RIDGEFIELD, Conn., Sept. 12, 2018 /PRNewswire/ -- Boehringer Ingelheim today announced results from a phase III study, confirming that Cyltezo® is equivalent to Humira®*, with no clinically meaningful differences in efficacy, safety and immunogenicity in people with moderate-to-severe chronic plaque psoriasis.1 The 16-week data was presented at the European Association of Dermatology and Venereology Annual Meeting (EADV 2018) in Paris.
"This phase III study builds on recent evidence that demonstrates Cyltezo®is equivalent to Humira® for the treatment of moderately-to-severely active rheumatoid arthritis," said Key Tetzlaff, Vice President and Medical Head of Therapeutic Area Biosimilars at Boehringer Ingelheim. "These data reinforce the robust body of evidence that Boehringer Ingelheim is collecting to provide safe and effective treatment options that will contribute to the quality and sustainability of healthcare systems."
In the phase III study (NCT 02850965), 318 patients between 18 and 78 years of age with moderate-to-severe chronic plaque psoriasis, who had not previously received treatment with one or more biologic, were randomized to receive Cyltezo® or Humira® at 80 mg on day 1, 40 mg on day 7 and 40 mg every other week thereafter.
The primary endpoint, which measured the proportion of patients achieving a 75 percent reduction in PASI (Psoriasis Area and Severity Index) at week 16, was met. The 24-week data from this study are expected to be presented next year.
These clinical data in the psoriasis population continue to build on the strong existing analytical, pharmacological, non-clinical similarity data as well as the clinically similar data in the rheumatoid arthritis population, which were used to support the approval of Cyltezo® by the U.S. Food and Drug Administration (FDA). In addition, Boehringer Ingelheim is conducting a clinical trial to demonstrate the interchangeability between Cyltezo® and Humira®. This is the first study in the U.S. to investigate an interchangeability designation for an adalimumab biosimilar.
Citrate-free Cyltezo® is not commercially available in the U.S. at this time. Boehringer Ingelheim is currently engaged in patent litigation with AbbVie in the U.S.
About Plaque Psoriasis
Plaque psoriasis is an autoimmune disease characterised by dry, red skin lesions which are covered in silver scales.2 Plaque psoriasis is the most common form of psoriasis, accounting for approximately 80 percent of all reported cases.3 Worldwide, plaque psoriasis affects approximately 125 million people.4 Common sites of the disease include elbows, knees, scalp and lower back, but affected areas can appear anywhere on the body.5
About Boehringer Ingelheim in Biologics and Biosimilars
Boehringer Ingelheim is one of the largest producers of biologic medicines in the world. As a pioneer in biologics with more than 35 years of experience, the company has manufactured more than 25 biologic medicines for global markets. This includes monoclonal antibodies in immunology and oncology, interferons, and other targeted medicines that are routinely used to treat many patients across a broad range of therapeutic areas. For more information about Boehringer Ingelheim's Biopharma and manufacturing capabilities, please click here https://www.boehringer-ingelheim.us/biopharma/biosimilars.
Boehringer Ingelheim further builds on its commitment to immunology to develop biosimilars as high quality, safe, and effective treatment options to patients with autoimmune diseases.
*Humira® is a registered trademark of AbbVie Biotechnology Ltd.
Cyltezo® is the first approved biosimilar for Boehringer Ingelheim in the U.S. and Europe for the treatment of multiple chronic inflammatory diseases including Rheumatoid arthritis, psoriasis and Crohn's disease. Cyltezo® was approved by the U.S. Food and Drug Administration (FDA) for the treatment of multiple chronic inflammatory diseases in August 20176, and in Europefor the treatment of multiple chronic inflammatory diseases in adults and children in November 2017.7
Rheumatoid Arthritis: CYLTEZO is indicated, alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs), for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
Juvenile Idiopathic Arthritis: CYLTEZO is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older.
Psoriatic Arthritis: CYLTEZO is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
Ankylosing Spondylitis: CYLTEZO is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
Adult Crohn's Disease: CYLTEZO is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy, and reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
Ulcerative Colitis: CYLTEZO is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of CYLTEZO has not been established in patients who have lost response to or were intolerant to TNF blockers.
Plaque Psoriasis: CYLTEZO is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. CYLTEZO should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
IMPORTANT SAFETY INFORMATION FOR CYLTEZO®
WARNING: SERIOUS INFECTIONS and MALIGNANCY
Patients treated with adalimumab products, including CYLTEZO, are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Discontinue CYLTEZO if a patient develops a serious infection or sepsis.
Reported infections include:
Carefully consider the risks and benefits of treatment with CYLTEZO prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with CYLTEZO, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6-MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.
Hepatitis B Virus Reactivation
Congestive Heart Failure
About Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.
Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about how we make more health for more people through our Corporate Social Responsibility initiatives.
In 2017, Boehringer Ingelheim achieved net sales of about $20.4 billion (18.1 billion euros). R&D expenditure corresponds to approximately $3.4 billion(three billion euros), or 17.0 percent of its net sales.
Boehringer Ingelheim Pharmaceuticals, Inc.
Name: Susan Holz
1 Menter A, et al. Biosimilar BI 695501 and Adalimumab Reference Product have Similar Efficacy and Safety in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: 16-week Results from a Phase III Study. Abstract presented at European Association of Dermatology and Venereology Annual Meeting (EADV 2018), Paris, September 12-16 2018.
2 National Psoriasis Foundation, 'About Psoriasis'. Available at: https://www.psoriasis.org/about-psoriasis. Accessed August 2018.
3 American Academy of Dermatology, 'Psoriasis'. Available at: https://www.aad.org/media/stats/conditions/psoriasis. Accessed August 2018.
4 International Federation of Psoriasis Associations. World Psoriasis Day. Available at: https://ifpa-pso.com/our-actions/world-psoriasis-day/. Accessed August 2018.
5 NHS Choices, 'Psoriasis'. Available at: http://www.nhs.uk/Conditions/Psoriasis/Pages/Introduction.aspx. Accessed August 2018.
6 U.S. Food & Drug Administration. 2017. Drugs@FDA: FDA Approved Drug Products. Available at: http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761058. [Accessed February 2018]
7 European Medicines Agency. Cyltezo. Authorisation details. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medici.... [Accessed February 2018]
SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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