THERAKOS ECP ImmunomodulationTM

WHAT IS THERAKOS ECP IMMUNOMODULATIONTM?

Extracorporeal photopheresis (ECP) – the basics

Extracorporeal photopheresis (ECP) is an immunomodulatory therapy that has demonstrated efficacy in various T-cell and immune-mediated diseases.1

Unlike immunosuppressive therapies, ECP has not been associated with an increased incidence of infections.2
Please refer to the Important Safety Information for more details.

HOW IS THERAKOS ECP IMMUNOMODULATIONTM DELIVERED?

THERAKOS ECP ImmunomodulationTM is delivered via a completely closed, integrated ECP platform, the THERAKOS™ CELLEX™ Photopheresis System

The procedural steps

  • The instrument collects a small fraction of blood from the patient
  • The blood is separated by centrifugation
  • Red blood cells and plasma are returned immediately to the patient
  • Methoxsalen* is added to the buffy coat fraction† and cells are photoactivated by ultraviolet A light
  • The photoactivated buffy coat fraction† is reinfused to the patient

Please refer to the appropriate operator’s manual for further details prior to prescribing ECP therapy.

*Exact mechanism of action of methoxsalen is unknown.
†The buffy coat fraction of a whole blood sample following centrifugation contains most of the white blood cells and platelets.

HOW DOES IT WORK?

THERAKOS ECP Immunomodulation™ employs the patient’s own immune cells to modulate dysregulated immune function.1,3-6

Take a short journey into the body and explore in depth the proposed immunomodulatory mechanisms that lead to clinical effects.

The mechanisms by which extracorporeal photopheresis (ECP) exerts its clinical effects are under continual investigation to be more fully understood.

Discover the roots of ECP here

THE ROOTS OF ECP

1. Jurkowitsch T, Knobler R. In: Björn L.O. (eds) Photobiology. Springer, New York, NY; 2008. p577-590.

2. Hönigsmann H. Photochem Photobiol Sci. 2013;12(1):16-21.

Discover the roots of ECP here

THE ROOTS OF ECP

1. Jurkowitsch T, Knobler R. In: Björn L.O. (eds) Photobiology. Springer, New York, NY; 2008. p577-590.

2. Hönigsmann H. Photochem Photobiol Sci. 2013;12(1):16-21.

WHAT ARE THE
CLINICAL APPLICATIONS?

ECP is recommended by international and national guidelines for
a spectrum of diseases, including cutaneous T-cell lymphoma (CTCL),
acute and chronic graft-versus-host disease (aGvHD and cGvHD),
systemic sclerosis (SSc), lung allograft rejection and after cardiac
transplantation.2,7-13

Please click on each clinical application to learn more

CTCL
cGvHD
aGvHD
Systemic Sclerosis
Lung Allograft Rejection
Cardiac Transplantation

ECP is recommended as first-line therapy for erythrodermic stage IIIA or IIIB patients, and for stage IVA1 or IVA2 patients by the European Dermatology Forum,1 and for maintenance therapy after remission has been achieved by the EORTC2

EORTC: European Organisation for Research and Treatment of Cancer.

1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2014;28 Suppl 1:1-37. 2. Trautinger F, et al. Eur J Cancer. 2017;77:57-74.

ECP is recommended as second-line therapy of steroid-refractory chronic GvHD with the highest level of recommendation (1B) among all second-line therapies considered by the British Committee for Standards in Haematology and the British Society for Blood and Marrow Transplantation1

1. Dignan FL, et al. Br J Haematol. 2012;158(1):46-61.

ECP is suggested for use as second-line therapy of steroid-refractory acute GvHD by the British Committee for Standards in Haematology and the British Society for Blood and Marrow Transplantation (2C) as well as the German Society of Hematology and Medical Oncology (DGHO)1,2

1. Dignan FL, et al. Br J Haematol. 2012;158(1):30-45. 2. Zeiser R, et al. Graft-versus-Host Erkrankung, akut. March 2019. Available at: https://www.onkopedia.com/de/onkopedia/guidelines/graft-versus-host-erkrankung-akut/@@view/html/index.html. Accessed April 2019.

The European Dermatology Forum recommends the use of ECP in systemic sclerosis as second-line or adjuvant therapy in mono- or combination therapy, and it is recommended that it should be applied in early progressive disease1,2

1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2014;28 Suppl 1:1-1-37. 2. Knobler R, et al. J Eur Acad Dermatol Venereol. 2017;31(9):1401-1424.

ECP is recommended by the American Society for Apheresis as a therapeutic option for the treatment of bronchiolitis obliterans syndrome (1C)1

1. Schwartz J, et al. J Clin Apher. 2016;31(3):149-162.

ECP is recommended by the American Society for Apheresis as a therapeutic option for the prophylactic treatment of cardiac rejection (2A) and (1B)* and by the International Society for Heart and Lung Transplant for resistant or recurrent rejections1,2

*In the US, the photosensitiser UVADEX® that is used in THERAKOS ECP Immunomodulation™ is not indicated for cardiac transplantation. US label: UVADEX® (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the THERAKOS® UVAR XTS® or THERAKOS® CELLEX® Photopheresis System in the palliative treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) that is unresponsive to other forms of treatment.3

1. Schwartz J, et al. J Clin Apher. 2016;31(3):149-162. 2. Constanzo MR, et al. J Heart Lung Transplant. 2010;29(8):914-956. 3. Uvadex Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020969s010lbl.pdf. Accessed October 2019.

CTCL

ECP is recommended as first-line therapy for erythrodermic stage IIIA or IIIB patients, and for stage IVA1 or IVA2 patients by the European Dermatology Forum,1 and for maintenance therapy after remission has been achieved by the EORTC2

EORTC: European Organisation for Research and Treatment of Cancer.

1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2014;28 Suppl 1:1-37. 2. Trautinger F, et al. Eur J Cancer. 2017;77:57-74.

cGvHD

ECP is recommended as second-line therapy of steroid-refractory chronic GvHD with the highest level of recommendation (1B) among all second-line therapies considered by the British Committee for Standards in Haematology and the British Society for Blood and Marrow Transplantation1

1. Dignan FL, et al. Br J Haematol. 2012;158(1):46-61.

aGvHD

ECP is suggested for use as second-line therapy of steroid-refractory acute GvHD by the British Committee for Standards in Haematology and the British Society for Blood and Marrow Transplantation (2C) as well as the German Society of Hematology and Medical Oncology (DGHO)1,2

1. Dignan FL, et al. Br J Haematol. 2012;158(1):30-45. 2. Zeiser R, et al. Graft-versus-Host Erkrankung, akut. March 2019. Available at: https://www.onkopedia.com/de/onkopedia/guidelines/graft-versus-host-erkrankung-akut/@@view/html/index.html. Accessed April 2019.

Systemic Sclerosis

The European Dermatology Forum recommends the use of ECP in systemic sclerosis as second-line or adjuvant therapy in mono- or combination therapy, and it is recommended that it should be applied in early progressive disease1,2

1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2014;28 Suppl 1:1-1-37. 2. Knobler R, et al. J Eur Acad Dermatol Venereol. 2017;31(9):1401-1424.

Lung Allograft Rejection

ECP is recommended by the American Society for Apheresis as a therapeutic option for the treatment of bronchiolitis obliterans syndrome (1C)1

1. Schwartz J, et al. J Clin Apher. 2016;31(3):149-162.

Cardiac Transplantation

ECP is recommended by the American Society for Apheresis as a therapeutic option for the prophylactic treatment of cardiac rejection (2A) and (1B)* and by the International Society for Heart and Lung Transplant for resistant or recurrent rejections1,2

*In the US, the photosensitiser UVADEX® that is used in THERAKOS ECP Immunomodulation™ is not indicated for cardiac transplantation. US label: UVADEX® (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the THERAKOS® UVAR XTS® or THERAKOS® CELLEX® Photopheresis System in the palliative treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) that is unresponsive to other forms of treatment.3

1. Schwartz J, et al. J Clin Apher. 2016;31(3):149-162. 2. Constanzo MR, et al. J Heart Lung Transplant. 2010;29(8):914-956. 3. Uvadex Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020969s010lbl.pdf. Accessed October 2019.

See a timeline for the clinical development of THERAKOS ECP Immunomodulation™ in CTCL and other therapy areas

CTCL

OTHER THERAPY AREAS

CTCL
other therapy areas

aGvHD: acute graft versus host disease; BOS: bronchiolitis obliterans syndrome; cGvHD: chronic graft versus host disease; CTCL: cutaneous T cell lymphoma; ECP: extracorporeal photopheresis; PUVA: psoralen plus ultraviolet A; SSc: systemic sclerosis; Treg: regulatory T-cell.

1. Edelson R, et al. N Engl J Med. 1974;291:293-294. 2. Gilchrest BA. Cancer Treat Rep. 1979;63:663-667. 3. Knobler R, et al. Med Clin North Am. 1986;70:109-138. 4. Edelson R, et al. N Engl J Med. 1987;316:297-303. 5. Uvadex Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020969s006lbl.pdf. Accessed October 2019. 6. Heald P, et al. J Am Acad Dermatol. 1992;27:427-433. 7. Rook AH, et al. Yale J Biol Med. 1989;62:639-645. 8. Owsianowski M, et al. Bone Marrow Transplant. 1994;14:845-848. 9. Andreu G, et al. J Heart Lung Transplant. 1995;14:793-796. 10. Barr ML, et al. N Engl J Med. 1998;339:1744-1751. 11. Knobler RM, et al. J Am Acad Dermatol. 2006;54:793-799. 12. Greinix HT, et al. Haematologica. 2006;91(3):405-408. 13. Couriel DR, et al. Blood. 2006;107(8):3074-3080. 14. Benden C, et al. Transplantation. 2008;86(11):1625-1627. 15. Flowers MED, et al. Blood. 2008;112:2667-2674. 16. Quaglino P, et al. Int J Immunopathol Pharmacol. 2009;22:353-362. 17. Papp G, et al. Clin Immunol. 2012;142:150-159. 18. Horina et al. The Lancet. 1995;346:61. 19. Sunder-Plassman et al. The Lancet. 1995;346(8973):506.

References:
1. Hart JW, et al. Ther Adv Hematol. 2013;4:320-334; 2. Knobler R, et al. J Eur Acad Dermatol Venereol. 2014;28 Suppl 1:1-37; 3. Yoo EK, et al. J Invest Dermatol. 1996;107:235-242; 4. Morelli AE, et al. Blood. 2003;101:611-620; 5. Craciun LI, et al. Transplantation. 2002;74:995-1000; 6. Lamioni A, et al. Transplantation. 2005;79:846-850; 7. Trautinger F, et al. Eur J Cancer. 2017;77:57 74. 8. Dignan FL, et al. Br J Haematol. 2012;158(1):46-61. 9. Dignan FL, et al. Br J Haematol. 2012;158(1):30-45. 10. Zeiser R, et al. Graft-versus-Host Erkrankung, akut. March 2019. Available at: https://www.onkopedia.com/de/onkopedia/guidelines/graft-versus-host-erkrankung-akut/@@view/html/index.html. Accessed April 2019. 11. Knobler R, et al. J Eur Acad Dermatol Venereol. 2017;31(9):1401-1424. 12. Schwartz J, et al. J Clin Apher. 2016;31(3):149-162. 13. Constanzo MR, et al. J Heart Lung Transplant. 2010;29(8):914-956.