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Infliksimabin biosimilaari nivelreuman hoidossa

Näytönastekatsaukset
Laura Pirilä
30.3.2015

Näytön aste: B

Infliksimabin biosimilaari (CT-P13) on tehon ja turvallisuuden suhteen nivelreuman hoidossa infliksimabin kaltainen ainakin lyhytaikaisessa käytössä.

A phase III randomised, double-blind, multicentre, multinational, parallel-group study compared the efficacy and safety of innovator infliximab (INX) and CT-P13, an INX biosimilar, in active rheumatoid arthritis patients (ACR 1987 criteria) with inadequate response to methotrexate (MTX) treatment «Yoo DH, Hrycaj P, Miranda P ym. A randomised, doub...»1. CT-P13 is an immunoglobulin (Ig)G1 chimeric human–murine monoclonal antibody biosimilar to INX. The study was funded by CELLTRION Inc.

Patients with active disease despite MTX (12.5–25 mg/week) were randomised to receive 3 mg/kg of CT-P13 (n = 302) or INX (n = 304) with MTX and folic acid. Patients with active disease despite MTX (12.5–25 mg/week) were randomised to receive 3 mg/kg of CT-P13 (n = 302) or INX (n = 304) with MTX and folic acid. Patients with active disease despite MTX (12.5–25 mg/week) were randomised to receive 3 mg/kg of CT-P13 (n = 302) or INX (n = 304) with MTX and folic acid.

The primary endpoint, ACR20 response at week 30, was equivalent between treatment groups and achieved in 60.9 % and 58.6 % in ITT (n = 606, 95 % CI -6 % to 10 %) and 73.4 % and 69.7 % in PP population (n = 499, 95 % CI -4 % to 12 %) for CT-P13 and INX, The secondary endpoints, ACR50 and 70 responses in the ITT population at week 30 were comparable (35.1 % and 16.6 % vs 34.2 % and 15.5 % for CT-P13 and INX, respectively).

Overall treatment-emergent AEs (TEAEs) were reported in 181 (60.1 %) patients and 183 (60.8 %) patients for CT-P13 and INX, respectively.

Antibodies to infliximab were detected using INX tag in 25.4 % (n = 69) and 25.8 % (n = 70) of patients for CT-P13 and INX at week 14 and 48.4 % (n = 122) and 48.2 % (n = 122) of patients for CT-P13 and INX, respectively, at week 30.

CT-P13 and INX were shown to be equivalent in terms of ACR20 response at week 30 in active RA patients with inadequate response to MTX treatment. Overall, CT-P13 was well tolerated and the safety profile of CT-P13 was comparable with that of INX

  • Tutkimuksen laatu: tasokas
  • Sovellettavuus suomalaiseen väestöön: hyvä

Kirjallisuutta

  1. Yoo DH, Hrycaj P, Miranda P ym. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis 2013;72:1613-20 «PMID: 23687260»PubMed