-- Hungarian National Registry reports interim results following Inflectra therapy in 90 patients with Crohn's disease and ulcerative colitis
-- These data add to the growing body of evidence supporting the efficacy and safety of Inflectra treatment in inflammatory bowel disease
BARCELONA and MADRID, Spain, Feb. 19, 2015 /PRNewswire/ -- Data have been presented today on the use of Hospira's Inflectra (infliximab), the world's first approved biosimilar monoclonal antibody (mAb), at the European Crohn's and Colitis Organisation Inflammatory Bowel Diseases (ECCO-ibd) conference. Results show a comparable response in patients treated with Inflectra to that expected with the reference product, Remicade(R) (infliximab), for inducing and maintaining remission in Crohn's disease (CD) and ulcerative colitis (UC). These data add to the body of evidence supporting Inflectra's use in inflammatory bowel disease (IBD).
Results presented from the ongoing independent, prospective, nationwide study in Hungary show that for the first 90 patients, (57 with CD and 33 with UC) treated with Inflectra, reductions compared with baseline were seen in validated measures of disease activity after both two and six weeks of treatment.(1*) C-reactive protein (CRP), a marker of inflammation, was also decreased during induction therapy for UC.(1) Four of the 90 patients showed an allergic reaction to treatment, all of who had previously received anti-TNF medication.(1) The abstract can be found at: P314 Biosimilar infliximab in inflammatory bowel diseases: first interim results from a prospective nationwide observational cohort.
Professor Peter Lakatos, one of the founders and leader of the Hungarian IBD Study Group said, "The results of this study thus far have been deeply informative to confirm the clinical efficacy and safety of biosimilar infliximab following its introduction to the Hungarian market last year. The induction and maintenance of remission in patients prescribed Inflectra are exactly as we would expect to see with Remicade."
Another abstract presented at ECCO-ibd by Kim A et al. reports that the introduction of biosimilar infliximab for the treatment of CD alone could lead to savings of between EUR76 million and EUR336 million across the United Kingdom, Italy and France within five years.(2) The abstract can be found at: P137 5 year budget impact analysis of CT-P13 (Infliximab) for the treatment of Crohn's Disease in UK, Italy and France. Biologic medicines have transformed the lives of people living with debilitating inflammatory diseases such as CD and UC, chronic conditions that affect more than 2.2 million people in Europe.(3) However, these medicines are expensive and many eligible patients across Europe have been unable to access the treatments they need to fight the disease.(4) Biosimilar medicines provide a more affordable alternative to high-cost originator biologic medicines while maintaining the same quality, efficacy and safety.(5)
Dr. Paul Audhya, vice president, Medical Affairs, Europe, Middle East and Africa, Hospira, said, "The introduction of biosimilars provides an opportunity to reduce the high cost of biologic treatment, giving patients access to more affordable care without compromising on quality, safety or efficacy. The dataset collected under the nationwide registry in Hungary further validates the long-established biosimilar regulatory pathway in the EU, and in particular the principle of extrapolation, which is fundamental to the biosimilar concept."
The data reported is derived from a network of centres across Hungary and has been compiled since Inflectra entered the Hungarian market in May 2014. The study will follow individual patients with CD for a period of 108 weeks, and patients with UC for a period of 54 weeks, following induction with Inflectra.(1)
The Hungarian registry will continue to enrol patients, adding to the evaluation of Inflectra's use in IBD in a number of ongoing studies assessing safety, adherence, long-term outcomes and cost. Additional abstracts are being presented on the use of biosimilar infliximab (CT-P13) in IBD at the ECCO-ibd conference, in total assessing 272 patients, and can be found at: -- https://www.ecco-ibd.eu/index.php/publications/congress-abstract-s/abstracts-2015.html
Infliximab is a cornerstone treatment for many inflammatory diseases, with more than 15 years of clinical data and experience.(6) Inflectra is a biosimilar version of the anti-TNF alpha blockbuster Remicade (infliximab), and is the first biosimilar mAb to be assessed and licensed by the European Commission (EC). A biosimilar developed in-line with EU requirements can be considered a therapeutic alternative to an existing biologic.(5) Inflectra was licensed by the European Commission in September 2013 for all indications of its reference product. Inflectra is licensed in adults for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PsO), Crohn's disease (CD) and ulcerative colitis (UC). Inflectra is also licensed in children and adolescents aged between six and 17 years for CD and UC.(7) Inflectra is available in 24 European countries.
* For CD: reduction in CD Activity Index (CDAI) score, p 0.001 compared with baseline; for UC: reduction in partial MAYO (pMAYO) score, from 6.4 to 3.7 (at week 2) and 3.6 (at week 6).
NOTES TO EDITORS:
About Inflectra(8)
Inflectra (infliximab) is a chimeric human--murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNF alpha but not to lymphotoxin alpha (TNF beta). Inflectra is indicated for:
Rheumatoid arthritis
Inflectra, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: -- adult patients with active disease when the response to disease--modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate.
-- adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.
In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X--ray, has been demonstrated.
Adult Crohn's disease
Inflectra is indicated for: -- treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
-- treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
Paediatric Crohn's disease
Inflectra is indicated for treatment of severe, active Crohn's disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy.
Ulcerative colitis
Inflectra is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6--mercaptopurine (6--MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Paediatric ulcerative colitis
Inflectra is indicated for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6--MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
Ankylosing spondylitis
Inflectra is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Psoriatic arthritis
Inflectra is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Inflectra should be administered -- in combination with methotrexate
-- or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.
Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X--ray in patients with polyarticular symmetrical subtypes of the disease.
Psoriasis
Inflectra is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA).
See the Summary of Product Characteristics (also part of the EPAR) for full details.
Important Safety Information
(MORE TO FOLLOW) Dow Jones Newswires
February 19, 2015 06:07 ET (11:07 GMT)
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