Induction therapy in lung transplantation: A prospective, controlled clinical trial comparing OKT3, anti-thymocyte globulin, and daclizumab

Malcolm V. Brock, Marvin C. Borja, Lawrence Ferber, Jonathan B. Orens, Roberto A. Anzcek, Jerry Krishnan, Steven C. Yang, John V. Conte

Research output: Contribution to journalArticle

108 Citations (Scopus)

Abstract

Background: Because acute rejection is associated with inferior outcomes in lung transplantation, we have routinely employed OKT3, anti-thymocyte globulin (ATG), or daclizumab as adjuncts to reduce rejection. Method: We performed a 4-year prospective, controlled clinical trial of these 3 therapies to determine differences in post-operative infection, rejection, survival, and bronchiolitis obliterans syndrome (BOS). Eighty-seven consecutive lung transplant patients received OKT3 (n = 30), ATG (n = 34), and daclizumab (n = 23) as induction agents. The groups had similar demographics and immunosuppression protocols differing only in induction agents used. Results: No differences were observed in immediate post-operative outcomes such as length of hospitalization, ICU stay, or time on ventilators. Twelve months post-transplant, OKT3 had more infections per patient than the other agents, a difference that only became significant 2 months post-operatively (p = 0.009). The most common infection was bacterial and OKT3 had more bacterial infections than any other agent. Daclizumab had more patients remain infection free in the first year (p = 0.02), having no fungal infections and a low rate of viral infections. No patient receiving daclizumab developed drug specific side-effects. Only those patients with episodes of acute rejection developed BOS. There were no significant differences in the freedom from acute rejection or BOS between the groups. The 2-year survival for the entire cohort was 68%, with no differences observed in patient survival. Conclusions: This study again reveals the importance of acute rejection in the subsequent development of BOS. Although daclizumab offers a low risk of post-transplant infection and drug specific side-effects, no drug is superior in delaying rejection or BOS or in prolonging long-term survival.

Original languageEnglish (US)
Pages (from-to)1282-1290
Number of pages9
JournalJournal of Heart and Lung Transplantation
Volume20
Issue number12
DOIs
StatePublished - Dec 1 2001

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Bronchiolitis Obliterans
Muromonab-CD3
Antilymphocyte Serum
Lung Transplantation
Controlled Clinical Trials
Drug-Related Side Effects and Adverse Reactions
Survival
Infection
Transplants
Bacterial Infections
Therapeutics
Mycoses
Proxy
Virus Diseases
Mechanical Ventilators
Immunosuppression
Hospitalization
Demography
daclizumab
Lung

All Science Journal Classification (ASJC) codes

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine
  • Transplantation

Cite this

Brock, Malcolm V. ; Borja, Marvin C. ; Ferber, Lawrence ; Orens, Jonathan B. ; Anzcek, Roberto A. ; Krishnan, Jerry ; Yang, Steven C. ; Conte, John V. / Induction therapy in lung transplantation : A prospective, controlled clinical trial comparing OKT3, anti-thymocyte globulin, and daclizumab. In: Journal of Heart and Lung Transplantation. 2001 ; Vol. 20, No. 12. pp. 1282-1290.
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abstract = "Background: Because acute rejection is associated with inferior outcomes in lung transplantation, we have routinely employed OKT3, anti-thymocyte globulin (ATG), or daclizumab as adjuncts to reduce rejection. Method: We performed a 4-year prospective, controlled clinical trial of these 3 therapies to determine differences in post-operative infection, rejection, survival, and bronchiolitis obliterans syndrome (BOS). Eighty-seven consecutive lung transplant patients received OKT3 (n = 30), ATG (n = 34), and daclizumab (n = 23) as induction agents. The groups had similar demographics and immunosuppression protocols differing only in induction agents used. Results: No differences were observed in immediate post-operative outcomes such as length of hospitalization, ICU stay, or time on ventilators. Twelve months post-transplant, OKT3 had more infections per patient than the other agents, a difference that only became significant 2 months post-operatively (p = 0.009). The most common infection was bacterial and OKT3 had more bacterial infections than any other agent. Daclizumab had more patients remain infection free in the first year (p = 0.02), having no fungal infections and a low rate of viral infections. No patient receiving daclizumab developed drug specific side-effects. Only those patients with episodes of acute rejection developed BOS. There were no significant differences in the freedom from acute rejection or BOS between the groups. The 2-year survival for the entire cohort was 68{\%}, with no differences observed in patient survival. Conclusions: This study again reveals the importance of acute rejection in the subsequent development of BOS. Although daclizumab offers a low risk of post-transplant infection and drug specific side-effects, no drug is superior in delaying rejection or BOS or in prolonging long-term survival.",
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Induction therapy in lung transplantation : A prospective, controlled clinical trial comparing OKT3, anti-thymocyte globulin, and daclizumab. / Brock, Malcolm V.; Borja, Marvin C.; Ferber, Lawrence; Orens, Jonathan B.; Anzcek, Roberto A.; Krishnan, Jerry; Yang, Steven C.; Conte, John V.

In: Journal of Heart and Lung Transplantation, Vol. 20, No. 12, 01.12.2001, p. 1282-1290.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Induction therapy in lung transplantation

T2 - A prospective, controlled clinical trial comparing OKT3, anti-thymocyte globulin, and daclizumab

AU - Brock, Malcolm V.

AU - Borja, Marvin C.

AU - Ferber, Lawrence

AU - Orens, Jonathan B.

AU - Anzcek, Roberto A.

AU - Krishnan, Jerry

AU - Yang, Steven C.

AU - Conte, John V.

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N2 - Background: Because acute rejection is associated with inferior outcomes in lung transplantation, we have routinely employed OKT3, anti-thymocyte globulin (ATG), or daclizumab as adjuncts to reduce rejection. Method: We performed a 4-year prospective, controlled clinical trial of these 3 therapies to determine differences in post-operative infection, rejection, survival, and bronchiolitis obliterans syndrome (BOS). Eighty-seven consecutive lung transplant patients received OKT3 (n = 30), ATG (n = 34), and daclizumab (n = 23) as induction agents. The groups had similar demographics and immunosuppression protocols differing only in induction agents used. Results: No differences were observed in immediate post-operative outcomes such as length of hospitalization, ICU stay, or time on ventilators. Twelve months post-transplant, OKT3 had more infections per patient than the other agents, a difference that only became significant 2 months post-operatively (p = 0.009). The most common infection was bacterial and OKT3 had more bacterial infections than any other agent. Daclizumab had more patients remain infection free in the first year (p = 0.02), having no fungal infections and a low rate of viral infections. No patient receiving daclizumab developed drug specific side-effects. Only those patients with episodes of acute rejection developed BOS. There were no significant differences in the freedom from acute rejection or BOS between the groups. The 2-year survival for the entire cohort was 68%, with no differences observed in patient survival. Conclusions: This study again reveals the importance of acute rejection in the subsequent development of BOS. Although daclizumab offers a low risk of post-transplant infection and drug specific side-effects, no drug is superior in delaying rejection or BOS or in prolonging long-term survival.

AB - Background: Because acute rejection is associated with inferior outcomes in lung transplantation, we have routinely employed OKT3, anti-thymocyte globulin (ATG), or daclizumab as adjuncts to reduce rejection. Method: We performed a 4-year prospective, controlled clinical trial of these 3 therapies to determine differences in post-operative infection, rejection, survival, and bronchiolitis obliterans syndrome (BOS). Eighty-seven consecutive lung transplant patients received OKT3 (n = 30), ATG (n = 34), and daclizumab (n = 23) as induction agents. The groups had similar demographics and immunosuppression protocols differing only in induction agents used. Results: No differences were observed in immediate post-operative outcomes such as length of hospitalization, ICU stay, or time on ventilators. Twelve months post-transplant, OKT3 had more infections per patient than the other agents, a difference that only became significant 2 months post-operatively (p = 0.009). The most common infection was bacterial and OKT3 had more bacterial infections than any other agent. Daclizumab had more patients remain infection free in the first year (p = 0.02), having no fungal infections and a low rate of viral infections. No patient receiving daclizumab developed drug specific side-effects. Only those patients with episodes of acute rejection developed BOS. There were no significant differences in the freedom from acute rejection or BOS between the groups. The 2-year survival for the entire cohort was 68%, with no differences observed in patient survival. Conclusions: This study again reveals the importance of acute rejection in the subsequent development of BOS. Although daclizumab offers a low risk of post-transplant infection and drug specific side-effects, no drug is superior in delaying rejection or BOS or in prolonging long-term survival.

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