EULAR lowers acceptable threshold for daily prednisone dose in lupus maintenance
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The acceptable threshold for glucocorticoid use for lupus maintenance therapy should be 5 mg per day prednisone equivalent or less, according to the updated 2023 EULAR recommendations for the management of systemic lupus erythematosus.
That represents a decrease from the previous update, released in 2019, which set the threshold at 7.5 mg per day prednisone equivalent.
“Since the 2019 update, the pace of new developments in SLE has accelerated,” Antonis Fanouriakis, MD, of Attikon University Hospital, in Athens, Greece, and colleagues wrote in Annals of Rheumatic Diseases. “These advances created the impetus for an update of the recommendations, to provide guidance on an evolving landscape and capitalize on the experience gained thus far. Given the drug pipeline and lessons learned regarding trial design from previous trial failures, it is likely that new therapeutic options will continue to emerge, and SLE may finally enter the era of more frequent updates of its management recommendations, similar to other diseases.”
To draft the new EULAR recommendations for SLE management, Fanouriakis and colleagues gathered a 46-person task force that included rheumatologists, nephrologists, patient representatives, methodologists and two fellows from five continents and 23 countries. Members were asked to provide input on the main research questions and population, intervention, comparison and outcomes questions. As part of a systematic literature review, fellows and methodologists examined papers from PubMed and Central that were published between January 2018 and December 2022.
Following the literature review, findings were presented to the full task force membership. Panelists were asked to vote on each recommendation, and all recommendations with at least 75% agreement were immediately included.
EULAR’s 2019 recommendations for SLE management featured four overarching principles and an expansive 33 individual recommendations. For the current review, panelists omitted or merged existing recommendations and formulated new ones.
The new recommendations include five overarching principles and 13 specific recommendations.
The overarching principles are:
- Management of SLE requires individualized care and shared decision-making.
- Physicians should evaluate SLE disease activity at each visit, with organ damage assessed at a minimum of once per year.
- Long-term outcomes can be improved with lifestyle interventions like sun protection, smoking cessation, healthy diet, regular exercise and protecting bone health.
- Medication should be selected based on each patient’s situation and preferences.
- To improve outcomes and quality of life, it is essential to diagnose early, regularly evaluate organ damage and strictly adhere to treatment aiming for remission or the lowest possible disease activity.
The recommendations follow:
- Hydroxychloroquine is the recommended treatment for all patients without contraindications.
- Glucocorticoids should be reduced to the lowest possible dose needed for maintenance and withdrawn when possible. The recommended maintenance dose is 5 mg per day prednisone equivalent or less.
- Immunomodulating agents — methotrexate, azathioprine or mycophenolate — and/or biological drugs — belimumab (Benlysta, GlaxoSmithKline) or anifrolumab (Saphnelo, Astra Zeneca) — can be considered in patients not responding to hydroxychloroquine, or who are unable to reduce their glucocorticoid use below acceptable doses.
- Intravenous cyclophosphamide or rituximab (Rituxan, Genentech) are recommended for life-threatening disease.
- Use topical agents, antimalarials or systemic glucocorticoids to treat active skin disease. To this end, methotrexate, mycophenolate, anifrolumab or belimumab can be considered as second-line therapy.
- In cases of neuropsychiatric disease due to SLE, consider combining glucocorticoids with immunosuppressive agents to reduce inflammation, or antiplatelet agents or anticoagulants for atherothrombotic or aPL-related manifestations.
- In cases of severe autoimmune thrombocytopenia, use high-dose glucocorticoids combined with intravenous immunoglobulin, rituximab or high-dose intravenous cyclophosphamide.
- In patients with proliferative lupus nephritis, use low-dose intravenous cyclophosphamide or mycophenolate with glucocorticoids.
- Lupus nephritis treatment should continue for at least 3 years following renal response.
- If a patient is considered at high risk for renal failure, physicians could combine high-dose intravenous cyclophosphamide with pulse intravenous methylprednisolone.
- When patients achieve SLE remission, begin tapering treatment — starting with glucocorticoids.
- Long-term vitamin K antagonists should be used to treat thrombotic antiphospholipid syndrome. Patients with a high risk for aPL can receive a low-dose aspirin daily.
- It is important for patients to be immunized to prevent infections. Physicians should also assess patients’ bone health, nephroprotection and cardiovascular risk.
“The 2023 recommendations for the management of SLE provide current state-of-the-art guidance for treating physicians around the world,” Fanouriakis and colleagues wrote. “This updated version will inform rheumatologists and nephrologists, health professionals, patients, regulators, payers and other stakeholders on the way modern treatment of SLE is perceived from experts in the field spanning four continents.”
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Fanouriakis, A, et al. Ann Rheum Dis. 2023;doi:10.1136/ard-2023-224762.
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