- Jodi was diagnosed with lupus nephritis 3 months ago and put on a regimen of MMF + high-dose steroids
- At 3-month follow-up, her UPCR had modestly declined
Not achieving EULAR/ERA–EDTA guideline recommendation for reduction in UPCR of at least 25% by 3 months1
- Her physician is considering adding treatment to help achieve a better renal response and decrease proteinuria levels
Lupus nephritis diagnosed 3 months ago
Biopsy findings at baseline
- ISN Class III + V
- Focal proliferative lupus nephritis affecting 40% of glomeruli
- Subendothelial, subepithelial, and mesangial immune deposition
- Basement membrane thickening
SLE history
- Diagnosed with SLE 1.5 years prior
Current medications
- MMF (2.5 g/day)
- Prednisone (20 mg/day)
- Hydroxychloroquine (200 mg BID)
- ACE inhibitor
- Hormonal IUD
| Baseline | 6 weeks | 3 months | |
|---|---|---|---|
| UPCR (mg/mg) | 2.2 | 1.9 | 2.1 |
| Urine microscopy | 5-10 RBC/HPF w/ dysmorphia and cellular casts | 5-10 RBC/HPF | 5-10 RBC/HPF |
| eGFR (mL/min/1.73 m2) | 85 | 87 | 85 |
| Serum creatinine (mg/dL) | 1.0 | 0.9 | 1.0 |
| C3 (mg/dL) | 60 | 78 | 80 |
| C4 (mg/dL) | 8 | 11 | 12 |
| Anti-dsDNA (IU/mL) | 130 | 84 | 80 |
| BP (mmHg) | 125/80 | 122/76 | 124/79 |
| Weight (lbs) | 155 | 162 | 166 |
Can more be done to help her achieve treatment goals?
Lupkynis Efficacy Download Profile- Julia was diagnosed with lupus nephritis 2 years ago and achieved a partial renal response after 12 months of treatment with MMF + steroids
- At her most recent follow-up, lab results showed significantly elevated UPCR relative to her previous visit
- Her physician wants to help ensure that the current flare of lupus nephritis is controlled as quickly as possible
Diagnosed with lupus nephritis 2 years ago
- UPCR 2.3 mg/mg at diagnosis
- Treated with MMF (2.5 g/day) and steroids for 12 months, achieved a partial response (50% reduction in UPCR)
Current biopsy findings
- ISN Class IV
- Diffuse proliferative lupus nephritis affecting 70% of glomeruli
- Subendothelial and mesangial immune deposition
SLE history
- Diagnosed with SLE 3.5 years prior
Current medications
- Hydroxychloroquine (200 mg BID)
- Prednisone (5 mg/day)
- MMF (1.5 g/day)
- Oral birth control
- Angiotensin II receptor blocker
| At lupus nephritis diagnosis (2 years prior) |
6 months prior | Present day | |
|---|---|---|---|
| UPCR (mg/mg) | 2.3 | 1.0 | 3.6 |
| Serum albumin (g/dL) | 3.0 | 3.6 | 2.8 |
| Urine microscopy | 5 RBC/HPF | No active sediment | 8 RBC/HPF |
| eGFR (mL/min/1.73 m2) | 88 | 90 | 80 |
| Serum creatinine (mg/dL) | 0.9 | 0.9 | 0.9 |
| C3 (mg/dL) | 60 | 90 | 55 |
| C4 (mg/dL) | 10 | 20 | 6 |
| Anti-dsDNA (IU/mL) | 100 | 70 | 125 |
| BP (mmHg) | 118/78 | 120/80 | 119/79 |
| Weight (lbs) | 148 | 150 | 155 |
How important is it to get her flaring signs and symptoms under control?
Lupkynis Efficacy Download Profile- Jenna was diagnosed with SLE 6 months ago
- Recent urinalysis was suggestive of lupus nephritis
Kidney biopsy confirmed diagnosis
- Her lab values and other clinical risk factors put her at high risk for poor long-term outcomes
Recent lupus nephritis diagnosis
Biopsy findings at baseline
- ISN Class IV + V
- Diffuse proliferative lupus nephritis affecting 60% of glomeruli
- Diffuse thickening of glomerular capillary wall
- Subendothelial, subepithelial, and mesangial immune deposition
SLE history
- Diagnosed 6 months prior after presenting with arthritis, malar rash, and positive serologies, along with hypertension and hyperlipidemia
Current medications
- Hydroxychloroquine (200 mg BID)
- Prednisone (5 mg/day)
- Statin
- Angiotensin II receptor blocker
| 6 months prior | Present day | |
|---|---|---|
| UPCR (mg/mg) | 0.1 | 4.1 |
| Serum albumin (g/dL) | 3.4 | 2.5 |
| Urine microscopy | No active sediment | 6 RBC/HPF w/ dysmorphia and cellular casts |
| eGFR (mL/min/1.73 m2) | 90 | 80 |
| Serum creatinine (mg/dL) | 0.9 | 1.0 |
| C3 (mg/dL) | 100 | 60 |
| C4 (mg/dL) | 20 | 8 |
| Anti-dsDNA (IU/mL) | 90 | 120 |
| BP (mmHg) | 130/80 | 120/76 |
| Weight (lbs) | 165 | 172 |
Do her risk factors require a strong start with treatment?
Lupkynis Efficacy Download Profile- Natalie was diagnosed with lupus nephritis 1 year ago and treated with MMF + steroids
- Follow-up appointments showed improvement; however, she was not reaching EULAR/ERA–EDTA-recommended treatment goals1
UPCR remains above recommendation of ≤0.5-0.7 mg/mgSteroid use remains above recommendation of ≤7.5 mg/day
- Her physician is concerned that she may be at risk for poor outcomes and is considering adding treatment
Lupus nephritis diagnosed 1 year ago
Biopsy findings at baseline
- ISN Class III
- Focal proliferative lupus nephritis affecting 40% of glomeruli
- Subendothelial and mesangial immune deposition
SLE history
- Diagnosed with SLE 2 years prior
Current medications
- MMF (3 g/day)
- Prednisone (10 mg/day)
- Hydroxychloroquine (200 mg BID)
- Hormonal IUD
- ACE inhibitor
| Baseline (12 months prior) | 6 months prior | Present day | |
|---|---|---|---|
| UPCR (mg/mg) | 1.8 | 1.2 | 1.2 |
| Serum albumin (g/dL) | 3.0 | 3.2 | 3.2 |
| Urine microscopy | 5 RBC/HPF | 2 RBC/HPF | No active sediment |
| eGFR (mL/min/1.73 m2) | 90 | 90 | 90 |
| Serum creatinine (mg/dL) | 0.8 | 0.8 | 0.8 |
| C3 (mg/dL) | 70 | 80 | 78 |
| C4 (mg/dL) | 10 | 12 | 9 |
| Anti-dsDNA (IU/mL) | 115 | 70 | 75 |
| BP (mmHg) | 120/80 | 119/79 | 118/78 |
| Weight (lbs) | 150 | 155 | 168 |
What more can be done for patients who aren't reaching treatment goals?
Lupkynis Efficacy Download Profile- April recently presented to her primary care physician with peripheral edema and hypertension; she was referred to a nephrologist after she was found to have nephrotic-range proteinuria
- Following a kidney biopsy, April was diagnosed with class V lupus nephritis and SLE
- Knowing that class V patients may be more difficult to treat, her physician wants to ensure she gets a strong treatment regimen from the start
Recent diagnosis of lupus nephritis
Biopsy findings at baseline
- ISN Class V
- Diffuse thickening of glomerular capillary wall
- Global subepithelial immune deposition
SLE history
- Diagnosed concurrently with lupus nephritis
Current medications
- ACE inhibitor
- Hormonal IUD
| Present day | |
|---|---|
| UPCR (mg/mg) | 4.2 |
| Serum albumin (g/dL) | 2.2 |
| Urine microscopy | No active sediment |
| eGFR (mL/min/1.73 m2) | 95 |
| Serum creatinine (mg/dL) | 0.8 |
| C3 (mg/dL) | 85 |
| C4 (mg/dL) | 15 |
| Anti-dsDNA (IU/mL) | 28 |
| BP (mmHg) | 135/82 |
| Weight (lbs) | 145 |
What more can be done to help difficult-to-treat patients?
Lupkynis Efficacy Download ProfileThese are hypothetical case studies. This resource is intended to help you determine the types of patients who may be appropriate for treatment with LUPKYNIS. These representations were not designed to assess efficacy for individual patient subgroups.
ACE=angiotensin-converting enzyme; BID=twice daily; BP=blood pressure; eGFR=estimated glomerular filtration rate; ERA–EDTA=European Renal Association–European Dialysis and Transplant Association; EULAR=European League Against Rheumatism; HPF=high-power field; IUD=intrauterine device; MMF=mycophenolate mofetil; RBC=red blood cell; SLE=systemic lupus erythematosus; UPCR=urine protein-to-creatinine ratio.
References: 1. Fanouriakis A, Kostopoulou M, Cheema K, et al. 2019 update of the joint European League Against Rheumatism and European Renal Association–European Dialysis and Transplant Association (EULAR/ERA–EDTA) recommendations for the management of lupus nephritis. Ann Rheum Dis. 2020;79(6):713-723. doi:10.1136/annrheumdis-2020-216924
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IMPORTANT SAFETY INFORMATION
BOXED WARNING: MALIGNANCIES AND SERIOUS INFECTIONS
LUPKYNIS increases the risk of serious infections and malignancies that may result in hospitalization or death. See full Prescribing Information for complete BOXED WARNING.
CONTRAINDICATIONS
- DO NOT use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin).
- DO NOT use LUPKYNIS if a patient has a history of serious hypersensitivity reactions, including anaphylaxis, to LUPKYNIS or any of its components.
WARNINGS AND PRECAUTIONS
- Nephrotoxicity may occur. Monitor eGFR and adjust dose as needed.
- Hypertension is common. Monitor blood pressure. May require antihypertensive therapy; watch for possibility of drug interactions with some antihypertensives.
- Neurotoxicity: Monitor for neurologic symptoms including risk of posterior reversible encephalopathy syndrome (PRES).
- Hyperkalemia: Monitor potassium, especially with concomitant agents associated with hyperkalemia.
- QT Prolongation: Monitor ECG and electrolytes in high-risk patients.
- Hypersensitivity Reactions (Including Anaphylaxis and Angioedema): Monitor and discontinue if reaction occurs.
- Pure Red Cell Aplasia: Monitor and consider discontinuation if diagnosed.
- Immunizations: Avoid live vaccines.
- Lymphomas and Other Cancers: Immunosuppressants increase the risk of lymphomas and other cancers, especially of the skin. Monitor for skin changes and advise sun protection and avoidance of artificial UV light.
ADVERSE REACTIONS
The most common adverse reactions (≥3% and ≥2% against placebo) include decreased GFR, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite. Nausea and vomiting have been reported during post-approval use.
SPECIFIC POPULATIONS
Pregnancy: Inform female patients of the potential risk to a fetus and to avoid use of LUPKYNIS during pregnancy.
Indication
LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN).
Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.
Please see full Prescribing Information, including BOXED WARNING, and Medication Guide for additional Important Safety Information about LUPKYNIS.
BOXED WARNING: MALIGNANCIES AND SERIOUS INFECTIONS
LUPKYNIS increases the risk of serious infections and malignancies that may result in hospitalization or death. See full Prescribing Information for complete BOXED WARNING.
CONTRAINDICATIONS:
- DO NOT use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin).
- DO NOT use LUPKYNIS if a patient has a history of serious hypersensitivity reactions, including anaphylaxis, to LUPKYNIS or any of its components.
WARNINGS AND PRECAUTIONS
- Nephrotoxicity may occur. Monitor eGFR and adjust dose as needed.
- Hypertension is common. Monitor blood pressure. May require antihypertensive therapy; watch for possibility of drug interactions with some antihypertensives.
- Neurotoxicity: Monitor for neurologic symptoms including risk of posterior reversible encephalopathy syndrome (PRES).
- Hyperkalemia: Monitor potassium, especially with concomitant agents associated with hyperkalemia.
- QT Prolongation: Monitor ECG and electrolytes in high-risk patients.
- Hypersensitivity Reactions (Including Anaphylaxis and Angioedema): Monitor and discontinue if reaction occurs.
- Pure Red Cell Aplasia: Monitor and consider discontinuation if diagnosed.
- Immunizations: Avoid live vaccines.
- Lymphomas and Other Cancers: Immunosuppressants increase the risk of lymphomas and other cancers, especially of the skin. Monitor for skin changes and advise sun protection and avoidance of artificial UV light.
ADVERSE REACTIONS
The most common adverse reactions (≥3% and ≥2% against placebo) include decreased GFR, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite. Nausea and vomiting have been reported during post-approval use.
SPECIFIC POPULATIONS
Pregnancy: Inform female patients of the potential risk to a fetus and to avoid use of LUPKYNIS during pregnancy.
Indication
LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN).
Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.
Please see full Prescribing Information, including BOXED WARNING, and Medication Guide for additional Important Safety Information about LUPKYNIS.