PUBLIC RELEASE DATE:
23-Oct-2014
Contact: Dr. Anna-Sabine Ernst presse@iqwig.de 49-022-135-6850 Institute for Quality and Efficiency in Health Care
Vedolizumab (trade name Entyvio) has been approved since May 2014 for patients with moderately to severely active Crohn disease or ulcerative colitis. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether the drug offers an added benefit over the appropriate comparator therapy in these patient groups. According to the findings, such an added benefit is not proven because the dossier contained no suitable data for any of the two therapeutic indications.
G-BA specified adalimumab or infliximab as comparator therapy
Crohn disease and ulcerative colitis are chronic inflammatory bowel diseases. Vedolizumab is an option when conventional therapy is not tolerated or does not provide sufficient release of symptoms. This conventional treatment can also be a tumour necrosis factor alpha (TNF) antagonist.
The Federal Joint Committee (G-BA) specified a TNF antagonist (adalimumab or infliximab) as appropriate comparator therapy for both therapeutic indications. It is to be noted that it is possible to switch to a different TNF antagonist or to adjust the dose in case of treatment failure with a TNF Antagonist.
Drug manufacturer presented no studies for Crohn disease
In its dossier, the manufacturer identified no randomized controlled trial (RCT) that directly compared vedolizumab with adalimumab for patients with moderately to severely active Crohn disease. Since it also conducted no indirect comparisons on the basis of RCTs, an added benefit of vedolizumab for the therapeutic indication Crohn disease is not proven.
Ulcerative colitis: indirect comparison with placebo as common comparator
Read this article:
Added benefit of vedolizumab is not proven
- GW Pharma Reports Preliminary Topline Results Of Ulcerative Colitis Trial [Last Updated On: October 15th, 2014] [Originally Added On: October 15th, 2014]
- Ulcerative Colitis: Facts on Symptoms, Treatment and Diet [Last Updated On: October 15th, 2014] [Originally Added On: October 15th, 2014]
- Ulcerative Colitis - National Digestive Diseases ... [Last Updated On: October 15th, 2014] [Originally Added On: October 15th, 2014]
- CCFA: What is Ulcerative Colitis | Inflammatory Bowel Disease [Last Updated On: October 15th, 2014] [Originally Added On: October 15th, 2014]
- Ulcerative Colitis: Get Facts on Symptoms and Diet [Last Updated On: October 15th, 2014] [Originally Added On: October 15th, 2014]
- Ulcerative colitis - Wikipedia, the free encyclopedia [Last Updated On: October 15th, 2014] [Originally Added On: October 15th, 2014]
- Ulcerative Colitis Testimonial - Video [Last Updated On: October 15th, 2014] [Originally Added On: October 15th, 2014]
- My Fight With Ulcerative Colitis - Video [Last Updated On: October 15th, 2014] [Originally Added On: October 15th, 2014]
- Diet in Ulcerative Colitis - Best and Worst Foods - Video [Last Updated On: October 15th, 2014] [Originally Added On: October 15th, 2014]
- Why Ulcerative Colitis is (Literally) a Pain in the Butt - Video [Last Updated On: October 15th, 2014] [Originally Added On: October 15th, 2014]
- My Journey= Ulcerative Colitis Proctitis PART 1 - Video [Last Updated On: October 15th, 2014] [Originally Added On: October 15th, 2014]
- Top 15 Ways to Cure Ulcerative Colitis Naturally - Diet & Home Remedies - Video [Last Updated On: October 15th, 2014] [Originally Added On: October 15th, 2014]
- Updates in Ulcerative Colitis & Crohn's disease [Last Updated On: October 17th, 2014] [Originally Added On: October 17th, 2014]
- Ulcerative colitis Symptoms - Diseases and Conditions ... [Last Updated On: October 17th, 2014] [Originally Added On: October 17th, 2014]
- Dr. Morse Explains Ulcerative Colitis and Intestinal Conditions - Video [Last Updated On: October 20th, 2014] [Originally Added On: October 20th, 2014]
- Depression Stress Anxiety IBS Colitis Arthritis Treatment Allergy Testing Reiki Healing Scotland W - Video [Last Updated On: October 20th, 2014] [Originally Added On: October 20th, 2014]
- Taylor Healing process - Video [Last Updated On: October 20th, 2014] [Originally Added On: October 20th, 2014]
- Treating Pediatric Inflammatory Bowel Disease - Video [Last Updated On: October 20th, 2014] [Originally Added On: October 20th, 2014]
- Take Steps Walk for Crohn's and Colitis - Video [Last Updated On: October 21st, 2014] [Originally Added On: October 21st, 2014]
- Ulcerative Colitis & Me - Video [Last Updated On: October 21st, 2014] [Originally Added On: October 21st, 2014]
- Ferring Pharmaceuticals: CORTIMENT MMX, a new treatment for ulcerative colitis, receives European approval [Last Updated On: October 22nd, 2014] [Originally Added On: October 22nd, 2014]
- Sleep duration affects risk for ulcerative colitis [Last Updated On: October 22nd, 2014] [Originally Added On: October 22nd, 2014]
- My Journey= Ulcerative Colitis Proctitis PART#3 - Video [Last Updated On: October 23rd, 2014] [Originally Added On: October 23rd, 2014]
- My Journey= Ulcerative Colitis Proctitis PART#2 - Video [Last Updated On: October 24th, 2014] [Originally Added On: October 24th, 2014]
- Why Food Network Star Sunny Anderson Can't Eat Vegetables [Last Updated On: October 24th, 2014] [Originally Added On: October 24th, 2014]
- New compounds reduce debilitating inflammation [Last Updated On: October 26th, 2014] [Originally Added On: October 26th, 2014]
- Sleep Duration Linked to Ulcerative Colitis Risk in Study [Last Updated On: October 27th, 2014] [Originally Added On: October 27th, 2014]
- Ulcerative colitis: MedlinePlus Medical Encyclopedia [Last Updated On: October 27th, 2014] [Originally Added On: October 27th, 2014]
- Ulcerative Colitis - American Society of Colon and Rectal ... [Last Updated On: October 27th, 2014] [Originally Added On: October 27th, 2014]
- NHS Ulcerative Colitis - NHS Choices - Your health, your ... [Last Updated On: October 27th, 2014] [Originally Added On: October 27th, 2014]
- Ulcerative Colitis [Last Updated On: October 27th, 2014] [Originally Added On: October 27th, 2014]
- How to heal intestines | Ulcerative Colitis | SCD Lifestyle - Video [Last Updated On: October 27th, 2014] [Originally Added On: October 27th, 2014]
- Ulcerative Colitis - Causes, Symptoms, Diet & Herbal Remedies in Punjabi - Video [Last Updated On: October 27th, 2014] [Originally Added On: October 27th, 2014]
- Receptos: good results for ulcerative colitis drug [Last Updated On: October 29th, 2014] [Originally Added On: October 29th, 2014]
- Should I Drink Alcohol if I Have Crohn's Disease or Ulcerative Colitis - Video [Last Updated On: October 29th, 2014] [Originally Added On: October 29th, 2014]
- New clinical trial data: Multiple sclerosis drug candidate also shows promise for ulcerative colitis [Last Updated On: October 30th, 2014] [Originally Added On: October 30th, 2014]
- TSRI's MS Drug Also Shows Promise In Ulcerative Colitis [Last Updated On: November 1st, 2014] [Originally Added On: November 1st, 2014]
- Justin Mirigliani repping 260lbs on the Bench! Never Surrender! Fighting Ulcerative Colitis! - Video [Last Updated On: November 1st, 2014] [Originally Added On: November 1st, 2014]
- Managing Ulcerative Colitis Naturally: Outlook & Perspective - Video [Last Updated On: November 1st, 2014] [Originally Added On: November 1st, 2014]
- My Ulcerative Colitis Diet - Video [Last Updated On: November 1st, 2014] [Originally Added On: November 1st, 2014]
- Healing my Ulcerative Colitis - Video [Last Updated On: November 2nd, 2014] [Originally Added On: November 2nd, 2014]
- Peoria Connections Interview - Successes with autoimmune disease, ADHD, ulcerative colitis - Video [Last Updated On: November 2nd, 2014] [Originally Added On: November 2nd, 2014]
- Crohns Disease & Ulcerative Colitis The Diagnosing Difficulties - Video [Last Updated On: November 2nd, 2014] [Originally Added On: November 2nd, 2014]
- My Ulcerative Colitis Story - Video [Last Updated On: November 3rd, 2014] [Originally Added On: November 3rd, 2014]
- Pudge Rodriguez will be special guest at Crohns and Colitis Foundation dinner [Last Updated On: November 4th, 2014] [Originally Added On: November 4th, 2014]
- Diagnosing Crohns Disease & Ulcerative Colitis - Video [Last Updated On: November 4th, 2014] [Originally Added On: November 4th, 2014]
- Natural Treatment for Ulcerative Colitis with Causes and Symptoms - Video [Last Updated On: November 5th, 2014] [Originally Added On: November 5th, 2014]
- Acute Severe Ulcerative Colitis - Video [Last Updated On: November 5th, 2014] [Originally Added On: November 5th, 2014]
- CME Outfitters and USF Health to Host Medical Symposium in Conjunction with the 2014 Advances in IBD Crohns & Colitis ... [Last Updated On: November 7th, 2014] [Originally Added On: November 7th, 2014]
- How sleep affects my Ulcerative Colitis Symptoms - Video [Last Updated On: November 7th, 2014] [Originally Added On: November 7th, 2014]
- Healing my Ulcerative Colitis Webcam video from November 4, 2014 05:49 PM - Video [Last Updated On: November 7th, 2014] [Originally Added On: November 7th, 2014]
- Managing Extra-Intestinal Manifestations of Crohn's Disease & Ulcerative Colitis - Video [Last Updated On: November 7th, 2014] [Originally Added On: November 7th, 2014]
- Causes and Treatment of Crohns Disease and Ulcerative Colitis - Video [Last Updated On: November 8th, 2014] [Originally Added On: November 8th, 2014]
- How to stop the Cause of IBS, Crohn's and Ulcerative Colitis - Video [Last Updated On: November 8th, 2014] [Originally Added On: November 8th, 2014]
- Introduction to Ulcerative Colitis - Video [Last Updated On: November 8th, 2014] [Originally Added On: November 8th, 2014]
- Ulcerative Colitis Dr Tehsina0 - Video [Last Updated On: November 8th, 2014] [Originally Added On: November 8th, 2014]
- Taking Steps Against Crohn's and Colitis [Last Updated On: November 9th, 2014] [Originally Added On: November 9th, 2014]
- How To Make Chicken 3 Ways + Gut Healing Bone Broth - by Thyroid Loving Care - Video [Last Updated On: November 10th, 2014] [Originally Added On: November 10th, 2014]
- Ileal Pouch - Anal Anastomosis in Chronic Ulcerative Colitis - Video [Last Updated On: November 10th, 2014] [Originally Added On: November 10th, 2014]
- Vlog #1 - November 10 2014 - Video [Last Updated On: November 11th, 2014] [Originally Added On: November 11th, 2014]
- Ulcerative Colitis Patient Success Story - Video [Last Updated On: November 11th, 2014] [Originally Added On: November 11th, 2014]
- How to Recover from Ulcerative Colitis - Video [Last Updated On: November 12th, 2014] [Originally Added On: November 12th, 2014]
- Vlog #2 - November 11, 2014 - Living with Ulcerative Colitis - Video [Last Updated On: November 13th, 2014] [Originally Added On: November 13th, 2014]
- How IBD (Crohn's Disease and Ulcerative Colitis) Affects Mental Health - Video [Last Updated On: November 15th, 2014] [Originally Added On: November 15th, 2014]
- Ulcerative Colitis Got Me Down - Video [Last Updated On: November 15th, 2014] [Originally Added On: November 15th, 2014]
- Surgeon Spotlight: Dr. Amit Merchea - Chronic Ulcerative Colitis - Video [Last Updated On: November 16th, 2014] [Originally Added On: November 16th, 2014]
- Ulcerative Colitis Proctitis: Doctor Update, Medications - Video [Last Updated On: November 16th, 2014] [Originally Added On: November 16th, 2014]
- Ulcerative Colitis Got You Down Too? - Video [Last Updated On: November 16th, 2014] [Originally Added On: November 16th, 2014]
- Management of ulcerative colitis - Wikipedia, the free ... [Last Updated On: November 17th, 2014] [Originally Added On: November 17th, 2014]
- IBD Support Group: Crohn's Disease and Ulcerative Colitis [Last Updated On: November 17th, 2014] [Originally Added On: November 17th, 2014]
- Crohn's Disease, Ulcerative Colitis and the Team Challenge endurance training program - Video [Last Updated On: November 17th, 2014] [Originally Added On: November 17th, 2014]
- Let's CRUSH Ulcerative Colitis LIke a Coke Can - Video [Last Updated On: November 19th, 2014] [Originally Added On: November 19th, 2014]
- 21 Weeks Pregnant Update! - Ultrasound & Ulcerative Colitis - Video [Last Updated On: November 20th, 2014] [Originally Added On: November 20th, 2014]
- Healing my Ulcerative Colitis Webcam video from November 17, 2014 02:48 PM - Video [Last Updated On: November 20th, 2014] [Originally Added On: November 20th, 2014]
- Is Crohns Disease or Ulcerative Colitis Hereditary? - Video [Last Updated On: November 22nd, 2014] [Originally Added On: November 22nd, 2014]
- Celebrity chef Sunny Anderson on living with irritable bowel disease [Last Updated On: November 23rd, 2014] [Originally Added On: November 23rd, 2014]
- 13 Years with Ulcerative Colitis - Video [Last Updated On: November 26th, 2014] [Originally Added On: November 26th, 2014]
- Mark: Healed of Ulcerative Colitis - Video [Last Updated On: November 26th, 2014] [Originally Added On: November 26th, 2014]
- Colonoscopy of Ulcerative Colitis - Video [Last Updated On: November 30th, 2014] [Originally Added On: November 30th, 2014]
- Boynton mother runs to help find a cure for Crohn's [Last Updated On: December 2nd, 2014] [Originally Added On: December 2nd, 2014]