Bioefficacy

Principal Investigator: Prof. Doctor Fernando Pimentel

Study duration: between March/2015 and November/2018

Study description:

The introduction of biological drugs, such as anti-TNF-α agents (infliximab, etanercept, adalimumab, golimumab and certolizumab) and anti-IL17A (secukinumab) changed clinical practice with several benefits in the management and prognosis of clinical cases.

However, although the majority of patients with Ankylosing Spondylitis respond well to these therapies, the partial response remains frequent. Identifying markers of response to treatment would be of great clinical benefit, as it allows selecting the drug according to the probability of therapeutic response. This possibility saves time and resources.

The clinical trial entitled "Identification of biomarkers of the efficacy of an anti-TNF-α agent in patients with Ankylosing Spondylitis using transcriptome analysis and mass spectrometry" aims to identify anti-TNF-α response biomarkers by these two techniques in patients with Ankylosing Spondylitis.

For this trial, patients diagnosed with Ankylosing Spondylitis (AS) and with criteria for initiating anti-TNF therapy (SPR Guidelines) are eligible. Patients were followed for 14 weeks, during which time they were treated with adalimumab. This study has the collaboration of 9 Rheumatology centers nationwide: Hospital Egas Moniz, Centro Hospitalar de São João, EPE - Hospital de São João, Centro Hospitalar de Tondela Viseu, Centro Hospitalar Lisboa Norte - Hospital de Santa Maria, Centro Hospitalar Médio Tejo - Torres Novas Hospital, Coimbra University Hospital Center, Vila Nova de Gaia Hospital Center, Portuguese Institute of Rheumatology and Alto Minho Local Health Unit.