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Wirta D, McLaurin E, Ousler G, Liu J, Kacmaz RO, Grieco J—Ophthalmology and Therapy, 2021
Disclosure statement: Funding to support this study was provided by Mallinckrodt Pharmaceuticals. The authors of this study have financial and/or employment relationships with Mallinckrodt Pharmaceuticals.
A Phase 4, multicenter, open-label study assessing the efficacy and safety of Acthar® Gel in 36* patients with treatment-resistant, refractory, severe, non-infectious keratitis1
Objective
To evaluate the efficacy and safety of Acthar Gel in patients with treatment-resistant, refractory, severe, non-infectious keratitis
*A target sample size of 36 patients was determined empirically. All 36 patients were included in the safety group. Efficacy endpoints were analyzed in the modified intent-to-treat (mITT) population (n=35), defined as all patients who received at least one dose of Acthar Gel and who contributed any post-baseline efficacy data to the study.
Study Design1,2
- A Phase 4, multicenter, open-label study of 36 patients with treatment-resistant, refractory, severe, non-infectious keratitis*
- Patients received 80 units of Acthar Gel twice weekly for 12 weeks, followed by a taper period of 4 weeks
*A target sample size of 36 patients was determined empirically. All 36 patients were included in the safety group. Efficacy endpoints were analyzed in the modified intent-to-treat (mITT) population (n=35), defined as all patients who received at least one dose of Acthar Gel and who contributed any post-baseline efficacy data to the study.
STUDY ASSESSMENTS1
PRIMARY ENDPOINTS
- Proportion of patients with ≥12-point improvement in the IDEEL-symptom bother score at Week 12
- Proportions of patients with ≥20%, ≥30%, and ≥50% improvement in the IDEEL-symptom bother score at Week 12
IDEEL=Impact of Dry Eye on Everyday Life.
EXPLORATORY ENDPOINTS
Patient-reported outcomes
- IDEEL Questionnaire
- Ocular Discomfort and 4-Symptom Questionnaire
- Visual analog scale (VAS)†
Ophthalmic assessments
- Corneal staining (fluorescein)
- Conjunctival staining (lissamine green)
- Conjunctival redness
- Schirmer’s test
- Visual acuity
- Slit-lamp examination
†The VAS is a validated patient-reported outcomes measure. The VAS in this study assesses various characteristic symptoms of dry eye disease.3
SAFETY ENDPOINTS
- Incidence and severity of ocular treatment-emergent adverse events (TEAEs), new or worsening cataracts, and mean change in intraocular pressure from baseline to Week 12
PATIENT OVERVIEW1
Patients had severe keratitis with tough-to-treat disease and high disease activity following prior treatment
LASIK=laser-assisted in situ keratomileusis.
Patient demographics and baseline characteristics
Patients had keratitis in both eyes and experienced symptoms for 4.4 years (mean)§ prior to treatment with Acthar Gel.
SD=standard deviation.
‡Data based on 35 patients in the mITT population.
§SD=5.4.
Study Limitations1
- Sample bias may exist as this was an open-label study, and patients were aware that they were receiving Acthar Gel
- There was a relatively small sample size with a short treatment period of 12 weeks
- The reported outcomes cannot be solely attributed to Acthar Gel. There is no control arm in this study, and other concomitant medications may not have been reported
PRIMARY ENDPOINTS1
Improvement in IDEEL-symptom bother score by ≥12 points for 50% (n=17) of patients† with severe keratitis at Week 12
The IDEEL Questionnaire assesses the burden of dry eye disease and was developed to meet the FDA patient-reported outcomes guidance4,5
In a previous study, IDEEL-symptom bother baseline scores were classified as mild: 40.0 (SD=7.5), moderate: 50.6 (SD=11.0), and severe: 64.3 (SD=8.0).6
IDEEL=Impact of Dry Eye on Everyday Life; SD=standard deviation.
†Data related to the IDEEL-symptom bother score were reported for 34 patients.
At least half of the patients saw improvement in their IDEEL-symptom bother score by ≥12 points1
Mean improvements in the IDEEL-symptom bother score were clinically important at every time point
Mean change from baseline in the IDEEL-symptom bother score1
Out of 34 patients† at 12 weeks
MCID=minimal clinically important difference.
†Data related to the IDEEL-symptom bother score were reported for 34 patients.
After 12 weeks of treatment with Acthar Gel1
‡95% CI: 33.2%, 66.8%.
§95% CI: 27.4%, 60.8%.
||95% CI: 2.8%, 26.5%.
EXPLORATORY ENDPOINTS1
Complete resolution of symptoms at Week 12 was assessed by the Ocular Discomfort and 4-Symptom Questionnaire1
- Patients reported improvements at Week 12 for each domain of the Ocular Discomfort and 4-Symptom Questionnaire
- 20% of patients reported complete resolution in ocular discomfort at Week 12
Proportion of patients who reported complete resolution of key symptoms of severe keratitis1
Improvements in key symptoms of severe keratitis were observed in the visual analog scale1
- The VAS is a validated patient-reported outcomes measure. The VAS in this study assesses various characteristic symptoms of dry eye disease3
- From baseline to Week 12, all symptoms assessed by the mean VAS score had improved, including:
- Pain
- Eye discomfort
- Burning/stinging
- Foreign body sensation
- Photophobia
- Eye dryness
- Itching
VAS=visual analog scale.
Improvements in ophthalmic assessments were observed as early as Week 4 and sustained through Week 121
Improvements in ophthalmic assessments after 4 weeks of treatment with Acthar Gel
Improvements in ophthalmic assessments after 12 weeks of treatment with Acthar Gel
NOTE: Confidence intervals only apply to observed numerical values for each assessment. They do not apply to percentage changes in improvement.
¶95% CI: -1.5%, -0.4%.
#95% CI: -0.9%, -0.2%.
**95% CI: -0.4%, 0.1%.
††95% CI: 0.4%, 3.9%.
‡‡Unanesthetized Schirmer's test to determine the amount of tears produced over 5 minutes.
§§95% CI: -1.6%, -0.6%.
||||95% CI: -1.2%, -0.2%.
¶¶95% CI: -0.6%, -0.1%.
##95% CI: -0.1%, 2.7%.
No clinically meaningful changes in visual acuity or slit-lamp examination were observed.
Safety ENDPOINTS1
Safety data were consistent with the established safety profile of Acthar Gel
- 33.3% (n=12) of patients experienced ≥1 TEAE; most TEAEs were single incidences
- Blurred vision and double vision were the only ocular TEAEs reported
- No new safety signals were identified
No new or worsening cataracts or clinically meaningful changes in intraocular pressure were observed.
TEAE=treatment-emergent adverse event.
†36 patients were enrolled and included in the safety population.
‡One serious TEAE of intentional overdose with fatal outcome was reported but was not related to Acthar Gel treatment.
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Dosing recommendations
See additional dosing information from clinical experience with Acthar Gel
Welcome to the Infantile Spasms Dosing Calculator.
This is a convenient and complete way to calculate the recommended dosage of Acthar Gel for the treatment of IS, from per-injection volume to a complete treatment regimen.
The recommended dosage for IS is 150 units/m2 divided into twice daily intramuscular injections of 75 units/m2 over a 2‑week period. Dosing should be gradually tapered and discontinued over a 2‑week period.
Choose initial dose or tapered dose and then enter measurements to determine the corresponding per-injection volume of Acthar Gel for a patient with IS.
INITIAL DOSE
TAPERED DOSE #1
Calculation information
For Infantile Spasms, the Acthar IS Dosing Calculator generates per-injection volume (mL) of Acthar by body surface area (BSA) using the following Mosteller formula calculation22:
To determine per-injection volume of Acthar:
To determine total daily dose:
Input exceeds the FDA-recommended dose
The FDA approved Acthar for IS with the following recommended dosing regimen1:
- Two daily intramuscular injections of 75 U/m2 for 2 weeks
- After 2 weeks of treatment, Acthar should be gradually tapered over 2 weeks, decreasing the dose to help avoid adrenal insufficiency
Input is below the FDA-recommended dose
The FDA approved Acthar for IS with the following recommended dosing regimen1:
- Two daily intramuscular injections of 75 U/m2 for 2 weeks
- After 2 weeks of treatment, Acthar should be gradually tapered over 2 weeks, decreasing the dose to help avoid adrenal insufficiency
Input exceeds the preceding total daily dose
After 2 weeks of treatment, Acthar should be gradually tapered, decreasing the dose to help avoid adrenal insufficiency. The FDA approved Acthar for IS with the following recommended taper schedule1:
30 U/m2 in the morning for 3 days; 15 U/m2 in the morning for 3 days; 10 U/m2 in the morning for 3 days; and 10 U/m2 every other morning for 6 days.
The previous dose is outside the FDA-approved recommendation for dose range; therefore, the default taper dose may need assessment
After 2 weeks of treatment, Acthar should be gradually tapered, decreasing the dose to help avoid adrenal insufficiency. The FDA approved Acthar for IS with the following recommended taper schedule1:
30 U/m2 in the morning for 3 days; 15 U/m2 in the morning for 3 days; 10 U/m2 in the morning for 3 days; and 10 U/m2 every other morning for 6 days.
Input differs from the FDA-recommended frequency of treatment
The FDA approved Acthar for IS with the following recommended dosing regimen1:
- Two daily intramuscular injections of 75 U/m2 for 2 weeks
- After 2 weeks of treatment, Acthar should be gradually tapered over 2 weeks, decreasing the dose to help avoid adrenal insufficiency
Input differs from the FDA-approved tapering schedule recommendation
After 2 weeks of treatment, Acthar should be gradually tapered, decreasing the dose to help avoid adrenal insufficiency. The FDA approved Acthar for IS with the following recommended taper schedule1:
30 U/m2 in the morning for 3 days; 15 U/m2 in the morning for 3 days; 10 U/m2 in the morning for 3 days; and 10 U/m2 every other morning for 6 days.
The symptoms of adrenal insufficiency in infants treated for infantile spasms can be difficult to identify. The symptoms are non-specific and may include anorexia, fatigue, lethargy, weakness, excessive weight loss, hypotension and abdominal pain. It is critical that parents and caregivers be made aware of the possibility of adrenal insufficiency when discontinuing Acthar Gel and should be instructed to observe for, and be able to recognize, these symptoms.
Input exceeds the preceding total daily dose
After 2 weeks of treatment, Acthar should be gradually tapered, decreasing the dose to help avoid adrenal insufficiency. The FDA approved Acthar for IS with the following recommended taper schedule1:
30 U/m2 in the morning for 3 days; 15 U/m2 in the morning for 3 days; 10 U/m2 in the morning for 3 days; and 10 U/m2 every other morning for 6 days.
Input exceeds the preceding total daily dose
After 2 weeks of treatment, Acthar should be gradually tapered, decreasing the dose to help avoid adrenal insufficiency. The FDA approved Acthar for IS with the following recommended taper schedule1:
30 U/m2 in the morning for 3 days; 15 U/m2 in the morning for 3 days; 10 U/m2 in the morning for 3 days; and 10 U/m2 every other morning for 6 days.
Input exceeds the FDA-recommended total daily dose
The FDA approved Acthar for IS with the following recommended dosing regimen1:
- Two daily intramuscular injections of 75 U/m2 for a total daily dose of 150 U/m2 for 2 weeks
- After 2 weeks of treatment, Acthar should be gradually tapered over 2 weeks, decreasing the dose to help avoid adrenal insufficiency
Please note that there are no data to support the use of Acthar at a total daily dose exceeding 150 U/m2. This dosing calculator is not a substitute for clinical judgment. Medical discretion is required to determine any appropriate daily dose and treatment course of Acthar for your IS patients.
Input is below the FDA-recommended total daily dose
The FDA approved Acthar for IS with the following recommended dosing regimen1:
- Two daily intramuscular injections of 75 U/m2 for a total daily dose of 150 U/m2 for 2 weeks
- After 2 weeks of treatment, Acthar should be gradually tapered over 2 weeks, decreasing the dose to help avoid adrenal insufficiency
Input differs from the FDA-recommended days on therapy
The FDA approved Acthar for IS with the following recommended dosing regimen1:
- Two daily intramuscular injections of 75 U/m2 for 2 weeks
- After 2 weeks of treatment, Acthar should be gradually tapered over 2 weeks, decreasing the dose to help avoid adrenal insufficiency
Input differs from the FDA-approved tapering schedule recommendation
After 2 weeks of treatment, Acthar should be gradually tapered, decreasing the dose to help avoid adrenal insufficiency. The FDA approved Acthar for IS with the following recommended taper schedule1:
30 U/m2 in the morning for 3 days; 15 U/m2 in the morning for 3 days; 10 U/m2 in the morning for 3 days; and 10 U/m2 every other morning for 6 days.
The symptoms of adrenal insufficiency in infants treated for infantile spasms can be difficult to identify. The symptoms are non-specific and may include anorexia, fatigue, lethargy, weakness, excessive weight loss, hypotension and abdominal pain. It is critical that parents and caregivers be made aware of the possibility of adrenal insufficiency when discontinuing Acthar Gel and should be instructed to observe for, and be able to recognize, these symptoms.
ADD TAPERED DOSE
REMOVE THIS DOSE
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USING THE CALCULATOR
Calculation information
For infantile spasms, the Acthar IS Dosing Calculator generates per-injection volume (mL) of Acthar by body surface area (BSA) using the following Mosteller formula calculation22:
To determine per-injection volume of Acthar:
To determine total daily dose:
Calculation information
To determine total volume of Acthar required to complete your selected course of treatment:
To determine number of vials needed:
Advise your patient's other doctors
Download and fill out the Doctor Notification Letter to share your patient's prescription with their other healthcare providers.
INDICATIONS
Acthar Gel is indicated for:
- Treatment during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis)
- Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus
- Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis
- Symptomatic sarcoidosis
- Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation
- Inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus
- Treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown Acthar to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease
- Monotherapy for the treatment of infantile spasms in infants and children under 2 years of age
Important Safety information
Contraindications
Acthar is contraindicated:
- For intravenous administration
- In infants under 2 years of age who have suspected congenital infections
- With concomitant administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of Acthar
- 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 origin
Warnings 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-adrenal (HPA) axis 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 axis suppression after stopping treatment
- Cushing’s syndrome 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. Monitor blood pressure and sodium and potassium levels
- 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 gastrointestinal (GI) bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain GI disorders. Monitor for signs of perforation and bleeding
- Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression to 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. Cases of anaphylaxis have been reported in the postmarketing setting. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH and Acthar activity
- There may be 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 in patients on long-term therapy
Adverse Reactions
- Commonly reported postmarketing adverse reactions for Acthar include injection site reaction, asthenic conditions (including fatigue, malaise, asthenia, and lethargy), fluid retention (including peripheral swelling), insomnia, headache, and blood glucose increased
- The most common adverse reactions for the treatment of infantile spasms (IS) are increased risk of infections, convulsions, hypertension, irritability, and pyrexia. Some patients with IS progress to other forms of seizures; IS sometimes masks these seizures, which may become visible once the clinical spasms from IS resolve
Pregnancy
- Acthar may cause fetal harm when administered to a pregnant woman
Please see full Prescribing Information for additional Important Safety Information.
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.
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- 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.
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- 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.
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- 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.
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- 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.
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- 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.
- 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.
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- Acthar Gel (repository corticotropin injection) [prescribing information]. Bridgewater, NJ: Mallinckrodt ARD LLC.
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.
- Schmitt J, Wozel G. The psoriasis area and severity index is the adequate criterion to define severity in chronic plaque-type psoriasis. Dermatology. 2005;210(3):194-199.
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- 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.
References:
- 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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- 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.
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- Acthar Gel (repository corticotropin injection) [prescribing information]. Bridgewater, NJ: Mallinckrodt ARD LLC.
- 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.
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- 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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- CellCept (mycophenolate mofetil) [prescribing information]. San Francisco, CA: Genentech USA, Inc.
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- Data on File – Ref-04990. Mallinckrodt Pharmaceuticals.
References:
- 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.
References:
- 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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