Abstract
Purpose Type I interferon (IFN) plays a major role in SLE pathogenesis. However, limited information exists about type I IFN gene signature (IFNGS) associations with disease severity and activity, health-related quality of life, and outcomes for the general population of patients with moderate to severe SLE receiving standard-of-care treatment.
Methods Initiated in June 2017, SPOCS is an international, multicenter cohort of 1500 patients with moderate to severe SLE evaluated biannually during a 3 year follow-up period. Participating countries include Canada, United States, France, Germany, Italy, Spain, United Kingdom, and Australia. SPOCS will systematically describe the comprehensive patient journey, including clinical features, disease progression and treatment, outcomes, health status, and health care resource utilisation, for a general population of patients with moderate to severe SLE (table 1).
Association of type I IFNGS expression with these elements will be assessed. The study includes 2 year enrollment and 3 year follow-up periods for each patient. Patients (≥18 years old) with a physician diagnosis that meets ACR or SLICC SLE criteria will be included. Additional study entry requirements include moderate to severe SLE as defined by a modified SLEDAI-2K score ≥4 or SLEDAI-2K score ≥6, ≥6 month treatment duration for active SLE with systemic SLE treatment beyond NSAIDs and analgesics, and current or historic serology of ANA or dsDNA. Exclusion criteria include enrollment in interventional trials involving investigational agents or active, severe, biopsy-confirmed class III or class IV±class V LN and/or urine protein:creatinine ratio >1 mg/mg. Patients will be followed as per local routine clinical practice.
Results First patient recruited was achieved in June 2017, and the last patient out is anticipated for Q2 2022. Data collection, which will include use of electronic case report forms and patient-reported outcomes, will take place at biannual study visits. Distribution of type I IFNGS (test–high vs test–low) will be determined, and any association with patient outcomes will be evaluated.
Conclusion SPOCS will provide important information about possible associations of type I IFNGS with disease characteristics and outcomes for patients with moderate to severe SLE.
