STELARA? (ustekinumab) Demonstrated Sustained Symptomatic and Corticosteroid-Free Remission Rates in Adults with Moderately to Severely Active Ulcerative Colitis at Nearly Three Years in Long
SPRING HOUSE, PENNSYLVANIA, July 9, 2021?? The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new three-year data from the long-term extension (LTE) of the STELARA??(ustekinumab) Phase 3 UNIFI study. The data demonstrated the majority (55.2 percent) of adult patients with moderately to severely active ulcerative colitis (UC) who initially responded to treatment with STELARA sustained symptomatic remissiona?rates at nearly three years (week 152).1?Furthermore, a majority (96.4 percent) of the patients in symptomatic remissiona?at week 152 were corticosteroid-free. These data are being presented today as a digital oral presentation (DOP83) at the 16th?Congress of the European Crohn?s and Colitis Organisation.1
?Despite recent substantial therapeutic gains, many patients living with ulcerative colitis still struggle to find lasting relief from their disease symptoms, especially without the use of steroids that can be associated with debilitating side effects when used long-term,? said Bruce E. Sands, M.D., M.S., Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at Mount Sinai Hospital and the Dr. Burrill B. Crohn Professor of Medicine (Gastroenterology) at the Icahn Institute for Medicine at Mount Sinai.b??The LTE of the UNIFI study underscores the importance of studying therapies long-term, with results showing ustekinumab as both an effective and enduring treatment option for patients living with moderately to severely active ulcerative colitis.?
Of the 348 patients in the intent-to-treat populationc?who had achieved clinical response at maintenance baseline and were randomized to STELARA 90 mg every eight weeks (q8w) or every 12 weeks (q12w):1
- 55.2 percent of patients were in symptomatic remissiona?at week 152.
- 96.4 percent (185/192) of patients in symptomatic remissiona?at week 152 were not receiving corticosteroids.
- 67.6 percent of patients were in symptomatic remissiona?at week 152.
- 76.4 percent of patients in clinical remissione?at week 44 were in symptomatic remissiona?at week 152.
- Your doctor should check you for TB before starting STELARA??and watch you closely for signs and symptoms of TB during treatment with STELARA?.
- If your doctor feels that you are at risk for TB, you may be treated for TB before and during treatment with STELARA?.
- think you have an infection or have symptoms of an infection such as:
- fever, sweats, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning when you urinate or urinate more often than normal
- feel very tired
- are being treated for an infection.
- get a lot of infections or have infections that keep coming back.
- have TB or have been in close contact with someone with TB.
- have any of the conditions or symptoms listed above for serious infections, cancers, or RPLS.
- ever had an allergic reaction to STELARA??or any of its ingredients. Ask your doctor if you are not sure.
- are allergic to latex. The needle cover on the prefilled syringe contains latex.
- have recently received or are scheduled to receive an immunization (vaccine). People who take STELARA??should not receive live vaccines. Tell your doctor if anyone in your house needs a live vaccine. The viruses used in some types of live vaccines can spread to people with a weakened immune system, and can cause serious problems.?You should not receive the BCG vaccine during the one year before receiving STELARA??or one year after you stop receiving STELARA?.
- have any new or changing lesions within psoriasis areas or on normal skin.
- are receiving or have received allergy shots, especially for serious allergic reactions.
- receive or have received phototherapy for your psoriasis.
- are pregnant or plan to become pregnant. It is not known if STELARA??can harm your unborn baby. You and your doctor should decide if you will receive STELARA?.
- are breastfeeding or plan to breastfeed. It is thought that STELARA??passes into your breast milk. Talk to your doctor about the best way to feed your baby if you receive STELARA?.
- Use STELARA??exactly as your doctor tells you to.
- STELARA??is intended for use under the guidance and supervision of your doctor. In children 6 years and older, it is recommended that STELARA??be administered by a healthcare provider. If your doctor decides that you or a caregiver may give your injections of STELARA??at home, you should receive training on the right way to prepare and inject STELARA?. Your doctor will determine the right dose of STELARA??for you, the amount for each injection, and how often you should receive it. Do not try to inject STELARA??yourself until you or your caregiver have been shown how to inject STELARA??by your doctor or nurse.
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References 1. Abreu, M. T.,?et al.?Efficacy and Safety of Ustekinumab for Ulcerative Colitis Through 3 Years: UNIFI Long-term Extension (Abstract DOP83). Presented at the 16th?Congress of ECCO July 8-10, 2021 2. STELARA??Prescribing Information. Available at:?http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf. Accessed May 27, 2021 3. Scherl, E. J.,?et al.?Corticosteroid-Sparing Effects of Ustekinumab Therapy for Ulcerative Colitis Through 3 Years: UNIFI Long-term Extension (Abstract DOP86). Presented at the 16th?Congress of ECCO July 8-10, 2021 4. Clinicaltrials.gov. A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UNIFI). Identifier: NCT02407236. Available at?https://clinicaltrials.gov/ct2/show/NCT02407236?Accessed May 27, 2021. 5.?The Facts About Inflammatory Bowel Diseases.?Crohn's & Colitis Foundation of America. Retrieved May 27, 2021, from?https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf 6.?What is Ulcerative Colitis??Crohn?s & Colitis Foundation. Retrieved May 27, 2021, from?https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis 7.?Signs and Symptoms of Ulcerative Colitis. Crohn?s & Colitis Foundation. Retrieved May 27, 2021, from?https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis/symptoms- Media Contact: Bridget Kimmel Mobile: (215) 688-6033 Investor Contact: Jennifer McIntyre Office: (732) 524-3922