Short summary

The current project is focusing on the management of Polymyalgia Rheumatica (PMR) and Giant Cell Arteritis (GCA) with the aim of 18F-FDG Positron Emission Tomography/computed tomography (18F-FDG PET/CT).

Three main areas of concern, including vasculitis process/vascular stiffness, osteoporosis/changes in body composition and malignancy will be evaluated during the project.

The results of our study reveal the role of 18F-FDG PET/CT scan in diagnosis and management of PMR/GCA. Furthermore, our results elucidate the three main problems including: malignancy, osteoporosis/changes in body composition, the vasculitis process, the interaction between them and ultimately elucidate factors for predicting the disease outcome.

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Rationale

Polymyalgia Rheumatica (PMR) and Giant Cell Arteritis (GCA) are common inflammatory conditions. The diagnosis of PMR/GCA possesses many challenges since there are no specific diagnostic tests. Recent literature emphasizes the ability of 18F-FDG PET/CT to assess global disease activity and/or inflammation burden. Vasculitis process/vascular stiffness, malignancy and osteoporosis are important areas of concern regarding the management of PMR/GCA.

Primary objective:

The primary objective of this study is to delineate the association of the 18F-FDG PET/CT detected vasculitis pattern of the large vessels (PET positivity) and the clinical presentation of PMR/GCA.

Secondary objectives:

1. To investigate the validity of 18F-FDG PET/CT scan for diagnosis of PMR/GCA compared to Temporal Artery Biopsy.
2. To investigate the efficacy of Chest X ray (CXR) plus abdominal ultrasound and 18F-FDG PET/CT scan to detect occult malignancies at diagnosis and during the first year after diagnosis.
3. To evaluate the influence of inflammation on Bone Mineral Density (BMD) and body composition as well as vasculitis/arterial stiffness of aorta at diagnosis of PMR and within a year after treatment initiation with prednisolone.

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Description of the cohort

Study setting:

Department of Rheumatology, Svendborg Hospital, Odense University Hospital Svendborg, Denmark.

Length of study:

One year from the last patient has been enrolled in the study.

Participants:

All new patients with clinical suspicion of PMR/GCA will be offered to be included in the study. At least five (A-E) components of the PMR diagnostic criteria, including: A. Age above or equal to 50 years, B. Bilateral shoulder or hip pain, C. Morning stiffness lasting >45 min, D. Elevated erythrocyte sedimentation rate (ESR), E. Elevated C-reactive protein (CRP), F. Disease duration >2 weeks, should be met to suspect PMR. For GCA the following criterias must be seen: Age >50 years, ESR/CRP >50, as well as at least two symptoms related to vasculitis (scalp tenderness, vision disturbances, headache (new or changed), jaw claudication, tenderness of the temporal arteria) if patients do not simultaneously have PMR. If the patient is suspected for PMR, one cranial symptom is enough to suspect GCA.                  

Exclusion criteria:

• Patients with dementia or inability to communicate in Danish
• Infections or malignancy when prednisolone is permanently unsuitable  
• Contraindication to imaging studies
• Initiation of steroid treatment before 18F-FDG PET/CT
• Inability to provide informed consent

Data and biological material

Following data will be collected during the project:

• Patients' demographics and clinical data
• Blood pressure, pulse rate, Body Mass Index and body weight
• Electrocardiogram
• Lab tests including Hemoglobin, White blood cells and Thrombocytes, Erythrocyte Sedimentation Rate, C-Reactive Protein, Sodium, Potassium, Lipid profile, Thyroid-stimulating hormone (TSH), Hemoglobin A1c (HbA1C), Blood Sugar, Creatinine, Liver Function Test (LFT), Alkaline phosphatase, Calcium, Vitamin D, Creatine Kinase, Immunoglobulin A, Immunoglobulin M, Immunoglobulin G, Antinuclear Antibody (ANA), Anti-Neutrophil Cytoplasmic Antibody (ANCA), IgM Rheumatoid Factor (IgM RF), Anti-Cyclic Citrullinated Peptide (Anti CCP), S-Fibrinogen, Prostate Specific Antigen (PSA), M component (Blood and Urine), serum-free light chains (sFLC), Urine Protein, Urine analysis.
• Questionnaire regarding the first visit and follow-up visit
• Charlson Comorbidity questionnaire
• Chest X ray and abdominal ultrasound results
• 18F-FDG PET/CT results
• Temporal artery biopsy results
• Pulse wave velocity assessment results
• Whole body Dual Energy X-ray Absorptiometry
• Patients' diaries

Collaborating researchers and departments

Department of Rheumatology, Odense University Hospital, Svendborg and Faculty of Health Sciences, University of Southern Denmark

• Associate Professor Inger Marie Jensen Hansen, PhD, DMSc

Department of Rheumatology, Odense University Hospital, Svendborg.

• Amir Emamifar, MD
• Rannveig Gildberg-Mortensen, MD
• Senior Nurse Pia Toftegaard
• Rikke Asmussen Andreasen, MD

Faculty of Health Sciences, University of Southern Denmark and Department of Rheumatology, King Christian 10^th Hospital for Rheumatic Disease.

• Professor Kim Hørslev-Petersen, DMSc

Faculty of Health Sciences, University of Southern Denmark and Department of Nuclear Medicine, Odense University Hospital and Department of Radiology and Nuclear Medicine, Southwest Jutland Hospital.

• Senior consultant and Associate Professor Søren Hess

Department of Nuclear Medicine, Odense University Hospital.

• Ziba Ahangarani Farahani, MD

Centre of Health Economics Research, University of Southern Denmark.

• Associate Professor Oke Gerke, PhD

Department of Endocrinology, Odense University Hospital.

• Associate Professor Anne Pernille Hermann, PhD

Department of Rheumatology, Odense University Hospital.

• Senior Consultant Helle Laustrup, PhD

Diagnostic Centre, Odense University Hospital, Svendborg.

• Senior Consultant Per Syrak Hansen

Diagnostic Centre, Odense University Hospital, Svendborg.

• Senior Consultant Peter Thye-Rønn

Department of Pathology, Odense University Hospital.

• Professor Niels Marcussen

Department of Ear Nose Throat surgery, Odense University Hospital, Svendborg.

• Senior Consultant Frank Svendstrup
• Sebastian le Greves, MD

Department of Radiology, Odense University Hospital, Svendborg.

• Senior Consultant Jacob Christian Bang

Department of Rheumatology, Southwest Jutland Hospital.

• Senior Consultant Stavros Chrysidis

Patient Research Partner, Department of Rheumatology, Odense University Hospital, Svendborg.

• Patient Research Partner Hanne Randi Andersen
• Patient Research Partner Rudolf Nezlo Olsen