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 fully integrated and validated ECP system, the THERAKOS™ CELLEX™ Photopheresis System2

The procedural steps3

  • 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 (MoA) of the photosensitising agent 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.1,4-7

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

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

Discover the roots of ECP here

THE ROOTS OF ECP

ECP, extracorporeal photopheresis.

1. Jurkowitsch T, Knobler R. In: Björn L.O. (eds) Photobiology. Springer, New York, NY; 2008; 577-590.

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

Discover the roots of ECP here

THE ROOTS OF ECP

ECP, extracorporeal photopheresis.

1. Jurkowitsch T, Knobler R. In: Björn L.O. (eds) Photobiology. Springer, New York, NY; 2008; 577-590.

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), chronic lung allograft dysfunction-bronchiolitis obliterans syndrome (CLAD-BOS) and after cardiac transplantation.2,8-19

Please click on each clinical application to learn more

CTCL
cGvHD
aGvHD
SSc
CLAD-BOS
Cardiac Transplantation

ECP is recommended as a first-line treatment for CTCL by the:

  • European Dermatology Forum – Erythrodermic MF (Stage IIIA/B) and MF/SS Stage IVA1 and IVA21
  • European Organisation for Research and Treatment of Cancer – MF Stage IIIA/B2
  • UK Photopheresis Society – CTCL Stage III or IVA3
  • American Society for Apheresis – Erythrodermic MF (Stage IIIA/B) and SS Stage IVA14

CTCL, cutaneous T-cell lymphoma; ECP, extracorporeal photopheresis; MF, mycosis fungoides; SS, Sézary syndrome; UK, United Kingdom.

1. Knobler R, et al. J Eur Acad Dermatol Venerol. 2020;34(12):2693-2716. 2. Trautinger F, et al. Eur J Cancer. 2017;77:57-74. 3. Alfred A, et al. Br J Haematol. 2017;177:287-310. 4. Padmanabhan A, et al. J Clin Apher. 2019;34(3):171-354.

ECP is recommended for the treatment of cGvHD by the:

  • European Dermatology Forum – Steroid-dependent, -intolerant or -resistant cGvHD patients with recurrent infections or high risk of relapse of underlying disease1
  • Italian Society of Haemapheresis and Cell Manipulation and the Italian Group for Bone Marrow Transplantation – Steroid-resistant or -dependent cGvHD, irrespective of disease extent and severity2
  • British Committee for Standards in Haematology and the British Society for Blood and Marrow Transplantation –cGvHD affecting skin, liver, or oral mucosa3
  • American Society for Apheresis*, Cancer Care Ontario (Canada), and the European Multinational Expert Consensus Conference – Steroid-refractory or -dependent cGvHD5–7
  • UK Photopheresis Society – Steroid-refractory, -dependent or -intolerant cGvHD4

*American Society for Apheresis recommendations specify extensive chronic GvHD.5

cGvHD, chronic graft-versus-host disease; ECP, extracorporeal photopheresis; UK, United Kingdom.

1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716. 2. Pierelli L, et al. Transfusion. 2013;53(10):2340-2352. 3. Dignan FL, et al. Br J Haematol. 2012;158(1):46-61. 4. Alfred A, et al. Br J Haematol. 2017;177:287-310. 5. Padmanabhan A, et al. J Clin Apher. 2019;34(3):171-354. 6. Bredeson C, et al. Curr Oncol. 2014;21(2):e310-325. 7. Wolff D, et al. Biol Blood Marrow Transplant. 2011;17:1-17.

ECP is recommended for the treatment of aGvHD by the:

  • European Dermatology Forum and German Society of Haematology and Medical Oncology – Second-line treatment of steroid-refractory aGvHD1,2
  • UK Photopheresis Society – Steroid-refractory, -dependent or -intolerant aGvHD Grade II-IV3
  • Cancer Care Ontario (Canada) – Steroid-refractory or -dependent aGvHD4
  • American Society for Apheresis, British Committee for Standards in Haematology, British Society for Blood and Marrow Transplantation, Italian Society of Haemapheresis and Cell Manipulation, and the Italian Group for Bone Marrow Transplantation – aGvHD not responsive to steroids and calcineurin inhibitors5–7

aGvHD, acute graft-versus-host disease; ECP, extracorporeal photopheresis; UK, United Kingdom.

1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716. 2. Zeiser R, et al. Graft-verus-Host Erkrankung, akut. March 2019. Available at: https://www.onkopedia.com/de/onkopedia/guidelines/graft-versushost-erkrankung-akut/@@guideline/html/index.html. Accessed November 2021. 3. Alfred A, et al. Br J Haematol. Appendix S3. 2017;177:287-310. 4. Bredeson C, et al. Curr Oncol. 2014;21(2):e310-325. 5. Dignan FL, et al.Br J Haematol. 2012;158(1):30-45. 6. Padmanabhan A, et al. J Clin Apher. 2019;34(3):171-354. 7. Pierelli L, et al. Transfusion. 2013;53(10):2340-2352.

ECP is recommended for the treatment of SSc by the:

  • European Dermatology Forum – Second-line or adjuvant treatment in mono- or combination therapy1
    • Should be applied in early progressive disease
    • In aggressive advancement of the disease, ECP should be considered as an approach to treat skin, but not organ involvement
  • American Society for Apheresis – A treatment option on an individualised basis2

ECP, extracorporeal photopheresis; SSc, systemic sclerosis.

1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2021;25(1):27-49. 2. Padmanabhan A, et al. J Clin Apher. 2019;34(3):171-354.

ECP is recommended as a second-line treatment option for CLAD-BOS by the American Society for Apheresis1

BOS, bronchiolitis obliterans syndrome; CLAD, chronic lung allograft dysfunction; ECP, extracorporeal photopheresis.

1. Padmanabhan A, et al. J Clin Apher. 2019;34(3):171-354.

ECP is recommended for the treatment of cardiac transplantation by the:

  • European Dermatology Forum – A promising strategy for treatment-resistant and ‑recurrent rejection1
  • UK Photopheresis Society – Rescue treatment for recurrent or severe rejection* and as an adjunct to standard immunosuppression for rejection prophylaxis2
  • American Society for Apheresis – Second-line treatment for cellular/recurrent rejection and as a rejection prophylaxis3
  • International Society for Heart and Lung Transplant – Recurrent or resistant acute cellular rejection4

*Associated with haemodynamic compromise.2

ECP, extracorporeal photopheresis; UK, United Kingdom.

1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2021;25(1):27-49. 2. Alfred A, et al. Br J Haematol. 2017;177:287-310. 3. Padmanabhan A, et al. J Clin Apher. 2019;34(3):171-354. 4. Costanzo MR, et al. J Heart Lung Transplant. 2010;29(8):914-956.

CTCL

ECP is recommended as a first-line treatment for CTCL by the:

  • European Dermatology Forum – Erythrodermic MF (Stage IIIA/B) and MF/SS Stage IVA1 and IVA21
  • European Organisation for Research and Treatment of Cancer – MF Stage IIIA/B2
  • UK Photopheresis Society – CTCL Stage III or IVA3
  • American Society for Apheresis – Erythrodermic MF (Stage IIIA/B) and SS Stage IVA14

CTCL, cutaneous T-cell lymphoma; ECP, extracorporeal photopheresis; MF, mycosis fungoides; SS, Sézary syndrome; UK, United Kingdom.

1. Knobler R, et al. J Eur Acad Dermatol Venerol. 2020;34(12):2693-2716. 2. Trautinger F, et al. Eur J Cancer. 2017;77:57-74. 3. Alfred A, et al. Br J Haematol. 2017;177:287-310. 4. Padmanabhan A, et al. J Clin Apher. 2019;34(3):171-354.

cGvHD

ECP is recommended for the treatment of cGvHD by the:

  • European Dermatology Forum – Steroid-dependent, -intolerant or -resistant cGvHD patients with recurrent infections or high risk of relapse of underlying disease1
  • Italian Society of Haemapheresis and Cell Manipulation and the Italian Group for Bone Marrow Transplantation – Steroid-resistant or -dependent cGvHD, irrespective of disease extent and severity2
  • British Committee for Standards in Haematology and the British Society for Blood and Marrow Transplantation –cGvHD affecting skin, liver, or oral mucosa3
  • American Society for Apheresis*, Cancer Care Ontario (Canada), and the European Multinational Expert Consensus Conference – Steroid-refractory or -dependent cGvHD5–7
  • UK Photopheresis Society – Steroid-refractory, -dependent or -intolerant cGvHD4

*American Society for Apheresis recommendations specify extensive chronic GvHD.5

cGvHD, chronic graft-versus-host disease; ECP, extracorporeal photopheresis; UK, United Kingdom.

1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716. 2. Pierelli L, et al. Transfusion. 2013;53(10):2340-2352. 3. Dignan FL, et al. Br J Haematol. 2012;158(1):46-61. 4. Alfred A, et al. Br J Haematol. 2017;177:287-310. 5. Padmanabhan A, et al. J Clin Apher. 2019;34(3):171-354. 6. Bredeson C, et al. Curr Oncol. 2014;21(2):e310-325. 7. Wolff D, et al. Biol Blood Marrow Transplant. 2011;17:1-17.

aGvHD

ECP is recommended for the treatment of aGvHD by the:

  • European Dermatology Forum and German Society of Haematology and Medical Oncology – Second-line treatment of steroid-refractory aGvHD1,2
  • UK Photopheresis Society – Steroid-refractory, -dependent or -intolerant aGvHD Grade II-IV3
  • Cancer Care Ontario (Canada) – Steroid-refractory or -dependent aGvHD4
  • American Society for Apheresis, British Committee for Standards in Haematology, British Society for Blood and Marrow Transplantation, Italian Society of Haemapheresis and Cell Manipulation, and the Italian Group for Bone Marrow Transplantation – aGvHD not responsive to steroids and calcineurin inhibitors5–7

aGvHD, acute graft-versus-host disease; ECP, extracorporeal photopheresis; UK, United Kingdom.

1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716. 2. Zeiser R, et al. Graft-verus-Host Erkrankung, akut. March 2019. Available at: https://www.onkopedia.com/de/onkopedia/guidelines/graft-versushost-erkrankung-akut/@@guideline/html/index.html. Accessed November 2021. 3. Alfred A, et al. Br J Haematol. Appendix S3. 2017;177:287-310. 4. Bredeson C, et al. Curr Oncol. 2014;21(2):e310-325. 5. Dignan FL, et al.Br J Haematol. 2012;158(1):30-45. 6. Padmanabhan A, et al. J Clin Apher. 2019;34(3):171-354. 7. Pierelli L, et al. Transfusion. 2013;53(10):2340-2352.

SSc

ECP is recommended for the treatment of SSc by the:

  • European Dermatology Forum – Second-line or adjuvant treatment in mono- or combination therapy1
    • Should be applied in early progressive disease
    • In aggressive advancement of the disease, ECP should be considered as an approach to treat skin, but not organ involvement
  • American Society for Apheresis – A treatment option on an individualised basis2

ECP, extracorporeal photopheresis; SSc, systemic sclerosis.

1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2021;25(1):27-49. 2. Padmanabhan A, et al. J Clin Apher. 2019;34(3):171-354.

CLAD-BOS

ECP is recommended as a second-line treatment option for CLAD-BOS by the American Society for Apheresis1

BOS, bronchiolitis obliterans syndrome; CLAD, chronic lung allograft dysfunction; ECP, extracorporeal photopheresis.

1. Padmanabhan A, et al. J Clin Apher. 2019;34(3):171-354.

Cardiac Transplantation

ECP is recommended for the treatment of cardiac transplantation by the:

  • European Dermatology Forum – A promising strategy for treatment-resistant and ‑recurrent rejection1
  • UK Photopheresis Society – Rescue treatment for recurrent or severe rejection* and as an adjunct to standard immunosuppression for rejection prophylaxis2
  • American Society for Apheresis – Second-line treatment for cellular/recurrent rejection and as a rejection prophylaxis3
  • International Society for Heart and Lung Transplant – Recurrent or resistant acute cellular rejection4

*Associated with haemodynamic compromise.2

ECP, extracorporeal photopheresis; UK, United Kingdom.

1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2021;25(1):27-49. 2. Alfred A, et al. Br J Haematol. 2017;177:287-310. 3. Padmanabhan A, et al. J Clin Apher. 2019;34(3):171-354. 4. Costanzo MR, et al. J Heart Lung Transplant. 2010;29(8):914-956.

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

GvHD: graft versus host disease; BOS: bronchiolitis obliterans syndrome; CTCL: cutaneous T cell lymphoma; ECP: extracorporeal photopheresis; FDA: Food and Drug Administration; PUVA: psoralen plus ultraviolet A; SSc: systemic sclerosis.

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. UVADEXTM Prescribing Information 2020. 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.

ECP, extracorporeal photopheresis; UVA, ultraviolet A.

References:
1. Hart JW, et al. Ther Adv Hematol. 2013;4:320-334. 2. Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716. 3. Operator’s Manual. THERAKOS™ CELLEX™ Photopheresis System. Therakos. 2019. 4. Yoo EK, et al. J Invest Dermatol. 1996;107:235-242. 5. Morelli AE, et al. Blood. 2003;101:611-620. 6. Craciun LI, et al. Transplantation. 2002;74:995-1000. 7. Lamioni A, et al. Transplantation. 2005;79:846-850. 8. Trautinger F, et al. Eur J Cancer. 2017;77:57 74. 9. Padmanabhan A, et al. J Clin Apher. 2019;34(3):171-354. 10. Alfred A, et al. Br J Haematol. 2017;177:287-310. 11. Cho A, et al. Front Med (Lausanne). 2018;5:236. 12. Zeiser R. et al. Graft-versus-Host Erkrankung, akut. 2021. Available at: https://www.onkopedia.com/de/onkopedia/guidelines/graft-versus-host-erkrankung-akut/@@view/html/index.html. Accessed February 2022. 13. Bredeson C, et al. Curr Oncol. 2014;21(2):e310-325. 14. Pierelli L, et al. Transfusion. 2013;53(10):2340-2352. 15. Wolff D, et al. Biol Blood Marrow Transplant. 2011;17:1-17. 16. Dignan FL, et al. Br J Haematol. 2012;158(1):30-45. 17. Dignan FL, et al. Br J Haematol. 2012;158(1):46-61. 18. Knobler R, et al. J Eur Acad Dermatol Venereol. 2021;25(1):27-49. 19. Costanzo MR, et al. J Heart Lung Transplant. 2010;29(8):914-956.