We spoke with Prof Ariane Herrick, Chief Investigator of the PRednisolone in early diffuse Systemic Sclerosis study (PRedSS) about its importance and how our members can help.
What is the PRedSS study?
Ultimately the study aims to answer the key clinical questions as to whether corticosteroids should or should not be prescribed for this painful, debilitating disease.
It's a randomised placebo-controlled study of moderate dose prednisolone for 6 months in patients with early diffuse cutaneous systemic sclerosis (dcSSc) i.e. within 3 years of the onset of skin thickening. Seventy-two patients will be recruited from across the UK. Identifying and recruiting eligible patients is the major challenge of PRedSS, due to the rarity of early diffuse disease. Co-primary end-points will be the Health Assessment Questionnaire – Disability Index and the modified Rodnan Skin Score. Patients will be assessed 5 times: screening, baseline, 6 weeks, 3 and 6 months, with a code-break on exit from the study at 6 months.
The study is funded by Versus Arthritis.
What type of patients is the study recruiting?
Adult patients (18 year and over) presenting with dcSSc with skin involvement of less than 3 years, extending to proximal limb and/or trunk. We currently have 11 open recruiting centres across the UK and expect to have another 5 centres and several supporting Participant Identification Centres (PICs) open by the end of 2019.
Why is it so important?
Diffuse cutaneous systemic sclerosis is a devastating illness with a very major impact on quality of life as well as on survival. Clinicians caring for patients with early dcSSc have tended (understandably) to focus on the internal organ involvement of early dcSSc (because this can be life-threatening) and to pay less attention to the aspects of disease which have the major impact upon patients’ day-to-day lives. These other aspects include painful, itchy skin, fatigue, and loss of function due to a combination of early contractures (especially of the fingers) and musculoskeletal involvement. Many of these early features which severely impact on quality of life have an inflammatory component and are potentially treatable with steroid therapy. However, corticosteroids are much less frequently prescribed in patients with systemic sclerosis compared with patients with other connective tissue diseases. This is because:
Systemic sclerosis is not generally considered primarily an inflammatory disease, but instead is characterised by fibrosis and ischaemia. However, as stated above, there is a degree of inflammation in early diffuse disease.
Steroids are a risk factor for renal crisis, which is most likely to occur in that subset of patients with early diffuse cutaneous disease.
How can our members help?
The success of the study really depends on identifying patients with this rare disease subset, help from the society's members to recruit patients would be hugely appreciated.
Where can they find further information?
Further details are available on the study website.