Treatment of Moderately to Severely Active Systemic Lupus Erythematosus with Adrenocorticotropic Hormone: a Single-site, Open-label Trial

Overview

Journal Lupus

Publisher Sage Publications

Specialty Rheumatology

Date 2014 May 6

PMID 24795067

Citations 32

Authors

J J Fiechtner

T Montroy

Affiliations

Soon will be listed here.

Abstract

Background: Alternative therapeutic options are needed for patients with systemic lupus erythematosus (SLE) not adequately controlled with or intolerant to traditional treatments. This study evaluated the efficacy of Acthar® Gel (ACTH(1-39)) for reducing active SLE severity among patients receiving underlying conventional maintenance therapies.

Methods: Ten females (mean age = 49 yrs, disease duration = 7 yrs, Systemic Lupus Erythematosus Disease Activity Index-2000 [SLEDAI-2 K] = 10) currently on maintenance self-administered ACTH(1-39) gel 1 mL (80 U/mL) for 7-15 days and were assessed weekly for 28 days. Outcome measures included Physician and Patient Global Assessments, SLEDAI-2 K, Lupus Quality of Life scale, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale, erythrocyte sedimentation rate, and C-reactive protein. Student's t-test compared data obtained at days 7, 14, and 28 with those from baseline.

Results: The primary endpoint of SLEDAI-2 K improvement was reached at all observation times (p < 0.05) and statistically significant improvements were observed for most other parameters. No treatment-related serious or unexpected adverse events were observed.

Conclusions: The trial results reveal that among SLE patients in need of therapeutic alternatives, ACTH(1-39) gel may provide significant disease activity reduction.

Citing Articles

Efficacy and tolerability of subcutaneous repository corticotropin injection in refractory ocular inflammatory diseases.

Yavari N, Ghoraba H, Or C, Thng Z, Mohammadi S, Karaca I J Ophthalmic Inflamm Infect. 2024; 14(1):56.

PMID: 39448433 PMC: 11502637. DOI: 10.1186/s12348-024-00428-8.

Acthar Gel Treatment for Patients with Autoimmune and Inflammatory Diseases: An Historical Perspective and Characterization of Clinical Evidence.

Kaplan J, Askanase A, Chu D, Abdellatif A, Basu D, Mirsaeidi M Clin Drug Investig. 2023; 43(10):739-761.

PMID: 37792273 PMC: 10575998. DOI: 10.1007/s40261-023-01303-5.

Acthar Gel (RCI): A Narrative Literature Review of Clinical and Economic Evidence.

Wan G, Niewoehner J, Hayes K Clinicoecon Outcomes Res. 2023; 15:499-512.

PMID: 37397803 PMC: 10312382. DOI: 10.2147/CEOR.S410082.

Cerebral Venous Sinus Thrombosis induced By Hypercoagulation in Patient With Systemic Lupus Erythematosus: A Case Report and Literature Review.

Amalia L J Blood Med. 2023; 14:1-6.

PMID: 36647371 PMC: 9840394. DOI: 10.2147/JBM.S387075.

Natural Adrenocorticotropic Hormone (ACTH) Relieves Acute Inflammation in Gout Patients by Changing the Function of Macrophages.

Xu R, Zhao L, Liu J, Cao L, Zhao T, Yu Y J Healthc Eng. 2022; 2022:9241835.

PMID: 35646298 PMC: 9132716. DOI: 10.1155/2022/9241835.

References

Slominski A, Wortsman J, Luger T, Paus R, Solomon S . Corticotropin releasing hormone and proopiomelanocortin involvement in the cutaneous response to stress. Physiol Rev. 2000; 80(3):979-1020. DOI: 10.1152/physrev.2000.80.3.979. View

Panopalis P, Yazdany J, Gillis J, Julian L, Trupin L, Hersh A . Health care costs and costs associated with changes in work productivity among persons with systemic lupus erythematosus. Arthritis Rheum. 2008; 59(12):1788-95. PMC: 2875149. DOI: 10.1002/art.24063. View

Turchetti G, Yazdany J, Palla I, Yelin E, Mosca M . Systemic lupus erythematosus and the economic perspective: a systematic literature review and points to consider. Clin Exp Rheumatol. 2012; 30(4 Suppl 73):S116-22. PMC: 3714226. View

Pranzatelli M, Chun K, Moxness M, Tate E, Allison T . Cerebrospinal fluid ACTH and cortisol in opsoclonus-myoclonus: effect of therapy. Pediatr Neurol. 2005; 33(2):121-6. DOI: 10.1016/j.pediatrneurol.2005.03.004. View

Baram T, Mitchell W, Tournay A, Snead O, Hanson R, Horton E . High-dose corticotropin (ACTH) versus prednisone for infantile spasms: a prospective, randomized, blinded study. Pediatrics. 1996; 97(3):375-9. PMC: 3100715. View

Isenberg D, Rahman A, Allen E, Farewell V, Akil M, Bruce I . BILAG 2004. Development and initial validation of an updated version of the British Isles Lupus Assessment Group's disease activity index for patients with systemic lupus erythematosus. Rheumatology (Oxford). 2005; 44(7):902-6. DOI: 10.1093/rheumatology/keh624. View

. Guidelines for referral and management of systemic lupus erythematosus in adults. American College of Rheumatology Ad Hoc Committee on Systemic Lupus Erythematosus Guidelines. Arthritis Rheum. 1999; 42(9):1785-96. DOI: 10.1002/1529-0131(199909)42:9<1785::AID-ANR1>3.0.CO;2-#. View

Yee C, Isenberg D, Prabu A, Sokoll K, Teh L, Rahman A . BILAG-2004 index captures systemic lupus erythematosus disease activity better than SLEDAI-2000. Ann Rheum Dis. 2007; 67(6):873-6. DOI: 10.1136/ard.2007.070847. View

Abu-Shakra M, Mader R, Langevitz P, Friger M, Codish S, Neumann L . Quality of life in systemic lupus erythematosus: a controlled study. J Rheumatol. 1999; 26(2):306-9. View

10.

Catania A, Gatti S, Colombo G, Lipton J . Targeting melanocortin receptors as a novel strategy to control inflammation. Pharmacol Rev. 2004; 56(1):1-29. DOI: 10.1124/pr.56.1.1. View

11.

Levine T . Treating refractory dermatomyositis or polymyositis with adrenocorticotropic hormone gel: a retrospective case series. Drug Des Devel Ther. 2012; 6:133-9. PMC: 3392138. DOI: 10.2147/DDDT.S33110. View

12.

Yee C, Farewell V, Isenberg D, Griffiths B, Teh L, Bruce I . The use of Systemic Lupus Erythematosus Disease Activity Index-2000 to define active disease and minimal clinically meaningful change based on data from a large cohort of systemic lupus erythematosus patients. Rheumatology (Oxford). 2011; 50(5):982-8. PMC: 3077910. DOI: 10.1093/rheumatology/keq376. View

13.

Slominski A, Zmijewski M, Zbytek B, Tobin D, Theoharides T, Rivier J . Key role of CRF in the skin stress response system. Endocr Rev. 2013; 34(6):827-84. PMC: 3857130. DOI: 10.1210/er.2012-1092. View

14.

Tsokos G . Systemic lupus erythematosus. N Engl J Med. 2011; 365(22):2110-21. DOI: 10.1056/NEJMra1100359. View

15.

Manna S, Aggarwal B . Alpha-melanocyte-stimulating hormone inhibits the nuclear transcription factor NF-kappa B activation induced by various inflammatory agents. J Immunol. 1998; 161(6):2873-80. View

16.

Schurmeyer T, Tsokos G, Avgerinos P, Balow J, DAgata R, Loriaux D . Pituitary-adrenal responsiveness to corticotropin-releasing hormone in patients receiving chronic, alternate day glucocorticoid therapy. J Clin Endocrinol Metab. 1985; 61(1):22-7. DOI: 10.1210/jcem-61-1-22. View

17.

Slominski A, Zmijewski M, Skobowiat C, Zbytek B, Slominski R, Steketee J . Sensing the environment: regulation of local and global homeostasis by the skin's neuroendocrine system. Adv Anat Embryol Cell Biol. 2012; 212:v, vii, 1-115. PMC: 3422784. DOI: 10.1007/978-3-642-19683-6_1. View

18.

Lai J, Beaumont J, Ogale S, Brunetta P, Cella D . Validation of the functional assessment of chronic illness therapy-fatigue scale in patients with moderately to severely active systemic lupus erythematosus, participating in a clinical trial. J Rheumatol. 2011; 38(4):672-9. DOI: 10.3899/jrheum.100799. View

19.

Bomback A, Tumlin J, Baranski J, Bourdeau J, Besarab A, Appel A . Treatment of nephrotic syndrome with adrenocorticotropic hormone (ACTH) gel. Drug Des Devel Ther. 2011; 5:147-53. PMC: 3063118. DOI: 10.2147/DDDT.S17521. View

20.

Kosinski M, Gajria K, Fernandes A, Cella D . Qualitative validation of the FACIT-fatigue scale in systemic lupus erythematosus. Lupus. 2013; 22(5):422-30. DOI: 10.1177/0961203313476360. View