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

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Efficacy
ATGAM®▼ (horse anti-human T-lymphocyte immunoglobulin) ± sirolimus

Haematological responsea, b at 6 months is 62% following ATGAM® + CsA treatment. The addition of sirolimus did not improve
outcomes1, 2

A prospective, randomised study comparing the haematological response of ATGAM® 40 mg/kg/day for 4 days + CsA (15 mg/kg/day for children under 12) with or without the addition of another immunosuppressant drug, sirolimus (1 mg/m2/day in children <40 kg). The study included 77 patients, 4 to 78 years of age, who were treated from June 2003 to October 20052

Example

In patients receiving ATGAM® (40 mg/kg/day for 4 days) + CsA only, overall completeb and partialc haematological response rates were 57% and 62% at 3 or 6 months, compared with 37% and 51% in the ATGAM® + CsA + sirolimus arm2

The overall haematologic response rate of patients with ATGAM® + CsA with and without sirolimus. Results include both completeb and partialc haematologic response2

 Title
The survival rate was 97% at 3 years with ATGAM® + CsA + sirolimus, compared to 90% with ATGAM® + CsA. The addition of sirolimus did not significantly improve rates of relapse, clonal evolution and survival compared to ATGAM and CsA alone2 
ATG, anti-thymocyte globulin; CsA, ciclosporin A; SAA, severe aplastic anaemia.

aA complete response was defined as satisfaction of all three peripheral blood count criteria: (i) absolute neutrophil count > 1x109/L; (ii) hemoglobin > 10 g/dL; (iii) platelet count 100x109/L
bA partial response is defined as blood counts no longer satisfying criteria for severe aplastic anemia but insufficient for a complete responseReferences:ATGAM® Summary of Product Characteristics. Pfizer Inc. Scheinberg P, et al. Haematologica. 2009;94(3):348–54.


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 Explore resources Loading
PP-ATG-GBR-0025. February 2023

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