Therakos ECP ImmunomodulationTM
What is Therakos ECP Immunomodulation™?
Extracorporeal photopheresis (ECP)
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
- A photosensitising agent* is added to the buffy coat fraction† and cells are photoactivated by UVA 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.
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), 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.
ECP is recommended for the treatment of CTCL by the:
- European Dermatology Forum (EDF)– First-line therapy for erythrodermic MF stage IIIA or IIIB patients, and forstage IVA1 or IVA2 MF/SS patients1
- European Organisation for Research and Treatment of Cancer (EORTC) – First-line therapy for MF stage III and for SS + maintenance therapy after remission has been achieved2
- European Society for Medical Oncology (ESMO) - ECP, either alone or in combination with other treatment modalities such as IFNα, retinoids, TSEBT and PUVA, has been suggested as the treatment of choice in SS and erythrodermic MF3
- UK Photopheresis Society – CTCL First-line in patients with erythrodermic CTCL, stage III and IVA.Maintenance therapy recommended when clinical durable benefit is derived4
- British Association of Dermatologists and UK Cutaneous Lymphoma Group - First-line therapy for erythrodermic MF (stage III) and SS (stage IVA1) (Strength of recommendation C)5
CTCL, cutaneous T-cell lymphoma; ECP, extracorporeal photopheresis; IFNα, interferon alpha; MF, mycosis fungoides; PUVA, psoralen plus ultraviolet-A radiation; SS, Sézary syndrome; TSEBT, total skin electron beam therapy; UK, United Kingdom.
1. Knobler R, et al. J Eur Acad Dermatol Venerol. 2020;34(12):2693-2716. 2. Latzka J, et al. Eur J Cancer. 2023;195:113343. 3. Willemze R, et al. Annals of Oncology. 2018;29(Suppl 4):IV30–IV40. 4. Alfred A, et al. Br J Haematol. 2017;177:287-310. 5. Gilson D, et al. Br J Dermatol. 2019;180(3):496-526.
ECP is recommended for the treatment of aGvHD by the:
- European Dermatology Forum (EDF) - Patients not responding to first-line therapy with corticosteroids1
- German Society of Hematology and Medical Oncology (DGHO) - As second-line therapy for aGVHD, treatment should be started as early as possible2
- UK Photopheresis Society - Second-line therapy in grades II–IV acute GvHD in SR, SD, SI patients3
- British Committee for Standard in Haematology/British Society for Blood and Marrow Transplantation (BCSH/BSBMT) - Second-line therapy of SR acute GvHD4
- Italian Society of Hemapheresis and Cell Manipulation/Italian Group for Bone Marrow Transplantation (SIdEM/GITMO) - In patients with acute GvHD refractory to first-line treatment, ECP is then suggested second-line and subsequent treatment5
- Nordic ECP Quality Group - ECP can be used in patients with SR, SD or SI acute GvHD6
- European Group for Blood & Marrow Transplantation (EBMT) - Listed as one of 14 second-line therapies. ECP is one of the second-line therapies in patients with SR acute GvHD, with no standard second-line treatment according to these guidelines (grade of evidence 2A)7
- Group of Hematopoietic Transplantation and Cellular Therapy (GETH) - ECP recommended as an adequate second-line therapy due to its effectiveness and specially safety profile, mainly in patients with only cutaneous involvement8
ECP, extracorporeal photopheresis; GvHD, graft-versus-host disease; SD, steroid-dependent; SI, steroid-intolerant; SR, steroid-refractory; UK, United Kingdom.
1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716. 2. Zeiser R, et al, Graft-versus-Host Erkrankung, akut. 2024. Available at: https://www.onkopedia.com/de/onkopedia/guidelines/graft-versus-hosterkrankung-akut/@@view/html/index.html. Accessed June 2025. 3. Alfred A, et al. Br J Haematol. Appendix S3. 2017;177:287-310. 4. Dignan FL, et al. Br J Haematol. 2012;158(1):30-45. 5. Colpo A et al. Transfus Apher Sci. 2024;63(5):103990. 6. Nygaard M, et al. Eur J Haematol. 2020;104(5):361-375. 7. Penack O, et al. Lancet Haematol. 2020;7:e157-e167. 8. Spanish comprehensive clinical practice guideline of Graft-versus-Host Disease. Spanish Group of Hematopoietic Transplantation and Cellular Therapy (GETH-TC). 2021. Available at: https://www.geth.es/acceso-profesionales/1/guias. Accessed: June 2025.
ECP is recommended for the treatment of cGvHD by the:
- European Dermatology Forum (EDF) - Second-line therapy in patients with SD, SI or SR chronic GvHD1
- UK Photopheresis Society - SR, SD, and SI chronic GvHD patients2
- Italian Society of Hemapheresis and Cell Manipulation/Italian Group for Bone Marrow Transplantation (SIdEM/GITMO) - In patients with chronic GvHD refractory to first-line treatment, ECP is then suggested second-line and subsequent treatment3
- Consensus Conference on Clinical Practice in Chronic GVHD - Second-line therapy of chronic GvHD4
- British Committee for Standard in Haematology/British Society for Blood and Marrow Transplantation (BCSH/BSBMT) - Second-line therapy in skin, oral or liver chronic GvHD5
- German Society of Hematology and Medical Oncology (DGHO) - ECP recommended as a salvage therapy for chronic GvHD, with steroid-sparing effect, good tolerance, and a venous access requirement6
- Nordic ECP Quality Group - Patients with SR, SD or SI chronic GvHD7
- European Group for Blood & Marrow Transplantation (EBMT) - Listed as one of 11 second-line therapies. ECP may be used in first-line in association with steroids (grade of recommendation 2C) and as a second-line therapy in SR-cGvHD (grade 2B)8
- Group of Hematopoietic Transplantation and Cellular Therapy (GETH) - ECP recommended as a second-line treatment due to its effectiveness and safety profiles as well as due to the broad clinical experience in patients with cGvHD9
ECP, extracorporeal photopheresis; GvHD, graft-versus-host disease; SD, steroid-dependent; SI, steroid-intolerant; SR, steroid-refractory; UK, United Kingdom.
1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716. 2. Alfred A, et al. Br J Haematol. 2017;177:287-310. 3. Colpo A, et al. Transfus Apher Sci. 2024;63(5):103990. 4. Wolff D, et al. Biol Blood Marrow Transplant. 2011;17(1):1-17. 5. Dignan FL, et al. Br J Haematol. 2012;158(1):46-61. 6. Wolff D, et al. Graft-versus-Host Erkrankung, chronisch. 2023. https://www.onkopedia.com/de/onkopedia/guidelines/graft-versus-hosterkrankung-chronisch/@@guideline/html/index.html. Accessed June 2025. 7. Nygaard M, et al. Eur J Haematol. 2020;104:361-375. 8. Penack O, et al. Lancet Haematol. 2020;7:e157-e167. 9. Spanish comprehensive clinical practice guideline of Graft-versus-Host Disease. Spanish Group of Hematopoietic Transplantation and Cellular Therapy (GETH-TC). 2021. Available at: https://www.geth.es/acceso-profesionales/1/guias. Accessed: June 2025.
ECP is recommended for lung transplant patients by the:
- European Dermatology Forum (EDF) - Salvage therapy for lung transplant rejection when conventional therapies do not produce an adequate response1
- American Society for Apheresis (ASFA) -
- Chronic Lung Allograft Dysfunction2
- Bronchiolitis Obliterans Syndrome2
ECP, extracorporeal photopheresis.
1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2021;35(1):27-49. 2. Connelly-Smith L, et al. J Clin Apher. 2023;38(2): 77-278.
ECP is recommended for heart transplant patients by the:
- American Society for Apheresis (ASFA) -
- Recurrent or resistant acute cellular rejection1
- Rejection prophylaxis1
- UK Photopheresis Society - Cardiac transplant rejection2
- International Society for Heart and Lung Transplant (ISHLT) - Can be considered for recurrent or resistant rejection3
ECP, extracorporeal photopheresis; UK, United Kingdom.
1. Connelly-Smith L, et al. J Clin Apher. 2023;38(2): 77-278. 2. Alfred A, et al. Br J Haematol. 2017;177:287-310. 3. Costanzo M, et al. The Journal of Heart and Lung Transplantation 2010; 29(8):914-956.
CTCL
Other therapies
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.
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.UVADEXTMPrescribing Information 2020. 6. Heald P, et al. J Am Acad Dermatol. 1992;27:427-433. 7. Owsianowski M, et al. Bone Marrow Transplant. 1994;14:845-848. 8. Andreu G, et al. J Heart Lung Transplant. 1995;14:793-796. 9. Barr ML, et al. N Engl J Med. 1998;339:1744-1751. 10. Greinix HT, et al. Haematologica. 2006;91(3):405-408. 11. Couriel DR, et al. Blood. 2006;107(8):3074-3080. 12. Benden C, et al. Transplantation. 2008;86(11):1625-1627. 13.Flowers MED, et al. Blood. 2008;112:2667-2674. 14. Quaglino P, et al. Int J Immunopathol Pharmacol. 2009;22:353-362. 15.Papp G, et al. Clin Immunol. 2012;142:150-159. 16. Horina et al. The Lancet. 1995;346:61. 17. Sunder-Plassman et al. The Lancet. 1995;346(8973):506.
ECP Guidelines and Recommendations Summary
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