Ustekinumab Real World Evidence Study
Research type
Research Study
Full title
Ustekinumab Real World Evidence Study
IRAS ID
265870
Contact name
JR Fraser Cummings
Contact email
Sponsor organisation
University Hospital Southampton NHS Trust
Duration of Study in the UK
3 years, 9 months, 15 days
Research summary
Lay summary of study results: What was this study about?
This study looked at how well ustekinumab works for people with Crohn's disease when used in everyday NHS clinical practice across the UK. Researchers also wanted to understand how treatment affected patients' symptoms, quality of life, and overall experience, not just disease activity.Who took part?
• 601 adults with Crohn's disease from 22 UK hospitals took part.
• Participants started ustekinumab as part of their usual medical care.
• About 20% had not previously received other advanced treatments for Crohn's disease.
•Patients were followed for up to 2 years.What did the researchers find?
Symptom control
• After 56 weeks (about 1 year), 33% of patients achieved clinical remission without needing steroid treatment.
• Many patients continued taking ustekinumab over time:
o 78% were still receiving treatment after 1 year.
o 63% were still receiving treatment after 2 years.Quality of life
• Patients reported a noticeable improvement in their overall wellbeing as early as 8 weeks after starting treatment.
• However, many people continued to experience some impact on their quality of life, even when their disease symptoms had improved.An interesting finding
• At the start of the study, many patients appeared to be doing reasonably well according to traditional symptom scores, but their own reports suggested that Crohn's disease was still having a significant effect on their daily lives.
• This suggests that patient experiences and quality of life are important factors when deciding on treatment, not just medical test results or symptom scores.Was ustekinumab safe?
• Most side effects reported were mild.
• The safety findings were consistent with what is already known about ustekinumab.
• No new major safety concerns were identified.What does this mean for patients?
This study shows that, in routine UK clinical practice:
➢ Ustekinumab can help many people with Crohn's disease achieve and maintain symptom improvement.
➢ Patients often experience improvements in their quality of life soon after starting treatment.
➢ Most patients tolerate the treatment well.
➢ Doctors should consider how Crohn's disease affects a patient's daily life and wellbeing, not just symptom scores, when making treatment decisions.Key message
Ustekinumab was effective and generally safe for many people with Crohn's disease in real-world clinical practice. Improvements in quality of life were an important benefit, highlighting the value of listening to patients' experiences as well as measuring disease activity.
Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: Results are publicly available through APT publication.
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
If yes, describe or provide URLs to disseminated materials: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fonlinelibrary.wiley.com%252Fdoi%252Ffull%252F10.1111%252Fapt.70833%2FNBTI%2FpU3HAQ%2FAQ%2Fa5ae5427-f4b4-4fb5-92e9-e38c83544f5d%2F2%2FvAyZuszHfA&data=05%7C02%7Cwestminster.rec%40hra.nhs.uk%7C372097d1913a40f84cd108def7839adc%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639220341776673314%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=py6A2LapqBlghhbyid4aCG6A7AFoFtzCvEVrAgZAuAA%3D&reserved=0
If pending, date when dissemination is expected:
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: Yes
If yes, describe and/or provide URLs to materials shared and how they were shared: Patients were asked on their final study visit whether they would like to be sent the results of the project when available and a log was kept of patients who wished to be informed of the results.Ustekinumab has been recently licensed for use in the management of Crohn's disease (CD) and approved by NICE. However, there is a paucity of real life outcomes data currently to inform decisions about its optimal use in clinical settings. This non-interventional clinical observational study aims to capture the experience of this new therapy across the UK. Any hospital in the UK will be eligible to participate in the study and all adult patients treated with ustekinumab will be eligible for the study. Patients will complete a number of simple questionnaires either at routine hospital visits or over the phone during their first 2 years of treatment. Teams will record data such as details of the patient's Crohn’s disease such as accurate characterisation of their disease, medications, previous history and blood tests that are taken part of the patients routine clinical data.
REC name
London - Westminster Research Ethics Committee
REC reference
19/LO/1369
Date of REC Opinion
3 Sep 2019
REC opinion
Favourable Opinion