Speaker: Treatment of systemic lupus erythematosus should be flexible
DESTIN, Fla. — Treatment of systemic lupus erythematosus should fluctuate based on the affected organs and severity of the condition, Janet Pope, MD, MPH, professor of medicine, epidemiology and biostatistics at the University of Western Ontario Schulich School of Medicine in London, Ontario, said at the Congress of Clinical Rheumatology Annual Meeting, here.
“Because of the heterogeneity of lupus, autoantibodies can vary, organ system functions may depend on different cytokines and cellular abnormalities, and true differences in renal hard outcomes may take more than a year to occur,” she said. “Activity varies, decreased reoccurrence may be a target and damage is often irreversible,” she added.
In recent systemic lupus erythematosus (SLE) treatment trials, populations have not been accurately represented, outcome measures have not shown differences and protocol has been confounded with mega-steroids or steroid tampering, Pope said.
“Also, while many current drugs are effective, there is a sense that type II errors have occurred, where a specific drug could work but is not shown to be positive,” she said.
Minimizing effects have been documented between groups where true differences may exist and, in general, most active patients will improve with traditional therapies and high doses of steroids, Pope said.
To address these issues, researchers assembled a group of SLE experts to conduct a literature review of randomized control trials. The goal was to determine what treatments should be considered in SLE when first-line treatment was insufficient.
“We wanted to achieve consensus on treatment by having each participant offer their opinion, assuming there was disease activity due to SLE, current flare with only one organ system, access to appropriate medications and full doses tolerated sufficiently before altering treatment,” Pope said. Other potential deterring factors were also ruled out.
Experts constructed and revised treatment diagrams, expressed their level of agreement with the final diagram and the most common order was selected.
Findings showed high consensus in the following three areas: the causes of pulmonary hypertension should be ruled out or proven by a right-heart catheterization; general infection should be ruled out; and a renal biopsy is needed for lupus nephritis. Experts also agreed hydroxychloroquine should be a cornerstone of prescriptions.
“Future SLE trials should have realistic expectations of benefit with outcome measures that are responsive to minimally important improvements,” Pope said. “Efficacy compared to placebo may not be the primary goal. Instead, steroid-sparing effect of [the] drug, better safety or favorable time to clinical worsening may be the goal.”
Pope noted randomized control trials were often free of data when multiple lines of prescriptions were given, and that in real-world instances, common sense and experience should take priority over algorithms. – by Shawn M. Carter
Pope J, et al. Lupus management after failure of first-line treatment. Presented at: Congress of Clinical Rheumatology Annual Meeting; May 12-15, 2015; Destin, Fla.
Disclosure: Pope reports the data was assisted in part by Actellion, Pfizer, GSK, United Therapeutics, Amgen, Abbott, Astra Zeneca, Genentech, BMS, Janssen Pharmaceutical Companies of Johnson & Johnson, MedImmune, Mediquest, Novartis Roche and UBC.