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New guidelines coming out
Healio: What were the strong recommendations in the new document?
Sammaritano: Our strong recommendations rely on a combination of evidence, clinical expertise, and patient panel input. They are important in preventing serious adverse outcomes and are applicable to almost all people with lupus nephritis.
Strong recommendations include screening at least every 6 to 12 months for proteinuria in people with SLE without known kidney disease, or when experiencing extra-renal flares, as well as quantifying proteinuria at least every 3 months in those with lupus nephritis who have not achieved complete renal response, and every 3 to 6 months in those with sustained complete renal response.
For those with active lupus nephritis who are not already on hydroxychloroquine, we strongly recommend initiation and continuation of hydroxychloroquine therapy to manage and prevent lupus clinical manifestations, unless contraindicated.
In people with lupus nephritis who have progressive refractory disease and are approaching kidney failure, we strongly recommend kidney transplantation over dialysis.
Finally, in those who are on current dialysis or who have had a kidney transplant, we strongly recommend regular follow up with a rheumatologist in addition to the nephrologist.
Healio: What do these recommendations mean for patient care? What impact do you expect them to have?
Sammaritano: Lupus nephritis manifests in close to half of people with SLE, and 10% to 22% of impacted patients develop end-stage kidney disease. We hope these new recommendations, which incorporate the most recently published treatment trials, enable clinicians and patients to have the best discussion possible regarding therapy, one that is based on the most recent data and clinical expertise.
We recognize that there are many variables involved in treatment decisions, including clinical presentation and patient preferences, and that treatment may be limited by access to specialists, procedures and medications.
As a result, this guideline does not preclude using available traditional therapies. We hope, however, that it expands the possibilities for improved outcomes for more people who are living with lupus nephritis.
Kidney function declines in everyone over time, but in people with lupus nephritis it occurs at an accelerated rate for as long as the inflammatory process is present. In addition, even after inflammation is controlled, a later recurrence of active lupus nephritis imposes further loss in kidney function.
Even with the preferred triple therapy, the complete response rates reported in studies were still only in the 40% to 50% range.
As a result, an important overall message is to diagnose and treat lupus nephritis as promptly and effectively as possible to minimize risk of long-term damage and preserve kidney function.
Healio: Were there topics you hoped to cover, or recommendations you were hoping to make, but were unable to for any reason? What are the shortcomings of this document?
Sammaritano: We compiled a research agenda based on those topics that are promising and/or relevant, but for which we do not have enough data or experience to formulate recommendations at this time. They include optimal timing of repeat kidney biopsy, most effective treatment for less common lupus nephritis subsets — for example, lupus podocytopathy and others — the potential use of non-immunosuppressive medications for other chronic kidney disease — such as sodium-glucose cotransporter-2 (SGLT2) inhibitors — and the use of serum and urinary biomarkers to better reflect disease activity.
Healio: Looking ahead, what ground do you expect to cover for the next iteration of lupus nephritis recommendations? Pending FDA approvals, new mechanisms of action, or other advances in the field?
Sammaritano: We are excited about the promise of new agents for the treatment of lupus nephritis that are in various phases of development. For example, data suggesting benefits from obinutuzumab (Gazyva, Genentech) treatment have been recently reported, although not yet formally published, and so were not considered for this current guideline.
We plan to revise this lupus nephritis guideline regularly, including when important new data are published. Assuming the evidence, voting panel discussion, and patient panel preference all support inclusion of newly approved agents, these would potentially be incorporated as recommended therapy in a revised, updated guideline.
References:
Furie R, et al. NEJM. 2020;doi:10.1056/NEJMoa2001180.
Rovin BH, et al. Lancet. 2021;doi:10.1016/S0140-6736(21)00578-X.
Published by:
healio rheumatology logo
Sources/DisclosuresCollapse
Disclosures: Sammaritano reports no relevant financial disclosures.
Read more about
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lupus
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American College of Rheumatology Annual Meeting
healio rheumatology logo
ByRob Volansky
Fact checked byShenaz Bagha
December 11, 2024
2 min read
SAVE
ACR recommends triple therapy for lupus nephritis in new 2024 guidelines
WASHINGTON — Early triple therapy may be the most effective strategy for lupus nephritis, according to the new 2024 American College of Rheumatology Guideline for the Screening, Treatment, and Management of Lupus Nephritis.
The 2024 document, which was presented in a press conference at ACR Convergence 2024, includes 41 recommendations overall.
Lisa Sammaritano, MD, speaks during ACR Convergence 2024.
“We have very convincing evidence that starting with triple therapy yields to better long-term outcomes for our patients,” Lisa Sammaritano, MD, said during a press conference. Image: Rob Volansky | Healio Rheumatology
“We have very convincing evidence that starting with triple therapy yields better long-term outcomes for our patients than starting with two agents and waiting to see if they respond before escalating to triple therapy,” Lisa Sammaritano, MD, lead author of the updated guideline, professor of clinical medicine at Weill Cornell Medicine, and an attending physician in the Hospital for Special Surgery, said at the press conference.
According to Sammaritano, the ACR’s previous lupus nephritis clinical practice guidelines had called for induction therapy, with high-dose glucocorticoids plus immunosuppressant medications, such as mycophenolate mofetil or cyclophosphamide, as well as mycophenolate for maintenance therapy.
“Since then, belimumab and voclosporin have been approved by the FDA for treatment, prompting a conceptual shift from induction and maintenance therapy to one of combination, ongoing therapy targeting different parts of the immune system,” Sammaritano said in a press release announcing the update.
Among the new document’s strong recommendations, the ACR counsels rheumatologists to screen for proteinuria at least every 6 to 12 months — or in the event of extra-renal flares — in patients with systemic lupus erythematosus who do not have known kidney disease. Quantifying proteinuria at least every 3 months in patients with lupus nephritis who have not reached a complete renal response is also strongly recommended. For patients with sustained complete renal response, proteinuria screening should occur every 3 to 6 months.
Meanwhile, a key conditional recommendation for screening suggests rheumatologists perform a kidney biopsy in patients with SLE demonstrate high protein levels in their urine — defined as 0.5 g/g — and/or impaired kidney function not otherwise explained.
Regarding treatment, an immunosuppressive triple-therapy regimen is conditionally recommended in patients with active Class III & IV lupus nephritis. This regimen may include glucocorticoid plus mycophenolate plus belimumab (Benlysta, GlaxoSmithKline), mycophenolate plus calcineurin inhibitor therapy, or low dose cyclophosphamide plus belimumab.
Lower doses of glucocorticoids are recommended after initial IV pulse therapy, according to the document.
In addition to recommendations for adults and pediatric patients, the guideline also includes recommendations for withdrawing therapy, according to Sammaritano.
“We are also recommending 3 to 5 years of treatment,” she said. “We know that while clinical response may occur, often times there is still ongoing inflammation in the kidney itself. We want to make sure that is completely treated before withdrawing medication.”
Published by:
healio rheumatology logo
Sources/DisclosuresCollapse
Source: Sammaritano L. Press conference. Presented at: ACR Convergence 2024; Nov. 14-19, 2024; Washington, D.C.
Disclosures: Sammaritano reports no relevant financial disclosures.
Healio: What were the strong recommendations in the new document?
Sammaritano: Our strong recommendations rely on a combination of evidence, clinical expertise, and patient panel input. They are important in preventing serious adverse outcomes and are applicable to almost all people with lupus nephritis.
Strong recommendations include screening at least every 6 to 12 months for proteinuria in people with SLE without known kidney disease, or when experiencing extra-renal flares, as well as quantifying proteinuria at least every 3 months in those with lupus nephritis who have not achieved complete renal response, and every 3 to 6 months in those with sustained complete renal response.
For those with active lupus nephritis who are not already on hydroxychloroquine, we strongly recommend initiation and continuation of hydroxychloroquine therapy to manage and prevent lupus clinical manifestations, unless contraindicated.
In people with lupus nephritis who have progressive refractory disease and are approaching kidney failure, we strongly recommend kidney transplantation over dialysis.
Finally, in those who are on current dialysis or who have had a kidney transplant, we strongly recommend regular follow up with a rheumatologist in addition to the nephrologist.
Healio: What do these recommendations mean for patient care? What impact do you expect them to have?
Sammaritano: Lupus nephritis manifests in close to half of people with SLE, and 10% to 22% of impacted patients develop end-stage kidney disease. We hope these new recommendations, which incorporate the most recently published treatment trials, enable clinicians and patients to have the best discussion possible regarding therapy, one that is based on the most recent data and clinical expertise.
We recognize that there are many variables involved in treatment decisions, including clinical presentation and patient preferences, and that treatment may be limited by access to specialists, procedures and medications.
As a result, this guideline does not preclude using available traditional therapies. We hope, however, that it expands the possibilities for improved outcomes for more people who are living with lupus nephritis.
Kidney function declines in everyone over time, but in people with lupus nephritis it occurs at an accelerated rate for as long as the inflammatory process is present. In addition, even after inflammation is controlled, a later recurrence of active lupus nephritis imposes further loss in kidney function.
Even with the preferred triple therapy, the complete response rates reported in studies were still only in the 40% to 50% range.
As a result, an important overall message is to diagnose and treat lupus nephritis as promptly and effectively as possible to minimize risk of long-term damage and preserve kidney function.
Healio: Were there topics you hoped to cover, or recommendations you were hoping to make, but were unable to for any reason? What are the shortcomings of this document?
Sammaritano: We compiled a research agenda based on those topics that are promising and/or relevant, but for which we do not have enough data or experience to formulate recommendations at this time. They include optimal timing of repeat kidney biopsy, most effective treatment for less common lupus nephritis subsets — for example, lupus podocytopathy and others — the potential use of non-immunosuppressive medications for other chronic kidney disease — such as sodium-glucose cotransporter-2 (SGLT2) inhibitors — and the use of serum and urinary biomarkers to better reflect disease activity.
Healio: Looking ahead, what ground do you expect to cover for the next iteration of lupus nephritis recommendations? Pending FDA approvals, new mechanisms of action, or other advances in the field?
Sammaritano: We are excited about the promise of new agents for the treatment of lupus nephritis that are in various phases of development. For example, data suggesting benefits from obinutuzumab (Gazyva, Genentech) treatment have been recently reported, although not yet formally published, and so were not considered for this current guideline.
We plan to revise this lupus nephritis guideline regularly, including when important new data are published. Assuming the evidence, voting panel discussion, and patient panel preference all support inclusion of newly approved agents, these would potentially be incorporated as recommended therapy in a revised, updated guideline.
References:
Furie R, et al. NEJM. 2020;doi:10.1056/NEJMoa2001180.
Rovin BH, et al. Lancet. 2021;doi:10.1016/S0140-6736(21)00578-X.
Published by:
healio rheumatology logo
Sources/DisclosuresCollapse
Disclosures: Sammaritano reports no relevant financial disclosures.
Read more about
lupus nephritis
lupus
chronic kidney disease
clinical guidelines
american college of rheumatology
Add topic to email alerts
Facebook
Twitter
LinkedIn
Email
Print
Comment
American College of Rheumatology Annual Meeting
healio rheumatology logo
ByRob Volansky
Fact checked byShenaz Bagha
December 11, 2024
2 min read
SAVE
ACR recommends triple therapy for lupus nephritis in new 2024 guidelines
WASHINGTON — Early triple therapy may be the most effective strategy for lupus nephritis, according to the new 2024 American College of Rheumatology Guideline for the Screening, Treatment, and Management of Lupus Nephritis.
The 2024 document, which was presented in a press conference at ACR Convergence 2024, includes 41 recommendations overall.
Lisa Sammaritano, MD, speaks during ACR Convergence 2024.
“We have very convincing evidence that starting with triple therapy yields to better long-term outcomes for our patients,” Lisa Sammaritano, MD, said during a press conference. Image: Rob Volansky | Healio Rheumatology
“We have very convincing evidence that starting with triple therapy yields better long-term outcomes for our patients than starting with two agents and waiting to see if they respond before escalating to triple therapy,” Lisa Sammaritano, MD, lead author of the updated guideline, professor of clinical medicine at Weill Cornell Medicine, and an attending physician in the Hospital for Special Surgery, said at the press conference.
According to Sammaritano, the ACR’s previous lupus nephritis clinical practice guidelines had called for induction therapy, with high-dose glucocorticoids plus immunosuppressant medications, such as mycophenolate mofetil or cyclophosphamide, as well as mycophenolate for maintenance therapy.
“Since then, belimumab and voclosporin have been approved by the FDA for treatment, prompting a conceptual shift from induction and maintenance therapy to one of combination, ongoing therapy targeting different parts of the immune system,” Sammaritano said in a press release announcing the update.
Among the new document’s strong recommendations, the ACR counsels rheumatologists to screen for proteinuria at least every 6 to 12 months — or in the event of extra-renal flares — in patients with systemic lupus erythematosus who do not have known kidney disease. Quantifying proteinuria at least every 3 months in patients with lupus nephritis who have not reached a complete renal response is also strongly recommended. For patients with sustained complete renal response, proteinuria screening should occur every 3 to 6 months.
Meanwhile, a key conditional recommendation for screening suggests rheumatologists perform a kidney biopsy in patients with SLE demonstrate high protein levels in their urine — defined as 0.5 g/g — and/or impaired kidney function not otherwise explained.
Regarding treatment, an immunosuppressive triple-therapy regimen is conditionally recommended in patients with active Class III & IV lupus nephritis. This regimen may include glucocorticoid plus mycophenolate plus belimumab (Benlysta, GlaxoSmithKline), mycophenolate plus calcineurin inhibitor therapy, or low dose cyclophosphamide plus belimumab.
Lower doses of glucocorticoids are recommended after initial IV pulse therapy, according to the document.
In addition to recommendations for adults and pediatric patients, the guideline also includes recommendations for withdrawing therapy, according to Sammaritano.
“We are also recommending 3 to 5 years of treatment,” she said. “We know that while clinical response may occur, often times there is still ongoing inflammation in the kidney itself. We want to make sure that is completely treated before withdrawing medication.”
Published by:
healio rheumatology logo
Sources/DisclosuresCollapse
Source: Sammaritano L. Press conference. Presented at: ACR Convergence 2024; Nov. 14-19, 2024; Washington, D.C.
Disclosures: Sammaritano reports no relevant financial disclosures.
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