COMBIO
Research type
Research Study
Full title
Safety and efficacy of combining two biological therapies together or a biological therapy with a small molecule in Inflammatory Bowel disease: The COMBIO study.
IRAS ID
288111
Contact name
Shaji Sebastian
Contact email
Sponsor organisation
BIRD
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 0 months, 30 days
Research summary
Summary of Research
A proportion of patients do not respond the existing medical therapies including biologics and surgery may be considered not suitable in a small proportion of these patients. In these patients some specialists are using two biologic agents or a biologic with a small molecule agents such as tofacitinib to obtain any additional benefit when single agents fail. These teatments are often given on compassionate basis. Clinicians have individually and anecdotally reported success with this approach but the number of cases treated in individual centers will be very small to have a full picture of efficacy and safety of this approach. Pooling all the experience across the world from IBD centers will allow identification of any patterns in relation to efficacy of this approach and also identify any safety signals. This retrospective chart review will record information on the patient and disease characteristics, prior treatments, response and any adverse effects to combination therapy.Summary of Results
A total of 104 combinations were collected in 98 patients. Concomitant IMID (Immune-mediated inflammatory diseases) were present in 41 patients. Reasons for starting combination therapy were active IBD (67%), active IMID or extra-intestinal manifestations (EIM) (22%), both (10%) and unclassified in 1. Median duration of combination was 8 months (interquartile range 5–16). During 122 patient-years of follow-up, 42 significant adverse events were observed, mostly related to uncontrolled IBD. There were 10 significant infections, 1 skin cancer and no death. IBD disease activity was clinically improved in 70% and IMID/EIM activity in 81% of the patients. Overall, combination was continued in 55% of the patients. Combination of biologics and small molecules in patients with IBD and IMID/EIM seems to be a promising therapeutic strategy but is also associated with a risk of opportunistic infections or infections leading to hospitalisation in 10%.REC name
North of Scotland Research Ethics Committee 1
REC reference
20/NS/0122
Date of REC Opinion
22 Oct 2020
REC opinion
Further Information Favourable Opinion