{
  "abstract": "Introduction Evidence of treat-to-target strategies including secukinumab dose escalation in patients with axial spondyloarthritis (axSpA) remains limited. We investigated the effect of a treat-to-target approach aiming for Axial Spondyloarthritis Disease Activity Score (ASDAS) remission, assessed by clinical and MRI outcomes over 24 weeks.Methods TRACE was a multicentre study including biologic-naïve patients with active axSpA. Sixteen weeks after secukinumab 150 mg initiation, patients in ASDAS remission (<1.3)(week 16 remitters) continued the same dose, while non-remitters (week 16 non-remitters) escalated to 300 mg/month. Sacroiliac joint (SIJ) and spine MRIs were performed at baseline, weeks 4, 16 and 24, and centrally scored using Spondyloarthritis Research Consortium of Canada (SPARCC) and Canada-Denmark scores for inflammation and structural lesions. The primary end point was total MRI-inflammation improvement ≥2 (weeks 16–24) comparing week 16 remitters and week 16 non-remitters.Results Of 90 patients, 68% were male, mean age was 35.4 years. At week 16, 30 (35%) patients achieved ASDAS remission. At week 24, 36 (49%) patients were in ASDAS remission, including 10 (22%) week 16 non-remitters, who responded after dose escalation (dose-escalation responders).Already at week 4, marked reductions in total MRI inflammation (SPARCC spine+SIJ) (–14.7), and structural lesion remodelling (reduced SIJ erosion; increased SIJ fat and backfill), were observed. These changes continued through week 16, with only minor improvements thereafter.The primary end point occurred in 14 (52%) of week 16 remitters versus 19 (41%) of week 16 non-remitters (p=0.53). Dose-escalation responders had a numerically larger mean total MRI inflammation reduction (–6.1) than dose-escalation non-responders (–2.2).Conclusion No statistically significant effect of secukinumab dose escalation on reducing MRI-detected inflammation was observed, except in a selected subgroup of patients. However, 22% achieved ASDAS remission after dose escalation. Notably, substantial MRI-detected inflammation reduction and structural remodelling occurred within the first 4 weeks.Trial registration number NCT03639740.",
  "authors": [
    {
      "affiliations": [
        "Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark"
      ],
      "name": "Nora Vladimirova"
    },
    {
      "affiliations": [
        "Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark",
        "Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark"
      ],
      "name": "Mikkel Østergaard"
    },
    {
      "affiliations": [
        "Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark"
      ],
      "name": "Sengül Seven"
    },
    {
      "affiliations": [
        "Department of Radiology, Copenhagen University Hospital—Herlev and Gentofte, Herlev, Denmark"
      ],
      "name": "Jakob M Møller"
    },
    {
      "affiliations": [
        "Center for Rheumatology and Spine Diseases, Rigshospitalet, Frederiksberg, Denmark"
      ],
      "name": "Bente Jensen"
    },
    {
      "affiliations": [
        "Department of Internal Medicine, Goedstrup Hospital, Herning, Denmark",
        "Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark"
      ],
      "name": "Rene Østgård"
    },
    {
      "affiliations": [
        "Center for Rheumatology and Spine Diseases, Rigshospitalet, Frederiksberg, Denmark"
      ],
      "name": "Rene Poggenborg"
    },
    {
      "affiliations": [
        "Center for Rheumatology and Spine Diseases, Rigshospitalet, Frederiksberg, Denmark"
      ],
      "name": "Ole Rintek Madsen"
    },
    {
      "affiliations": [
        "Department of Internal Medicine, Esbjerg Hospital—University Hospital of Southern Denmark, Esbjerg, Denmark",
        "Danish Hospital for Rheumatic Diseases, Sønderborg, Denmark",
        "Department of Regional Health Research, University of Southern Denmark, Region of Southern Denmark, Denmark"
      ],
      "name": "Oliver Hendricks"
    },
    {
      "affiliations": [
        "Department of Radiology, Silkeborg Regional Hospital, Silkeborg, Denmark",
        "Comparative Medicine Lab, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark"
      ],
      "name": "Lau Brix"
    },
    {
      "affiliations": [
        "Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark"
      ],
      "name": "Stylianos Georgiadis"
    },
    {
      "affiliations": [
        "Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark",
        "Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark",
        "The DANBIO Registry, Rigshospitalet, Glostrup, Denmark"
      ],
      "name": "Susanne Juhl Pedersen"
    }
  ],
  "title": "Effect of secukinumab dose escalation on MRI-detected inflammation and structural damage in axial spondyloarthritis: a clinical, investigator-initiated, treat-to-target study (TRACE)",
  "uid": "5695b911-fd71-50bb-911d-8ed7ebd727f8"
}