Combination Therapy With Two Biologicals

Study Overview
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Brief Summary
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The efficacy and safety of dual biological therapy.

Detailed Description
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Data of all patients treated with the combination of two biologicals in four Finnish tertiary centres were collected and analysed. Inclusion criteria were simultaneous use of two biological treatments (infliximab, adalimumab, golimumab, vedolizumab or ustekinumab), age 16 years or over and follow-up for at least induction period after introduction of second biological therapy. The primary outcome was effectiveness, defined as remission assessed by physician after at least four months of DBT. The secondary outcome was safety defined by any adverse events or infection complications during DBT.

Official Title
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Combining Biological Therapies in Patients With Inflammatory Bowel Disease: a Finnish Multi-centre Study.

Conditions
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IBD

Intervention / Treatment
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* Biological: dual biological therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Simultaneous use of two different biological treatments for IBD. Treatment duration with combination therapy for at least for induction period. Exclusion Criteria: -Age under 16 years.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: dual biological therapy|Simultaneous use of two biologicals.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response | In CD, clinical response was assessed using a modified Harvey-Bradshaw index (HBI, omitting abdominal palpation) and clinical remission was defined as HBI<5. In UC, partial MAYO score <3 was cut the off value for clinical remission. Patients symptoms were assessed at baseline, 4, 12 and 18 months after initiation of treatment. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic response | Endoscopic response was assessed by Mayo endoscopic score for UC, simple endoscopic score for CD based on endoscopic characteristics (MAYO ≤ 1 and SES-CD < 3 as cut off values for endoscopic remission). Endoscopy was performed at baseline and 4, 12 or 18 months after initiation of treatment. | 18 months | 
| Haemoglobin level improvement | Blood haemoglobin ≥117 g/L for females and ≥134 g/L for males. Measured at baseline and 4, 12 and 18 months after initiation of treatment. | 18 months | 
| Calprotectin level improvement | Change in fecal Calprotectin level measured from baseline and 4, 12 and 18 months of treatment. Feacal calprotectin level ≤ 250 µg/g as cut-off value for remission. | 18 months | 
| C-reactive protein level improvement. | CRP < 10 mg/L. CRP levels were measured at baseline and 4, 12 and 18 months after initiation of treatment. | 18 months | 
| Treatment related infections | Infection complications reported during treatment. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biological, combination therapy, adalimumab, ustekinumab, vedolizumab, golimumab