Systemic Lupus Erythematosus (SLE) is an autoimmune disease that triggers inflammation in body tissues. The immune systems of SLE patients attacks various parts of the body and internal organs and may affect skin, kidneys, joints, brain, lungs, and blood vessels. It typically causes fatigue, arthralgia, rash, and/or fever and attacks women of childbearing age. The Lupus Foundation of America approximates that 1.5 million Americans have a form of lupus with 16,000 cases reported annually.1 The CDC estimated that from 2010 to 2014 lupus was responsible for an average of 1,803 deaths annually as an underlying or contributing cause of death.2
Although lupus is incurable, it can be chronically managed by medications. Until the last 15 years, there were relatively few clinical trials for lupus. In 2011, belimumab became the first drug approved for the treatment of active lupus in over 50 years and the first biologic ever approved for SLE. Although few treatments are approved for lupus, many medications licensed for other autoimmune or rheumatic conditions are used in SLE off-label.
Since SLE is a relatively rare condition adversely affecting the young and productive population, understanding real-world treatment patterns and care gaps is important to guide the development of new treatment options for this debilitating disease. To fill the gap in recent real-world studies on SLE, we present the analysis of real-world care patterns of US community rheumatology practices using the largest real-world US dataset, consisting of EMR data linked with point-of-care claims.
Cardinal Health has funded a retrospective observational study of the adult patients diagnosed with SLE between January 2012 and March 2017 using real-world data from the Cardinal Health Rheumatology database (CH-RHEUM). The CH-RHEUM database consists of longitudinal linked electronic medical records (EMR) and point-of-care claims for patients treated at 82 large rheumatology clinics across 48 states in the United States. This database contains over 560,000 unique patients, including more than 30,000 patients with SLE diagnosis. De-identified, HIPAA-compliant, patient-level data is available from 2007 and is updated weekly. The CH-RHEUM database provides information on demographics, diagnoses (ICD-9/10 code and diagnosis name), including comorbidities, laboratory values (e.g., ANA, CRS, ESR, RF), disease activity scores (e.g., DAS28, CDAI, RAPID3, SLEDAI, etc.), drug/procedure names and codes (HCPCS/NDC), and dose/strength.
The study criteria included patients with their first rheumatologist clinical visit for SLE (ICD-9 710.0, ICD-10 M32.X) between January 2012 and March 2017, aged 18+ at baseline and with at least one year of follow-up from diagnosis to the last visit. Patients who participated in clinical trials at any point were excluded. Patients who qualified for the study were followed to the last available visit. The primary study objectives were to describe demographic and clinical characteristics, real-world treatment patterns, and duration of therapy of the SLE patients newly presenting at US community rheumatology practices. The secondary objective was to evaluate the role of the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) in real-world assessment of this population.
Of 12,506 newly presenting SLE patients, 7,871 (63%) received drug therapy, and only 1,823 (15%) received biologic therapy. Mean age at the first visit for SLE was 51.2 years, time to treatment initiation was 9.7 months, and mean length of follow-up available from the first visit to the last visit was 3.0 years. Most of the patients (92%) were female, and 29% of all new patients received at least two lines of drug therapy.
Corticosteroids represented the cornerstone of treatment of this SLE population and were prescribed to 89% of the drug-treated patients. The three most frequently used therapies regardless of the drug class were: prednisone (70%, 5,468 patients), methylprednisolone (39%, 3,095), triamcinolone (23%, 1,789); while approved therapies with longest therapy duration were prednisone, triamcinolone and budesonide, with the mean duration of 9.8, 5.4, and 5.1 months, respectively.
Compared to the patients on non-biologic therapy, the patients on biologics were younger at treatment initiation (mean age 48.6 vs. 52.7 years), were more likely to have lupus nephritis (7.8% vs. 5%), and shorter treatment duration (6.6 vs. 11.9 months). The most frequently used biologics were belimumab, rituximab, and abatacept. Biologics with the longest duration of therapy were etanercept, ustekinumab and abatacept.
Additionally, we aimed to evaluate to what extent a disease activity metric is used in a routine medical practice for switching the drug or the drug class, initiating the drug treatment, or simply charting an objective measure of disease activity. The most commonly used lupus activity score in clinical trials is the SLE Disease Activity Index (SLEDAI).
Of 12,506 newly presenting patients, only 698 (8%) had at least one SLEDAI score. Patients receiving biologics were more likely to have SLEDAI scores compared to patients receiving non-biologic drug therapy (13% vs. 3%, P‹0.001); however, the use of SLEDAI for treatment decision making is not yet occurring, as the majority of the patients do not have multiple scores.
Our study of the largest real-world SLE sample from US community rheumatology practices found that corticosteroids are remaining the most frequently used drug class in the newly diagnosed SLE patients, and biologics are underutilized in this population. Although belimumab is the only biologic approved in SLE, other biologics used for autoimmune or rheumatic disease are prescribed off-label to over one-third of the patients receiving biologics. Disease activity scores used in clinical trials are rarely used in real-world SLE patients. Physician education is needed to improve application of the disease activity scores in routine medical practice.