Combination Therapy With Two Biologicals

Tampere University Hospital16 enrolled

Overview

The efficacy and safety of dual biological therapy.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

IBD

Interventions

dual biological therapyBIOLOGICAL

Simultaneous use of two biologicals.

Eligibility

Sex: ALLMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Heli Eronen

Lempäälä, Finland

Outcomes

Primary Outcomes

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.

Time frame: 18 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 18 months

Treatment related infections

Infection complications reported during treatment.

Time frame: 18 months

Data from ClinicalTrials.gov

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