Janssen Presents Results of First Head-to-Head Study of Biologic Therapies in Patients with Moderate to Severe Crohn?s Disease
SPRING HOUSE, PENNSYLVANIA, May 23, 2021?? The Janssen Pharmaceutical Companies of Johnson & Johnson today announced efficacy and safety data for STELARA??(ustekinumab) in Crohn?s disease (CD) and ulcerative colitis (UC),1-4including data from the SEAVUE study, the first head-to-head study of biologic therapies in patients with CD, presented in a Clinical Science Late-Breaking Abstract Plenary session.1?SEAVUE data showed treatment with STELARA demonstrated high rates of clinical remission, corticosteroid-free remission, clinical response and endoscopic response through one year in biologic-na?ve patients with moderately to severely active CD, although the primary endpoint of statistical superiority versus adalimumab was not demonstrated.1?These head-to-head data are one of 20 abstracts Janssen presented from the Company?s gastroenterology pipeline and portfolio at DDW Virtual 2021, which took place May 21-23.1-4
?As the first head-to-head study of biologic therapies in Crohn?s disease, SEAVUE is filling an important knowledge gap in the gastrointestinal community,? 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, and SEAVUE study principal investigator.a??SEAVUE has generated data that confirm STELARA as an important option for people living with moderately to severely active Crohn?s disease who are new to biologic therapy.?
STELARA vs. adalimumab efficacy and safety in biologic-na?ve CD patients through one year (Presentation?#775d):1?The SEAVUE study examined a total of 386 patients with moderately to severely active CD. Patients were randomized 1:1 to treatment with STELARA approximately 6 mg/kg intravenous (IV) at baseline, then 90 mg subcutaneous (SC) every eight weeks (q8w), or treatment with adalimumab 160/80 mg SC at baseline/week two, then 40 mg SC every two weeks per the U.S. Food and Drug Administration-approved regimens without dose modifications. Results did not show statistically significant differences:
- 64.9 percent of STELARA-treated patients and 61 percent of adalimumab-treated patients achieved clinical remission (Crohn?s Disease Activity Index [CDAI] <150) at one year (week 52), the study?s primary endpoint.
- Major secondary endpoints were not significantly different between the groups:
- 60.7 percent of STELARA-treated patients and 57.4 percent of adalimumab-treated patients achieved corticocosteroid-free remission.
- 72.3 percent of STELARA-treated patients and 66.2 percent of adalimumab-treated patients achieved clinical response.
- 56.5 percent of STELARA-treated patients and 55.4 percent of adalimumab-treated patients achieved patient-reported outcome (PRO)-2 symptom remission.
- At week 16, 57.1 percent of STELARA-treated patients and 60 percent of adalimumab-treated patients achieved clinical remission.
- At week 52, in patients with Simple Endoscopic Score for Crohn?s Disease (SES-CD)b?=3 at baseline, 28.5 percent of STELARA-treated patients and 30.7 percent of adalimumab-treated patients achieved endoscopic remission.
- Benefits for both treatments were also demonstrated across additional efficacy endpoints, but did not demonstrate statistically significant differences:
- At week 52, in patients with SES-CD =3 at baseline, 41.9 percent of STELARA-treated patients and 36.9 percent of adalimumab-treated patients achieved endoscopic response.
- Clinical response achieved at week 16 was maintained at week 52 in 88.6 percent of STELARA-treated patients and 78 percent of adalimumab-treated patients.
- The mean change from baseline to week 52 in the number of liquid/soft stools in the prior seven days was -19.9 for STELARA-treated patients and -16.2 for adalimumab-treated patients. The mean change from baseline to week 52 in the sum of number of liquid/soft stools and abdominal pain scores in the prior seven days was -29.6 for STELARA-treated patients and -25.1 for adalimumab-treated patients.
- Safety results were consistent with prior experience for both treatments. Discontinuation rates were numerically lower for STELARA-treated patients (15.2 percent) versus adalimumab-treated patients (23.6 percent) who discontinued before week 52. Among STELARA-treated patients and adalimumab-treated patients, 6.3 percent and 11.3 percent had adverse events (AEs) that led to discontinuation of study drug, respectively.
- 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. Sands, B. E.,?et al.?Ustekinumab Versus Adalimumab for Induction and Maintenance Therapy in Moderate-to-Severe Crohn?s Disease: The SEAVUE Study. Presented at the 2021 Digestive Disease Week Virtual Meeting May 21-23 2. Sandborn, W. J.,?et al.?Safety of Ustekinumab in IBD: Pooled Safety Analysis Through 5 Years in CD and 2 Years in UC. Presented at the 2021 Digestive Disease Week Virtual Meeting May 21-23 3. Sandborn, W. J.,?et al.?Long-term (5-Year) Maintenance of Clinically Meaningful Improvement in Health-Related Quality of Life in Patients with Moderate to Severe Crohn?s disease Treated with Ustekinumab in the IM-UNITI Long-term Extension Study. Presented at the 2021 Digestive Disease Week Virtual Meeting May 21-23 4. Johnson, A.,?et al.?The Real-World Effectiveness of Ustekinumab in the Treatment of Crohn?s Disease. Presented at the 2021 Digestive Disease Week Virtual Meeting May 21-23 5. Klenske, E.,?et al.?(2019). Targeting mucosal healing in Crohn?s disease: what the clinician needs to know.?Therapeutic Advances in Gastroenterology,?12, 175628481985686.?https://doi.org/10.1177/1756284819856865 6.?36-Item Short Form Survey from the RAND Medical Outcomes Study. (n.d.). Rand Corporation. Retrieved April 22, 2021, from?https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form.html#:%7E:text=SF%2D36%20is%20a%20set,care%20outcomes%20in%20adult%20patients 7. Clinicaltrials.gov. Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year (SEAVUE). Identifier: NCT03464136. Available at:?https://clinicaltrials.gov/ct2/show/study/NCT03464136. Accessed April 22, 2021. 8. Clincialtrials.gov. A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI). Identifier: NCT01369355. Available at:?https://clinicaltrials.gov/ct2/show/NCT01369355. Accessed April 22, 2021. 9.?Overview of Crohn?s Disease. Crohn?s & Colitis Foundation. Retrieved April 22, 2021, from?https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview 10.?Causes of Crohn?s Disease. Crohn?s & Colitis Foundation. Retrieved April 22, 2021, from?https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes 11.?Signs and Symptoms of Crohn?s Disease. Crohn?s & Colitis Foundation. Retrieved April 22, 2021, from?https://www.crohnscolitisfoundation.org/what-is-crohns-disease/symptoms 12.?Crohn?s disease - Symptoms and causes. (2020, October 13). Mayo Clinic.?https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304 13.?The Facts About Inflammatory Bowel Diseases.?Crohn?s & Colitis Foundation of America. Retrieved April 22, 2021, from?https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf 14.?What is Ulcerative Colitis??Crohn?s & Colitis Foundation. Retrieved April 22, 2021, from?https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis 15.?Signs and Symptoms of Ulcerative Colitis. Crohn?s & Colitis Foundation. Retrieved April 22, 2021, from?https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis/symptoms 16. STELARA??Prescribing Information. Available at:?Share this article on WhatsApp, LinkedIn and Twitter
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