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AB0750 The GO-DACT protocol: a randomized controlled trial to compare the efficacy of golimumab in combination with methotrexate (MTX) versus mtx monotherapy, in improving dactylitis and enthesitis, in MTX NAÏVE psoriatic arthritis patients
  1. E Vieira-Sousa1,
  2. H Canhão2,
  3. JE Fonseca1,
  4. on behalf of GO-DACT research team
  1. 1Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa and Rheumatology Department, Hospital de Santa Maria, Lisbon Academic Medical Centre
  2. 2CEDOC, NOVA Medical School, Universidade Nova de Lisboa, Lisbon, Portugal

Abstract

Background Dactylitis is a hallmark manifestation of psoriatic arthritis (PsA) and a key feature for PsA diagnosis. Active dactylitis is associated with a higher risk of erosions and can severely impact function. The therapeutic strategies for dactylitis are however largely empirical, with a profound absence of knowledge regarding efficacy, as primary endpoint, and impact on disease progression. The use of biologic disease modifying anti-rheumatic drugs (DMARDs) in patients with dactylitis, refractory to non-steroidal anti-inflammatory drugs (NSAIDs) or local corticosteroids, is recommended by EULAR guidelines, over the use of conventional DMARDs, based in the scarcity of evidence and properly designed studies in this field.

Methods GO-DACT is an investigator initiated ongoing multicentric trial, involving 13 national Rheumatology departments. Patients older than 18 years, with the diagnosis of PsA and active dactylitis (tenderness score≥1), refractory to NSAIDs, for 3 months, were included. Patients were randomized on a 1:1 ratio, to either MTX in combination with golimumab or placebo, for a period of 24 weeks. The primary aim of this trial is to determine differences of efficacy between the two treatment arms, in improving dactylitis (and enthesitis), as assessed by the dactylitis severity score (DSS) at 24 weeks. Key secondary outcomes include: Leeds dactylitis index (LDI), Leeds enthesitis index (LEI), joint counts, psoriasis area and severity index (PASI) and nail psoriasis severity index (NAPSI), health assessment questionnaire (HAQ), Dermatology life quality index (DLQI) and composite indexes for disease activity. The effect of treatment arms, on different tissue compartments, will be analysed by contrast-enhanced magnetic resonance imaging (MRI), with high resolution images for dactylitis, at baseline and 24 weeks.

Results The results from GO-DACT are expected to have implications in clinical practice, bringing robust and valid data for the definition of dactylitis treatment stratification and algorithm.GO-DACT will also contribute to understand dactylitis pathogenesis through the assessment of treatment efficacy, namely in distinct tissue compartments as defined by MRI. https://www.clinicaltrials.gov(NCT02065713)

Acknowledgements Acknowledgments: This investigator initiated trial was supported by a research grant from Merck Sharp and Dohme

Disclosure of Interest None declared

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