New type of treatment for Crohn’s disease is approved by NICE: Ustekinumab

[AndyPR]

Not sure if this is interesting or not.

Following NICE recommendations, patients with Crohn’s disease will have routine NHS access to drug ustekinumab, which offers a new way of treating the condition.

Ustekinumab (also called Stelara, manufactured by Janssen) will be available for patients with moderate to severe Crohn’s disease.

It is recommended by NICE as an option for treating the disease in adults who have had little or no response, or an intolerance to existing therapies.

Crohn’s disease is an inflammatory bowel disease, and can affect any part of the digestive system. Symptoms can include stomach cramps, diarrhoea and fatigue. It is a chronic condition which means that is it lifelong.

Ustekinumab works in a different way to existing treatments and is already recommended by NICE to treat psoriasis and psoriatic arthritis.

It is an innovative human monoclonal antibody treatment which binds to specific proteins on cells, known as IL-21 and IL-23. This stops the production of cytokines which cause the inflammatory response inside the body.

Professor Carole Longson, director of the health technology evaluation centre at NICE, said: “We are delighted to be able to recommend ustekinumab for routine NHS use. Crohn’s disease can have a debilitating impact on a person’s quality of life, from self-esteem through to experiencing regular relapses.

“Ustekinumab provides a convenient and viable option for patients with Crohn’s. It is a new way of treating the disease compared to conventional treatment, and can be used where other options have already been tried and stopped working.”

There is an estimated 132,049 people with Crohn’s in England and Wales, and just under 28,000 are estimated to be eligible for this treatment.

The committee heard that the disease follows an unpredictable pattern of remission and relapse, significantly impacting patients’ everyday lives. The evidence showed ustekinumab improved quality of life and is well tolerated amongst patients.

More at https://www.nice.org.uk/news/article/new-type-of-treatment-for-crohn-s-disease-is-approved-by-nice

 

[Clodomir]

FDA Approves STELARA® (Ustekinumab) for Treatment of Adults With Moderately to Severely Active Crohn’s Disease
Horsham, Pa., September 26, 2016 ― Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved STELARA® (ustekinumab) for the treatment of moderately to severely active Crohn’s disease in adults (18 years or older) who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers. STELARA® is the first biologic therapy for Crohn’s disease targeting interleukin (IL)-12 and IL-23 cytokines, which play a key role in inflammatory and immune responses.

“Crohn’s disease is a complex condition to treat, and not all therapies work for every patient,” said William J. Sandborn, MD, Chief, Division of Gastroenterology, and Professor of Medicine, UC San Diego School of Medicine, and study investigator. “The FDA approval of STELARA®represents an important advancement in treating patients with Crohn’s disease, as this therapy offers an alternate mechanism of action to induce and maintain clinical remission over time. Based on the results of the clinical development program, STELARA® has the potential to benefit many adults living with Crohn’s disease.”

In clinical studies of patients who were either new to, experienced with, or failed biologic therapy (TNF blockers), between 34% (UNITI-1 study) and 56% (UNITI-2 study) of patients experienced relief from their Crohn’s disease symptoms in just six weeks after receiving the one-time intravenous (IV) infusion of STELARA®. Noticeable improvement was observed as early as three weeks. Additionally, the majority of those who responded to induction dosing and continued treatment with STELARA® subcutaneous maintenance doses every 8 weeks were in remission at the end of 44 weeks (52 weeks from initiation of the induction dose).

STELARA® is the only treatment for Crohn’s disease that starts with a weight-based, one-time intravenous (IV) infusion induction dose (260 mg [55 kg or less], 390 mg [more than 55 kg to 85 kg], or 520 mg [more than 85 kg]) to help reduce symptoms, followed by 90 mg subcutaneous maintenance injections every 8 weeks to help keep the symptoms under control. The first dose of STELARA® is an induction dose, administered intravenously, under the supervision of a healthcare professional. Subsequent maintenance doses are administered as a subcutaneous injection every 8 weeks, either by a healthcare professional or self-injected by the patient after proper training.

Janssen will work closely with payers, providers and pharmacy benefit managers to ensure STELARA® is broadly accessible and affordable for patients, and that the cost for payers is competitive with currently available biologic therapies for Crohn’s disease. Janssen offers a number of patient support programs including a co-pay card for patients with commercial insurance that reduces their out-of-pocket cost for STELARA® to no more than $5 per dose (IV and/or subcutaneous injection), which is also offered for patients with psoriasis and psoriatic arthritis.

“The approval of STELARA® for Crohn’s disease underscores our commitment to provide innovative treatment options for people living with chronic inflammatory and immune-mediated diseases,” said Andrew Greenspan, MD, vice president of medical affairs at Janssen Biotech, Inc. “We are confident STELARA® will improve the lives of many people living with Crohn’s disease and are committed to ensuring that it is accessible to patients who qualify for this new therapeutic option.”

From https://www.jnj.com/media-center/pr...-moderately-to-severely-active-crohns-disease

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