AMSTERDAM, The Netherlands – Doctors attending the EULAR meeting have been told to be cautious about the optimal management of mild to severe systemic lupus erythematosus (SLE), particularly regarding the benefits of lifestyle modifications and primary prevention interventions. New treatment guidelines, drawn up by a EULAR task force,1 are based on "an excellent level of agreement among experts," but a virtual absence of an evidence base, according to the task force chair, Dimitrios Boumpas, MD, professor of rheumatology at the University of Crete in Greece.

The expert consensus on the management of SLE should not blind doctors to the fact that few randomized controlled trials have been performed to establish the optimal management of SLE, he said.

"With only a few randomized controlled trials performed to establish optimal management of SLE, doctors should remain open-minded about its treatment." —Dimitrios Boumpas, MD
"There have been no randomized controlled trials to evaluate the effectiveness of lifestyle modifications or the impact of primary interventions, including aspirin, osteoprotection, statins, and antihypertensives on SLE patients," Dr. Boumpas said. "Nor has there been an adequate evaluation of the role of low-dose aspirin in the prevention of thrombolytic events or of antiphospholipid antibodies to prevent pregnancy loss."

The validity of renal biopsy, urinary sediment analysis, proteinuria, and immunological tests as surrogate markers in the treatment of lupus nephritis has also not been established. And there have been no trials to document that the measurement of routine laboratory and immunological tests alters patient management and outcome.

Stressing the importance of an integrated approach to this complex systemic disease, Dr. Boumpas said the EULAR recommendations are meant to sensitize everyone involved in care, whether rheumatologists, nephrologists, or dermatologists.

Among the key guidelines, due to be posted on the EULAR Web site and submitted for publication in the journal Annals of Rheumatic Disease, are recommendations to:

  • Maintain a high index of suspicion regarding potential comorbidities, including urinary tract infections and other infectious diseases, atherosclerosis, hypertension, dyslipidemias, diabetes, osteoporosis, avascular necrosis, and malignancies, especially non-Hodgkin's lymphoma
  • Use antimalarials, NSAIDs, or glucocorticoids for SLE without major organ manifestation, and consider immunosuppressive agents such as azathioprine (Imuran®), mycophenolate mofetil (CellCept®) and methotrexate (Trexall®, Rheumatrex®) in nonresponsive patients or those who are not able to reduce steroids below doses acceptable for chronic use
  • Consider immunosuppressive therapy for SLE patients with major neuropsychiatric manifestations considered to be of inflammatory origin
  • Recognize that pregnancy affects SLE patients in several ways, putting women at increased risk of developing pre-eclampsia as well as increasing the risk of miscarriage, stillbirth, premature delivery, and intrauterine growth restriction in those with a history of lupus nephritis
  • Consider adjunct therapy where appropriate, including photoprotection, estrogens including oral contraceptives or hormonal replacement therapy, and lifestyle modifications including smoking cessation, weight control, and exercise
  • Consider low-dose aspirin to prevent thrombosis in patients with SLE and anti-phospholipid antibodies

For patients with proliferative lupus nephritis, there is good evidence that glucocorticosteroids in combination with immunosuppressive agents are effective against progression to end-stage renal disease. Long-term efficacy has been demonstrated only for cyclophosphamide, which also has a favorable toxicity profile.

Dr. Boumpas told CIAOMed that SLE treatment is improving all the time. "We are getting better at treating SLE, and we are learning more about the disease, enabling better drugs to be developed that will improve our ability to treat patients. But doctors should also be aware that there are many unresolved issues, and until more data becomes available, doctors need to remain open-minded about treatment," he said.

Reference

  1. Boumpas D, Gordon C, Bertsias G, Ionnidis J. EULAR recommendations for the management of systemic lupus erythematosus (SLE). Presented at: 2006 EULAR Meeting; June 21–24; Amsterdam, the Netherlands. Abstract THU0254.