Three-year outcomes in kidney transplant patients randomized to steroid-free immunosuppression or steroid withdrawal, with enteric-coated mycophenolate sodium and cyclosporine: the infinity study.
In a six-month, multicenter, open-label trial, de novo kidney transplant recipients at low immunological risk were randomized to steroid avoidance or steroid withdrawal with IL-2 receptor antibody (IL-2RA) induction, enteric-coated mycophenolate sodium (EC-MPS: 2160 mg/day to week 6, 1440 mg/day thereafter), and cyclosporine. Results from a 30-month observational follow-up study are presented. Of 166 patients who completed the core study on treatment, 131 entered the follow-up study (70 steroid avoidance, 61 steroid withdrawal). The primary efficacy endpoint of treatment failure (clinical biopsy-proven acute rejection (BPAR) graft loss, death, or loss to follow-up) occurred in 21.4% (95% CI 11.8-31.0%) of steroid avoidance patients and 16.4% (95% CI 7.1-25.7%) of steroid withdrawal patients by month 36 (P = 0.46). BPAR had occurred in 20.0% and 11.5%, respectively (P = 0.19). The incidence of adverse events with a suspected relation to steroids during months 6-36 was 22.9% versus 37.1% (P = 0.062). By month 36, 32.4% and 51.7% of patients in the steroid avoidance and steroid withdrawal groups, respectively, were receiving oral steroids. In conclusion, IL-2RA induction with early intensified EC-MPS dosing and CNI therapy in de novo kidney transplant patients at low immunological risk may achieve similar three-year efficacy regardless of whether oral steroids are withheld for at least three months.
Service de Néphrologie, Hémodialyse et Transplantation Rénale, Hôpital La Milétrie, et INSERM U927, CHU, 86021 Poitiers, France.
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Thierry
Service de Néphrologie et Transplantation Rénale, Hôpital Lapeyronie, 371 rue du Doyen Gaston Giraud, 34295 Montpellier, France.
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Mourad
Service de Transplantation Rénale, CHU Bretonneau, 2, Boulevard Tonnellé, 37044 Tours Cedex, France.
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Büchler
Service de Néphrologie, Médecine Interne, Dialyse, Transplantation Rénale et Réanimation, Hôpital Sud, Avenue Laënnec, 80054 Amiens Cedex 1, France ; CHU Amiens et INSERM ERI-12, Université Jules Verne Picardie, Chemin du Thil, 80000 Amiens, France.
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Choukroun
Service de Néphrologie et Transplantation Rénale, Hôpital Maison Blanche, 45 rue Cognacq Jay, 51092 Reims Cedex, France.
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Toupance
Service de Néphrologie-Transplantation, Hôpital de Rangueil, 1 rue Jean Poulhès, 31403 Toulouse Cedex 4, France.
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Kamar
Service de Néphrologie, CHU Angers, 4 rue Larrey, 49033 Angers, France.
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Villemain
Service de Néphrologie et Transplantation Rénale, Hôpital La Cavale Blanche, Boulevard Tanguy Prigent, 29200 Brest, France.
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Le Meur
Service de Néphrologie et Transplantation Rénale, Hôpital Necker, 161 rue de Sèvres, 75015 Paris, France.
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Legendre
Service de Néphrologie et Transplantation Rénale, Hôpital Pellegrin, Place Amélie Raba Léon, 33076 Bordeaux, France.
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Merville
Service de Néphrologie et Transplantation Rénale, CHU de Nancy, rue du Morvan, 54511 Vandoeuvre les Nancy, France.
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Kessler
Service de Néphrologie, Hôpital Gabriel Montpied, rue Montalembert, 63003 Clermont Ferrand Cedex 1, France.
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Heng
Clinique Médicale B, Hôpital Civil, 1 Place de l'Hôpital, 67091 Strasbourg Cedex, France.
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Moulin
Unité Immuno-Transplantation, Novartis Pharma SAS, rue Lionel Terray, 92500 Rueil-Malmaison, France.
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Queré
Unité Immuno-Transplantation, Novartis Pharma SAS, rue Lionel Terray, 92500 Rueil-Malmaison, France.
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Di Giambattista
Unité Immuno-Transplantation, Novartis Pharma SAS, rue Lionel Terray, 92500 Rueil-Malmaison, France.
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Lecuyer
Service de Néphrologie, Hémodialyse et Transplantation Rénale, Hôpital La Milétrie, et INSERM U927, CHU, 86021 Poitiers, France.
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Touchard