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DOP052 Lower long-term colectomy rates with IFX than with CsA treatment in moderate to severe UC

N. Duijvis*1, 2, A. ten Hove3, C. Ponsioen3, G. van den Brink3, A. te Velde2, G. D'Haens3, M. Löwenberg3

1Amsterdam Medical Center, Tytgat institute for liver and intestinal research, Amsterdam, Netherlands, 2Academic Medical Center, Tytgat Institute for Liver and Intestinal Research, Amsterdam, Netherlands, 3Academic Medical Center, Inflammatory Bowel Disease Centre, Amsterdam, Netherlands

Background

Cyclosporine A (CsA) and infliximab (IFX) are similarly effective in preventing short-term colectomy in patients with moderate to severe ulcerative colitis (UC), but long-term outcomes are lacking. The aim of this study was to compare long-term efficacy of CsA and IFX in moderate to severe UC by analyzing colectomy rates as the outcome parameter for treatment success.

Methods

We retrospectively studied a cohort of patients who had received treatment with CsA or IFX between January 2000 and May 2014 at the Academic Medical Centre in Amsterdam for moderate to severe UC. The primary end point was time to colectomy. Variables such as gender, age, Mayo endoscopic subscore at start of treatment, extent of the disease and concomitant treatments were studied as relevant variables affecting outcome.

Results

182 patients were studied (CsA group, n=43; IFX group, n=139). Follow-up of at least 6 months was available for all patients. Patient characteristics (age, gender, disease duration, disease extent and severity) were comparable between the two groups, with the exception that the mean follow-up was significantly longer in CsA treated patients (IFX 61.5 months + 36.8 vs. CsA 124.7 months + 41.5), and steroid use was significantly higher in CsA treated patients (CsA 73% vs. IFX 40%). Colectomy-free survival at different end points was significantly higher in the IFX group as compared to CsA treated patients, as listed in table 1. Colectomy rates for complete follow-up are depicted in a Kaplan Meier survival curve (figure 1). CsA treated patients were at increased risk of undergoing colectomy (HR 2.61, P<0.001). When adding all significant covariates into a multivariate Cox regression model, therapy with CsA or IFX barely not reaches significance anymore (HR 1.84, P=0.084) (table 2). Independent predictors for colectomy were male sex (p=0.022; HR=1.89), younger age (p=0.036; HR 0.98) and endoscopic disease severity (p=0.001; HR 2.59).

 

Table 1: Colectomy-free survival at different time intervals after treatment initiation with CsA or IFX in patients with moderate to severe UC

Colectomy-free survivalCsAIFXP (Chi-Square)
1 month74% (32/43)98% (136/139)P<0.0005
6 months56% (24/43)84% (117/139)P<0.0005
12 months49% (21/43)80% (108/135)P<0.0005
36 months45% (19/42)67% (67/100)P=0.015

Table 2: Cox regression model. All significant factors with P<0.05 were combined in a multivariate model, as well as steroid use since this factor was significantly different between treatment groups.

Cox regression modelunivariatemultivariate
HR (C.I.)PHR (C.I)P
Therapy: cyclosporin2.61 (1.58–4.31)0.0011.84 (0.92–3.67)0.084
Gender: male1.69 (1.02–2.82)0.0431.89 (1.09–3.24)0.022
Age: years0.98 (0.96–0.99)0.0150.98 (0.96–0.99)0.036
Follow-up: months1.01 (1.00–1.01)0.0031.01 (0.99–1.01)0.135
Mayo score: Mayo32.46 (1.49–4.09)<0.0012.59 (1.51–4.44)0.001
Disease duration: months0.99 (0.99-0.99)0.0191.00 (0.99–1.00)0.272
Concomitant treatment: steroids1.29 (0.79–2.11)0.310.74 (0.43–1.29)0.285
Disease extend: E31.00 (0.99–1.00)0.45

 

ECCOJC jju027 DOP052 F0001

“Figure 1 Kaplan Meier survival analysis, Log Rank P<0.0005. CsA, Cyclosporine A; IFX, infliximab.”

 

Conclusion

IFX treatment is associated with lower colectomy rates compared to CsA in patients with moderate to severe UC.