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Published on: November 8, 2015
Tacrolimus Exerts Only a Transient Effectiveness in Refractory Pediatric Crohn Disease: A Case Series
Oriane Truffinet1, Christine Martinez-Vinson, Emilie Guerriero
1*Pediatric Gastroenterology Department †Pharmacy Department, Hôpital Robert-Debré, Assistance Publique-Hôpitaux de Paris ‡Université Paris Diderot-Sorbonne Paris Cité and INSERM UMR1149, Paris, France.
Insights
Tacrolimus shows transient effectiveness in treating pediatric refractory Crohn disease (CD) colitis, with frequent adverse events. It may serve as a bridge therapy to other treatments in children with CD.
Area of Science:
- Pediatric Gastroenterology
- Immunosuppressive Therapy
- Inflammatory Bowel Disease
Background:
- Tacrolimus, an immunosuppressive agent, has been explored for severe ulcerative colitis.
- Refractory Crohn disease (CD) colitis in children presents a significant treatment challenge.
Purpose of the Study:
- To evaluate the effectiveness and safety of oral tacrolimus in pediatric patients with refractory CD colitis.
- To assess clinical response and remission rates during tacrolimus treatment.
Main Methods:
- A study included 8 children with refractory CD colitis treated with oral tacrolimus.
- Patients were refractory to steroids and infliximab.
- Clinical response and remission were monitored using the Pediatric Crohn Disease Activity Index (PCDAI) over 24 months. Tacrolimus blood levels and adverse events were recorded.
Main Results:
- At 2 months, 6/8 patients showed clinical response and 4/8 achieved remission, with a significant PCDAI decrease (P=0.004).
- Mean tacrolimus plasma levels were 8.75 ng/mL at 2 months.
- Adverse events occurred in 6/8 patients, including renal dysfunction and diabetes, necessitating treatment interruption in 2 cases.
Conclusions:
- Tacrolimus can be considered for transient treatment of refractory pediatric CD colitis.
- It may function as a bridge therapy to alternative medical options for children with CD.
- Frequent adverse events associated with tacrolimus require careful consideration.
Objectives:
Tacrolimus is an immunosuppressive agent that has been proposed in the treatment of severe ulcerative colitis. The present study examined the effectiveness and safety of tacrolimus in treating refractory Crohn disease (CD) colitis in children.
Methods:
All children treated by oral tacrolimus for CD colitis at a tertiary pediatric center were included in the study. All patients were refractory to steroids and infliximab. Clinical response (decreased pediatric CD activity index [PCDAI] >15 and PCDAI <30) and remission (PCDAI <10) were monitored at 2, 4, 6, 12, and 24 months after induction. Tacrolimus blood levels and adverse effects were also noted.
Results:
Among 220 patients with CD, 8 children (including 3 girls, median age 14 [9.5-18] years) were registered with a median PCDAI of 58.7 (32.5-65) before tacrolimus initiation. In patients treated with tacrolimus, the overall clinical response rates were 6/8, 3/8, 2/8, 2/8, and 1/8 with a remission rate of 4/8, 0/8, 0/8, 2/8, and 0/8 at 2, 4, 6, 12, and 24 months, respectively. At 2 months, the PCDAI scores were lower than those at induction (median 11.2; P = 0.004) with the mean whole plasma level of tacrolimus being 8.75 ng/mL (5.9-10 ng/mL). Adverse events occurred in 6 of 8 patients, including renal dysfunction, insulin-dependent diabetes, paresthesia, and tremor. Tacrolimus interruption was required in 2 cases.
Conclusions:
Tacrolimus could be considered to transiently treat refractory CD colitis. Tacrolimus could be used as a "bridge" toward another medical option in pediatric CD, although its adverse events are frequent.
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