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.

The GO-DACT is an investigator’s initiative trial, in patients with psoriatic arthritis and active dactylitis, which aims to contribute to the clarification of the therapeutic algorithm of dactylitis as a clinical manifestation associated with a worse prognosis.

This is a multicenter, randomized, double-blind, placebo-controlled, phase IIIb trial, which assesses for the first time the comparative efficacy of a TNF inhibitor (golimumab) in combination with MTX versus MTX monotherapy, in improving the dactylitis and enthesitis, in patients with psoriatic arthritis naïve to MTX and biotechnological therapies. The primary endpoint is defined as the variation in the Dactylitis Severity Score (DSS) between the baseline and week 24 of treatment. As secondary endpoints were included the variation in the Leeds Dactilytis Index (LDI) and in the imaging score of dactylitis assessed by magnetic resonance at 24 weeks, as well as the proportion of patients who reached DSS 20, 50 and 70 and LDI 20, 50 and 70 in this timepoint, two innovative indexes developed within the scope of this essay.

Leeds Enthesitis Index, compound indexes and of psoriatic arthritis activity response, as well as indexes related to skin and nail involvement by psoriasis, were additionally evaluated. Reuma.pt worked as a database for this trial, and some of the screens created, such as the DSS screen, later became part of the Reuma.pt clinical practice protocol for patients with psoriatic arthritis.

In the context of this trial, a randomization system was also developed to guarantee equity in the probability of each patient receive the medication allocated to each treatment arm of the trial; a system of therapy management called Reuma.pt-Farmácias, which allows, among other functions, receiving the experimental medication and dispensing it to patients; these tools are available for future use in other clinical trials.

GO-DACT had the collaboration of 11 Rheumatology centers nationwide and reached its primary endpoint demonstrating for the first time that the combination of a TNF inhibitor (golimumab) and methotrexate is superior to methotrexate alone in improving dactylitis active psoriatic disease assessed by DSS and LDI. Consistently, patients treated with this therapeutic combination achieved DSS 50, 70 and LDI 20/50 and 70 response rates significantly higher than patients under MTX monotherapy.

Vieira-Sousa E, Alves P, Rodrigues AM, Teixeira F, Tavares-Costa J, Bernardo A, Pimenta S, Pimentel-Santos FM, Gomes JL, Aguiar R, Pinto P, Videira T, Catita C, Santos H, Borges J, Sequeira G, Ribeiro C, Teixeira L, Ávila-Ribeiro P, Martins FM, Canhão H, McInnes IB, Ribeiro RM, Fonseca JE. GO-DACT: a phase 3b randomised, double-blind, placebo-controlled trial of GOlimumab plus methotrexate (MTX) versus placebo plus MTX in improving DACTylitis in MTX-naive patients with psoriatic arthritis. Ann Rheum Dis. 2020 Apr;79(4):490-498. doi: 10.1136/annrheumdis-2019-216500. PMID: 32193187; PMCID: PMC7147178.

Vieira-Sousa E, Canhão H, Alves P, Rodrigues AM, Teixeira F, Tavares-Costa J, Bernardo A, Pimenta S, Pimentel-Santos F, Gomes JL, Aguiar R, Videira T, Pinto P, Catita C, Santos H, Borges J, Sequeira G, Ribeiro C, Teixeira L, Ávila-Ribeiro P, Martins FM, Ribeiro RM, Fonseca JE. The GO-DACT protocol: a multicentre, randomized, double-blind, parallel-group study to compare the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapy. Acta Reumatol Port. 2018 Apr-Jun;43(2):80-92. English. PMID: 30091952.

DSS: Dactylitis Severity Score GLM: golimumab; MTX: methotrexate; n: number

According to the Sustainable Development Goals (SDGs), created by the United Nations and defined for the period from 2015 to 2030, food security, nutrition and sustainable agriculture are essential goals to achieve by 2030.

In Portugal, the objective of the National Health Plan (pns.dgs.pt) is to maximize health gains and improve the health of all stakeholders, through a set of strategies aimed at promoting equity in health. However, the lack of valid and useful epidemiological information to support political decision-making is a major public health challenge.

Taking these principles into account, Saúde.Come – Promoting Food Security developed a robust registry of food insecurity (limited or uncertain access to adequate feeding, due to social and / or economic factors, preventing the maintenance of a healthy life) and its determinants in Portuguese families, paying particular attention to the identification of especially vulnerable population groups. In a second phase, the project developed two pilot intervention studies that aimed to promote healthy lifestyles, namely with regard to healthy eating habits and physical activity, in priority vulnerable groups (adolescents and seniors), using the value added of new information technologies (Web platform and interactive TV applications).

The Saúde.Come – Promoting Food Security consortium is composed of a group of specialists in different areas, ensuring the sharing of knowledge and experiences, essential to achieve the objectives. This project is crucial for the development of future public health decisions on health inequalities, improving health information systems and requesting data on food insecurity and, ultimately, contributing to an improvement in nutritional status among vulnerable groups.

This study aims to test the hypothesis that Intra-Articular Hyaluronic Acid (AHIA) is superior to placebo in delaying structural progression as well as in the long-term symptomatic effect in patients with primary knee osteoarthritis (OA). Patients with a diagnosis of primary knee osteoarthrosis were included, followed up in a rheumatology appointment at the Santa Maria and Egas Moniz hospitals.

It is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary endpoint is defined as the average change in the articular interline of the most affected compartment of the tibiofemoral joint, on the knee X-ray, at the end of the follow-up.

However, several other secondary endpoints are contemplated, namely:

• the proportion of patients who achieved symptomatic relief according to the 2004 OMERACT / OARSI response criteria at 6 months of follow-up in both groups;
• the proportion of patients who achieved symptomatic relief according to the 2004 OMERACT / OARSI response criteria at each follow-up visit;
• the proportion of patients undergoing knee arthroplasty at the end of the follow-up;
• the average consumption of paracetamol and NSAIDs (mg/day) in each visit;
• the average value of the SF-36 questionnaire in each medical appointment;
• the total number of adverse events that occur in both groups at each follow-up visit.

The assessment of disease activity includes the KOOS, SF36, and EQ5D questionnaires, patients and physicians visual analogue scales, as well as the assessment of pain in both the target knee and the opposite knee.

Each patient will attend 10 follow-up visits within 2 years, with questionnaires of pain, function and quality of life, as well as ultrasound of the knee and biological samples collection to quantify markers of bone and cartilage remodeling.