POS0075 SAFETY AND EFFICACY OF GOLIMUMAB FOR THE TREATMENT OF POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS - AN UPDATE FROM THE BIKER REGISTRY
Authors: A. Zimmer, A. Klein, K. Minden, T. Hospach, F. Weller-Heinemann, J. Kuemmerle-Deschner, M. Fasshauer, N. Hofmann, H. Koessel, I. Foeldvari, S. Mrusek, D. Windschall, N. Onken, M. Hufnagel, D. Foell, N. Brueck, P. T. Oommen, F. Dressler, A. Helling-Bakki, G. Horneff
Journal: Annals of the Rheumatic Diseases (2021)

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