BENLYSTA recommended across multiple guidelines for both lupus and lupus nephritis1-4

Recommended by ACR, EULAR, and KDIGO1-4

ACR guidelines summary for lupus

EULAR recommendations for lupus

ACR guidelines for lupus nephritis

EULAR recommendations for lupus nephritis

KDIGO guidelines for lupus nephritis

BENLYSTA recommended across multiple guidelines for both lupus and lupus nephritis1-4

Recommended by ACR, EULAR, and KDIGO1-4

ACR guidelines summary for lupus

EULAR recommendations for lupus

ACR guidelines for lupus nephritis

EULAR recommendations for lupus nephritis

KDIGO guidelines for lupus nephritis

Add BENLYSTA early, after hydroxychloroquine,* in patients with lupus

See how leading guidelines position BENLYSTA

* As part of standard therapy.

ACR = American College of Rheumatology; EULAR = European Alliance of Associations for Rheumatology; KDIGO = Kidney Disease Improving Global Outcomes.

Recommendations and guidelines for lupus

Select 2025 ACR guidelines summary for lupus1

Implement guidelines to optimize lupus care across patient needs

The 2025 ACR guidelines emphasize early, individualized treatment of lupus to control disease activity and minimize glucocorticoid exposure.1

The ACR guidelines summary includes early introduction of biologics such as BENLYSTA.1

ACR recommends1:

  • Universal use of hydroxychloroquine
  • Minimizing glucocorticoid exposure
  • Early introduction of conventional and/or biologic immunosuppressive therapies

The 2025 ACR guidelines conditionally recommend tapering immunosuppressives after 3–5 years in stable patients.1

The 2025 ACR guidelines endorse the conditional inclusion of BENLYSTA when lupus disease activity in organ systems is refractory to initial therapy.1

Select recommendations from 2025 ACR guidelines summary for lupus: from disease monitoring to comprehensive treatment strategies

Treatment goals and medication guidance1

  • Aim for optimal control: achieving remission or low disease activity to improve long-term outcomes
  • Glucocorticoids: use lowest dose for the shortest duration; minimize glucocorticoid-related toxicity by early introduction of immunosuppressive therapies
  • Immunosuppressive therapy: conditionally taper after 3–5 years in patients with stable disease who have achieved sustained remission or low disease activity

Individualized, shared decision-making is essential to respecting patient values and preferences in lupus treatment.1

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  • Monitoring and risk managementSUP1

    • ACR conditionally recommended assessing disease activity regularly, including when there is a change in clinical status or lupus-directed medications
    • Assessing disease damage at least annually is conditionally recommended
    • All patients with lupus should receive screening, monitoring, and management for comorbid conditions associated with lupus and its therapies (including infection, cardiovascular disease, bone and joint damage, malignancy, reproductive health complications, and presence of antiphospholipid antibodies)

  • Glucocorticoid, hydroxychloroquine, and immunosuppressive therapySUP1

    Glucocorticoids therapy

    • ACR strongly recommends tapering prednisone to ≤5 mg/day (ideally 0) within 6 months in patients with stable controlled lupus who are receiving prednisone >5 mg/day
    • If unable to taper prednisone to ≤5 mg/day, ACR conditionally recommends initiating or escalating immunosuppressive therapy 

    Hydroxychloroquine therapy

    • ACR strongly recommends routine treatment with HCQ unless contraindicated

    Immunosuppressive therapy

    • In sustained remission or low disease activity, ACR conditionally recommends tapering immunosuppressive therapy after 3–5 years, with the goal of discontinuation

     

    HCQ = hydroxychloroquine.

These are select guidelines, not the complete guidelines published by the ACR. Full guidelines for lupus are pending release by ACR.

Adapted from the summary of the 2025 American College of Rheumatology guidelines for systemic lupus erythematosus.

See the full 2025 ACR guidelines summary for lupus

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Ready to see how these recommendations extend to lupus nephritis?

Jump to the ACR guidelines for lupus nephritis

Summary of select 2023 EULAR recommendations for lupus2

Lupus

Consider adding biologics, such as BENLYSTA (belimumab) or anifrolumab, after HCQ:

  • If not responding to HCQ (alone or in combination with GC)
  • Or if unable to taper steroids below doses acceptable for chronic use

Steroids

Maintenance steroid dose should be ≤5 mg/day and, when possible, withdrawn.

These are only select recommendations, not the complete EULAR recommendations.

GC = glucocorticoid; HCQ = hydroxychloroquine.

BENLYSTA was acknowledged to have more than 10 years of real-life clinical experience2

Select overarching principles from the 2023 EULAR recommendations for lupus2

Select overarching principles from the 2023 EULAR recommendations for lupus
Select overarching principles from the 2023 EULAR recommendations for lupus

  • EULAR treatment algorithm for lupusSUP2

    According to EULAR, prior use of a conventional immunosuppressive drug should not be mandatory for initiating a biologic.

    Treatment of non-renal lupus

    EULAR treatment algorithm of non-renal systemic lupus erythematosus
    EULAR treatment algorithm of non-renal systemic lupus erythematosus

    Used with permission from Fanouriakis A, et al. Ann Rheum Dis. 2024;83(1):15-29. © BMJ.

    * Mild disease: constitutional symptoms; mild arthritis; rash ≤9% BSA; PLTs 50–100 x 109/L; SLEDAI ≤6; BILAG C or ≤1 BILAG B manifestation. Moderate disease: moderate–severe arthritis (‘RA-like’); rash 9%–18% BSA; PLTs 20–50 x 109/L; serositis; SLEDAI 7–12; ≥2 BILAG B manifestations). Severe disease: major organ threatening disease (cerebritis, myelitis, pneumonitis, mesenteric vasculitis); thrombocytopenia with platelets <20 x 109/L; TTP-like disease or acute haemophagocytic syndrome; rash >18% BSA SLEDAI >12; ≥1 BILAG A manifestations.

    † Recommendation of belimumab and anifrolumab as first-line therapy in severe disease refers to cases of extrarenal SLE with non-major organ involvement, but extensive disease from skin, joints, and so on. The use of anifrolumab as add-on therapy in severe disease refers mainly to severe skin disease. For patients with severe neuropsychiatric disease, anifrolumab and belimumab are not recommended.

    ANI = anifrolumab; aPL = antiphospholipid antibodies; APS = antiphospholipid syndrome; AZA = azathioprine; BEL = belimumab; BILAG = British Isles Lupus Assessment Group; BSA = body surface area; CNI = calcineurin inhibitor; CYC = cyclophosphamide; IV = intravenous; MMF = mycophenolate mofetil; MTX = methotrexate; PLTs = platelet count; PO = oral administration; RTX = rituximab; SLE = systemic lupus erythematosus; SLEDAI = SLE Disease Activity Index; TTP = thrombotic thrombocytopenia purpura; VKA = vitamin K antagonist.

See the full 2023 EULAR recommendations

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Looking for EULAR recommendations on lupus nephritis?

Jump to recommendations on lupus nephritis.

Use BENLYSTA early as part of initial therapy in patients with lupus nephritis

See where BENLYSTA fits in expert recommendations

Recommendations and guidelines for lupus nephritis

2024 ACR guidelines for lupus nephritis3

BENLYSTA has been recommended as part of first-line therapy

In patients with active, newly diagnosed, or flaring Class III/IV ± V lupus nephritis:

First-line triple therapy3

ACR conditionally recommends a triple immunosuppressive regimen consisting of pulse IV glucocorticoids (GCs) 250–1000 mg methylprednisolone daily x 1–3 days, followed by oral GC ≤0.5 mg/kg/day (maximum dose 40 mg/day) with taper to a target dose of ≤5 mg/day by 6 months plus:

  • Mycophenolic acid analogs (MPAA) plus BENLYSTA,* or
  • MPAA plus a calcineurin inhibitor (CNI),† or
  • Euro-Lupus Nephritis Trial (ELNT) low-dose cyclophosphamide (CYC) plus BENLYSTA (MPAA substituted for CYC after CYC course complete)

Extra-renal manifestations: lupus disease activity3

With moderate to severe extra-renal manifestations, ACR conditionally recommends a triple immunosuppressive regimen that contains BENLYSTA.

BENLYSTA is preferred in specific high-risk patient subgroups3

BENLYSTA is conditionally recommended over CNIs for patients with:

  • eGFR ≤45
  • Blood pressure >165/105
  • Significant chronicity on kidney biopsy

In these subgroups of patients, ACR recommends BENLYSTA over a CNI regimen because of potential CNI-associated nephrotoxicity and hypertension.

Therapy should be maintained for at least 3–5 years after achievement of complete renal response (CRR) to help sustain remission.

Complete renal response (CRR): within 6–12 months of starting therapy (may take >12 months):

  • Reduction in proteinuria <0.5 g/g (50 mg/mmol) (24-hour collection or urine protein/creatinine ratio; AND
  • Stabilization or improvement in kidney function (+20% baseline, ie, at least 80% of baseline)

These are selected guidelines, not the complete ACR guidelines.

* Recommended preferentially when significant extra-renal manifestations present.

† Recommended preferentially when proteinuria ≥3.0 g.

IV = intravenous.

  • Select treatment algorithm from the 2024 ACR guidelines for lupus nephritisSUP3,5

    For the treatment of active, newly diagnosed, or flaring Class III/IV ± V lupus nephritis

    Select treatment algorithm from the 2024 ACR guidelines for lupus nephritis
    Select treatment algorithm from the 2024 ACR guidelines for lupus nephritis

    Adapted from the 2024 American College of Rheumatology guidelines for lupus nephritis.

    ‡ Discuss adjunctive treatments with systemic anticoagulation with nephrology for patients with LN and significant risk factors for thrombosis (e.g., low serum albumin in context of severe proteinuria).

    § MPAA including MMF.

    ‖ Recommended preferentially when significant extrarenal manifestations present.

    ¶ Recommended preferentially when proteinuria ≥3.0 g.

    ** Substitute MPAA once low-dose CYC cycle is completed.

    Goal: Complete renal response (CRR)

    • Within 6–12 months, reduction in proteinuria to ≤0.5 g/g, and
    • Stabilization or improvement in kidney function (±20% baseline)

    Duration of therapy: at least 3–5 years after achievement of CRR.

    Glucocorticoids pulse/oral taper: pulse IV glucocorticoids (250–1000 mg methylprednisolone daily x 1–3 days) followed by oral glucocorticoids ≤0.5 mg/kg/day (maximum dose 40 mg/day) and taper to a target dose of ≤0.5 mg/day by 6 months.

    Low dose CYC: as per ELNT protocol, 500 mg IV CYC every 2 weeks for 6 doses.4

    Dual therapy: glucocorticoid pulse/oral taper plus one immunosuppressive agent, usually MPAA or low-dose CYC.

    These are selected guidelines, not the complete ACR guidelines.

    LN = lupus nephritis; MMF = mycophenolate mofetil; MPA = mycophenolic acid; RAAS-I = renin-angiotensin-aldosterone system inhibitors.

See the full 2024 ACR LN guidelines

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Clinical trial data for BENLYSTA contributed to its inclusion in recommended triple therapy regimens for lupus nephritis.

Dive deeper into the data.

EULAR recommendations in lupus nephritis2

According to EULAR, changes in the treatment landscape have inspired discussions on a “paradigm shift” in the treatment of lupus nephritis, moving from the traditional “induction-maintenance” regimen to the early use of combination therapies.

Consider the addition of BENLYSTA or CNIs at the beginning of treatment for ALL patients with active proliferative lupus nephritis.2

Following renal response, continue treatment for at least 3 years.2

  • Treatment of lupus nephritisSUP2

    EULAR treatment algorithm of lupus nephritis
    EULAR treatment algorithm of lupus nephritis
    Used with permission from Fanouriakis A, et al. Ann Rheum Dis. 2024;83(1):15-29. © BMJ.
    * In addition to general protective measures outlined in treatment of non-renal SLE treatment figure.
    † Belimumab should always be given in combination with MMF or low-dose CYC as initial therapy, and with MMF or AZA as maintenance therapy.
    ‡ CNIs should be given in combination with MMF.
    § Particularly recommended in the presence of poor prognostic factors: reduced eGFR, histological presence of cellular crescents or fibrinoid necrosis, or severe interstitial inflammation.
    ¶ Extension of high-dose CYC to subsequent phase refers to severe lupus nephritis cases, in which bimonthly or quarterly CYC pulses may be given following 6 monthly pulses.
    ** In relapsing/refractory disease, especially after failure to CYC-based regimens.
    ACEi = angiotensin-converting enzyme inhibitor; ARB = angiotensin receptor blocker; eGFR = estimated glomerular filtration rate; MP = methylprednisolone; SGLT2i = sodium glucose cotransporter-2 inhibitor; TAC = tacrolimus; UPr = urine protein; VOC = voclosporin.
See the full 2023 EULAR recommendations

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2024 KDIGO guidelines summary4

KDIGO guidelines recommend that patients with active Class III or IV lupus nephritis, with or without a membranous component, be treated initially with glucocorticoids plus either one of the following4:

  • Mycophenolic acid analogs (MPAA) (1B); or
  • Low-dose IV cyclophosphamide (CYC) (1B); or
  • BENLYSTA and either MPAA or low-dose IV CYC (1B); or
  • MPAA and a calcineurin inhibitor (CNI) when kidney function is not severely impaired (1B)

Patients treated with triple immunosuppressive regimens that include BENLYSTA (belimumab) or a CNI, in addition to standard maintenance immunosuppression can be continued for 2–3 years.4

A triple immunosuppressive regimen of BENLYSTA with glucocorticoids and either MPAA or reduced-dose cyclophosphamide may be preferred in patients with repeated kidney flares or at high-risk for progression to kidney failure due to severe chronic kidney disease.4

  • Recommended approach for initial therapy of active Class III/IV lupus nephritisSUP4

    KDIGO recommended approach for initial therapy of active Class III/IV lupus nephritis
    Recommended approach for initial therapy of active Class III/IV lupus nephritis

    These are only select guideline recommendations, not the complete KDIGO guidelines.
    Caution is warranted when CNIs are used in patients with significantly impaired kidney function, in view of increased susceptibility for severe consequences due to CNI nephrotoxicity. The eGFR and SCr levels stated in the figure were patient selection criteria adopted in the respective clinical trials.
    b.i.d. = twice daily; p.o. = oral; q2wk = every 2 weeks; q4wk = every 4 weeks; SCr = serum creatinine.

See the full 2024 KDIGO guidelines

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Choose BENLYSTA after HCQ* in lupus and as a part of initial therapy in lupus nephritis.

* As part of standard therapy.

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BENLYSTA for Lupus

BENLYSTA improved key clinical outcomes for appropriate patients.

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BENLYSTA for lupus nephritis

BENLYSTA improved key clinical outcomes for appropriate patients.

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