Budget Impact Analysis of the Introduction of Subcutaneous Infliximab (CT-P13 SC) for the Treatment of Rheumatoid Arthritis in the United Kingdom.

Background: CT-P13 subcutaneous (SC)-the first and only SC version of infliximab-is approved by the European Medicines Agency for the treatment of rheumatoid arthritis (RA). This new mode of infliximab administration will allow patients to self-inject at home, significantly reducing the number of outpatient visits and costs of intravenous (IV) administration. This paper describes the economic impact of introducing CT-P13 SC to the market from the UK societal perspective.

Comparative efficacy of subcutaneous (CT-P13) and intravenous infliximab in adult patients with rheumatoid arthritis: a network meta-regression of individual patient data from two randomised trials.

Background: A subcutaneous (SC) formulation of infliximab biosimilar CT-P13 is approved in Europe for the treatment of adult patients with rheumatoid arthritis (RA). It may offer improved efficacy versus intravenous (IV) infliximab formulations.

Methods: A network meta-regression was conducted using individual patient data from two randomised trials in patients with RA, which compared CT-P13 SC with CT-P13 IV, and CT-P13 IV with reference infliximab IV.

Efficacy and safety of subcutaneous infliximab versus adalimumab, etanercept and intravenous infliximab in patients with rheumatoid arthritis: a systematic literature review and meta-analysis.

Objectives: There are few comparative data for tumor necrosis factor inhibitors in patients with rheumatoid arthritis (RA).

Methods: Historical data for reference product/biosimilar intravenous infliximab, or adalimumab and etanercept, were pooled and compared with phase 3 study results for a subcutaneous (SC) formulation of the infliximab biosimilar CT-P13, in a systematic review and meta-analysis (PROSPERO: CRD42019149621).

Results: The authors identified 13 eligible controlled trials that randomized over 5400 participants to prespecified treatments of interest.

A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis.

Objective: To demonstrate pharmacokinetic equivalence of CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA) with inadequate responses or intolerances to antitumour necrosis factor agents.

Methods: In this randomised phase I trial, patients with active RA were randomly assigned (2:1) to receive 1000 mg CT-P10 or RTX at weeks 0 and 2 (alongside continued methotrexate therapy). Primary endpoints were area under the serum concentration-time curve from time zero to last quantifiable concentration (AUC) and maximum serum concentration after second infusion (C).

The immunogenicity of biosimilar infliximab: can we extrapolate the data across indications?

Biopharmaceuticals or 'biologics' have revolutionized the treatment of many diseases. However, some patients generate an immune response to such drugs, potentially limiting clinical efficacy and safety. Infliximab (Remicade(®)) is a monoclonal antibody used to treat several immune-mediated inflammatory disorders.