AB0650 BIOSIMILAR INFLIXIMAB EXPERIENCE IN SPONDYLOARTRITIS PATIENTS: TREASURE REAL LIFE RESULTS
Authors: N. S. Yasar Bilge, T. Kaşifoğlu, S. Kiraz, A. İ. Ertenli, E. Dalkiliç, C. Bes, H. Emmungil, B. N. Seniz, B. Yağiz, M. Çinar, S. Akar, Ö. Gerçik, D. Ersözlü, G. Kimyon, R. Mercan, O. Karadag, Y. Pehlivan, L. Kiliç, U. Kalyoncu
Journal: Annals of the Rheumatic Diseases (2020)

Background: Biosimilar infliximab (bio-INF) was approved for all indications of the reference product in several countries. It has been marketed since 2014 in Turkey and used in the same indications with its bio-originator. Objectives: Herein, we aimed to analyse clinical features and the drug survival rates of spondyloarthritis patients who have recieved bio-INF. Methods: This multicenter, prospective observational cohort study used the TReasure database in which web-based registration of rheumatoid arthritis and SpA patients are being performed in 13 centers across different regions of Turkey. Age, gender, and acute phase responses (erythrocyte sedimentation rate and C-reactive protein), HAQ scores, VAS patient global, VAS fatigue, VAS pain, VAS physician global, BASDAI, BASFI, ASDAS ESH and ASDAS CRP values, clinical findings of SpA patients, number of patients who has received bio-INF as first line therapy or after switch, treatments which are used before bio-INF, the reasons for switching bio-INF to another biologic DMARD and drug survival rates were retrospectively evaluated. Results: A total number of 231 SpA (94 (40.7 %) female, 137 (59.3%) male, mean age 43±11 yrs) patients have received biosimilar infliximab in the database. Of the 231 patients 127 (55%) had received bio-INF as first line therapy, whereas 104 (46 (19.9%) 2 nd choice, 58 (25.1%) 3 rd choice) patients used switching after another biologic DMARD. Previously used biologic and synthetic DMARDs were adalimumab (28.6%), etanercept (22.5%), golimumab (9.1%), original infliximab (8.2%), secukinumab (13.4%), methotrexate (23.8%), leflunamid (10.4%), sulphasalazine (60.6%). The baseline and first visit (3. Months) diseases activity scores were shown in Table 1. Drug survival rates were 79.1 in 12. months, 65.5 in 24. months and 54.6 in 60. months. (Figure 1). The most common reasons for switching from biosimilar infliximab to another biologic DMARD is secondary (25(10.8%)), and primary ineffectiveness (22(9.5%)). Other reasons to discontinuation of treatment are psoriasis (5 (2.1%)), infusion reaction (3(1.2%)), allergic reaction (22(8.8 %)), chest pain (3(1.2%)), dyspnea (1 (0.4%)), vasculitis (1 (0.4%)) and patient or doctor wish (7 (3.4%)). Conclusion: The results of this real life data provides evidence that biosimilar infliximab is an effective and safe treatment option with long term use in SpA patients. Drug survival rates of bio-INF is similar to its bio-originator. Table 1. Disease activity scores Baseline visit 3.month p median (Q1-Q3) median (Q1-Q3 ) HAQ score 0,63 (0,4-1) 0,25 (0-1) &lt;0,001 BASDAI 6,2 (4,8-7) 2,8 (1-5) &lt;0,001 BASFI 5,05 (3,3-6) 2,1 (0,45-4) &lt;0,001 VAS Patient Global 70 (50-80) 30 (10-50) &lt;0,001 VAS Doctor Global 60 (40-70) 30 (20-40) &lt;0,001 VAS Pain 50 (3-80) 30 (10-50) 0,572 VAS fatigue 70 (50-80) 40 (10-65) &lt;0,001 ESR 24 (11-45) 11 (6-23) &lt;0,001 CRP 12,1 (4,4-30) 3,91 (2,19-9) &lt;0,001 ASDAS ESR 3,12 (2,51-4) 2,05 (1,39-3) &lt;0,001 ASDAS CRP 3,53 (2,86-4) 2,21 (1,5-3) &lt;0,001 *Wilcoxon Signed Rank Test Figure 1. Drug survival rates Disclosure of Interests: Nazife Sule Yasar Bilge: None declared, Timuçin Kaşifoğlu: None declared, Sedat Kiraz: None declared, Ali İhsan Ertenli: None declared, Ediz Dalkiliç: None declared, Cemal Bes: None declared, Hakan Emmungil: None declared, Belkis Nihan Seniz: None declared, Burcu Yağiz: None declared, Muhammet Çinar: None declared, Servet Akar: None declared, Önay Gerçik: None declared, Duygu Ersözlü: None declared, Gezmiş Kimyon: None declared, Ridvan Mercan: None declared, Omer Karadag: None declared, Yavuz Pehlivan: None declared, Levent Kiliç: None declared, Umut Kalyoncu Consultant of: Abbvie, Amgen, Janssen, Lilly, Novartis, UCB