H.P. Acthar Gel Evaluated in Nephrotic Syndrome Study

Questcor Pharmaceuticals announced results from an investigator-initiated clinical study evaluating the dosing and effectiveness of H.P. Acthar Gel (repository corticotrophin injection) in 20 patients with nephrotic syndrome due to idiopathic membranous nephropathy (iMN).

The study involved patients with biopsy proven iMN, randomized 1:1 to receive Acthar 40 or 80 units administered twice weekly following an initial induction period. Changes in proteinuria, albumin, cholesterol profile, estimated glomerular filtration rate and serum anti-PLA2R antibodies were assessed at baseline and in response to treatment along with tolerance and safety.

Results demonstrated that the use of Acthar could be a potentially useful therapy for inducing remission of proteinuria in patients suffering from nephrotic syndrome secondary to iMN. The study also found that clearance of anti-PLA2R antibodies, which is an immunological marker of iMN disease activity, typically preceded or paralleled improvements in proteinuria as a result of Acthar treatment in patients with detectable antibody levels.

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During the follow-up period at 12 months, there was a significant improvement in proteinuria in the entire cohort, decreasing to 3.87±4.24 g/day (P<0.001) with significant improvements in serum albumin (P=0.001), total cholesterol (P<0.001) and LDL (P=0.001). A >50% decrease in proteinuria was noted in 65% (13/20) of the patients with a trend towards better outcomes among patients who received greater cumulative doses.

H.P. Acthar Gel, is an injectable drug already approved by the FDA for the treatment of 19 indications:

• Induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus
• During an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus or systemic dermatomyositis (polymyositis)
• Symptomatic sarcoidosis
• Severe erythema multiforme or Stevens-Johnson syndrome
• Severe acute/chronic allergic and inflammatory processes involving the eye and its adnexa such as keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, and anterior segment inflammation
• Treatment of acute exacerbations of multiple sclerosis (MS) in adults
• Treatment of infantile spasms in infants and children <2yrs of age
• Short-term (acute episode or exacerbation) adjunctive therapy in psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis

For more information call (510) 400-0700 or visit Questcor.com.