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FRI0329 Efficacy and safety of infliximab originator in patients with takayasu arteritis within the RTU (temporary recommendation of use) in france
  1. J-F Kleinmann1,
  2. L Arnaud1,
  3. E Sauleau2,
  4. N Gouyette3,
  5. R Tajima1,
  6. J Sibilia1,
  7. on behalf of CRI (Club Rhumatismes et Inflammation)
  1. 1Rheumatology
  2. 2Public Health, Strasbourg's University Hospital, Strasbourg
  3. 3MSD France, Courbevoie, France

Abstract

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

  1. Mekinian et al, Efficacy of Biological-Targeted Treatments in Takayasu Arteritis: Multicenter, Retrospective Study of 49 Patients, Circulation 132(18) (2015) 1693–700.

  2. Mekinian et al, Efficacy and tolerance of infliximab in refractory Takayasu arteritis: French multicentre study, Rheumatology (Oxford) 51(5) (2012) 882–6.

  3. Kerr and al. Takayasu arteritis. Ann Intern Med. 1994; 120: 919–29.

References

Acknowledgements The patients were included by AP-HP Cochin (Dr X Puéchal), CHU Angers (Dr C Lavigne), CHU Tours (Pr E Diot), CHU Besançon (Pr N Magy, Dr H Gil), CHU Lille (Pr E Hachulla, Pr M Lambert, Dr H Maillard), AP-HP Kremlin-Bicêtre (Pr I Koné-Paut), AP-HM Marseille (Pr JR Harlé, 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

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