Medical Dialogues
  • Dermatology
Login Register
This site is intended for healthcare professionals only
Login Register
  • MD Brand Connect
  • Vaccine Hub
  • MDTV
    • Breaking News
    • Medical News Today
    • Health News Today
    • Latest
    • Journal Club
    • Medico Legal Update
    • Latest Webinars
    • MD Shorts
    • Health Dialogues
  • Fact Check
  • Health Dialogues
Medical Dialogues
  • Medical News & Guidelines
      • Anesthesiology
      • Cardiology and CTVS
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • ENT
      • Gastroenterology
      • Medicine
      • Nephrology
      • Neurology
      • Obstretics-Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics-Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
      • Laboratory Medicine
      • Diet
      • Nursing
      • Paramedical
      • Physiotherapy
  • Health news
      • Doctor News
      • Government Policies
      • Hospital & Diagnostics
      • International Health News
      • Medical Organization News
      • Medico Legal News
      • NBE News
      • NMC News
  • Fact Check
      • Bone Health Fact Check
      • Brain Health Fact Check
      • Cancer Related Fact Check
      • Child Care Fact Check
      • Dental and oral health fact check
      • Diabetes and metabolic health fact check
      • Diet and Nutrition Fact Check
      • Eye and ENT Care Fact Check
      • Fitness fact check
      • Gut health fact check
      • Heart health fact check
      • Kidney health fact check
      • Medical education fact check
      • Men's health fact check
      • Respiratory fact check
      • Skin and hair care fact check
      • Vaccine and Immunization fact check
      • Women's health fact check
  • AYUSH
    • Ayurveda
    • Homeopathy
    • Siddha
    • Unani
    • Yoga
  • State News
      • Andaman and Nicobar Islands
      • Andhra Pradesh
      • Arunachal Pradesh
      • Assam
      • Bihar
      • Chandigarh
      • Chattisgarh
      • Dadra and Nagar Haveli
      • Daman and Diu
      • Delhi
      • Goa
      • Gujarat
      • Haryana
      • Himachal Pradesh
      • Jammu & Kashmir
      • Jharkhand
      • Karnataka
      • Kerala
      • Ladakh
      • Lakshadweep
      • Madhya Pradesh
      • Maharashtra
      • Manipur
      • Meghalaya
      • Mizoram
      • Nagaland
      • Odisha
      • Puducherry
      • Punjab
      • Rajasthan
      • Sikkim
      • Tamil Nadu
      • Telangana
      • Tripura
      • Uttar Pradesh
      • Uttrakhand
      • West Bengal
  • Medical Education
      • Ayush Education News
      • Dentistry Education News
      • Medical Admission News
      • Medical Colleges News
      • Medical Courses News
      • Medical Universities News
      • Nursing education News
      • Paramedical Education News
      • Study Abroad
  • Industry
      • Health Investment News
      • Health Startup News
      • Medical Devices News
      • Pharma News
      • Pharmacy Education News
      • Industry Perspective
  • MDTV
      • Health Dialogues MDTV
      • Health News today MDTV
      • Latest Videos MDTV
      • Latest Webinars MDTV
      • MD shorts MDTV
      • Medical News Today MDTV
      • Medico Legal Update MDTV
      • Top Videos MDTV
      • Health Perspectives MDTV
      • Journal Club MDTV
      • Medical Dialogues Show
This site is intended for healthcare professionals only
LoginRegister
Medical Dialogues
LoginRegister
  • Home
  • Medical news & Guidelines
    • Anesthesiology
    • Cardiology and CTVS
    • Critical Care
    • Dentistry
    • Dermatology
    • Diabetes and Endocrinology
    • ENT
    • Gastroenterology
    • Medicine
    • Nephrology
    • Neurology
    • Obstretics-Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics-Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Urology
    • Laboratory Medicine
    • Diet
    • Nursing
    • Paramedical
    • Physiotherapy
  • Health news
    • Doctor News
    • Government Policies
    • Hospital & Diagnostics
    • International Health News
    • Medical Organization News
    • Medico Legal News
    • NBE News
    • NMC News
  • Fact Check
    • Bone Health Fact Check
    • Brain Health Fact Check
    • Cancer Related Fact Check
    • Child Care Fact Check
    • Dental and oral health fact check
    • Diabetes and metabolic health fact check
    • Diet and Nutrition Fact Check
    • Eye and ENT Care Fact Check
    • Fitness fact check
    • Gut health fact check
    • Heart health fact check
    • Kidney health fact check
    • Medical education fact check
    • Men's health fact check
    • Respiratory fact check
    • Skin and hair care fact check
    • Vaccine and Immunization fact check
    • Women's health fact check
  • AYUSH
    • Ayurveda
      • Ayurveda Giuidelines
      • Ayurveda News
    • Homeopathy
      • Homeopathy Guidelines
      • Homeopathy News
    • Siddha
      • Siddha Guidelines
      • Siddha News
    • Unani
      • Unani Guidelines
      • Unani News
    • Yoga
      • Yoga Guidelines
      • Yoga News
  • State News
    • Andaman and Nicobar Islands
    • Andhra Pradesh
    • Arunachal Pradesh
    • Assam
    • Bihar
    • Chandigarh
    • Chattisgarh
    • Dadra and Nagar Haveli
    • Daman and Diu
    • Delhi
    • Goa
    • Gujarat
    • Haryana
    • Himachal Pradesh
    • Jammu & Kashmir
    • Jharkhand
    • Karnataka
    • Kerala
    • Ladakh
    • Lakshadweep
    • Madhya Pradesh
    • Maharashtra
    • Manipur
    • Meghalaya
    • Mizoram
    • Nagaland
    • Odisha
    • Puducherry
    • Punjab
    • Rajasthan
    • Sikkim
    • Tamil Nadu
    • Telangana
    • Tripura
    • Uttar Pradesh
    • Uttrakhand
    • West Bengal
  • Medical Education
    • Ayush Education News
    • Dentistry Education News
    • Medical Admission News
    • Medical Colleges News
    • Medical Courses News
    • Medical Universities News
    • Nursing education News
    • Paramedical Education News
    • Study Abroad
  • Industry
    • Health Investment News
    • Health Startup News
    • Medical Devices News
    • Pharma News
      • CDSCO (Central Drugs Standard Control Organisation) News
    • Pharmacy Education News
    • Industry Perspective
  • Home
  • Gastroenterology
  • Gastroenterology News
  • FDA approves...

FDA approves Upadacitinib for Crohn's disease in adults

Written By : Dr. Kamal Kant Kohli Published On 2023-05-19T10:00:46+05:30  |  Updated On 19 May 2023 12:51 PM IST
FDA approves Upadacitinib for Crohns disease in adults
  • facebook
  • twitter
  • linkedin
  • whatsapp
  • Telegram
  • Email

The U.S. Food and Drug Administration (FDA) has approved Upadacitinib for treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers.

This is the seventh FDA approval for RINVOQ across rheumatology, dermatology, and gastroenterology, where it is now indicated in both ulcerative colitis and Crohn's disease.

"AbbVie recognizes the need for more treatment options for Crohn's disease that can help address both rapid relief of symptoms along with the visible reduction of intestinal lining damage," said Thomas Hudson, M.D., senior vice president of research and development, chief scientific officer, AbbVie. "We're pleased that RINVOQ may provide this relief and is now available to treat Crohn's disease."

Endoscopic Response and Clinical RemissionThe approval is supported by data from two induction studies, U-EXCEED and U-EXCEL, and the U-ENDURE maintenance study.1 Statistical significance was achieved for the co-primary endpoints and key secondary endpoints with RINVOQ 45 mg in the induction studies and RINVOQ 15 mg and 30 mg in the maintenance study compared to placebo.

  • Endoscopic response: In the two induction studies, 34% and 46% of patients treated with RINVOQ 45 mg achieved endoscopic response (defined as a decrease of greater than 50% from the baseline Simplified Endoscopic Score for CD [SES-CD] or for patients with isolated ileal disease and a baseline SES-CD of 4, at least a 2-point reduction from baseline) at week 12, respectively, compared to 3% and 13% of patients receiving placebo.1 In the maintenance study, 28% and 41% of patients treated with RINVOQ 15 mg and 30 mg achieved endoscopic response at week 52, respectively, compared to 7% of patients receiving placebo.
  • Clinical remission: In the two induction studies, 36% and 46% of patients treated with RINVOQ 45 mg achieved clinical remission (defined as a Crohn's Disease Activity Index [CDAI] of less than 150) at 12 weeks, respectively, compared to 18% and 23% of patients receiving placebo. Additionally, in the maintenance trial, 42% and 55% of patients treated with RINVOQ 15 mg and 30 mg achieved clinical remission at 52 weeks, respectively, compared to 14% of patients receiving placebo.1

"Symptoms of moderately to severely active Crohn's disease can be disruptive and uncomfortable for patients, so relief as early as possible is key. Given the progressive nature of the disease, endoscopic response is just as important," said Edward V. Loftus, Jr., M.D., professor of medicine in the division of gastroenterology and hepatology at Mayo Clinic in Rochester, Minnesota and U-EXCEL study investigator.* "Based on the clinical trial results, treatment with RINVOQ shows both early and long-term symptom relief along with evidence of a visible reduction of damage to the intestinal lining caused by excess inflammation."

"I started feeling better within a couple weeks. My symptoms lessened – less cramping, firmer stools, and the bleeding stopped. When I stopped bleeding, I had more energy," said Danielle, who is living with Crohn's disease and received RINVOQ in an open-label treatment arm in one of the clinical trials.

Rapid Clinical Response and Corticosteroid-free Clinical Remission

  • Onset of clinical response based on CDAI was observed as early as two weeks in U-EXCEED and U-EXCEL, with a greater proportion of patients achieving clinical response at week 2 in RINVOQ-treated patients compared with placebo.
  • This is the first clinical program of an approved moderate-to-severe Crohn's disease treatment to require steroid taper during the induction period, with a corticosteroid taper regimen initiated at week 4. Corticosteroid-free clinical remission (defined as discontinuation of steroid and achievement of clinical remission per CDAI [CDAI less than 150]) among patients on steroid at baseline was achieved at week 12 by more patients treated with RINVOQ in U-EXCEED and U-EXCEL (30% and 40%, respectively) compared to placebo (11% and 13%, respectively). In U-ENDURE, corticosteroid-free remission (defined as no corticosteroids for 90 days prior to week 52 and achievement of clinical remission) was achieved by more patients treated with RINVOQ 15 mg and 30 mg (42% and 53%, respectively) compared to 14% with placebo.

RINVOQ Safety Considerations

  • Overall, the safety profile observed in patients with Crohn's disease treated with RINVOQ was consistent with the known safety profile for RINVOQ in other indications.
  • RINVOQ may cause serious side effects, including:
    • Serious infections. RINVOQ can lower ability to fight infections. Serious infections, some fatal, occurred, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses.
    • Increased risk of death in people age 50+ with at least 1 heart disease risk factor.
    • Cancer and immune system problems. Increased risk of some cancers, including lymphoma and skin. Current or past smokers have higher risk for lymphoma and lung cancer.
    • Increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50+ with at least 1 heart disease risk factor, especially in current or past smokers.
    • Blood clots, some fatal, in veins of the legs or lungs and arteries. This occurred more often in people 50+ with at least 1 heart disease risk factor.
    • Serious allergic reactions. Do not take if allergic to RINVOQ or its ingredients.
    • Tears in the stomach or intestines; changes in certain laboratory test results.
FDAupadacitinibRINVOQCrohn's Diseaseulcerative colitis
Dr. Kamal Kant Kohli
Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

Show Full Article
Next Story

Editorial

Aspirin Use in Male Smokers Aged 40-45 Years with Hypertension: Identifying the Ideal Candidates

Aspirin Use in Male Smokers Aged 40-45 Years with Hypertension: Identifying the Ideal Candidates

National Consensus 2025 on Role of Bisoprolol Across CV Continuum in Women: Top 10 Takeaways

National Consensus 2025 on Role of Bisoprolol Across CV Continuum in Women: Top 10 Takeaways

Relevance of Pioglitazone in Indian T2DM Care Continuum

Relevance of Pioglitazone in Indian T2DM Care Continuum

Azmarda Outperforms Generic Sacubitril/Valsartan in HFrEF Management, says new study

Azmarda Outperforms Generic Sacubitril/Valsartan in HFrEF Management, says new study

First Indian Consensus on Managing Refractory Gastroesophageal Reflux Disease Recommends Vonoprazan

First Indian Consensus on Managing Refractory Gastroesophageal Reflux Disease Recommends Vonoprazan

View All

Journal Club Today

New Nasal Deformity Classification System May Enhance Standardization in Cleft Lip and Palate Assessment: Research Shows

New Nasal Deformity Classification System May Enhance Standardization in Cleft Lip and Palate...

View All

Health News Today

Health Bulletin 03/June/2025

Health Bulletin 03/June/2025

View All
© 2022 All Rights Reserved.
Powered By: Hocalwire
X
We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok