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HomeEfficacyATGAM® efficacyEfficacy homeTrial: ATGAM® versus rabbit ATGTrial: ATGAM® ± sirolimusTrial: ATGAM® other pivotal studiesSafetyDosing & administrationSupport & resourcesMaterialVideo

Information on how to access prescribing information and adverse event reporting can be found towards the bottom of the page.

ATGAM® (horse anti-human T-lymphocyte immunoglobulin) efficacy



Atgam is indicated for use in adults and in children aged 2 years and older for the treatment of acquired moderate to severe aplastic anaemia of known or suspected immunologic aetiology as part of standard immunosuppressive therapy in patients who are unsuitable for haematopoietic stem cell transplantation (HSCT) or for whom a suitable HSC donor is not available.

ATGAM® is associated with partial or complete haematologic recoverya and improved survival rates in patients with aplastic anaemia of known or suspected immunologic aetiology in patients who are unsuitable for bone marrow transplant1, 3-6

Key points from the five clinical studies1, 3-6

Example

The efficacy data for ATGAM are derived from five clinical
studies1, 3-6

One study compared 77 patients treated with ATGAM® + CsA across 4 days with or without the addition of the immunosuppressant drug, sirolimus.1, 3

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Another study investigated 120 patients treated with ATGAM® + CsA versus rabbit ATG + CsA.1, 4

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Three studies evaluated the efficacy of ATGAM® across 8 or 10 days in a total of 115 patients with moderate-to-severe aplastic anaemia.1, 5, 6

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The haematologic response ratesb with ATGAM® + CsA at 6 months were statistically superior to those for rabbit ATG + CsA, those with ATGAM showing response rates of 68% versus 37% for rATG (p<0.001)4Current guidelines recommend the standard first-line IST for the treatment of acquired moderate-to-severe aplastic anaemia in patients who are unsuitable for HSCT is ATG derived from horse, combined with another immune system-inhibiting drug, CsA1,2AA, aplastic anaemia; ATG, anti-thymocyte globulin; CsA, ciclosporin A; HSCT, haematopoietic stem-cell transplantation; IST, immunosuppressive therapy; HSC, haematopoietic stem cell.

aHematologic response is defined differently in different studies. This will be defined throughout when referring to specific studies.
bHematologic response defined as no longer meeting criteria for severe aplastic anaemia.2
References:ATGAM® Summary of Product Characteristics. Pfizer Inc. Killick SB, et al. Br J Haematol. 2016;172(2):187–20; Scheinberg P, et al. Haematologica. 2009;94(3):348–54.Scheinberg P, et al. N Engl J Med. 2011;365(5):430–8.Champlin R, et al. N Engl J Med. 1983;308:113-118Champlin RE, et al. Blood. 1985;66:184-188
Prescribing Information
Click here for Prescribing Information for ATGAM (horse anti-human T-lymphocyte immunoglobulin)
ATGAM® efficacyLearn about the safety profile of ATGAM®  Find out more LoadingLearn about ATGAM® dosing & administration Find out more LoadingMore information is available in support & resources Find out more Loading
PP-ATG-GBR-0025. February 2023

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