Autoimmune rheumatologic diseases
Background: Systemic lupus erythematosus (SLE) is a heterogenous, multifactorial disease with a debilitating and highly variable clinical course. Real world data are critical to better understanding these patients and their unmet clinical needs, particularly as inclusion and exclusion criteria for clinical studies are by design highly restrictive and typically not representative of the overall SLE population. Methods: The OM1 SLE Registry (OM1, Boston), an ongoing, continually enrolling, representative sample of patients with SLE in the U.S. who are followed prospectively, was used to assess clinical, laboratory, , symptomatic and disease activity information. Results: The average age of the 35,484 SLE Registry patients was 49.9 years (SD 15.1), 92% of patients were female, 18% had evidence of lupus nephritis, and 2% had lupus endocarditis or pericarditis. While 8.5% of patients were treated with the disease-modifying therapy (DMT) Benlysta, 75% were treated with anti-malarials and many with other ‘off label’ therapies. One-third of patients had at least a one Health Assessment Questionnaire functional ability index score (HAQ) and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) scores were reported for over 1400 patients. Among patients with SLEDAI scores available, 20% showed high or very high disease activity. Conclusions: Use of a representative, real-world cohort of SLE patients followed by rheumatologists provides unique information on treatment patterns and outcomes. Treatment options are currently limited to a single DMT and more typically a combination of off-label immunosuppressants and steroids, demonstrating an unmet clinical need for patients with this debilitating condition.