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Date of Award

Spring 2020

Degree Name

Master of Medical Science (Physician Assistant)

Department

Physician Assistant; College of Health Sciences

First Advisor

Shannon N. Diallo MMS, PA-C

Second Advisor

Amanda L. Seymour MS, PA-C

Abstract

Introduction: Systemic Lupus Erythematosus (SLE) is a complex disease process that involves the insidious activation of inflammatory and immune processes within the body. Autoimmune activity is initiated as immune complexes are then formed and can deposit into diverse organ tissues causing impaired functionality and damage. These processes can clinically manifest in a variety of ways and generally involve multiple organ systems. One such commonly affected tissue is that of the kidneys. Lupus Nephritis (LN) is a common repercussion of those that suffer with SLE and is generally managed, as SLE is, with immunosuppressive drugs coupled with corticosteroids. This work analyzes the use of ACTHar Gel as a replacement for standard of care (SOC) corticosteroid use in those patients that are immunosuppressive/corticosteroid resistant.

Methods: An extensive literature search was completed in November 2018 utilizing the PubMed, Google Scholar, and Ovid databases. This work includes those articles that are of most relevance to the proposed treatment regimen. Their relevance was based on several criteria including publication date, mention of SLE, use of ACTHar Gel or Repository Corticotropin Injection (RCI), that the work must not be a meta analysis or systematic review, that it cannot include an animal trial, and must be available in English.

Results: Several of the articles in this work reported a statistically significant improvement in the patients’ condition with the use of the ACTHar gel and subsequently support for the medication. Many of these values were generated with the use of standardized scoring systems such as the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K). These statistical analyses, certainly based in standardized outcome measurements, were very limited in nature and should be approached with caution. There were weaknesses in each study design and the information that has been gathered on the use of the medication to treat LN is very limited. Many of the studies were retrospective case studies (RCS). There have been very few studies that implement this treatment to a larger sample size, more effective, blinded trial.

Discussion: Further research is needed to truly understand the efficacy of this treatment regimen. Many of the articles suggest that ACTHar Gel has some place in clinical practice and could be used as an appropriate second line treatment for those that are immunosuppressive/corticosteroid resistant. Improvement in patients’ conditions was found statistically significant in most studies but ultimately further research is needed. The creation of clinical trials that involve a blind or double blind character, increased sample sizes, trials of a longer duration with supervised treatment, as well as careful oversight, to ensure lack of bias, would be necessary to further investigate this topic.

Conclusion: The need for more effective and less detrimental treatment courses for those patients suffering with SLE, and further, LN, is paramount. This work explored the prospect that ACTHar Gel could play a role in decreasing nephropathy and proteinuria while increasing GFR and renal function in those within this patient population. Ultimately it was found that ACTHar Gel could have a place in clinical practice, but that further research is needed to understand its effects and efficiency. This work fails to suggest this treatment regimen as a replacement for the current SOC.

Additional Files

SLE ACTHar Gel Poster Presentation.pptx (1018 kB)

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Could the administration of ACTHar Gel cause a decrease in nephropathy and proteinuria and an increase in GFR when taken by immunosuppressive/corticosteroid treatment resistant patients with Lupus Nephritis?

Introduction: Systemic Lupus Erythematosus (SLE) is a complex disease process that involves the insidious activation of inflammatory and immune processes within the body. Autoimmune activity is initiated as immune complexes are then formed and can deposit into diverse organ tissues causing impaired functionality and damage. These processes can clinically manifest in a variety of ways and generally involve multiple organ systems. One such commonly affected tissue is that of the kidneys. Lupus Nephritis (LN) is a common repercussion of those that suffer with SLE and is generally managed, as SLE is, with immunosuppressive drugs coupled with corticosteroids. This work analyzes the use of ACTHar Gel as a replacement for standard of care (SOC) corticosteroid use in those patients that are immunosuppressive/corticosteroid resistant.

Methods: An extensive literature search was completed in November 2018 utilizing the PubMed, Google Scholar, and Ovid databases. This work includes those articles that are of most relevance to the proposed treatment regimen. Their relevance was based on several criteria including publication date, mention of SLE, use of ACTHar Gel or Repository Corticotropin Injection (RCI), that the work must not be a meta analysis or systematic review, that it cannot include an animal trial, and must be available in English.

Results: Several of the articles in this work reported a statistically significant improvement in the patients’ condition with the use of the ACTHar gel and subsequently support for the medication. Many of these values were generated with the use of standardized scoring systems such as the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K). These statistical analyses, certainly based in standardized outcome measurements, were very limited in nature and should be approached with caution. There were weaknesses in each study design and the information that has been gathered on the use of the medication to treat LN is very limited. Many of the studies were retrospective case studies (RCS). There have been very few studies that implement this treatment to a larger sample size, more effective, blinded trial.

Discussion: Further research is needed to truly understand the efficacy of this treatment regimen. Many of the articles suggest that ACTHar Gel has some place in clinical practice and could be used as an appropriate second line treatment for those that are immunosuppressive/corticosteroid resistant. Improvement in patients’ conditions was found statistically significant in most studies but ultimately further research is needed. The creation of clinical trials that involve a blind or double blind character, increased sample sizes, trials of a longer duration with supervised treatment, as well as careful oversight, to ensure lack of bias, would be necessary to further investigate this topic.

Conclusion: The need for more effective and less detrimental treatment courses for those patients suffering with SLE, and further, LN, is paramount. This work explored the prospect that ACTHar Gel could play a role in decreasing nephropathy and proteinuria while increasing GFR and renal function in those within this patient population. Ultimately it was found that ACTHar Gel could have a place in clinical practice, but that further research is needed to understand its effects and efficiency. This work fails to suggest this treatment regimen as a replacement for the current SOC.