Long-term efficacy of infliximab for refractory ulcerative colitis: results from a single center experience

Abstract

BackgroundThe long-term efficacy of infliximab (IFX) for patients with refractory ulcerative colitis (UC) is unclear. The aim of this study was to assess the long-term outcomes of IFX treatment in patients with refractory UC.MethodsThirty-three patients with refractory UC who received IFX treatment at Kyoto University Hospital between 2003 and 2013 were retrospectively evaluated. IFX intensification was defined as a dose escalation (up to 10 mg/kg) and/or shorter intervals between infusions (every 4–6 weeks).ResultsOf the 33 patients who received scheduled infusions of IFX, 24 (72.7%) achieved clinical remission within 8 weeks after initiating IFX treatment. Of these 24 responders, 17 (70.8%) experienced a relapse of UC and required IFX intensification, and 16 (66.7%) eventually maintained clinical remission with IFX treatment, including IFX intensification. Of the 33 patients, 6 (18.2%) underwent colectomy during IFX treatment. Multivariate regression analysis showed that a serum C-reactive protein (CRP) concentration <5 mg/L two weeks after starting IFX was a predictor of a positive clinical response to IFX induction therapy. No severe adverse events occurred in UC patients treated with IFX.ConclusionIFX intensification was necessary for long-term maintenance of remission and to prevent colectomy in patients with refractory UC.

Frequency, predictors, and consequences of maintenance infliximab therapy intensification in ulcerative colitis

“…This intensification rate is much lower than shown in other studies (1,3,6,(10)(11)(12). In the study by Ferrante et al nearly 40% of the 73 patients on maintenance with IFX were intensified (10), and a Spanish study also shows an intensification rate of 40% in the setting of UC (3).…”

“…In the study by Ferrante et al nearly 40% of the 73 patients on maintenance with IFX were intensified (10), and a Spanish study also shows an intensification rate of 40% in the setting of UC (3). Other studies report a need for intensification of up to 70% (6). Also, 40% of children receiving 5 mg/kg every 8 weeks must be intensified (12).…”

“…Ten of the 36 patients with shortened intervals were de-intensified after 12 months (IQR, [4][5][6][7][8][9][10][11][12][13][14][15][16], and 3 of these were again re-intensified. Two of the seven patients with increased doses were de-intensified after 2 and 4 months, respectively.…”

“…The standard regimen for maintenance consists of 5 mg/kg every 8 weeks, but the need for dose increases or dose interval shortening as shown by pivotal studies (2) is lower than in clinical practice or real-world studies (3,4). Intensification is usually effective for IFX response recovery, thus avoiding therapy changes or colectomy (5)(6)(7)(8), but has an impact on treatment cost (3) and perhaps patient safety. We intend to establish the frequency and form of maintenance IFX therapy intensification in patients with UC and loss of response to IFX, to identify intensification predictors, and to study efficacy and outcome for patients on intensified versus non-intensified therapy.…”

Refractory Distal Ulcerative Colitis: Is Proctocolectomy Always Necessary?

“…However, endoscopy, which was performed in 7 of these patients, detected mucosal improvement in 4 patients, persistent moderate disease activity in 2 patients and no improvement in the last patient [24]. Even though other investigators have shown interesting results with infliximab therapy intensification in order to maintain remission in responders [25], it has been suggested that in cases which ultimately require surgery because of drug failure, preoperative infliximab treatment might increase the risk of short-term postoperative complications [26]. A prospective pilot study has shown effectiveness of topical rectal tacrolimus with 6 out of 8 patients achieving remission, but additional case control trials are needed [27].…”