ankylosing Spondylitis (AS) in A Real-Life Setting in Germany
Authors: K. Krüger, G.R. Burmester, S. Wassenberg, M. Bohl-Bühler, M.H. Thomas
Journal: Annals of the Rheumatic Diseases (2016)

<h3>Background</h3> Golimumab (GOL) has shown its efficacy and safety in various randomized clinical trials with patients eligible for clinical studies. Data from daily clinical practice in Germany are still lacking. <h3>Objectives</h3> To gather data in daily clinical practice from German patients with RA, PsA, AS starting a treatment with GOL sc once monthly. The aim was to monitor safety, effectiveness, socio- and health economic parameters, as well as patient reported quality of life in a real-life setting. <h3>Methods</h3> Patients were enrolled in the non-interventional study GO-NICE at 168 German sites to explore days of sick leave, ability to work, data of quality of life and clinical effectiveness by DAS28, PsARC and BASDAI as well as safety. <h3>Results</h3> 1,613 patients were documented. A total of 1,458 (90.4%) patients were eligible for final analysis, and had a baseline assessment as weel as at least one additional visit. 664 (41.2%) completed the 24-month observational period. <i>RA-patients</i> (n=474): Mean age was 54.9 years, 72.8% were female, 45.7% were employed and 64.7% were biologic-naïve at baseline (BL). DAS28 was initially 5.0 and dropped to 2.9 within 24 months (p&lt;0.0001). After 3 months of therapy, 33.7% of patients were in remission (DAS28 &lt;2.6), and after 24 months 44.6%. <i>PsA-patients</i> (n=501): Mean age was 50.5 years, 54.1% were female, 55.7% were employed, 56.5% were biologic-naïve at BL. 197 patients had a nail involvement (39.3%), 106 dactylitis (21.2%) and 70 enthesitis (14.0%) at BL. 54.1% showed a good response (mod. PsARC) after 3 months with a further increase to 67.9% after 24 months. <i>AS-patients</i> (n=483): Mean age was 43.6 years, 66.5% were male, 69.6% were employed, 61.0% were biologic-naïve at BL. The most common extra-articular manifestations were iritis (15.1%), enthesitis (12.4%), IBD (5.8%) and dactylitis (3.5%). The mean BASDAI score (1–10) decreased from 5.1 (month 0) to 2.4 (month 24) (p=0.0001). <i>Days of absenteeism</i> from work due to the underlying disease in the last 6 months were evaluated at BL and after 2 years of treatment. These dropped from 16.2 to 4.1 (RA), from 10.6 to 2.0 (PsA) and from 14.7 to 3.9 days (AS). The disease impact on <i>quality of work</i> within the last 6 months, determined by 0 (no impact) to 10 (very severe impact) decreased within 24 months of treatment from 4.8 to 2.4 (RA-), from 4.8 to 2.2 (PsA-) and from 4.8 to 2.0 (AS-patients). An improvement of <i>quality of life</i> (EQ-5D-3L) and <i>functional ability</i> (FFbH) was seen in all three patient groups after 6 months and was maintained over 24 months. After 24 months the treating rheumatologists rated more than 80% of the treatment courses as "successful", 10–15% as "partially successful", and less than 4% as "unsuccessful". The <i>safety profile</i> of GOL was consistent with that observed in other studies of GOL. 4 deaths occurred: 1 patient unlikely related, and 3 patients not drug-related to treatment of GOL. <h3>Conclusions</h3> GOL sc once monthly was an effective treatment in patients with RA, PsA and AS in a real-life setting in Germany. It showed remarkable improvements in clinical effectiveness, health economic and patient-reported quality of life parameters. No new safety signals were detected. <h3>Disclosure of Interest</h3> K. Krüger Grant/research support from: AbbVie, BMS, Celgene,Janssen Biologics, Pfizer, Roche, Sanofi-Aventis, G. Burmester Grant/research support from: AbbVie, Bristol-Myers Squibb, MSD Sharp &amp; Dohme, Pfizer, Roche, UCB, S. Wassenberg Grant/research support from: AbbVie, Chugai, Janssen Biologics, MSD, Novartis, Pfizer, Roche, M. Bohl-Bühler Grant/research support from: AbbVie, Hexal, MSD, Roche, UCB, M. Thomas Employee of: MSD Sharp Dohme GmbH