CHMP Backs Baricitinib, Lifmior for Rheumatoid Arthritis

Troy Brown, RN

Disclosures

December 16, 2016

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for baricitinib (Olumiant, Eli Lilly Nederland B.V.) and etanercept (Lifmior, Pfizer Ltd).

The committee recommended barticitinib for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) and etanercept for the treatment of RA, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and nonradiographic axial spondyloarthritis), plaque psoriasis, and pediatric plaque psoriasis.

Baricitinib

The committee recommended baricitinib for those with inadequate response to, or those who are intolerant of, one or more disease-modifying antirheumatic drugs (DMARDs). More than half of patients do not respond satisfactorily to current treatments for RA, and new treatments are needed.

Baricitinib is a Janus kinase (JAK) inhibitor that is taken orally alone or in combination with methotrexate (MTX). If approved, "[I]t would be first JAK inhibitor to be used in the treatment of [RA] in the EU and offers a different mode of action to what is currently available," according to an EMA news release.

The committee's recommendation follows a review of data from four randomized controlled trials in 3100 adults with moderate to severe active RA. One study compared baricitinib with MTX, one study compared baricitinib with adalimumab, and two studies compared baricitinib with placebo.

Overall, baricitinib reduced disease activity more effectively compared with MTX and adalimumab. Baricitinib demonstrated maintenance of efficacy in 52-week-long trials. Patients who had not responded to biologic DMARDs, as well as those who had never been treated before, experienced maintenance of efficacy.

The most frequent adverse effects were increased serum lipid levels, upper respiratory tract infections, and nausea.

The European Commission will consider the committee's opinion and adopt a decision on whether to authorize European Union (EU)–wide marketing; if granted, each member state will decide on price and reimbursement.

Etanercept

Lifmior is an identical product to Enbrel (Amgen), an injectable medication that was approved in the EU in February 2000. Its active substance is etanercept, a tumor necrosis factor (TNF)-α inhibitor. It is believed to competitively inhibit TNF — an inflammatory cytokine — binding to cell surface TNF receptors, in turn preventing TNF-mediated cellular responses and rendering TNF biologically inactive.

Etanercept will be available in 10-mg, 25-mg, and 50-mg strengths as a powder and solvent for an injectable solution or as a premixed injectable solution.

The full indication for etanercept is as follows:

  • Adults with moderate to severe active RA with inadequate response to DMARDs, including MTX (unless contraindicated), in combination with MTX; as monotherapy in those who are intolerant to MTX or in whom continued treatment with MTX is inappropriate; and adults with severe, active, and progressive RA in MTX-naive adults.

  • In patients with juvenile idiopathic arthritis, children and adolescents with polyarthritis and extended oligoarthritis aged 2 years and older who have responded inadequately to or are intolerant of MTX; treatment of psoriatic arthritis in adolescents aged 12 years and older who have responded inadequately to or are intolerant of MTX; and treatment of enthesitis-related arthritis in adolescents aged 12 years and older who have responded inadequately to or are intolerant of conventional therapy. Etanercept has not been studied in children younger than 2 years.

  • Adults with psoriatic arthritis who have responded inadequately to previous DMARD therapy. Etanercept improved physical function in patients with psoriatic arthritis and reduced the rate of peripheral joint damage progression as measured by radiography in patients with certain subtypes of the disease.

  • Adults with ankylosing spondylitis who have responded inadequately to conventional therapy and adults with severe nonradiographic axial spondyloarthritis who have responded inadequately to nonsteroidal anti-inflammatory drugs.

  • Adults with moderate to severe plaque psoriasis who did not respond to, have a contraindication to, or are intolerant of other systemic therapy, including ciclosporin, MTX, or psoralen, and ultraviolet-A light.

  • Children and adolescents aged 6 years and older with pediatric plaque psoriasis who are inadequately controlled by or are intolerant of other systemic therapies or phototherapies.

Treatment with etanercept should be initiated and supervised by specialist physicians with experience in the diagnosis and treatment of RA, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, nonradiographic axial spondyloarthritis, plaque psoriasis, or pediatric plaque psoriasis.

The summary of product characteristics will contain detailed recommendations for the use of etanercept; it will be published in the European public assessment report and will be available in all official EU languages after the European Commission grants marketing authorization.

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