FRI0329 Efficacy and safety of infliximab originator in patients with takayasu arteritis within the RTU (temporary recommendation of use) in france

Background The benefit/risk ratio of infliximab in refractory patient with Takayasu arteritis (TA) is assumed to be favorable, based on retrospective studies with limited sample size [1, 2] in which infliximab has been prescribed off-label. Since 2013, the French Temporary Recommendation of Use (RTU) provides a temporary framework allowing the use of infliximab originator in “TA patients refractory to conventional treatment” during a 3-year period. Objectives The aim of the study was to evaluate the real-life efficacy and safety of infliximab originator in TA patients initiating or with ongoing infliximab treatment. Methods Prospective, multicenter, observational, open-label, study of TA patients treated with infliximab originator. Results As of 2016 (2 years of follow-up), the study included 14 patients (13/14 were female; median age 32 [range 12–56] years) with TA (diagnosis according to Ishikawa criteria). At study entry, the median TA duration was 4.7 (0.4–16) years, 12 patients were already treated with infliximab originator (for a median duration of 34 [1–78] months) and 11 patients were receiving corticosteroids (CS). Infliximab originator was administered at a median dose of 5 (3–6) mg/kg with a median interval of 8 (2–67) weeks between each infusion. Seven patients had an improvement in at least 1 of the NIH disease activity criteria for TA [3] after a median follow-up time of 2 (0.4–11) months), 4 had smoldering disease and 1 patient worsened. The median daily dose of CS decreased from 13 (5–35) mg/day of prednisone or equivalent at baseline to 7 (5–10) mg/day at 6 months, to 5 (5–6) mg/day at 12 months, and remained stable up to 22 months of follow-up. Infliximab was discontinued in 6 patients due to inefficacy (n=3), prior to pregnancy (n=2), or remission of TA (n=1). Two adverse events (1 disease flare and 1 spontaneous miscarriage) were reported, without infliximab interruption. Conclusions Infliximab originator appears to provide an effective and favourable benefit:risk treatment option to refractory TA patients. References Mekinian et al, Efficacy of Biological-Targeted Treatments in Takayasu Arteritis: Multicenter, Retrospective Study of 49 Patients, Circulation 132(18) (2015) 1693–700. Mekinian et al, Efficacy and tolerance of infliximab in refractory Takayasu arteritis: French multicentre study, Rheumatology (Oxford) 51(5) (2012) 882–6. Kerr and al. Takayasu arteritis. Ann Intern Med. 1994; 120: 919–29. Acknowledgements The patients were included by AP-HP Cochin (Dr X Puechal), CHU Angers (Dr C Lavigne), CHU Tours (Pr E Diot), CHU Besancon (Pr N Magy, Dr H Gil), CHU Lille (Pr E Hachulla, Pr M Lambert, Dr H Maillard), AP-HP Kremlin-Bicetre (Pr I Kone-Paut), AP-HM Marseille (Pr JR Harle, Dr N Schleinitz), HEGP Pompidou (Dr JE Kahn), CH Royan (Dr A Bonnin), CHU Strasbourg (Pr T Martin, Dr V Poindron), CHU Bordeaux (Pr J Constans). Disclosure of Interest J.-F. Kleinmann Consultant for: MSD, L. Arnaud: None declared, E. Sauleau Consultant for: MSD, N. Gouyette Employee of: MSD, R. Tajima: None declared, J. Sibilia Consultant for: MSD