POS0075 SAFETY AND EFFICACY OF GOLIMUMAB FOR THE TREATMENT OF POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS - AN UPDATE FROM THE BIKER REGISTRY

Background: Golimumab (GOL) is approved for treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years and older. Data on long-term safety GOL this indication are limited. Objectives: To assess efficacy pJIA patients. Methods: In ongoing non-interventional observational study, clinical characteristics, disease activity parameters were analysed using the German Biologics Paediatric Rheumatology (BiKeR) registry. 81 pJIA-patients treated with body weight-matched 162 receiving alt. tumor necrosis factor inhibitors (TNFi) biologic–naïve under methotrexate (MTX)-therapy. Results: Baseline differed from alternative TNFi MTX cohorts. starting treatment, duration was longer, corticosteroid use less activity, measured by mean number active joints JADAS10, lower (Table 1). The highlighted a decrease JADAS 10 11.6 (baseline) to 5.2 after 24 months. After years, minimal reached 44.4 % patients, whereas 22.2 remission JIA ACR 30/50/70/90 response rates 77.8/72.2/66.7/55.6% respectively. AE, SAE infectious AE between three cohorts comparable cohort, 4 (1 uveitis, 1 flare, fibromyalgia syndrome abscess) reported, while group 7 SAEs cohort noted One serious event documented had influenza no events seen control group. Table 1. adverse n=81 n=162 p-value ∞ vs Gender female ° 67 (83) 127 (78) 64 (79) 0.5 0.7 Disease (yrs ) 7.1±4.3 4.3±3.7 1.2±2.1 <0.0001 RF neg. Polyarthritis 40 (49) 79 50 (62) 1.0 0.15 pos. 8 (10) 22 (14) 16 (20) 0.1 Extended Oligoarthritis 30 (37) 54 (33) 13 (16) 0.6 0.004 Psoriatic 3 (4) (3) 1.0/1.0 Pretreatment bDMARD 68 (84.0) 35 (21.6) 0 Concomitant systemic steroids, n (% 38 (24) 39 (48) 0.2 Active joint count # 4.6±4.8 4.9±5.7 9.6±6.5 0.4 CHAQ DI 0.4±0.5 0.5±0.5 0.6±0.6 0.02 JADAS10 11.6±6.2 12.1±6.1 16.8±5.3 * 91 (107.4; 88-132) 213 (88.7; 78-101) 113 (119.8; 100-144) (4.7; 2-13) (2.9; 1-6) (1.1; 0.1-8) Serious infections (1.2; 0.2-8.4) (0.8; 0.2-3.3) n.a. Autoimmune process (2.4) (1.9) (1.2) Patients uveitis new manifestation study entry 0.2-8) 0.5-3) flare preexisting at baseline* 6 (7.1; 3-16) Rheumatoid (RF), biologic modifying antirheumatic drug (bDMARD), childhood health assessment questionnaire disability index (CHAQ Di), (JADAS), (AE), patient year (PY), (%), (SD), (rate/100PY; 95%CI), (GOL), inhibitor (alt. TNFi), (MTX), t-test or χ2-test as appropriate. Few autoimmune processes occurred: incident psoriasis), cases (2 psoriasis,) MTX-patients (celiac disease) Out 20 baseline, events; there reported flares 17 MTX-group. No malignancies deaths reported. Conclusion: Our interim results show an acceptable profile therapy, MTX. signals occurred. outcome data confirm benefits Acknowledgements: We greatly appreciate kind support Z. Huang, S. Calhoun. Disclosure Interests: Angela Zimmer: None declared, Ariane Klein: Kirsten Minden: Toni Hospach: Frank Weller-Heinemann: Jasmin Kuemmerle-Deschner: Maria Fasshauer: Nadja Hofmann: Hans Koessel: Ivan Foeldvari: Sonja Mrusek: Daniel Windschall: Nils Onken: Markus Hufnagel: Dirk Foell: Normi Brueck: Prassad Thomas Oommen: Dressler: Astrid Helling-Bakki: Gerd Horneff Speakers bureau: MSD.