Ixifi (infliximab-qbtx) is a monoclonal antibody developed by Pfizer (and Sandoz in Europe) that binds to and blocks tumor necrosis factor-alpha (TNFα), a cell signaling molecule involved in inflammation. It is indicated for the reduction of signs and symptoms in patients with active ankylosing spondylitis (AS).
The U.S. Food and Drug Administration (FDA) recently approved Ixifi for the treatment of patients with AS, rheumatoid arthritis (RA), Crohn’s disease, ulcerative colitis, psoriatic arthritis, and plaque psoriasis.
Ixifi is a biosimilar to Remicade (infliximab). Its approval is based on data showing that it is highly similar in terms of indications, dosing regimen, strength, safety, and route of administration to the FDA-approved reference product Remicade.
How Ixifi works
Ixifi works by binding to TNFα, thereby inhibiting TNFα’s binding to its receptors. Normally, TNFα mediates several functions, such as inducing inflammation and activating immune cells such as neutrophils. The exact mechanism by which infliximab products produce clinical effects is unknown. However, in preclinical studies, they were found to heal joints in a mouse model of arthritis.
Ixifi in clinical trials
Ixifi’s FDA approval followed the acceptance of the company’s Biologics License Application for Ixifi in April 2017. Approval is based on data demonstrating similarity to Remicade. These data were obtained from a Phase 3 study (NCT02222493), called REFLECTIONS B537-02, in patients with moderate to severe active RA. The randomized, multicenter, double-blind, two-arm, parallel group study evaluated Ixifi’s safety, efficacy, and immunogenicity (the ability to elicit an immune response) versus Remicade in combination with methotrexate to treat patients with moderate to severe RA who had an inadequate response to methotrexate therapy alone. The study showed that Ixifi and Remicade had similar efficacy, safety, and immunogenicity.
Ixifi’s safety and efficacy also were assessed in a randomized, multicenter, double-blind, placebo-controlled study in 279 patients with active AS. The study showed improvement in the signs and symptoms of AS at 24 weeks in 60 percent of patients treated with Ixifi compared to only 18 percent of patients treated with placebo.
Ixifi is administered as an infusion into the bloodstream over a period of two hours. Ixifi is not recommended for patients with serious infections, malignancies, Hepatitis B virus reactivation, tuberculosis, liver toxicity, or heart problems.
Side effects include upper respiratory infections, infusion-related reactions, headache, and abdominal pain.
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