Resources

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Appeals Kit

If a patient's insurance provider denies coverage for Acthar Gel, the Appeals Kit simplifies the process for you to create and submit a customized Letter of Medical Necessity (LMN) when appealing a denial.

Each Appeals Kit contains:

  • An LMN template that guides the response based on the reason for denial
  • Clinical studies that support Acthar Gel's use
  • Step-by-step instructions to complete the LMN template

Appeals Kits are delivered directly to you from the Acthar Support team or your local ARM.

To request an Appeals Kit

Call 1-888-435-22841-888-435-2284 • Monday through Friday, 8 AM to 9 PM ET,
Saturday, 9 AM to 2 PM ET

videos

How to Use SelfJect (English version)

See how to inject with the Acthar Gel single-dose pre-filled SelfJect™ injector (for administration by people 18 years of age or older).

How to Use SelfJect (Spanish version)

See how to inject with the Acthar Gel single-dose pre-filled SelfJect™ injector (for administration by people 18 years of age or older).

Step-by-Step Injection Training Video (English version)

See how to inject Acthar Gel (for indications except infantile spasms).

SELECT CHAPTER

  •  
    1. Welcome to Acthar Gel
  •  
    2. Injecting Acthar Gel: Introduction
  •  
    3. Getting started with Acthar Gel
  •  
    4. Preparing to inject
  •  
    5. Where to inject subcutaneously
  •  
    6. Subcutaneous injection instructions
  •  
    7. Post-injection instructions
  •  
    8. About Acthar Patient Support
  •  
    9. Indications and Important Safety Information
  •  
    10. Where to inject intramuscularly
  •  
    11. Intramuscular injection instructions

Step-by-Step Injection Training Video (Spanish version)

See how to inject Acthar Gel (for indications except infantile spasms).

SELECT CHAPTER

  •  
    1. Bienvenido a Acthar
  •  
    2. Introducción a la inyección de Acthar
  •  
    3. Empezando con Acthar
  •  
    4. Preparándose para inyectar
  •  
    5. Donde inyectarse por manera subcutánea
  •  
    6. Instrucciones de inyección subcutánea
  •  
    7. Instrucciones posteriores de la inyección
  •  
    8. Sobre el soporte a los pacientes de Acthar
  •  
    9. Las Indicaciones y la Información Importante de la Seguridad
  •  
    10. Donde inyectar por manera intramuscular
  •  
    11. Instrucciones para inyectarse de manera intramuscular
Robert Baughman MD, discusses the updated European Respiratory Society (ERS) guidelines

Hear from Dr. Baughman on updated European Respiratory Society (ERS) guidelines

Findings from the US sarcoidosis expert panel consensus study, as well as the ERS guidelines that reference the use of Acthar Gel.

 

PATIENT CASE STUDIES LIBRARY

Real-world experience with Acthar Gel

Read about real patient case studies provided by leading doctors in the field. Download a copy of the case studies below to keep for your reference.

RHEUMATOLOGY

Rheumatoid arthritis clinical case studyDr. Ara Dikranian
Polymyositis clinical case studyDr. Dhiman Basu
Dermatomyositis clinical case studyDr. Sanjay Chabra
Systemic lupus erythematosus clinical case studyDr. Kostas Botsoglou

PULMONOLOGY

Sarcoidosis clinical case study Dr. Robert Baughman
Sarcoidosis clinical case study Dr. Kostas Botsoglou

OPHTHALMOLOGY

Keratitis clinical case study Dr. John C. Affeldt
Keratitis clinical case study Dr. Melissa Toyos
Uveitis clinical case study Dr. Quan Dong Nguyen
OCP clinical case study Dr. David Chu
Retinal vasculitis clinical case study Dr. Stephen D. Anesi

NEPHROLOGY

FSGS clinical case study Dr. Arvind Madan
Multi-condition clinical case study Dr. Arvind Madan
IgAN clinical case study Dr. Raja Zabaneh

NEUROLOGY

MS relapse clinical case study Dr. Jeffrey M. Kaplan
MS relapse clinical case study Dr. Regina Radner Berkovich
icn-outline-nurse

Want to share additional information with your patients?

See downloads & videos for patients

References:

  • Baughman RP, Barney JB, O’Hare L, Lower EE. A retrospective pilot study examining the use of Acthar Gel in sarcoidosis patients. Respir Med. 2016;110:66-72.
  • Baughman RP, Sweiss N, Keijsers R, et al. Repository corticotropin for chronic pulmonary sarcoidosis. Lung. 2017;195(3):313-322.
  • Madan A, Mijovic-Das S, Stankovic A, Teehan G, Milward AS, Khastgir A. Acthar Gel in the treatment of nephrotic syndrome: a multicenter retrospective case series. BMC Nephrol. 2016;17:37.
  • Aggarwal R, Marder G, Koontz DC, Nandkumar P, Qi Z, Oddis CV. Efficacy and safety of adrenocorticotropic hormone gel in refractory dermatomyositis and polymyositis. Ann Rheum Dis. 2018;77(5):720-727.
  • Fiechtner JJ, Montroy T. Treatment of moderately to severely active systemic lupus erythematosus with adrenocorticotropic hormone: a single-site, open-label trial. Lupus. 2014;23(9):905-912.
  • Alhamad T, Dieck JM, Younus U, et al. ACTH Gel in resistant focal segmental glomerulosclerosis after kidney transplantation. Transplantation. 2019;103(1):202-209.
  • Nelson WW, Lima AF, Kranyak J, et al. Retrospective medical record review to describe use of repository corticotropin injection among patients with uveitis in the United States. J Ocul Pharmacol Ther. 2019;35(3):182-188.
  • Chopra I, Qin Y, Kranyak J, et al. Repository corticotropin injection in patients with advanced symptomatic sarcoidosis: retrospective analysis of medical records. Ther Adv Respir Dis. 2019;13:1-11
  • Zand L, Canetta P, Lafayette R, et al. An open-label pilot study of adrenocorticotrophic hormone in the treatment of lgA nephropathy at high risk of progression. Kidney Int Rep. 2020;5(1):58-65.
  • Fleischmann R, Furst DE, Connolly-Strong E, Liu J, Zhu J, Brasington R. Repository corticotropin injection for active rheumatoid arthritis despite aggressive treatment: a randomized controlled withdrawal trial. Rheumatol Ther. 2020;7(2):327-344.
  • Ho-Mahler N, Turner B, Eaddy M, Hanke ML, Nelson WW. Treatment with repository corticotropin injection in patients with rheumatoid arthritis, systemic lupus erythematosus, and dermatomyositis/polymyositis. Open Access Rheumatol. 2020;12:21-28.
  • Acthar Gel (repository corticotropin injection) [prescribing information]. Bridgewater, NJ: Mallinckrodt ARD LLC.
  • Data on File – Ref-06550. Mallinckrodt Pharmaceuticals.
  • Data on File – Ref-05336. Mallinckrodt Pharmaceuticals.
  • Data on File – Ref-07068. Mallinckrodt Pharmaceuticals.
  • Wirta D, Mclaurin E, Ousler G, Liu J, Kacmaz RO, Grieco J. Repository corticotropin injection (Acthar® Gel) for refractory severe noninfectious keratitis: efficacy and safety from a phase 4, multicenter, open-label study. Ophthamol Ther. 2021;10(4):1077-1092.
  • Tumlin J, Galphin C, Santos R, Rovin B. Kidney Int Rep. 2017;2(5):924-932.
  • Grafals M, Sharfuddin A. Adrenocorticotropic hormone in the treatment of focal segmental glomerulosclerosis following kidney transplantation. Transplant Proc. 2019;51(6):1831-1837.
  • Hladunewich MA, Cattran D, Beck LH, et al. A pilot study to determine the dose and effectiveness of adrenocorticotrophic hormone (H.P. Acthar® Gel) in nephrotic syndrome due to idiopathic membranous nephropathy. Nephrol Dial Transplant. 2014;29(8):1570-1577.
  • Filippone EJ, Dopson SJ, Rivers DM, et al. Adrenocorticotropic hormone analog use for podocytopathies. Int Med Case Rep J. 2016;9:125-133.
  • Bomback AS, Tumlin JA, Baranski J, et al. Treatment of nephrotic syndrome with adrenocorticotropic hormone (ACTH) gel. Drug Des Devel Ther. 2011;5:147-153.
  • Bomback AS, Canetta PA, Beck LH Jr, Ayalon R, Radhakrishnan J, Appel GB. Treatment of resistant glomerular diseases with adrenocorticotropic hormone gel: a prospective trial. Am J Nephrol. 2012;36(1):58-67.
  • Kaplan J, Miller T, Baker M, Due B, Zhao E. A prospective observational registry of repository corticotropin injection (Acthar® Gel) for the treatment of multiple sclerosis relapse. Front Neurol. 2020;11:598496.
  • Bryan MS, Sergott RC. Changes in visual acuity and retinal structures following repository corticotropin injection (RCI) therapy in patients with acute demyelinating optic neuritis: improvement in low contrast visual acuity in both affected and contralateral eyes in a single-armed open-label study. J Neurol Sci. 2019;407:116505.
  • Mallinckrodt Pharmaceuticals. Acthar® Gel (repository corticotropin injection) Reference Bibliography. https://www.mallinckrodt.com/globalassets/documents/corporate/bibliography/acthar-gel-repository-corticotropin-injection-reference-bibliography.pdf. Accessed December 7, 2023.
  • Wynn D, Goldstick L, Bauer W, et al. Results from a multi-center, randomized, double-blind, placebo-controlled study of repository corticotropin injection for multiple sclerosis relapse that did not adequately respond to corticosteroids. CNS Neurosci Ther. 2022;28:364-371.
  • Saygin D, Oddis CV, Marder G, et al. Follow-up results of myositis patients treated with Acthar gel. Rheumatology (Oxford). 2020;59(10):2976-2981.
  • Fernandez AP, Gallop J, Polly S, Khanna U. Efficacy and safety of repository corticotropin injection for refractory cutaneous dermatomyositis: a prospective, open-label study. Rheumatology (Oxford). 2023 Nov 6. doi: 10.1093/rheumatology/kead595. Epub ahead of print.
  • Anesi SD, Chang PY, Maleki A, et al. Treatment of noninfectious retinal vasculitis using subcutaneous repository corticotropin injection. J Ophthalmic Vis Res. 2021;16(2):219-233.
  • Anesi SD, Chang PY, Maleki A, et al. Effects of subcutaneous repository corticotropin gel injection on regulatory T cell population in noninfectious retinal vasculitis. Ocul Immunol lnflamm. 2023;31(3):556-565.

References:

  • Acthar Gel (repository corticotropin injection) [prescribing information]. Bridgewater, NJ: Mallinckrodt ARD LLC.
  • Huang JY, Galen K, Zweifel B, Brooks LR, Wright AD. Distinct binding and signaling activity of Acthar Gel compared to other melanocortin receptor agonists. J Recept Signal Transduct Res. 2020;1-9. doi:10.1080/10799893.2020.1818094.
  • Healy LM, Jang JH, Lin YH, Rao V, Antel JP, Wright D. Melanocortin receptor mediated anti-inflammatory effect of repository corticotropin injection on human monocyte-derived macrophages [ECTRIMS-ACTRIMS abstract EP1481]. Mult Scler J. 2017;23(suppl 3):777.
  • Wright D, Hayes K. Acthar Gel inhibits the activation of CD4+ and CD8+ T cells. J Interferon Cytokine Res. 2023;43(4):182-187. doi: 10.1089/jir.2022.0257.
  • Olsen NJ, Decker DA, Higgins P, et al. Direct effects of HP Acthar Gel on human B lymphocyte activation in vitro. Arthritis Res Ther. 2015;17:300. doi:10.1186/s13075-015-0823-y.
  • U.S. National Library of Medicine. DailyMed website. https://dailymed.nlm.nih.gov/dailymed/. Accessed March 3, 2022.

References:

  • Acthar Gel (repository corticotropin injection) [prescribing information]. Bridgewater, NJ: Mallinckrodt ARD LLC.
  • Catania A, Lonati C, Sordi A, Carlin A, Leonardi P, Gatti S. The melanocortin system in control of inflammation. ScientificWorldJournal. 2010;10:1840-1853. doi:10.1100/tsw.2010.173.
  • Huang YJ, Galen K, Zweifel B, Brooks LR, Wright AD. Distinct binding and signaling activity of Acthar Gel compared to other melanocortin receptor agonists. J Recept Signal Transduct Res. 2021;41(5):425-433.
  • Olsen NJ, Decker DA, Higgins P, et al. Direct effects of HP Acthar Gel on human B lymphocyte activation in vitro. Arthritis Res Ther. 2015;17:300. doi:10.1186/s13075-015-0823-y.
  • Healy LM, Jang JH, Lin YH, Rao V, Antel JP, Wright D. Melanocortin receptor mediated anti-inflammatory effect of repository corticotropin injection on human monocyte-derived macrophages [ECTRIMS-ACTRIMS abstract EP1481]. Mult Scler J. 2017;23(suppl 3):777.
  • Wright D, Hayes K. Acthar Gel inhibits the activation of CD4+ and CD8+ T cells. J Interferon Cytokine Res. 2023;43(4):182-187. doi: 10.1089/jir.2022.0257.
  • Benko AL, McAloose CA, Becker PM, et al. Repository corticotrophin injection exerts direct acute effects on human B cell gene expression distinct from the actions of glucocorticoids. Clin Exp Immunol. 2018;192(1):68‐81.
  • Gong R. The renaissance of corticotropin therapy in proteinuric nephropathies. Nat Rev Nephrol. 2011;8(2):122-128.
  • Caruso V, Lagerström MC, Olszewski PK, Fredriksson R, Schiöth HB. Synaptic changes induced by melanocortin signalling. Nat Rev Neurosci. 2014;15(2):98‐110.
  • Zhong Q, Sridhar S, Ruan L, et al. Multiple melanocortin receptors are expressed in bone cells. Bone. 2005;36(5):820‐831.
  • Lisak RP, Benjamins JA. Melanocortins, melanocortin receptors and multiple sclerosis. Brain Sci. 2017;7(104):1‐18.
  • Taylor AW, Lee D. Applications of the role of α‐MSH in ocular immune privilege. Adv Exp Med Biol. 2010;681:143‐149.
  • Artuc M, Grützkau A, Luger T, Henz BM. Expression of MC1‐ and MC5‐receptors on the human mast cell line HMC‐1. Ann N Y Acad Sci. 1999;885:364‐367.
  • Chang M, Chen B, Shaffner J, Dworkin LD, Gong R. Melanocortin system in kidney homeostasis and disease: novel therapeutic opportunities. Front Physiol. 2021;12:651236.
  • Lisak R, Bealmear B, Nedlekoska L, et al. Schwann cells express melanocortin receptor subtypes: activation by ACTH 1–39 and alpha‐MSH enhances proliferation [abstract P1.430]. Neurology. 2018;90(suppl 15):1‐2.
  • Kaneva MK, Kerrigan MJ, Grieco P, Curley GP, Locke IC, Getting SJ. Chondroprotective and anti‐inflammatory role of melanocortin peptides in TNF‐α activated human C‐20/A4 chondrocytes. Br J Pharmacol. 2012;167(1):67‐79.
  • Grässel S, Opolka A, Anders S, et al. The melanocortin system in articular chondrocytes: melanocortin receptors, pro‐opiomelanocortin, precursor proteases, and a regulatory effect of alpha‐melanocyte‐stimulating hormone on proinflammatory cytokines and extracellular matrix components. Arthritis Rheum. 2009;60(10):3017‐3027.

References:

  • Acthar Gel (repository corticotropin injection) [prescribing information]. Bridgewater, NJ: Mallinckrodt ARD LLC.
  • Poola N, Due B, Wright D, Brooks LR, Zaman F. Pharmacokinetics and pharmacodynamics of repository corticotropin injection compared with synthetic ACTH1-24 depot and methylprednisolone in healthy subjects [published online ahead of print]. Clin Pharmacol Drug Dev. 2021. doi:10.1002/cpdd.1020.
  • Data on file: REF-03003. Mallinckrodt ARD LLC.

References:

  • Acthar Gel (repository corticotropin injection) [prescribing information]. Bridgewater, NJ: Mallinckrodt ARD LLC.
  • Olsen NJ, Decker DA, Higgins P, et al. Direct effects of HP Acthar Gel on human B-lymphocyte activation in vitro. Arthritis Res Ther. 2015;17:300.
  • Data on file: REF-04768. Mallinckrodt ARD LLC
  • Healy LM, Jang JH, Lin YH, Rao V, Antel JP, Wright D. Melanocortin receptor mediated anti-inflammatory effect of repository corticotropin injection on human monocyte-derived macrophages [ECTRIMS-ACTRIMS abstract EP14841]. Mult Scler J. 2017;23(suppl 3):777.
  • Healy LM, Lin YH, Jang JH, Rao V, Antel JP, Wright D. Melanocortin receptor mediated anti-inflammatory effect of repository corticotropin injection on human monocyte-derived macrophages. Poster presented at: 7th Joint ECTRIMS-ACTRIMS Meeting; October 25-28, 2017; Paris, France. Poster EP1481.

References:

  • Acthar Gel (repository corticotropin injection) [prescribing information]. Bridgewater, NJ: Mallinckrodt ARD LLC.
  • Aggarwal R, Marder G, Koontz DC, Nandkumar P, Qi Z, Oddis CV. Efficacy and safety of adrenocorticotropic hormone gel in refractory dermatomyositis and polymyositis. Ann Rheum Dis. 2018;77(5):720-727.
  • Fiechtner JJ, Montroy T. Treatment of moderately to severely active systemic lupus erythematosus with adrenocorticotropic hormone: a single-site, open-label trial. Lupus. 2014;23(9):905-912.
  • Fleischmann R, Furst DE, Connolly-Strong E, Liu J, Zhu J, Brasington R. Repository corticotropin injection for active rheumatoid arthritis despite aggressive treatment: a randomized controlled withdrawal trial. Rheumatol Ther. 2020;7(2):327-344.
  • Fiechtner JJ, Montroy T, June J. A single-site, investigator initiated open-label trial of H.P. Acthar® Gel (repository corticotropin injection) an adrenocorticotropic hormone (ACTH) analogue in subjects with moderately to severely active psoriatic arthritis (PsA). J Dermatol Res Ther. 2016;2(5):1-7.
  • Baughman RP, Sweiss N, Keijsers R, et al. Repository corticotropin for chronic pulmonary sarcoidosis. Lung. 2017;195(3):313-322.
  • Zand L, Canetta P, Lafayette R, et al. An open-label pilot study of adrenocorticotrophic hormone in the treatment of IgA nephropathy at high risk of progression. Kidney Int Rep. 2020;5(1):58-65.
  • Wirta D, McLaurin E, Ousler G, Liu J, Kacmaz RO, Grieco J. Repository corticotropin injection (Acthar® Gel) for refractory severe noninfectious keratitis: efficacy and safety from a phase 4, multicenter, open-label study. Ophthalmol Ther. 2021;10(4):1077-1092.
  • Anesi SD, Chang PY, Maleki A, et al. Treatment of noninfectious retinal vasculitis using subcutaneous repository corticotropin injection. J Ophthalmic Vis Res. 2021;16(2):219-233.
  • Bryan MS, Sergott RC. Changes in visual acuity and retinal structures following repository corticotropin injection (RCI) therapy in patients with acute demyelinating optic neuritis: improvement in low contrast visual acuity in both affected and contralateral eyes in a single-armed open-label study. J Neurol Sci. 2019;407:116505.
  • Wynn D, Goldstick L, Bauer W, et al. Results from a multi-center, randomized, double-blind, placebo-controlled study of repository corticotropin injection for multiple sclerosis relapse that did not adequately respond to corticosteroids. CNS Neurosci Ther. 2022;28:364-371.

References:

  • Acthar Gel (repository corticotropin injection) [prescribing information]. Bridgewater, NJ: Mallinckrodt ARD LLC.
  • Acthar Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect Injector, 40 USP Units/0.5 mL [Instructions for Use]. Bridgewater, NJ: Mallinckrodt ARD LLC.
  • Acthar Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect Injector, 80 USP Units/1.0 mL [Instructions for Use]. Bridgewater, NJ: Mallinckrodt ARD LLC.
  • Data on File — Ref-07341. Mallinckrodt Pharmaceuticals.

References:

  • Acthar Gel (repository corticotropin injection) [prescribing information]. Bridgewater, NJ: Mallinckrodt ARD LLC.
  • Kaplan J, Askanase A, Chu D, et al. Acthar® Gel treatment for patients with autoimmune and inflammatory diseases: an historical perspective and characterization of clinical evidence. Clin Drug Invest. 2023;43:739-761.
  • Saygin D, Oddis CV, Marder G, et al. Follow-up results of myositis patients treated with Acthar gel. Rheumatology (Oxford). 2020;59(10):2976-2981.
  • Fleischmann R, Furst DE, Connolly-Strong E, Liu J, Zhu J, Brasington R. Repository corticotropin injection for active rheumatoid arthritis despite aggressive treatment: a randomized controlled withdrawal trial. Rheumatol Ther. 2020;7(2):327-344.
  • Chopra I, Qin Y, Kranyak J, et al. Repository corticotropin injection in patients with advanced symptomatic sarcoidosis: retrospective analysis of medical records. Ther Adv Respir Dis. 2019;13:1-11.
  • Baughman RP, Barney JB, O'Hare L, Lower EE. A retrospective pilot study examining the use of Acthar Gel in sarcoidosis patients. Respir Med. 2016;110:66-72.
  • Zand L, Canetta P, Lafayette R, et al. An open-label pilot study of adrenocorticotrophic hormone in the treatment of lgA nephropathy at high risk of progression. Kidney Int Rep. 2020;5(1):58·65.
  • Alhamad T, Manllo Dieck J, Younus U, et al. ACTH gel in resistant focal segmental glomerulosclerosis after kidney transplantation. Transplantation. 2019;103(1):202-209.
  • Nelson WW, Lima AF, Kranyak J, et al. Retrospective medical record review to describe use of repository corticotropin injection among patients with uveitis in the United States. J Ocul Pharmacol Ther. 2019;35(3):182-188.
  • Kaplan J, Miller T, Baker M, Due B, Zhao E. A prospective observational registry of repository corticotropin injection (Acthar® Gel) for the treatment of multiple sclerosis relapse. Front Neurol. 2020;11:598496.
  • Bryan MS, Sergott RC. Changes in visual acuity and retinal structures following repository corticotropin injection (RCI) therapy in patients with acute demyelinating optic neuritis: improvement in low contrast visual acuity in both affected and contralateral eyes in a single-armed open-label study. J Neurol Sci. 2019;407:116505.
  • Aggarwal R, Marder G, Koontz DC, Nandkumar P, Qi Z, Oddis CV. Efficacy and safety of adrenocorticotropic hormone gel in refractory dermatomyositis and polymyositis. Ann Rheum Dis. 2018;77(5):720-727.
  • Baughman RP, Sweiss N, Keijsers R, et al. Repository corticotropin for chronic pulmonary sarcoidosis. Lung. 2017;195(3):313-322.

References:

  • Fleischmann R, Furst DE, Connolly-Strong E, Liu J, Zhu J, Brasington R. Repository corticotropin injection for active rheumatoid arthritis despite aggressive treatment: a randomized controlled withdrawal trial. Rheumatol Ther. 2020;7(2):327-344.
  • US Department of Health and Human Services. Enrichment strategies for clinical trials to support determination of effectiveness of human drugs and biological products. Guidance for industry. March 2019. https://www.fda.gov/media/121320/download. Accessed June 11, 2019.
  • Fleischmann R, Furst DE, Connolly-Strong E, Liu J, Zhu J, Brasington R. A multicenter study assessing the efficacy and safety of repository corticotropin injection in patients with persistently active rheumatoid arthritis. Poster presented at: European Congress of Rheumatology; June 12-15, 2019; Madrid, Spain.
  • Curtis JR, Yang S, Chen L, et al. Determining the minimally important difference in the clinical disease activity index for improvement and worsening in early rheumatoid arthritis patients. Arthritis Care Res (Hoboken). 2015;67(10):1345-1353.
  • Orbai AM, Bingham CO III. Patient reported outcomes in rheumatoid arthritis clinical trials. Curr Rheumatol Rep. 2015;17(4):28.

References:

  • Ho-Mahler N, Turner B, Eaddy M, Hanke ML, Nelson WW. Treatment with repository corticotropin injection in patients with rheumatoid arthritis, systemic lupus erythematosus, and dermatomyositis/polymyositis. Open Access Rheumatol. 2020;12:21-28.
  • Acthar Gel (repository corticotropin injection) [prescribing information]. Bridgewater, NJ: Mallinckrodt ARD LLC.

References:

  • Aggarwal R, Marder G, Koontz DC, Nandkumar P, Qi Z, Oddis CV. Efficacy and safety of adrenocorticotropic hormone gel in refractory dermatomyositis and polymyositis. Ann Rheum Dis. 2018;77(5):720-727.
  • National Institute of Environmental Health Sciences. Disease activity core set measures. https://www.niehs.nih.gov/research/resources/imacs/diseaseactivity/index.cfm. Updated August 31, 2017. Accessed October 10, 2022.

References:

  • Saygin D, Oddis CV, Marder G, et al. Follow-up results of myositis patients treated with Acthar gel. Rheumatology (Oxford). 2020;59(10):2976-2981.

References:

  • Fiechtner JJ, Montroy T. Treatment of moderately to severely active systemic lupus erythematosus with adrenocorticotropic hormone: a single-site, open-label trial. Lupus. 2014;23(9):905-912.

References:

  • Kaplan J, Miller T, Baker M, Due B, Zhao E. A prospective observational registry of repository corticotropin injection (Acthar® Gel) for the treatment of multiple sclerosis relapse. Front Neurol. 2020;11:598496.doi:10.3389/fneur.2020.598496.
  • Polman CH, Reingold SC, Banwell B, et al. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald Criteria. Ann Neurol. 2011;69(2):292-302.
  • Hobart J, Lamping D, Fitzpatrick R, Riazi A, Thompson A. The Multiple Sclerosis Impact Scale (MSIS-29): a new patient-based outcome measure. Brain. 2001;124(pt 5):962-973.
  • Jones KH, Ford DV, Jones PA, et al. The physical and psychological impact of multiple sclerosis using the MSIS-29 via the web portal of the UK MS Register. PLoS One. 2013;8(1):e5542. doi:10.1371/journal.pone.0055422.
  • Costelloe L, O'Rourke K, Kearney H, et al. The patient knows best: significant change in the physical component of the Multiple Sclerosis Impact Scale (MSIS-29 physical). J Neurol Neurosurg Psychiatry. 2007;78(8):841-844.
  • Widener GL, Allen DD. Measurement characteristics and clinical utility of the 29-item Multiple Sclerosis Impact Scale. Arch Phys Med Rehabil. 2014;95(3):593-594.
  • Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983;33(11):1444-1452.
  • Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007;4(7):28-37.
  • Acthar Gel (repository corticotropin injection) [prescribing information]. Bridgewater, NJ: Mallinckrodt ARD LLC.

References:

  • Bryan MS, Sergott RC. Changes in visual acuity and retinal structures following repository corticotropin injection (RCI) therapy in patients with acute demyelinating optic neuritis: improvement in low contrast visual acuity in both affected and contralateral eyes in a single-armed open-label study. J Neurol Sci. 2019;407:116505. doi:10.1016/j.jns.2019.116505.

References:

  • Knupp KG, Coryell J, Nickels KC, et al. Response to treatment in a prospective national infantile spasms cohort. Ann Neurol. 2016;79(3):475-484.

References:

  • Madan A, Mijovic-Das S, Stankovic A, Teehan G, Milward AS, Khastgir A. Acthar gel in the treatment of nephrotic syndrome: a multicenter retrospective case series. BMC Nephrol. 2016;17(1):37. doi:10.1186/s12882-016-0241-7.
  • Data on File – Ref-00742. Mallinckrodt Pharmaceuticals.
  • Kidney Disease: Improving Global Outcomes (KDIGO) Glomerulonephritis Work Group. Clinical practice guideline for glomerulonephritis. Kidney Int Suppl. 2012;2(2):139-274.

References:

  • Baughman RP, Barney JB, O'Hare L, Lower EE. A retrospective pilot study examining the use of Acthar gel in sarcoidosis patients. Respir Med. 2016;110:66-72.

References:

  • Baughman RP, Sweiss N, Keijsers R, et al. Repository corticotropin for chronic pulmonary sarcoidosis. Lung. 2017;195(3):313-322.

References:

  • Data on File – Ref-05336. Mallinckrodt Pharmaceuticals.
  • Data on File – Ref-05814. Mallinckrodt Pharmaceuticals.
  • Fleischmann R, Furst DE, Connolly-Strong E, Liu J, Zhu J, Brasington R. Repository corticotropin injection for active rheumatoid arthritis despite aggressive treatment: a randomized controlled withdrawal trial. Rheumatol Ther. 2020;7(2):327-344.
  • Chopra I, Qin Y, Kranyak J, et al. Repository corticotropin injection in patients with advanced symptomatic sarcoidosis: retrospective analysis of medical records. Ther Adv Respir Dis. 2019;13:1753466619888127. doi:10.1177/1753466619888127.
  • Wirta D, McLaurin E, Ousler G, Liu J, Kacmaz RO, Grieco J. Repository corticotropin injection (Acthar® Gel) for refractory severe noninfectious keratitis: efficacy and safety from a phase 4, multicenter, open-label study. Ophthalmol Ther. 2021;10(4):1077-1092.
  • Zand L, Canetta P, Lafayette R, et al. An open-label pilot study of adrenocorticotrophic hormone in the treatment of IgA nephropathy at high risk of progression. Kidney Int Rep. 2020;5(1):58-65.
  • Kaplan J, Miller T, Baker M, Due B, Zhao E. A prospective observational registry of repository corticotropin injection (Acthar® Gel) for the treatment of multiple sclerosis relapse. Front Neurol. 2020;11:598496.doi:10.3389/fneur.2020.598496.

References:

  • Alhamad T, Manllo Dieck J, Younus U, et al. ACTH gel in resistant focal segmental glomerulosclerosis after kidney transplantation. Transplantation. 2019;103(1):202-209.
  • Acthar Gel (repository corticotropin injection) [prescribing information]. Bridgewater, NJ: Mallinckrodt ARD LLC.
  • Hladunewich MA, Cattran D, Beck LH, et al. A pilot study to determine the dose and effectiveness of adrenocorticotrophic hormone (Acthar® Gel) in nephrotic syndrome due to idiopathic membranous nephropathy. Nephrol Dial Transplant. 2014;29(8):1570-1577.
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  • Zand L, Canetta P, Lafayette R, et al. An open-label pilot study of adrenocorticotrophic hormone in the treatment of lgA nephropathy at high risk of progression. Kidney Int Rep. 2020;5(1):58-65.

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  • Baram TZ, Mitchell WG, Tournay A, Snead OC, Hanson RA, Horton EJ. High-dose corticotropin (ACTH) versus prednisone for infantile spasms: a prospective, randomized, blinded study. Pediatrics. 1996;97(3):375-379.
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References:

  • Data on file: REF-MNK14084113. Mallinckrodt ARD LLC.

References:

  • Bryan MS, Sergott RC. Changes in visual acuity and retinal structures following repository corticotropin injection (RCI) therapy in patients with acute demyelinating optic neuritis: improvement in low contrast visual acuity in both affected and contralateral eyes in a single-armed open-label study. J Neurol Sci. 2019;407:116505. doi:10.1016/j.jns.2019.116505.

References:

  • Fiechtner JJ, Montroy T, June J. A single-site, investigator initiated open-label trial of H.P. Acthar® Gel (repository corticotropin injection) an adrenocorticotropic hormone (ACTH) analogue in subjects with moderately to severely active psoriatic arthritis (PsA). J Dermatol Res Ther. 2016;2(5):1-7.
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References:

  • Chopra I, Qin Y, Kranyak J, et al. Repository corticotropin injection in patients with advanced symptomatic sarcoidosis: retrospective analysis of medical records. Ther Adv Respir Dis. 2019;13:1753466619888127. doi:10.1177/1753466619888127.

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  • Tumlin J, Galphin C, Santos R, Rovin B. Kidney Int Rep. 2017;2(5):924-932.

References:

  • Nelson WW, Lima AF, Kranyak J, et al. Retrospective medical record review to describe use of repository corticotropin injection among patients with uveitis in the United States. J Ocul Pharmacol Ther. 2019;35(3):182-188.

References:

  • Wirta D, McLaurin E, Ousler G, Liu J, Kacmaz RO, Grieco J. Repository corticotropin injection (Acthar® Gel) for refractory severe noninfectious keratitis: efficacy and safety from a phase 4, multicenter, open-label study. Ophthalmol Ther. 2021;10(4):1077-1092.
  • Data on File – Ref-04624. Mallinckrodt Pharmaceuticals.
  • US Food and Drug Administration Center for Drug Evaluation and Research. Clinical outcome assessment review. 2016. Accessed January 19, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208073Orig1s000MedR.pdf.
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References:

  • Rahaghi FF, Sweiss NJ, Saketkoo LA, et al. Management of repository corticotrophin injection therapy for pulmonary sarcoidosis: a Delphi study. Eur Respir Rev. 2020;29(155):190147. doi:10.1183/16000617.0147-2019.
  • Baughman RP, Scholand MB, Rahaghi FF. Clinical phenotyping: role in treatment decisions in sarcoidosis. Eur Respir Rev. 2020;29(155):190145. doi:10.1183/16000617.0145-2019.
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  • Rahaghi FF, Baughman RP, Saketkoo LA, et al. Delphi consensus recommendations for a treatment algorithm in pulmonary sarcoidosis. Eur Respir Rev. 2020;29(155):190146. doi:10.1183/16000617.0146-2019.

References:

  • Data as of 01/22. Data on File – Ref-05336. Mallinckrodt Pharmaceuticals.

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  • Data on File – Ref-05118. Mallinckrodt Pharmaceuticals.

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  • Data on File – Ref-05292. Mallinckrodt Pharmaceuticals.

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  • Data on File – Ref-05291. Mallinckrodt Pharmaceuticals.

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  • Data on File – Ref-04568. Mallinckrodt Pharmaceuticals.
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  • Data on File – Ref-04990. Mallinckrodt Pharmaceuticals.

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  • Madan A. Repository corticotropin injection in a patient presenting with focal segmental glomerulosclerosis, rheumatoid arthritis, and optic neuritis: a case report. Int J Gen Med. 2015;8:119-124.

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  • Fernandez AP, Gallop J, Polly S, Khanna U. Efficacy and safety of repository corticotropin injection for refractory cutaneous dermatomyositis: a prospective, open-label study. Rheumatology (Oxford). 2023 Nov 6. Epub ahead of print. doi: 10.1093/rheumatology/kead595
  • Anyanwu CO, Fiorentino DF, Chung L, et al. Validation of the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI): characterizing disease severity and assessing responsiveness to clinical change. Br J Dermatol. 2015;173(4):969-974.

References:

  • Anesi SD, Chang PY, Maleki A, et al. Treatment of noninfectious retinal vasculitis using subcutaneous repository corticotropin injection. J Ophthalmic Vis Res. 2021;16(2):219-233.

References:

  • Anesi SD, Chang PY, Maleki A, et al. Effects of subcutaneous repository corticotropin gel injection on regulatory T cell population in noninfectious retinal vasculitis. Ocul Immunol Inflamm. 2023;31(3):556-565.

References:

  • Hladunewich MA, Cattran D, Beck LH, et al. A pilot study to determine the dose and effectiveness of adrenocorticotrophic hormone (H.P. Acthar® Gel) in nephrotic syndrome due to idiopathic membranous nephropathy. Nephrol Dial Transplant. 2014;29(8):1570-1577.
  • Acthar Gel (repository corticotropin injection) [prescribing information]. Bridgewater, NJ: Mallinckrodt ARD LLC.

References:

  • Wynn D, Goldstick L, Bauer W, et al. Results from a multi-center, randomized, double-blind, placebo-controlled study of repository corticotropin injection for multiple sclerosis relapse that did not adequately respond to corticosteroids. CNS Neurosci Ther. 2022;28:364-371.
  • Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983;33(11):1444-1452.
  • Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007;4(7):28-37.
  • Hobart J, Lamping D, Fitzpatrick R, Riazi A, Thompson A. The Multiple Sclerosis Impact Scale (MSIS-29): a new patient-based outcome measure. Brain. 2001;124(Pt 5):962-973.
  • Kaplan J, Miller T, Baker M, Due B, Zhao E. A prospective observational registry of repository corticotropin injection (Acthar® Gel) for the treatment of multiple sclerosis relapse. Front Neurol. 2020;11:598496.

References:

  • Data on File – Ref-07075. Mallinckrodt Pharmaceuticals.

References:

  • Data on File – Ref-07195. Mallinckrodt Pharmaceuticals.
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