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New study data also confirm STELARA's effectiveness® (Ustekinumab) in tumor necrosis factor (TNF) antagonist-naive patients or those who do not tolerate this
Janssen Pharmaceuticals of Johnson & Johnson today announced new three-year data from the IM-UNITI study, confirming the persistent efficacy of ustekinumab in the US. Improvement in clinical remission rates and showing that Crohn's patients generally tolerate ustekinumab well .1 Data from the IM-UNITI study, which will last another two years, will be presented today. the 26th Congress of the European Week of Gastroenterology (UEGW) in Vienna.
"The new results of the three-year IM-UNIT study are encouraging as they underscore the important role that ustekinumab therapy can play in helping Crohn's patients achieve a clinical response to the disease. long term."Professor William Sandborn, director of the Center for Inflammatory Bowel Diseases, University of California San Diego, USA."Clinical remission is an important goal of treatment because patients have a better quality of life and feel better when they are less afraid of recurrence.".
These data are the first to be presented on the basis of an evaluation after three years of treatment with 90 mg of subcutaneous ustékinumab (SC) in Crohn's disease. Evaluations of overall efficacy at week 152 showed that 60.3% of all randomized patients treated with ustekinumab included in the long-term extension study were in clinical remission. In addition, 68.8% of these randomized patients treated with ustekinumab had a clinical response.1
The main results of the study for different doses showed that 61.9% of patients randomized to receive 90 mg of Ustekinumab SC every 12 weeks (after 12 yds) and that treatment with this dose during of the extension study were in clinical remission were. In patients randomized to continue the dose with doses of 90 mg ustekinumab every 8 weeks (every 8 weeks), 69.5% of patients were in clinical remission.1
The study also showed that 67.6% of TNF-antagonist-naive patients treated with ustekinumab were in clinical remission at week 156.1. This shows that patients who have not yet received anti-TNF treatment (those in addition, some patients treated with ustekinumab had already failed anti-TNF therapy (ie. After the first success, a new onset of illness, or failure to tolerate anti-TNF therapy, 48.4% achieved clinical remission.
Jaime Oliver, MD, Head of Janssen Therapeutic Area, Immunology, Europe, Middle East and Africa, Cilag GmbH International, said: "The goal of Janssen is to improve the lives of people with Crohn's disease. With this in mind, we are very pleased that the results of this study indicate that ustekinumab can help a significant proportion of patients with moderate to severe Crohn's disease achieve a clinical response. The IM-UNITI study will further study ustekinumab for another two years. This is part of our ongoing commitment to our patients, our innovation and our scientific leadership.".
Safety-related events (per 100 patient-years) were not higher in all patients treated with ustekinumab in the long-term extension study by compared to the placebo group from week 44 to week 156. No new safety signal was detected.1
Three deaths were reported between week 96 and week 156 (one for acute myocardial infarction, one for renal failure and one for sepsis) .1 In addition, two cases of non-melanoma skin cancer occurred in these groups. treated with ustekinumab (adenocarcinoma of the small intestine and chronic myeloid leukemia [CML]) .1
Common adverse reactions (≥ 1/100) reported during control periods of clinical trials regarding adult psoriasis, psoriatic arthritis and Crohn's disease with ustekinumab and post-hoc experience Articralgia (joint pain), back pain, diarrhea, dizziness, tiredness, headache, pain at the site of infection, erythema at the injection site, myalgia (muscle pain), nasopharyngitis, nausea, pain oropharyngeal, pruritus (itching), upper respiratory infection and vomiting.3
Janssen will present a total of four abstracts to this year's UEGW Congress, including more data from the UNITI clinical program, as well as the latest UNIFI clinical trial data evaluating the effectiveness of the program. Ustekinumab in patients with moderate to severe ulcerative colitis.4
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* Professor William Sandborn is a paid Janssen advisor. He was not paid for his work in the media.
Übger UEGW
The Congress of the European Week of United Gastroenterology (UEGW) will be held from Saturday 20 to Wednesday 24 October 2018 in Vienna. More information is available at: https://www.ueg.eu/week/.
About Crohn's disease
Europe has up to one million people with Crohn's disease. Every year, nearly 33,000 new cases are diagnosed5. Crohn's disease is a chronic inflammatory bowel disease of unknown origin, but this disorder is badociated with immune system abnormalities that can be caused by genetic engineering, nutrition or other environmental factors. The symptoms of Crohn's disease may vary, but they often include abdominal pain, frequent diarrhea, kidney bleeding, weight loss, and fever. Currently, Crohn's disease can not be cured
About the IM-UNITI study
IM-UNITI, a Phase III, parallel-group, randomized, double-blind, placebo-controlled Phase III study, is designed to evaluate the safety effectiveness of maintenance treatment by the patient. Ustekinumab in adult patients with moderate to severe Crohn's disease. Patients who responded to a single intravenous dose of ustekinumab in the UNITI-1 or UNITI-2 induction studies were also randomized to receive maintenance treatment with uskumatin by subcutaneously (SC) at 90 mg every 8 or 12 weeks or placebo. Patients meeting the criteria for loss of response between week 8 and week 32 had a single dose adjusted to 90 mg every 8 weeks. All patients who completed week 44 were qualified to participate in the long-term extension program and continued their current treatment until week 152. Patients will continue to participate in the IM-UNITI study at the 252nd week .
About STELARA® (ustekinumab) 3
In the European Union, Ustekinumab is approved for the treatment of moderate to severe plaque psoriasis in adults who have not responded or who are intolerant to other systemic treatments, including those containing cyclosporine , methotrexate and PUVA (psoralen plus UVA) or contraindicated against such therapies. Ustekinumab is also approved for the treatment of moderate to severe plaque psoriasis cases in 12-year-old patients who have not responded or are intolerant to other systemic treatments or phototherapy. . In addition, usselkinumab used alone or in combination with methotrexate is approved for the treatment of active psoriatic arthritis in adults when response to prior treatment with antirheumatic, antirheumatic, non-pharmacological and Was not considered satisfactory. In November 2016, the European Commission approved usstekinumab for the treatment of moderate to severe cases of Crohn's disease not responding to conventional therapy or a TNF-alpha antagonist in which the response was lost or intolerant. or with medical contraindications for these therapies.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. We are inspired by changing people's lives by finding new and better ways to prevent, stop, cure and cure disease. We bring together the best minds and pursue the most promising scientific approaches.
We are Janssen. We work with the world to improve the health of all people who live there. More information on www.janssen.com/EMEA. Follow us on Twitter: @JanssenEMEA.
Janssen-Cilag International NV and Cilag GmbH International are among Janssen's pharmaceutical companies of Johnson & Johnson.
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sources
1. Sandborn W, Rutgeerts P, et al. Efficacy and safety of ustekinumab for the treatment of Crohn's disease: results of the long-term extension of IM-UNITI over three years. European Week of Gastroenterology (UEGW 2018) 20th-24th October 2018; Vienna.
2. Crohn's & Colitis UK. Biologic Drugs: Information Sheet. Available at: http://s3-eu-west-1.amazonaws.com/files.crohnsandcolitis.org.uk/Publications/Biologic-drugs-in-ibd. Last accessed in October 2018.
3. European Medicines Agency. (2018) Summary of product characteristics Ustekinumab. Available at the following address: https://www.ema.europa.eu/documents/product-information/stelara-epar-product-information_en.pdf. Last accessed in October 2018.
4. Sands B, Sandborn W, et al, Ulcerative colitis: results of the UNIFI phase 3 study. Week of Gastroenterology United Europe (UEGW) 2018 20th-24th October 2018; Vienna: LB01.
5. Lens of Janssen's disease. Ulcerative colitis. Available at: https://www.crohnsandcolitis.org.uk/about-inflammatory-bowel-disease/ulcerative-colitis. Last accessed in October 2018.
6. Crohn's and Colitis UK. Crohn's disease. Available at: http://www.crohnsandcolitis.org.uk/about-inflammatory-bowel-disease/crohns-disease. Last accessed in October 2018.
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