Gilles Boschetti1, Stéphane Nancey2, Driffa Moussata3, Carmen Stefanescu4, Xavier Roblin5, Marion Chauvenet3, Karine Stroeymeyt3, Yoram Bouhnik4, Bernard Flourié1. 1. INSERM U-1111 CIRI (International Center for Infectiology Research) and University Claude Bernard Lyon 1, Lyon, France; Hospices Civils de Lyon, Department of Gastroenterology, Lyon-Sud Hospital, Pierre-Bénite, France. 2. INSERM U-1111 CIRI (International Center for Infectiology Research) and University Claude Bernard Lyon 1, Lyon, France; Hospices Civils de Lyon, Department of Gastroenterology, Lyon-Sud Hospital, Pierre-Bénite, France. Electronic address: stephane.nancey@chu-lyon.fr. 3. Hospices Civils de Lyon, Department of Gastroenterology, Lyon-Sud Hospital, Pierre-Bénite, France. 4. Assistance Publique-Hopitaux de Paris, Department of Gastroenterology, Beaujon Hospital, Clichy, France. 5. Department of Gastroenterology, Saint-Etienne University Hospital, Saint-Etienne, France.
Abstract
BACKGROUND: Tacrolimus in refractory ulcerative colitis often serves as a bridge to long-term maintenance therapy with thiopurines. Our aim was to review efficacy and safety of tacrolimus in active ulcerative colitis resistant to conventional therapies, including anti-tumour necrosis factor. METHODS: Charts of consecutive outpatients with refractory ulcerative colitis, in whom tacrolimus was orally administered as a 12 week-induction (target trough levels 10-15ng/mL) followed by a maintenance therapy (target trough levels 5-10ng/mL), were retrospectively reviewed. Clinical remission and response at weeks 4, 12 and 52 as well as adverse events within 1-year therapy were reported. RESULTS: Twelve (40%) and six (20%) of the 30 patients included (14 males, mean age 37.1±1.4 years) achieved a clinical remission and response, respectively, at week 12. Three responders to tacrolimus initiation experienced drug-related adverse events requiring discontinuation. Among the 18 remaining initial responders who tolerated tacrolimus, 8 (27%) were in clinical remission at week 52, whereas the remainder either experienced adverse events requiring drug withdrawal (n=4) or relapsed (n=6). Overall adverse events were recorded in 14 patients (46%), mainly finger tremor and urinary infections. CONCLUSION: Oral monotherapy with tacrolimus may be a valuable long-term therapeutic option in selected patients with moderate-to-severe active refractory ulcerative colitis.
BACKGROUND:Tacrolimus in refractory ulcerative colitis often serves as a bridge to long-term maintenance therapy with thiopurines. Our aim was to review efficacy and safety of tacrolimus in active ulcerative colitis resistant to conventional therapies, including anti-tumour necrosis factor. METHODS: Charts of consecutive outpatients with refractory ulcerative colitis, in whom tacrolimus was orally administered as a 12 week-induction (target trough levels 10-15ng/mL) followed by a maintenance therapy (target trough levels 5-10ng/mL), were retrospectively reviewed. Clinical remission and response at weeks 4, 12 and 52 as well as adverse events within 1-year therapy were reported. RESULTS: Twelve (40%) and six (20%) of the 30 patients included (14 males, mean age 37.1±1.4 years) achieved a clinical remission and response, respectively, at week 12. Three responders to tacrolimus initiation experienced drug-related adverse events requiring discontinuation. Among the 18 remaining initial responders who tolerated tacrolimus, 8 (27%) were in clinical remission at week 52, whereas the remainder either experienced adverse events requiring drug withdrawal (n=4) or relapsed (n=6). Overall adverse events were recorded in 14 patients (46%), mainly finger tremor and urinary infections. CONCLUSION: Oral monotherapy with tacrolimus may be a valuable long-term therapeutic option in selected patients with moderate-to-severe active refractory ulcerative colitis.