A comparative study of PF-06438179/GP1111 (an infliximab biosimilar) and reference infliximab in patients with moderate to severe active rheumatoid arthritis: A subgroup analysis.

PF-06438179/GP1111 (PF-SZ-IFX) is a biosimilar of reference infliximab (Remicade® ). This analysis compared the efficacy of PF-SZ-IFX and reference infliximab sourced from the European Union (IFX-EU) in patient subgroups from a randomized, comparative study of PF-SZ-IFX versus IFX-EU. Patients with rheumatoid arthritis were randomized 1:1 to PF-SZ-IFX (n = 324) or IFX-EU (n = 326); study drug (3 mg/kg) was administered intravenously at weeks 0, 2, and 6, then every 8 weeks thereafter. Subgroup analyses of efficacy endpoints such as American College of Rheumatology criteria for ≥20% clinical improvement (ACR20), change in high-sensitivity C-reactive protein (hs-CRP), and change in Disease Activity Score in 28 joints, four components based on hs-CRP (DAS28-CRP) at weeks 14 and 30 were performed by age, gender, race, region, immunogenicity status, and treatment history. Overall, ACR20 response rates as well as changes in DAS28-CRP and hs-CRP at week 14 were similar between PF-SZ-IFX and IFX-EU within the subgroups of age, gender, race, region, treatment history, and immunogenicity status. Results to week 30 support overall similarity in efficacy between the two treatment arms in all subgroups. Overall, PF-SZ-IFX and IFX-EU were similar in efficacy within the analyzed subgroups of age, gender, race, region, treatment history, and immunogenicity status. The efficacy results from these subgroup analyses were aligned with the previously described results for the overall population up to week 30.

Kameda H ，Uechi E ，Atsumi T ，Abud-Mendoza C ，Kamei K ，Matsumoto T ，Ponce de Leon D ，Rehman MI ，Zhang M ，Radominski SC ... -  《-》

Randomised, double-blind, phase III study comparing the infliximab biosimilar, PF-06438179/GP1111, with reference infliximab: efficacy, safety and immunogenicity from week 30 to week 54.

Alten R ，Batko B ，Hala T ，Kameda H ，Radominski SC ，Tseluyko V ，Babic G ，Cronenberger C ，Hackley S ，Rehman M ，von Richter O ，Zhang M ，Cohen S ... -  《-》

Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54-78 Data From a Randomized, Double-Bli

Cohen SB ，Radominski SC ，Kameda H ，Kivitz AJ ，Tee M ，Cronenberger C ，Zhang M ，Hackley S ，Rehman MI ，von Richter O ，Alten R ... -  《-》

A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy.

Cohen SB ，Alten R ，Kameda H ，Hala T ，Radominski SC ，Rehman MI ，Palaparthy R ，Schumacher K ，Schmitt S ，Hua SY ，Ianos C ，Sewell KL ... -  《-》

Population pharmacokinetics of PF-06438179/GP1111 (an infliximab biosimilar) and reference infliximab in patients with moderately to severely active rheumatoid arthritis.

Palaparthy R ，Rehman MI ，von Richter O ，Yin D ... -  《-》