Mallinckrodt Announces Publication of Findings on Treatment Patterns and Outcomes in Patients with Two Types of Arthritis Treated with Acthar® Gel (repository corticotropin injection)
Mallinckrodt (NYSE:MNK) has published findings from a cross-sectional physician survey and medical chart review regarding Acthar® Gel treatment in patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA). The study, published in Open Access Rheumatology: Research and Reviews, demonstrated that some patients experienced positive treatment outcomes including reduced symptoms, decreased pain, improved physical function, and reduced corticosteroid use.
Acthar Gel, an FDA-approved complex mixture of ACTH analogs and pituitary peptides, is indicated for treating various autoimmune disorders and inflammatory conditions. The research provides valuable real-world data on the medication's clinical application and effectiveness in treating these complex arthritic conditions.
Mallinckrodt (NYSE:MNK) ha pubblicato i risultati di un sondaggio trasversale tra medici e di una revisione delle cartelle cliniche riguardo al trattamento con Acthar Gel in pazienti affetti da spondilite anchilosante (AS) e artrite psoriasica (PsA). Lo studio, pubblicato su Open Access Rheumatology: Research and Reviews, ha dimostrato che alcuni pazienti hanno sperimentato esiti terapeutici positivi, tra cui riduzione dei sintomi, diminuzione del dolore, miglior funzione fisica e ridotto uso di corticosteroidi. Acthar Gel, una miscela complessa di analoghi ACTH e peptidi ipofisari approvata dalla FDA, è indicato per il trattamento di vari disturbi autoimmuni e condizioni infiammatorie. La ricerca fornisce preziosi dati del mondo reale sull'applicazione clinica e sull’efficacia del farmaco nel trattamento di queste complesse condizioni artritiche.
Mallinckrodt (NYSE:MNK) ha publicado los hallazgos de una encuesta transversal entre médicos y una revisión de historias clínicas sobre el tratamiento con Acthar Gel en pacientes con espondilitis anquilosante (AS) y artritis psoriásica (PsA). El estudio, publicado en Open Access Rheumatology: Research and Reviews, mostró que algunos pacientes experimentaron resultados positivos del tratamiento, como reducción de síntomas, disminución del dolor, mejora de la función física y reducción del uso de corticosteroides. Acthar Gel, una mezcla compleja de análogos de ACTH y péptidos hipofisarios, aprobado por la FDA, está indicado para tratar diversos trastornos autoinmunes y condiciones inflamatorias. La investigación ofrece valiosos datos del mundo real sobre la aplicación clínica y la eficacia del fármaco en el tratamiento de estas complejas condiciones artríticas.
Mallinckrodt (NYSE:MNK)는 강직성 척추염(AS) 및 건선성 관절염(PsA) 환자에서 Acthar Gel 치료에 관한 의사 설문조사와 의무기록 검토의 횡단면 연구 결과를 발표했습니다. 연구는 Open Access Rheumatology: Research and Reviews에 게재되었으며, 일부 환자가 증상 감소, 통증 감소, 신체 기능 개선 및 코르티코스테로이드 사용 감소를 포함한 긍정적인 치료 결과를 경험했다는 것을 보여주었습니다. FDA가 승인한 Acthar Gel은 ACTH 유사체와 뇌하수체 펩타이드의 복합 혼합물로, 다양한 자가면역 질환 및 염증성 질환의 치료에 적합하다고 명시되어 있습니다. 이 연구는 이러한 복잡한 관절 질환 치료에서 약물의 임상 적용과 효과에 대한 귀중한 실제 데이터를 제공합니다.
Mallinckrodt (NYSE:MNK) a publié les résultats d’une enquête transversale auprès des médecins et d’un contrôle des dossiers médicaux concernant le traitement par Acthar Gel chez des patients atteints de spondylarthrite ankylosante (AS) et d’arthrite psoriasique (PsA). L’étude, publiée dans Open Access Rheumatology: Research and Reviews, a montré que certains patients ont connu des résultats positifs du traitement, notamment une réduction des symptômes, une diminution de la douleur, une amélioration de la fonction physique et une réduction de l’utilisation de corticostéroïdes. Acthar Gel, un mélange complexe d’analogues de l’ACTH et de peptides hypophysaires approuvé par la FDA, est indiqué dans le traitement de divers troubles auto-immunes et conditions inflammatoires. La recherche fournit des données réelles précieuses sur l’application clinique et l’efficacité du médicament dans le traitement de ces conditions arthritiques complexes.
Mallinckrodt (NYSE:MNK) hat Ergebnisse einer querschnittsartigen Befragung von Ärzten und einer Überprüfung von Krankengeschichten im Zusammenhang mit der Behandlung von Acthar Gel bei Patienten mit Spondylitis ankylosans (AS) und Psoriasis-Arthritis (PsA) veröffentlicht. Die im Open Access Rheumatology: Research and Reviews veröffentlichte Studie zeigte, dass einige Patienten positive Behandlungsergebnisse erfuhren, darunter reduzierte Symptome, verringerter Schmerz, verbesserte körperliche Funktion und verringerter Corticoid-Verbrauch. Acthar Gel, eine von der FDA zugelassene komplexe Mischung aus ACTH-Analoga und hypophysisären Peptiden, ist zur Behandlung verschiedener Autoimmunerkrankungen und entzündlicher Zustände vorgesehen. Die Forschung liefert wertvolle Real-World-Daten über die klinische Anwendung und Wirksamkeit des Medikaments bei der Behandlung dieser komplexen Gelenkerkrankungen.
Mallinckrodt (NYSE:MNK) أصدرت نتائج من استطلاع عابر بين الأطباء ومراجعة للسجلات الطبية حول علاج Acthar Gel لمرضى التهاب الفقار اللاصق (AS) والتهاب المفاصل الصدفي (PsA). أظهرت الدراسة، التي نُشرت في Open Access Rheumatology: Research and Reviews، أن بعض المرضى شهدوا نتائج علاجية إيجابية بما في ذلك تقليل الأعراض، وتخفيف الألم، وتحسن الوظيفة البدنية، وتقليل استخدام الكورتيكوستيرويدات. Acthar Gel، وهو مزيج مركّب من نظائر ACTH وببتيدات فروانية، معتمد من إدارة الغذاء والدواء الأمريكية FDA ومخصص لعلاج اضطرابات مناعية ذاتية وحالات التهابية مختلفة. توفر هذه الأبحاث بيانات واقعية قيّمة حول التطبيق السريري وفعالية الدواء في علاج هذه الحالات المفصلية المعقدة.
Mallinckrodt（NYSE:MNK）公开了关于 Acthar Gel 在强直性脊柱炎（AS）和银屑病关节炎（PsA）患者治疗的横断面医生调查与病历回顾的研究结果。该研究发表于 Open Access Rheumatology: Research and Reviews，显示部分患者在治疗中获得积极疗效，包括症状减轻、疼痛缓解、身体功能改善以及糖皮质激素使用减少。Acthar Gel 是经过 FDA 批准的一种由 ACTH 类似物和脑垂体肽组成的复杂混合物，适用于多种自身免疫性疾病和炎性状态的治疗。这项研究为该药在治疗这些复杂性关节病中的临床应用及有效性提供了有价值的真实世界数据。
- Study showed multiple positive outcomes including reduced symptoms and pain
- Demonstrated potential for reduced corticosteroid use in treated patients
- Publication provides new real-world evidence supporting treatment effectiveness
- None.
– Cross-sectional physician survey and medical chart review showed some patients evaluated with AS or PsA who were treated with Acthar Gel experienced a reported reduction in overall symptoms, decreased pain, improved physical function, reduced corticosteroid use, improved strength, and improved fatigue using prespecified assessments1 –
Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone (ACTH) analogs and other pituitary peptides.2 Acthar Gel is approved by the FDA for the treatment or adjunct treatment of several autoimmune disorders and medical conditions known to cause inflammation.2
Please see Indications and Important Safety Information for Acthar Gel below.
"Until recently, there was limited real-world data to help us understand how Acthar Gel is used in clinical practice for patients with ankylosing spondylitis or psoriatic arthritis," said George Wan, Ph.D., M.P.H., Vice President, Evidence Generation and Data Sciences, Mallinckrodt. "These physician insights provide further data regarding Acthar Gel as a treatment option for appropriate patients with these complex conditions."
"It is imperative that individuals living with chronic inflammatory conditions, like ankylosing spondylitis or psoriatic arthritis, have access to treatments that can help manage a variety of symptoms that affect their daily lives," said Cassie Shafer, Chief Executive Officer, Spondylitis Association of America. "We value our collaboration with organizations like Mallinckrodt, whose commitment to research in these areas continues to make a meaningful difference for patients and their families."
About the Chart Review
"Treatment Patterns and Outcomes of Acthar Gel in Ankylosing Spondylitis and Psoriatic Arthritis: A Physician-Reported Chart Review" was conducted among a group of physician participants who were blinded to the sponsor, and vice versa.1 Data received from participating physicians were validated for accuracy and completeness.1 Patients in the sample were aged ≥18 years, had a diagnosis of AS or PsA, had received treatment with Acthar Gel in the previous 24 months, and had completely accessible medical records. Patients with contraindications, comprising adrenocortical hyperfunction, congestive heart failure, ocular herpes simplex, osteoporosis, peptic ulcers, primary adrenocortical insufficiency, scleroderma, systemic fungal infections, and uncontrolled hypertension, were excluded.1
The chart review collected data abstracted from the records of 63 patients with AS and 77 patients with PsA between April 2022 and November 2024.1 The mean age of patients with AS was 44 years, and the mean age of patients with PsA was 51 years.1 The majority of patients with AS were male (
41% (n=26/63) of patients with AS and44% (n=34/77) with PsA had fair-to-poor health status89% (n=56/63) of patients with AS had back pain,76% (n=48/63) had lower back/hip stiffness, and62% (n=39/63) had fatigue81% (n=62/77) of patients with PsA had joint swelling and pain,70% (n=54/77) had reduced range of motion, and66% (n=51/77) had fatigue
Based on physician assessment,
Among the patients with improved health status, further findings reported included1:
70% (n=42/60) of patients with AS and63% (n=43/68) of patients with PsA had a reduction in overall symptoms68% (n=41/60) of patients with AS and62% (n=42/68) of patients with PsA had decreased pain53% (n=32/60) of patients with AS and54% (n=37/68) of patients with PsA had improved physical function37% (n=22/60) of patients with AS and38% (n=26/68) of patients with PsA had improved strength35% (n=21/60) of patients with AS and32% (n=22/68) of patients with PsA had improved fatigue30% (n=18/60) of patients with AS and31% (n=21/68) of patients with PsA had reduced corticosteroid use
Summary of limitations of the research include1:
- Survey data was derived from patient medical records, which may contain inaccuracies or omissions.
- This chart review population is limited to patients receiving Acthar Gel and those included in the reviewed records, potentially limiting generalizability to broader AS and PsA populations, particularly those in different healthcare settings or with varying disease severity.
- As a real-world chart review, a uniform disease-activity instrument was not used. Instead, disease status was abstracted as documented in the record (physician assessments and routinely recorded clinical signs/symptoms).
- Collecting standardized disease activity measures from observational data presents substantial challenges. In previously published studies using electronic medical records from two separate rheumatology care management organizations, such measures were available in only up to
20% of patient records. - Variability in physician documentation and subjective assessments of patient improvement could introduce bias, especially without standardized objective measures of disease activity.
- Absence of a control group limits the ability to determine the true effectiveness of Acthar Gel.
- These results should not be interpreted as comparative effectiveness.
- This chart review does not quantify diagnostic or safety outcomes and primarily captures short-term effects, limiting understanding of the impact of long-term treatment.
- While some patients may receive Acthar Gel alongside short-term glucocorticoids, this descriptive chart review did not collect standardized safety endpoints or detailed concomitant dosing and therefore cannot compare adverse events between concomitant-use and non-concomitant-use groups; prospective studies with predefined safety outcomes are needed.
This research was sponsored by Mallinckrodt Pharmaceuticals.
INDICATIONS
Acthar Gel is indicated for:
- Treatment during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis) and 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 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.
About Ankylosing Spondylitis (AS)
Ankylosing spondylitis (AS) is a form of arthritis that is characterized by systemic inflammation leading to fusion of the axial skeleton.3 Most commonly appearing in people in their mid-20s and more commonly in men, AS can significantly impact a person's physical and mental health.3 It affects an estimated one in every 200 people.4
About Psoriatic Arthritis (PsA)
Psoriatic arthritis (PsA) is characterized by chronic arthritis in the presence of psoriasis, and is found in up to
About Mallinckrodt
Mallinckrodt is dedicated to enhancing lives by providing therapeutics that strive to address unmet patient needs, and is a world-class manufacturer of high-quality generics, sterile injectables, and active pharmaceutical ingredients.
Our company consists of multiple wholly owned subsidiaries that operate in two businesses. Our Brands business is focused on autoimmune and rare diseases in areas including endocrinology, gastroenterology, hepatology, neonatal respiratory critical care, nephrology, neurology, pulmonology, ophthalmology, orthopedics, rheumatology, and urology. Our Par Health business includes generic drugs, sterile injectables, and active pharmaceutical ingredients. To learn more, visit www.MNK-Endo.com.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements, including with regard to Acthar Gel, its potential to improve health and treatment outcomes, and its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the effects of each of Mallinckrodt's and Endo's recent emergences from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; changes in market demand; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with Acthar Gel; and other risks identified and described in more detail in the "Risk Factors" and the "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Mallinckrodt's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission (SEC), all of which are available from the SEC's website (www.sec.gov) and Mallinckrodt's website (www.mallinckrodt.com). The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
CONTACT
Media Inquiries
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mediainquiries@grcomms.com
Investor Relations
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862-240-8194
avendano.juan@endo.com
Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners.
©2025 Mallinckrodt. US-2500420 09/25
References
1 Patel A., Shanbhag P., Evans D., et al. Treatment Patterns and Outcomes of Acthar Gel in Ankylosing Spondylitis and Psoriatic Arthritis: A Physician-Reported Chart Review. Open Access Rheumatology: Research and Reviews. 2025;17:193-202. https://doi.org/10.2147/OARRR.S538839
2 Acthar® Gel (repository corticotropin injection) [Prescribing Information].
3 Crossfield S.S.R., Marzo-Ortega H., Kingsbury S.R., et al. Changes in ankylosing spondylitis incidence, prevalence and time to diagnosis over two decades. RMD Open. 2021;7:e001888. https://rmdopen.bmj.com/content/7/3/e001888
4 Hwang M.C., Ridley L., Reveille J.D., Ankylosing spondylitis risk factors: a systematic literature review. Clinical Rheumatol. 2021;40:3079-3093. https://doi.org/10.1007/s10067-021-05679-7
5 Ibrahim G., Waxman R., Helliwell P.S. The Prevalence of Psoriatic Arthritis in People With Psoriasis. Arthritis & Rheumatism. 2009;61:1373-1378. https://doi.org/10.1002/art.24608
6 Kishimoto M., Deshpande G.A., Fukuoka K., et al. Clinical features of psoriatic arthritis. Best Practice & Research Clinical Rheumatology. 2021;35(2). https://doi.org/10.1016/j.berh.2021.101670
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FAQ
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