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  • FRI0137 Efficacy, safety and immunogenicity from week 30 to week 54 in a randomised, double-blind phase iii study comparing a proposed infliximab biosimilar (PF-06438179/GP1111) with reference infliximab

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FRIDAY, 15 JUNE 2018
Rheumatoid arthritis – biological DMARDs
FRI0137 Efficacy, safety and immunogenicity from week 30 to week 54 in a randomised, double-blind phase iii study comparing a proposed infliximab biosimilar (PF-06438179/GP1111) with reference infliximab
  1. R. Alten1,
  2. V. Tseluyko2,
  3. T. Hala3,
  4. S. Mehmedagic4,
  5. M. Pileckyte5,
  6. E. Dokoupilová6,
  7. D. Jovic7,
  8. M. Rehman8,
  9. M. Zhang9,
  10. L. Sewell10,
  11. S. Hackley11,
  12. S. Salts9,
  13. C. Cronenberger12,
  14. K. Schumacher13,
  15. O. von Richter13,
  16. B. Batko14
  1. 1Schlosspark Klinik, Berlin, Germany
  2. 2Kharkiv Medical Academy of Postgraduate Education, Kharkiv, Ukraine
  3. 3Center for Clinical and Basic Research, Pardubice, Czech Republic
  4. 4Clinical Center University of Sarajevo, Sarajevo, Bosnia and Herzegovina
  5. 5Hospital of Lithuanian University of Health Sciences, Kaunas, Lithuania
  6. 6Medical Plus s.r.o., Uherske Hradiste, University of Veterinary and Pharmaceutical Sciences, Brno, Czech Republic
  7. 7University Clinical Centre of the Republic of Srpska, Banja Luka, Bosnia and Herzegovina
  8. 8Pfizer Inc., Andover, MA
  9. 9Pfizer Inc., La Jolla, CA
  10. 10Pfizer Inc., Cambridge, MA, USA
  11. 11Pfizer Ltd, Sandwich, UK
  12. 12Pfizer Inc., Collegeville, PA, USA
  13. 13Sandoz Biopharmaceuticals, Holzkirchen, Germany
  14. 14J. Dietl Specialist Hospital, Krakow, Poland

Abstract

Background PF-06438179/GP1111 (GP1111) is an infliximab (IFX) biosimilar in development for the treatment of immune-mediated inflammatory diseases, including rheumatoid arthritis (RA). The efficacy, safety and immunogenicity of GP1111 and European reference IFX (IFX-EU) have been reported to be similar over 30 weeks (Wks).

Objectives To evaluate the efficacy, safety and immunogenicity of GP1111 and IFX-EU with longer-term treatment, and after treatment transition from IFX-EU to GP1111.

Methods A randomised, double-blind, parallel-group study compared GP1111 with IFX-EU in biologic-naïve, adult patients with moderate-to-severe active RA on a stable dose of methotrexate (MTX). Patients were randomised (1:1) to GP1111 or IFX-EU (3 mg/kg IV at Wks 0, 2, 6, and then every 8 wks, with one dose escalation to 5 mg/kg allowed at or after Wk 14 for inadequate responders) for 30 weeks (treatment period 1). The primary endpoint was a≥20% improvement in ACR response (ACR20) at Wk 14. At Wk 30 (treatment period 2 [TP2]), patients receiving IFX-EU were blindly re-randomised (1:1) to remain on IFX-EU or transition to GP1111 for 24 wks. Here we report longer-term efficacy, safety and immunogenicity data from Wks 30–54.

Results 650 patients were randomised initially (GP1111, n=324; IFX-EU, n=326). At Wk 30, 566 patients entered TP2 (continued GP1111, n=280; continued IFX-EU, n=143; switched from IFX-EU to GP1111, n=143). ACR20 rates and DAS28-CRP scores were comparable between groups at all TP2 visits after re-randomisation in the TP2 population (figure 1). Incidences of TP2 treatment-emergent adverse events (AEs) (36.8%, 33.6%, and 37.8%), serious AEs (4.6%, 7.7% and 2.8%) and infusion-related reactions (3.2%, 8.4% and 4.2%) were comparable between the GP1111/GP1111, IFX-EU/IFX-EU, and IFX-EU/GP1111 groups, respectively. Pre-dose ADA rates at Wk 30 (TP2) were 47.1%, 53.8% and 45.5% for the GP1111/GP1111, IFX-EU/IFX-EU, and IFX-EU/GP1111 groups, respectively. Overall, post-dose ADA rates in TP2 were comparable between groups (52.1%, 60.1%, and 58.0% respectively).

Abstract FRI0137 – Figure 1
Abstract FRI0137 – Figure 1

ACR20 response rate and change in DAS28-CRP score at Wk 30 and 54 for the overall population during TP2

Conclusions Results from TP2 (Wks 30–54) continued to show the absence of clinically meaningful differences in efficacy, safety and immunogenicity between patients with RA remaining on GP1111 or IFX-EU, or when blindly switched from IFX-EU to GP1111.

Disclosure of Interest R. Alten Grant/research support from: Pfizer Inc., Consultant for: Pfizer Inc., Speakers bureau: Pfizer Inc., V. Tseluyko Speakers bureau: Pfizer Inc., AstraZeneca, Bayer, Boehringer Ingelheim, Servier, Sanofi, Takeda, KRKA, T. Hala: None declared, S. Mehmedagic: None declared, M. Pileckyte: None declared, E. Dokoupilová: None declared, D. Jovic: None declared, M. Rehman Shareholder of: Proctor and Gamble, Employee of: Pfizer Inc., M. Zhang Shareholder of: Pfizer Inc., Employee of: Pfizer Inc., L. Sewell Shareholder of: Pfizer Inc., Employee of: Pfizer Inc., S. Hackley Shareholder of: Pfizer Inc., Employee of: Pfizer Inc., S. Salts Shareholder of: Pfizer Inc., Mirati Therapeutics, Employee of: Pfizer Inc., C. Cronenberger Shareholder of: Pfizer Inc., Employee of: Pfizer Inc., K. Schumacher Shareholder of: Novartis, Employee of: Sandoz Biopharmaceuticals, O. von Richter Employee of: Sandoz Biopharmaceuticals, B. Batko Consultant for: Pfizer Inc., Sandoz, MSD

https://doi.org/10.1136/annrheumdis-2018-eular.5121

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