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Infliximab versus Cyclosporine Treatment for Severe Corticosteroid-Refractory Ulcerative Colitis: A Korean, Retrospective, Single Center Study.

Kim EH, Kim DH, Park SJ, Hong SP, Kim TI, Kim WH, Cheon JH - Gut Liver (2015)

Bottom Line: A follow-up of 12 months was completed for all patients.In the subgroup analysis, infliximab with azathioprine was superior to cyclosporine for preventing colectomy (hazard ratio of infliximab with azathioprine compared with cyclosporine only, 0.073; 95% confidence interval, 0.008 to 0.629).However, infliximab with azathioprine may be more effective than cyclosporine alone for preventing colectomy.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.

ABSTRACT

Background/aims: In patients with corticosteroid-refractory ulcerative colitis (UC), cyclosporine or infliximab may be added to the treatment regimen to induce remission. Here, we aimed to compare the efficacy of cyclosporine and infliximab.

Methods: Between January 1995 and May 2012, the medical records of 43 patients with corticosteroid-refractory UC who received either infliximab or cyclosporine as a rescue therapy at a tertiary care hospital in Korea were reviewed.

Results: Among the 43 patients, 10 underwent rescue therapy with cyclosporine and the remaining 33 patients received infliximab. A follow-up of 12 months was completed for all patients. The colectomy rate at 12 months was 30% and 3% in the cyclosporine and the infliximab groups, respectively (p=0.034). However, the Cox proportional hazard model indicated that the treatment of rescue therapy was not an independent associate factor for preventing colectomy (p=0.164). In the subgroup analysis, infliximab with azathioprine was superior to cyclosporine for preventing colectomy (hazard ratio of infliximab with azathioprine compared with cyclosporine only, 0.073; 95% confidence interval, 0.008 to 0.629).

Conclusions: No difference between infliximab and cyclosporine with respect to preventing colectomy was noted. However, infliximab with azathioprine may be more effective than cyclosporine alone for preventing colectomy.

No MeSH data available.


Related in: MedlinePlus

Kaplan-Meier plots for colectomy-free survival according to the drug for rescue therapy.
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f1-gnl-09-601: Kaplan-Meier plots for colectomy-free survival according to the drug for rescue therapy.

Mentions: A 12-month follow-up was completed for all patients. Three months after the acute episode requiring either cyclosporine or infliximab treatment, the colectomy rate was 10% (1 of 10) in the cyclosporine group and 0% (0 of 33) in the infliximab group (p=0.233). At 12 months, the colectomy rate increased to 30% in the cyclosporine group versus 3% in the infliximab group (p=0.034) (Table 2). In terms of remission inducing and maintenance rates, clinical remission was achieved numerically more frequently in infliximab group, but that was not statistically significant between the two groups (30.0% vs 45.5%, p=0.485). Moreover, remission maintenance rates at 12 months were also not significantly different between the two groups (20.0% vs 48.5%, p=0.153). At the end of the follow-up, the colectomy had been performed in six of 10 patients and one of 33 patients in the cyclosporine and the infliximab groups, respectively (cyclosporine vs infliximab, 60% vs 3%; p<0.001). In six cases of patients who underwent colectomy after the treatment with cyclosporine, the median time to colectomy was 11.3 months with range of 1.7 to 21.3 months. The one patient who underwent colectomy after being treated with infliximab, the colectomy was done at 7.6 months after the treatment. The cumulative colectomy rates are shown in the Kaplan-Meier plot in Fig. 1. Colectomy-free survival in the infliximab group was superior to that in the cyclosporine group (p<0.001). In contrast to the result of univariate analysis, Cox proportional hazard model showed that the drug for rescue therapy was not related to the colectomy-free survival (hazard ratio [HR] of infliximab compared to cyclosporine, 0.166; 95% confidence interval [CI], 0.013 to 2.088) (Table 3). In addition, we proposed another Cox proportional hazard model for colectomy in patients treated with either cyclosporine only or infliximab with azathioprine, because most patients who received azathioprine belonged to the infliximab group (28 of 32 patients). Table 4 shows infliximab with azathioprine for rescue therapy was superior to cyclosporine only for preventing colectomy (HR of infliximab with azathioprine compared to cyclosporine only, 0.073; 95% CI, 0.008 to 0.629).


Infliximab versus Cyclosporine Treatment for Severe Corticosteroid-Refractory Ulcerative Colitis: A Korean, Retrospective, Single Center Study.

Kim EH, Kim DH, Park SJ, Hong SP, Kim TI, Kim WH, Cheon JH - Gut Liver (2015)

Kaplan-Meier plots for colectomy-free survival according to the drug for rescue therapy.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4562776&req=5

f1-gnl-09-601: Kaplan-Meier plots for colectomy-free survival according to the drug for rescue therapy.
Mentions: A 12-month follow-up was completed for all patients. Three months after the acute episode requiring either cyclosporine or infliximab treatment, the colectomy rate was 10% (1 of 10) in the cyclosporine group and 0% (0 of 33) in the infliximab group (p=0.233). At 12 months, the colectomy rate increased to 30% in the cyclosporine group versus 3% in the infliximab group (p=0.034) (Table 2). In terms of remission inducing and maintenance rates, clinical remission was achieved numerically more frequently in infliximab group, but that was not statistically significant between the two groups (30.0% vs 45.5%, p=0.485). Moreover, remission maintenance rates at 12 months were also not significantly different between the two groups (20.0% vs 48.5%, p=0.153). At the end of the follow-up, the colectomy had been performed in six of 10 patients and one of 33 patients in the cyclosporine and the infliximab groups, respectively (cyclosporine vs infliximab, 60% vs 3%; p<0.001). In six cases of patients who underwent colectomy after the treatment with cyclosporine, the median time to colectomy was 11.3 months with range of 1.7 to 21.3 months. The one patient who underwent colectomy after being treated with infliximab, the colectomy was done at 7.6 months after the treatment. The cumulative colectomy rates are shown in the Kaplan-Meier plot in Fig. 1. Colectomy-free survival in the infliximab group was superior to that in the cyclosporine group (p<0.001). In contrast to the result of univariate analysis, Cox proportional hazard model showed that the drug for rescue therapy was not related to the colectomy-free survival (hazard ratio [HR] of infliximab compared to cyclosporine, 0.166; 95% confidence interval [CI], 0.013 to 2.088) (Table 3). In addition, we proposed another Cox proportional hazard model for colectomy in patients treated with either cyclosporine only or infliximab with azathioprine, because most patients who received azathioprine belonged to the infliximab group (28 of 32 patients). Table 4 shows infliximab with azathioprine for rescue therapy was superior to cyclosporine only for preventing colectomy (HR of infliximab with azathioprine compared to cyclosporine only, 0.073; 95% CI, 0.008 to 0.629).

Bottom Line: A follow-up of 12 months was completed for all patients.In the subgroup analysis, infliximab with azathioprine was superior to cyclosporine for preventing colectomy (hazard ratio of infliximab with azathioprine compared with cyclosporine only, 0.073; 95% confidence interval, 0.008 to 0.629).However, infliximab with azathioprine may be more effective than cyclosporine alone for preventing colectomy.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.

ABSTRACT

Background/aims: In patients with corticosteroid-refractory ulcerative colitis (UC), cyclosporine or infliximab may be added to the treatment regimen to induce remission. Here, we aimed to compare the efficacy of cyclosporine and infliximab.

Methods: Between January 1995 and May 2012, the medical records of 43 patients with corticosteroid-refractory UC who received either infliximab or cyclosporine as a rescue therapy at a tertiary care hospital in Korea were reviewed.

Results: Among the 43 patients, 10 underwent rescue therapy with cyclosporine and the remaining 33 patients received infliximab. A follow-up of 12 months was completed for all patients. The colectomy rate at 12 months was 30% and 3% in the cyclosporine and the infliximab groups, respectively (p=0.034). However, the Cox proportional hazard model indicated that the treatment of rescue therapy was not an independent associate factor for preventing colectomy (p=0.164). In the subgroup analysis, infliximab with azathioprine was superior to cyclosporine for preventing colectomy (hazard ratio of infliximab with azathioprine compared with cyclosporine only, 0.073; 95% confidence interval, 0.008 to 0.629).

Conclusions: No difference between infliximab and cyclosporine with respect to preventing colectomy was noted. However, infliximab with azathioprine may be more effective than cyclosporine alone for preventing colectomy.

No MeSH data available.


Related in: MedlinePlus