Positive Outcomes With H.P. Acthar® Gel In Proteinuria In Nephrotic Syndrome Reported At National Kidney Foundation Spring Congress
The first presentation on a retrospective case series included outcomes of nine patients from different medical practices diagnosed with IgA nephropathy, membranous lupus nephritis or minimal change disease. After treatment with Acthar for at least six months, nearly 80 percent (7/9) of the patients showed proteinuria reduction of 30 percent or more from baseline, ranging from 36.4 percent to 99.4 percent. Two patients had a complete response, four had a partial response, and one had a clinically meaningful response, as measured by criteria from the
"There is a tremendous need for additional therapeutic options for treatment-resistant nephrotic syndrome," said Anupa Khastgir, M.D., a nephrologist in private practice in
The nine patients were the latest additions to a larger retrospective case series of 44 Acthar-treated patients submitted by physicians around the country.2 Dr. Khastgir's findings of similar outcomes in the series from 13 other patients with NS due to various underlying disorders were recently presented at the
Separately at the NKF meeting, a case review of a patient with the extremely rare kidney disorder fibrillary glomerulonephritis (FGN) with advanced kidney failure was presented. After eight weeks of treatment with Acthar, the patient achieved partial remission as measured by the study criteria. According to the author's conclusions:
- The patient achieved partial remission of proteinuria,
- The treatment was well-tolerated with only mild cushingoid side effects, and
- This case study suggests Acthar Gel may help meet an important treatment need in FGN, a subtype of NS.
"There are no randomized, controlled trials to inform treatment decisions for patients with idiopathic FGN, and retrospective studies have not shown significant benefit from a variety of immunosuppressive therapies," said
About Nephrotic Syndrome
Nephrotic syndrome (NS) is a collection of symptoms that occur when the blood vessels in the kidney begin to leak. This results in proteinuria, a condition which allows protein to leave the body through the urine in large amounts. A variety of diseases and underlying disorders damage the kidneys and cause proteinuria in people with NS. These can include: membranous nephropathy, focal segmental glomerulosclerosis, minimal change disease, membranoproliferative glomerulonephritis, lupus nephritis, and IgA nephropathy. In these and other related diseases, the glomeruli, or small blood vessels that work as the kidney's filtering system, are damaged.
Proteinuria is one of the most important adverse prognostic factors for progression to end stage renal failure in patients with chronic renal disease. One of the main goals of treating nephrotic syndrome is to reduce or eliminate proteinuria.3
About H.P. Acthar® Gel (repository corticotropin injection)
H.P. Acthar Gel (repository corticotropin injection), is an injectable drug approved by the
IMPORTANT RISK INFORMATION
Indication: H.P. Acthar Gel is repository corticotropin injection currently approved by the
Important Safety Information
- Acthar should never be administered intravenously.
- Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of Acthar.
- Acthar is contraindicated where congenital infections are suspected in infants.
- Acthar is contraindicated in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction, or sensitivity to proteins of porcine origins.
Warning and Precautions
- The adverse effects of Acthar are related primarily to its steroidogenic effects.
- Acthar may increase susceptibility to new infection or reactivation of latent infections.
- Suppression of the hypothalamic-pituitary-axis (HPA) may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland patients should be protected from the stress (e.g., trauma or surgery) by the use of corticosteroids. Monitor patients for effects of HPA suppression after stopping treatment.
Cushing'ssyndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms.
- Acthar can cause elevation of blood pressure, salt and water retention, and hypokalemia. Blood pressure, sodium and potassium levels may need to be monitored.
- Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapy.
- Acthar can cause GI bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain gastrointestinal disorders. Monitor for signs of bleeding.
- Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, severe depression, and psychosis. Existing conditions may be aggravated.
- Patients with comorbid disease may have that disease worsened. Caution should be used when prescribing Acthar in patients with diabetes and myasthenia gravis.
- Prolonged use of Acthar may produce cataracts, glaucoma and secondary ocular infections. Monitor for signs and symptoms.
- Acthar is immunogenic and prolonged administration of Acthar may increase the risk of hypersensitivity reactions. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH activity.
- There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver.
- Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients.
- Decrease in bone density may occur. Bone density should be monitored for patients on long-term therapy.
- Pregnancy Class C: Acthar has been shown to have an embryocidal effect and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Common adverse reactions for Acthar are similar to those of corticosteroids and include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite, and weight gain.
- Specific adverse reactions reported in IS clinical trials in infants and children under 2 years of age included: infection, hypertension, irritability, Cushingoid symptoms, constipation, diarrhea, vomiting, pyrexia, weight gain, increased appetite, decreased appetite, nasal congestion, acne, rash, and cardiac hypertrophy. Convulsions were also reported, but these may actually be occurring because some IS patients progress to other forms of seizures and IS sometimes mask other seizures, which become visible once the clinical spasms from IS resolve.
Other adverse events reported are included in the full Prescribing Information.
Please see full Prescribing Information for additional important safety information.
For patients, parents and caregivers, please also see Medication Guide.
Senior Vice President, Communications
1 Funding for development, editorial, design and production for all referenced studies was provided by
2 Treatment of Nephrotic Syndrome with Acthar® Gel: A Retrospective Case Series; Madan, Milward,Teehan, Mijovic-Das, Khastgir. Presented at the
3 National Institutes of Health,
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