A comparison of short-term therapeutic efficacy between infliximab and tacrolimus for moderate to severe ulcerative colitis

Abstract

Introduction. Both infliximab (IFX) and tacrolimus (Tac) are effective for inducing clinical remission in patients with ulcerative colitis (UC). However, no randomized study has addressed the relative efficacies of IFX and Tac for patients with moderate to severe UC. This study aimed to conduct a retrospective study on the relative efficacy of IFX and Tac in patients with moderate to severe UC, using an inverse probability of treatment weighting (IPTW) technique to adjust background factors statistically.Methods. Between July 2009 and March 2016, data obtained from 122 patients with moderate to severe UC who were treated with either IFX (n = 58) or Tac (n = 64) were analyzed retrospectively. We compared the short-term therapeutic efficacy between the IFX group and Tac group using IPTW technique.Results. The clinical remission rate at 14 weeks after treatment was 37.9% (22/58) in the IFX group and 50% (32/64) in the Tac group, respectively. The efficacy of IFX and Tac for clinical remission rate was not different according to univariate (Odds ratio [OR] 1.64, 95% confidence interval [CI] 0.80-3.37 P = 0.18) and multivariate analyses (OR 2.19, 95% CI 0.85-5.61, P = 0.10). After the background and confounders factors were adjusted by using IPTW based on propensity score, the efficacy of IFX and Tac for clinical remission rate was not differed statistically (OR, 1.483; 95% CI, 0.581-3.785; P = 0.409) Conclusion. IFX and Tac have equivalent short-term efficacies for induction in patients with moderate to severe UC.

Comparison of Safety and Efficacy of Tacrolimus versus Infliximab for Active Ulcerative Colitis

“…Our literature search (Medline, Embase, Ovid and The Cochrane Library) identified 5 studies directly comparing the outcomes of TAC versus IFX for active UC [7][8][9][10][11]. The following keywords and MeSH headings were used individually and in combination: "ulcerative colitis," "anti-tumour necrosis factor agent(s)," "biologic(s)," "infliximab," "calcineurin inhibitor(s)," "tacrolimus," "efficacy," "remission," "relapse," "colectomy," "safety," "adverse event(s)," "second-line therapy" and "rescue therapy."…”

“…TAC was generally administered orally at an initial dose of 0.05-0.1 mg/kg/day in 2 divided doses [7][8][9][10][11]. The dosage of TAC was adjusted to achieve whole blood trough level 10-15 ng/mL (high trough range) for initial 2 weeks and subsequently 5-10 ng/mL (low trough range).…”

“…TAC is usually withdrawn at week 12, and thereafter azathioprine is given as maintenance therapy because TAC treatment over 3 months has not been approved in Japan. In the IFX group, 5 mg/kg was administered by intravenous infusion at weeks 0, 2, and 6, then every 8 weeks [7][8][9][10][11]. Blood concentration of IFX was not routinely measured.…”

“…Four studies [7][8][9][10] assessed the safety and adverse events of TAC and IFX, and the other study [11] did not.…”

“…Recently, several studies directly comparing safety and efficacy of TAC versus IFX for patients with active UC were published [7][8][9][10][11]. The present study reviewed these studies to determine which medication, TAC or IFX is safer and more effective in the management of active UC.…”