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Efficacy and Safety

Efficacy: Thymoglobulin® [Anti-thymocyte Globulin (Rabbit)] Offers Proven, Proactive Protection Against Acute Rejection in Kidney Transplant1

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Thymoglobulin Demonstrated Superiority to Basiliximab in Reducing Treatment Failure1

The open-label, randomized, active-controlled trial compared the efficacy and safety of Thymoglobulin and of basiliximab in kidney transplant patients at increased risk for acute rejection or delayed graft function.1,2

A schematic diagram titled "Study Design: Open-label, randomized, active-controlled trial¹." On the left, a teal box reads: "Deceased donor kidney transplant patients at increased risk for acute rejection or delayed graft function (N=278)." A circle in the center shows "1:1 R." To the right of the circle, two treatment boxes appear: a green box labeled "Thymoglobulin 1.5 mg/kg on days 0–4 (n=141)" and a gray box labeled "Basiliximab 20 mg on days 0 and 4 (n=137)." On the far right, a teal box labeled "Primary End Point" contains the text: "Composite of biopsy-proven acute rejection (BPAR) (grade I–III), graft loss, death, and lost to follow-up (considered treatment failure)."
  • First induction treatment was initiated prior to reperfusion of the kidney1
  • All patients received triple-maintenance immunosuppression involving cyclosporine, MMF, and corticosteroids1
  • Patients were followed for 12 months or until they were withdrawn from the study or lost to follow-up1

Thymoglobulin Significantly Reduced Treatment Failure Rates Compared to Basiliximab1,*

Treatment failure was based on the composite end point of BPAR, graft loss, death, or lost to follow-up within 12 months.1

The image presents "Treatment failure at 12 months¹," showing a grey bar for Basiliximab with "38%" labeled "Basiliximab (n=52/137)" and a green bar for Thymoglobulin with "25%" labeled "Thymoglobulin (n=35/141)" and "P=0.02," alongside text stating "34% Relative reduction in treatment failure associated with Thymoglobulin compared with Basiliximab." Below this, a table titled "Individual components¹" lists the following parameters with their respective values: for BPAR†, Thymoglobulin shows 18 (13%) and Basiliximab 29 (21%) with a difference of –8% (–17.2% to 0.4%); for Graft loss, Thymoglobulin 11 (8%) and Basiliximab 13 (10%); for Death, Thymoglobulin 6 (4%) and Basiliximab 6 (4%); and for Lost to follow-up⁸, Thymoglobulin 7 (5%) and Basiliximab 11 (8%).

* The original primary end point of the trial published by Brennan et al was a composite of the first occurrence of BPAR, DGF, graft loss, or death.2 The FDA filing used a new composite end point, which removed DGF and included lost to follow-up, accounting for differences in the Brennan et al data compared with the Thymoglobulin label.3 The composite end point is defined as the occurrence of any of the following: BPAR (grade I-III), graft loss, death, or lost to follow-up. A patient can be counted in more than 1 category with the exception of lost to follow-up.1

†Treatment failure was defined as a composite of BPAR, graft loss, death, and lost to follow-up.1

‡BPAR is defined as the destruction of transplanted tissue or organ by the host’s immune system that has been confirmed clinically by decreased transplant organ function and biopsy.2

§Lost to follow-up was defined as not having BPAR, graft loss, or death within 12 months post transplantation, and last visit date was prior to the lower bound of 12-month window (12 months ± 30 days after transplantation).1

Thymoglobulin Demonstrated Non-inferiority to Daclizumab in Reducing Treatment Failure1

The open-label, randomized, active-controlled, investigator-sponsored trial compared BPAR incidence in high-immunological-risk renal transplant patients (n=230) receiving induction therapy with either Thymoglobulin or daclizumab.1,4

A schematic diagram titled "Study design is described as an open-label, randomized, active-controlled trial¹." On the left, a teal box reads: "Deceased donor kidney transplant patients at higher immunological risk of rejection (N=230)." A circle in the center shows “1:1 R.” To the right of the circle, two treatment boxes appear: a green box labeled "Thymoglobulin 1.25 mg/kg on days 0–7 (n=114)" and a gray box labeled "Daclizumab 1 mg/kg on days 0, 14, 28, 42, and 56 (n=116)." On the far right, a teal box labeled "Primary End Point" contains the text: "Composite of BPAR (grade I–III), graft loss, death, and lost to follow-up (considered treatment failure)."
  • First induction treatment was initiated prior to reperfusion of the kidney1
  • All patients received triple-maintenance immunosuppression involving cyclosporine, MMF, and corticosteroids1
  • Patients were followed for 12 months or until they were withdrawn from the study or lost to follow-up1

Thymoglobulin Significantly Reduced Treatment Failure Rates Compared to Daclizumab1

Treatment failure was based on the composite end point of BPAR, graft loss, death, or lost to follow-up within 12 months.1

The image shows "Treatment failure at 12 months¹" with a grey bar labeled "34%" for Basiliximab (n=39/116) and a green bar labeled "25%" for Thymoglobulin (n=29/114). To the right of the bars, text reads "26% Relative reduction in treatment failure associated with Thymoglobulin compared with Daclizumab." Below this, a table titled "Components of Composite End Point⁸" includes the following rows: for BPAR, Thymoglobulin (n=114) shows 12 (11%) and Basiliximab (n=116) shows 24 (21%) with a difference of –10% (–19.4% to 0.9%); for Graft loss, Thymoglobulin shows 17 (15%) and Basiliximab 13 (11%); for Death, Thymoglobulin shows 5 (4%) and Basiliximab 4 (3%); and for Lost to follow-up¹, Thymoglobulin shows 2 (2%) and Basiliximab 3 (3%).

* Maximum dose of 100 mg.1

†The original primary end point of the trial published by Noël et al was BPAR within 1 year.4 The FDA filing used a common composite end point that included BPAR (grade I-III), graft loss, death, or lost to follow-up, which was included in the Thymoglobulin prescribing information. Different end points account for the differences in the treatment failure rate between the Noël publication and the Thymoglobulin prescribing information.3

‡ Lost to follow-up was defined as not having BPAR, graft loss, or death within 12 months post transplantation, and last visit date was prior to the lower bound of 12-month window (12 months ± 30 days post transplantation).1

Efficacy and Safety of Thymoglobulin: Background and Overview of Pivotal Studies

Understanding how Thymoglobulin may help in the prevention and treatment of acute rejection.

Thymoglobulin Adverse Reactions and Laboratory Abnormalities1

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The image presents a table titled "Adverse reactions and laboratory abnormalities reported more frequently (incidence >5%) following Thymoglobulin vs basiliximab¹." Two sections are shown: Adverse reactions, n (%)* and Laboratory abnormalities†, comparing Thymoglobulin (n=141) and Basiliximab (n=137). Adverse reactions reported were: Urinary tract infection—55 (39%) vs 36 (26%); Pyrexia—39 (28%) vs 25 (18%); Headache—26 (18%) vs 17 (12%); Hyperlipidemia (high blood lipids)—21 (15%) vs 9 (7%); Anxiety—20 (14%) vs 12 (9%); Chills—13 (9%) vs 5 (4%). Laboratory abnormalities included: Leukopenia (low WBC count)—89 (63%) vs 20 (15%); Hyperkalemia (high potassium)—81 (57%) vs 70 (51%); Thrombocytopenia (low platelet count)—23 (16%) vs 7 (5%).

* Adverse reactions are TEAEs reported as related in at least 1 patient.1

†Leukopenia:  WBC <3,000 cells /mm3;  hyperkalemia: blood potassium ≥5.5 mmol /L;  thrombocytopenia: platelet count <75,000 cells/mm3.1

  • Infections occurred in 76% of patients treated with Thymoglobulin (severe in 23%) and in 63% of patients treated with basiliximab (severe in 15%)1

Please see additional Important Safety Information below and click here for full Prescribing Information.

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Important Safety Information

WARNING: IMMUNOSUPPRESSION. Thymoglobulin should only be used by physicians experienced in immunosuppressive therapy in transplantation.
  • Contraindications. Thymoglobulin is contraindicated in patients with a history of allergy or anaphylaxis to rabbit proteins or to any product excipients, or who have active acute or chronic infections which contraindicate any additional immunosuppression.
  • Management of Immunosuppression. To prevent over-immunosuppression, physicians may wish to decrease the dose of the maintenance immunosuppression regimen during the period of Thymoglobulin use. Dosing for Thymoglobulin is different from dosing for other ATG products, because protein composition and concentrations vary depending on the source of ATG. Thymoglobulin should be used under strict medical supervision in a hospital setting, and patients should be carefully monitored during the infusion.
  • Immune Mediated Reactions. Serious immune-mediated reactions, including anaphylaxis or severe cytokine release syndrome (CRS), have been reported with the use of Thymoglobulin. Fatal anaphylaxis has been reported. If an anaphylactic reaction occurs, the infusion should be terminated immediately.
  • Infusion-Associated Reactions. Cases consistent with cytokine release syndrome (CRS) have been reported with rapid infusion rates. CRS is attributed to the release of cytokines by activated monocytes and lymphocytes. Severe acute CRS can cause serious cardiorespiratory events and/or death. Close compliance with the recommended dosage and infusion time may reduce the incidence and severity of infusion-associated reactions (IARs). Slowing the infusion rate may minimize many of these IARs. Reactions at the infusion site may include pain, swelling, and redness of the skin.
  • Hematologic Effects. Low counts of platelets and white blood cells (including low counts of lymphocytes and neutrophils) have been identified and are reversible following dose adjustments. Total white blood cell and platelet counts should be monitored.
  • Infection and Malignancy. Infections, reactivation of infection, febrile neutropenia, sepsis, malignancies including lymphoproliferative disorders (LPD) and other lymphomas as well as solid tumors have been reported after Thymoglobulin administration in combination with multiple immunosuppressive agents. These events can be fatal.
  • Immunization. The safety of immunization with attenuated live vaccines following Thymoglobulin therapy has not been studied; therefore, immunization with attenuated live vaccines is not recommended for patients who have recently received Thymoglobulin.
  • Overdosage. Thymoglobulin overdosage may result in leukopenia (including lymphopenia and neutropenia) and/ or thrombocytopenia, which can be managed with dose reduction.
  • Adverse Reactions. The most common adverse reactions and laboratory abnormalities (incidence >5% higher than comparator) are urinary tract infection, abdominal pain, hypertension, nausea, shortness of breath, fever, headache, anxiety, chills, increased potassium levels in the blood, and low counts of platelets and white blood cells.
  • During post-marketing surveillance, arthralgia/myalgia, lymphadenopathy, proteinuria, and decreased oxygen saturation tend to occur 5 to 15 days after Thymoglobulin infusion and are consistent with serum sickness. Symptoms are manageable with corticosteroid treatment.

Click here for full Prescribing Information including Boxed WARNING.

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Important Safety Information

Abbreviations: CI, confidence interval; DGF, delayed graft function; FDA, Food and Drug Administration; MMF; Mycophenolate mofetil; TEAE, treatment-emergent adverse event; WBC, white blood cell.

References:

1. Thymoglobulin [prescribing information]. Cambridge, MA: Genzyme Corporation; 2026.
2. Brennan DC, Daller JA, Lake KD, Cibrik D, Del Castillo D; Thymoglobulin Induction Study Group. Rabbit antithymocyte globulin versus basiliximab in renal transplantation. N Engl J Med. 2006;355(19):1967-1977.
3. Data on file. sBLA Section 2.5. Sanofi Genzyme, 2015.
4. Noel C, Abramowicz D, Durand D, et al. Daclizumab versus antithymocyte globulin in high-immunological-risk renal transplant recipients. J Am Soc Nephrol. 2009;20(6):1385-1392.

Thymoglobulin and Sanofi are registered trademarks of Sanofi or an affiliate. MAT-US-2600050-v1.0-03/2026

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