Pfizer reports positive top-line data from REFLECTIONS B538-02 study of PF-06410293
Pfizer has reported positive top-line data from its REFLECTIONS B538-02 study of PF-06410293 compared with Humira to treat moderate-to-severe rheumatoid arthritis (RA).
PF-06410293 is a monoclonal antibody (mAb) being developed as a potential biosimilar to Humira (adalimumab) and will act as a tumour necrosis factor inhibitor.
The REFLECTIONS B538-02 trial is being conducted as a multi-national, randomised, double blind, two-arm, parallel group equivalence study that intends to determine the safety, efficacy and immunogenicity of PF-06410293 against Humira in combination with methotrexate when administered subcutaneously to treat 597 patients with moderate-to-severely active RA.
The study was primarily focused on achieving an equivalent ACR20 response according to American College of Rheumatology (ACR) criteria after 12 weeks of treatment.
Pfizer Essential Health research and development head Sumant Ramachandra said: “Today’s announcement builds on Pfizer’s robust biosimilar pipeline, which has now delivered positive top-line data results for three of our proposed biosimilars.
“As the leading global biosimilars company, we continue to advance our commitment to expand access to high-quality treatment options for patients living with chronic, debilitating conditions, such as those in inflammation.
“Inflammation remains one of the core research areas for Pfizer, spanning over 60 years and including a number of assets in various stages of development.”
Humira is currently approved in the US, EU and other markets for multiple indications such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.