Feb. 14, 2020: The Janssen Pharmaceutical Companies of Johnson & Johnson announced temporary data from the Phase IIIb STARDUST study. At week 16, 79 per cent of the patients with moderately to severely active Crohn’s disease (CD) achieved clinical response1 and 67 per cent were in clinical cutback after receiving one ~6 mg/kg IV dose followed by one 90 mg SC dose of the STELARA® (ustekinumab), open-label.
Intestinal ultrasound (IUS) responses were considered and were detected as early as week 4. Week 16 data (digital oral presentation, or DOP 13) and IUS response data (DOP 10) from STARDUST, also presented as digital oral presentations at the 15th Congress of the European Crohn’s & Colitis Organization (ECCO).
The primary endpoint of the 48-week STARDUST study is relative endoscopic response among all adult patients with CD receiving STELARA maintenance therapy.
At week 16, patients who attained ≥70 point decrease in Crohn’s Disease Activity Index score (CDAI70 responders) were randomized into the treat-to-target or routine standard of care treatment groups at the 1:1 ratio.
“Of the 220 CDAI70 responders randomized to treat-to-target arm, 37 percent attained endoscopic response at the week 16.
Endoscopy at week 16 was measured only in the treat-to-target group. Treat-to-target is the practical treatment strategy where regularly monitored outcomes, like endoscopic response, biomarkers and clinical symptoms, guide use of the medication.
STARDUST is the first study of a treat-to-target strategy in the CD using endoscopic response to guide treatment.
IUS is a corresponding method of assessing CD activity which is based upon measuring transmural bowel features, like the thickness of the bowel wall and presence of the hypervascularization. STARDUST is the first study in order to use IUS for monitoring CD patients in an interventional setting. Prospect studies need to verify whether early IUS response at week 4 is predictive of longer-term (i.e., week 16 and up to week 48) clinical and endoscopic outcomes for the CD patients. Janssen is presenting a total of the 23 abstracts at this year in ECCO congress. At present STELARA is approved for the treatment of adults with moderately to severely active Crohn’s disease in the U.S., Canada, EU and Japan.
About STARDUST Trial
STARDUST is a randomized, international, multicenter, interventional Phase IIIb study assessing the proportion of patients with endoscopic response, identified as a 50% reduction in simple endoscopic score of Crohn’s disease (SES-CD) at week 48 from baseline. STARDUST is evaluating 500 participants receiving an IV induction dose of STELARA 6 mg/kg, followed by a week 8 injection of STELARA 90 mg SC. At week 16, patients with a 70 point CDAI reduction (CDAI70) were randomized to dose-to target or standard arms (1:1 ratio) and followed through the end of the study (48 weeks).
About STELARA® (ustekinumab)
STELARA® (ustekinumab), a human IL-12 and IL-23 antagonist, is accepted in the United States for the treatment of:
1) Adults and children (12 years) and older with moderate to severe plaque psoriasis and are candidates for the phototherapy or systemic therapy;
2) Adult patients (18 years or older) who have active psoriatic arthritis, used alone or in combination with the methotrexate (MTX);
3) Adult patients (18 years and older) with moderately to harshly active Crohn’s disease;
4) Adult patients (18 years and older) with moderately to harshly active ulcerative colitis.
STELARA Dosing for Crohn’s Disease
Adults with Crohn’s disease will receive the first dose of STELARA through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider. It takes at least 1 hour to receive the full dose of medicine. STELARA will then be given as an injection under the skin (subcutaneous injection) 8 weeks after the first dose of STELARA, then every 8 weeks thereafter. See full Prescribing Information for Dosing Information for other indications. The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA®.
IMPORTANT SAFETY INFORMATION
STELARA® is a prescription medicine that can affect your immune system. STELARA® have serious side effects including:
Serious Infections
It lowers the ability to fight infections and may increase the risk of infections. While taking STELARA®, patients may suffer from serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.
Before starting STELARA®, tell your doctor if you:
think you have any type of infection or have symptoms of an infection such as:
fever, sweats, or chills
muscle aches
cough
feel very tired
weight loss
shortness of breath
blood in phlegm
warm, red, or painful skin or sores on your body
diarrhea or stomach pain
burning when you urinate or urinate more often than normal are being treated for an infection.
get a lot of infections or have infections that keep coming back.
“After starting STELARA®, call your doctor right away if you have any symptoms of an infection (see above). People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL‐12) and the interleukin 23 (IL‐23) are at a higher risk for the certain serious infections that can spread throughout the body and cause death. People who take STELARA® may also get these infections”.
Cancers
STELARA® can decrease the activity of your immune system and add to your risk for certain types of cancer. Tell your doctor if you ever had any type of cancer. Some people who had risk factors for skin cancer can develop certain types of skin cancers while receiving STELARA®. Tell your doctor if you observe any new skin growths.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS is a rare condition that can affect the brain and can cause death. If RPLS can detect early and treated, most people can recover.
Serious Allergic Reactions: If you have any symptoms of a serious allergic reaction such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash then stop using STELARA® and get medical help right away
Lung Inflammation: Cases of lung inflammation can occur in some people who receive STELARA® and may be serious. You should not receive the BCG vaccine during one year before receiving the STELARA® or one year after you stop receiving STELARA®. Tell your doctor about all the medicines you take, including prescription and all other medicines, vitamins, and herbal supplements.
When prescribed STELARA®: Use STELARA® exactly as your doctor prescribed you.STELARA® is intended for the use under the guidance and supervision of your doctor. In children 12 years and older, it is suggested that STELARA® can be administered by a healthcare provider. Common side effects of STELARA® include: nasal congestion, and runny nose, sore throat, upper respiratory infections, fever, headache, tiredness, nausea, itching and vomiting, redness at the injection site, urinary tract infections, vaginal yeast infections, sinus infection, stomach pain, diarrhoea, and joint pain. These are not all of the possible side effects with STELARA®. Discuss with your doctor about any side effect that you experience.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‐800‐FDA‐1088”.
https://www.janssen.com/new-phase-3b-interim-data-stardust-study-show-two-thirds-patients-moderately-severely-active-crohns
