Infliximab Maintenance Research Articles

Two cases of generalized pustular psoriasis: successful treatment with infliximab.

Dear Editor: In case 1, a 41-year-old woman presented with a 3-year history of recurrent pustules on erythematous skin. The patient had been treated with methotrexate, sulfasalazine and cyclosporine for psoriatic arthritis and generalized pustular psoriasis (GPP) for 2 years. However, these treatments failed to yield satisfactory improvement. Physical examination revealed the presence of extensive erythematous patches with pustules over the entire body (Fig. 1A) and inflammatory arthritis was noted in the distal interphalangeal, sacroiliac and knee joints. We decided to use infliximab (3 mg/kg) to treat the GPP and psoriatic arthritis. The patient's pustular lesions cleared quickly within 48 hours after the first injection. After the second injection of infliximab (3 mg/kg), marked improvement in arthralgia was observed (Fig. 1B). She has since been receiving infliximab 3 mg/kg every 8 weeks as maintenance therapy. No recurrence of pustules or arthritis symptoms has been detected during 12 months of follow-up. Fig. 1 Pustular psoriasis in case 1 (A). Marked improvement was observed after the second injection of infliximab (B). In case 2, a 39-year-old woman with a 20-year history of plaque type psoriasis was admitted to our department for lower limb cellulitis. Rapid resolution of cellulitis was achieved after systemic antibiotic treatment (cefazolin 6 g/day). Three days after antibiotic treatment, she experienced abrupt onset of pustules on erythematous skin affecting more than 90% of body (Fig. 2A, B). She was initially treated with infliximab (3 mg/kg) combined with acitretin (30 mg/day) for pustular flares. Within 48 hours of the first infusion, the pustules were resolved, but diffuse erythema on the trunk and extremities remained (Fig. 2C, D). The patient received acitretin (20 mg/day) for maintenance after a single dose of infliximab. No relapse of the pustules has been noted, but mild psoriatic plaques have followed. Fig. 2 Generalized pustular papules on the entire body in case 2 (A, B). Near remission of a pustular eruption was seen 48 hours after infliximab infusion (C, D). Infliximab is a chimeric immunoglobulin G1 anti-tumor necrosis factor-α monoclonal antibody that is effective in treating moderate to severe psoriasis and psoriatic arthritis1. Several studies have documented a rapid improvement in recalcitrant GPP with infliximab (5 mg/kg)2,3. Because infliximab has a faster onset of action than that of other modalities including biologics, some researchers recommended that infliximab be used as the first-line treatment modality in patients with severe and acute GPP4. Both patients in the current study experienced dramatic resolution of pustules within 48~72 hours of infliximab infusion without any serious adverse events. Although the optimal infliximab dose and maintenance regimen for GPP has not yet been established, low dose (3 mg/kg) of infliximab showed excellent response in the current cases. In an earlier report, there was no significant difference between the 3 mg/kg treatment group and the 5 mg/kg treatment group for moderate to severe psoriasis5. However, more research is needed and we believed that low dose infliximab with or without acitretin may have an effect on acute GPP. Since infliximab appears to offer the advantage of rapid response and reduced morbidity, we may consider it extremely effective and well tolerated in adult patients with severe and acute GPP. However, since GPP tends to relapse frequently, large population studies are needed to evaluate the efficacy of maintenance infliximab therapy for GPP with recurrent pustular episodes.

Antibodies to Infliximab and Risk of Infusion Reactions in Patients With Inflammatory Bowel Disease

Antibodies to infliximab (ATIs) have been associated with a risk of infusion reactions in some studies of patients with inflammatory bowel disease. However, many factors, such as immunomodulators and dosing schedule, may influence this association. The aim of this article was to provide a pooled estimate of the risk of infusion reactions according to patients' ATI status and analyze the relationship of immunomodulators to this risk. Public databases were searched for eligible studies. Quality assessment was undertaken for all studies using Grading of Recommendations Assessment, Development and Evaluation criteria. Raw data from studies meeting inclusion criteria were pooled for meta-analysis of effect estimates. Sensitivity analysis was performed for all outcomes. Funnel plot was performed to assess for publication bias. Eight studies met the inclusion criteria, with a pooled total of 1351 subjects. Seven of the 8 studies had a high risk of bias in at least 1 quality domain. The cumulative data indicated that there was a higher risk ratio (RR) of any acute infusion reaction (RR 2.4; 95% confidence interval [CI] 1.5-3.8, P < 0.001) and severe infusion reactions (RR 5.8, 95% CI 1.7-19, P = 0.004) in patients with ATIs when compared with patients without ATIs. The RR of delayed hypersensitivity reactions was not significantly different between ATI+ and ATI- patients (RR 2.8, 95% CI 0.2-33, P = 0.4). Patients prescribed immunomodulators during maintenance infliximab therapy had a reduction in their risk for ATI development (RR 0.6, 95% CI 0.4-0.9, P = 0.02) and infusion reactions (RR 0.6, 95% CI 0.4-0.8, P < 0.001). The presence of ATIs is associated with a significantly higher risk of acute infusion reactions, but not delayed hypersensitivity reactions, in patients with inflammatory bowel disease. Concomitant immunomodulators reduce this risk.

Pharmacokinetics of Infliximab in Children with Moderate-to-Severe Ulcerative Colitis

To assess infliximab pharmacokinetics in pediatric ulcerative colitis (UC). This phase 3, randomized, open-label multicenter study enrolled 60 children (6-17 yr) with moderate-to-severely active UC (Mayo score, 6-12; endoscopic subscore, ≥2), despite conventional therapy. Patients received infliximab 5-mg/kg induction infusions at weeks 0, 2, and 6. Week 8 clinical responders (n = 45) were randomized to infliximab 5 mg/kg given every 8 weeks (q8w) through week 46 or every 12 weeks (q12w) through week 42. Patients losing response during maintenance infliximab were eligible to increase the dose (5→10 mg/kg) and/or shorten the dosing interval (q12w→q8w). Blood samples were collected for infliximab concentration and pharmacokinetic determinations. Infliximab pharmacokinetics were not influenced by age (6-11 yr versus 12-17 yr), baseline immunomodulator use, or the extent of UC. At week 8, higher serum infliximab concentrations (≥41.1 μg/mL) were associated with greater proportions of patients achieving efficacy endpoints (clinical response, 92.9%; mucosal healing, 92.9%; and clinical remission, 64.3%) versus those with lower serum concentrations (<18.1 μg/mL; 53.9%, 53.9%, and 30.8%, respectively). At week 30, higher median trough serum infliximab concentrations were observed with infliximab 5 mg/kg q8w (1.9 μg/mL) versus q12w (0.8 μg/mL) and with infliximab 10 mg/kg (2.9 μg/mL) versus 5 mg/kg (1.1 μg/mL) among patients who are regimen adjusted. Infliximab pharmacokinetics/exposure-response relationship in patients with UC aged 6 to 17 years were generally comparable with those observed in reference adult UC populations, supporting using infliximab 5 mg/kg at weeks 0, 2, and 6 followed by maintenance dosing with 5 mg/kg q8w in these patients. A positive relationship was noted between serum infliximab level and clinical effect following induction therapy similar to adults.

P-024 Infliximab Is Effective for Maintaining Remission in Chronic Refractory Ulcerative Colitis

Infliximab has been established as an effective rescue treatment for acute, severe ulcerative colitis (UC) and for induction and maintenance of clinical and endoscopic remission in chronic refractory UC (1). Limited data exist regarding the long-term clinical outcomes and colectomy rates of patients with ulcerative colitis treated with maintenance Infliximab. We aimed to assess the long-term outcome of Infliximab treatment in the real life setting, as determined by colectomy rates and steroid free survival for patients with chronic refractory ulcerative colitis. We performed a retrospective cohort study of patients treated with Infliximab for chronic, refractory ulcerative colitis at our institution. All patients received induction dosing at 5 mg/kg (week 0, 2 and 6) and those that received maintenance therapy went on to 5 mg/kg every 8 weeks. All patients had previously been treated with steroids, with or without a combination of 5-ASA and /or immunomodulator. Between September 2008 and February 2013, 48 patients were treated with Infliximab for chronic refractory UC. The cohort was predominantly male (61.7%), with a mean age 39.6 ± 14.3 years (range 19–74 years). The mean disease duration was 6.63 years and mean Mayo score of 7.98 prior to commencing Infliximab treatment. Twenty-four patients (51%) were on immunomodulators and 35 (72.9%) were on 5-ASA preparation prior to Infliximab. The mean period of follow-up was 25.3 months. Thirty-six patients were given induction and maintenance therapy with infliximab and 12 were given only induction therapy. Table 1 demonstrates the outcome data. Chronic, refractory ulcerative colitis can be effectively managed with long-term maintenance Infliximab, which prevents colectomy and maintains steroid-free remission in more than 86% of patients.

Conflicting Results on the Efficacy of Enteral Nutrition During Infliximab Maintenance Therapy for Crohn’s Disease Are Correct

Conflicting Results on the Efficacy of Enteral Nutrition During Infliximab Maintenance Therapy for Crohn’s Disease Are Correct

Loss of Response to Long-Term Infliximab Therapy in Children with Crohn’s Disease

Secondary loss of response (LoR) often precludes further use of infliximab in children with Crohn’s disease. Immunomodulators may reduce the incidence of LoR but their combination with infliximab presents safety concerns. We aimed to determine the long-term durability of infliximab response in paediatric Crohn’s, effect of immunomodulators on LoR, and secondarily the effect of infliximab on growth. We retrospectively audited patients on maintenance infliximab at a single centre. Data included height and weight, Paediatric Crohn’s Disease Activity Index (PCDAI), and immunomodulator use. 71 children (32% female, mean age 14.4 years) had been commenced on maintenance infliximab before July 2011. 89% had been on immunomodulators concurrently with infliximab. LoR occurred in 20 (28%), with a median time to LoR of 4.31 years. LoR was significantly increased in children who did not enter remission (PCDAI ≤ 10) after induction (p < 0.05). LoR occurred more frequently in the 72% who ceased immunomodulators, but this failed to reach statistical significance (p = 0.300). Height and weight SDS improved significantly on infliximab. Infliximab is a durable long-term therapy for paediatric Crohn’s refractory to conventional therapy. A large-magnitude increase in the rate of loss of response after immunomodulator cessation was not observed.

Consecutive Fecal Calprotectin Measurements to Predict Relapse in Patients with Ulcerative Colitis Receiving Infliximab Maintenance Therapy

This study examined whether fecal calprotectin can be used in daily practice as a marker to monitor patients with ulcerative colitis (UC) receiving infliximab maintenance therapy. This prospective multicenter study enrolled adult patients with UC in clinical remission under infliximab maintenance therapy. Fecal calprotectin levels were measured every 4 weeks. Sigmoidoscopies were performed at inclusion and at study end. Relapse was defined as a clinical need for change in treatment or an endoscopic Mayo subscore of ≥2 at week 52. Sustained deep remission was defined as a partial Mayo score <3 at all points and an endoscopic Mayo score 0 at week 52. Full analysis was possible for 87 of 113 included patients with UC (77%). Of these patients, 30 (34.4%) were considered to be in sustained deep remission and 13 (14.9%) to have relapsed. Calprotectin levels in patients with sustained deep remission remained very low (median < 40 mg/kg at all time points). Patients who flared had significantly higher calprotectin levels (median > 300 mg/kg) already 3 months before the flare. Further receiver operator curve analysis suggested that a calprotectin level >300 mg/kg had a reasonable sensitivity (58.3%) and specificity (93.3%) to model flare. Two consecutive calprotectin measurements of >300 mg/kg with 1-month interval were identified as the best predictor of flare (61.5% sensitivity and 100% specificity). Fecal calprotectin can be used in daily practice to monitor patients with UC receiving infliximab maintenance therapy. Two consecutive measurements >300 mg/kg is more specific than a single measurement for predicting relapse.

NASPGHAN Clinical Report on the Evaluation and Treatment of Pediatric Patients With Internal Penetrating Crohn Disease

Natural History of Pediatric Crohn Disease T he natural history of pediatric Crohn disease (CD) remains unpredictable, although some trends are observed that differentiate children from adults. Pediatric CD often presents with more severe disease and more frequent need for immunosuppressive therapy (1). Growth failure, present in 15% to 20% of patients, is a unique characteristic of pediatric CD not seen in adult-onset CD (2). Colonic disease distribution is common in patients younger than 10 years (1). The need for surgical intervention also varies, with 1 study reporting the actuarial risk of having undergone an extensive intestinal resection being 48.6% 5% in a childhood-onset group versus 14.6% 2% in the adult-onset group (P< 0.001) (1). More recently, long-term follow-up of patients enrolled in pediatric registries shows a cumulative surgical rate of 14% to 17% at 5 years and 28% at 10 years (3,4).

Tolerability of one hour 10 mg/kg infliximab infusions in inflammatory bowel diseases: A prospective multicenter cohort study

Background and AimIn patients with inflammatory bowel disease (IBD) tolerating 2-h infusions of 5mg/kg infliximab scheduled maintenance therapy, the infusion time can be shortened to 1-h with good tolerability. A retrospective study with small sample size demonstrated the feasibility of 1-hour infusion time for 10mg/kg infliximab in IBD patients. MethodsBetween November 2011 and July 2012, 63 patients received 1-hour 10mg/kg infliximab infusions under standard operating procedures and were enrolled in a prospective observational study. Intravenous steroid premedication was given to all patients. ResultsSixty-three IBD patients on infliximab maintenance therapy (43 Crohn's disease, 34 males) received 1-hour 10mg/kg infusions during the study period. A total of 182 infliximab infusions were administered. Seventeen (26%) patients were receiving concomitant immunomodulators. Two patients experienced (2/182, 1%) severe acute infusion reactions consisting on a cutaneous lupus and one severe anaphylactic reaction. We also observed one (1/182, 0.5%) severe delayed reaction after the first 1-hour infliximab infusion consisting on acne generalis. All 3 reactions led to infliximab discontinuation. No mild acute reactions and 6 mild delayed reactions (6/182, 3%) occurred. ConclusionsIn patients with IBD receiving infliximab scheduled maintenance therapy, 1-hour infusion time for 10mg/kg infliximab seems to be well tolerated. This option might be considered in clinical practice in order to decrease the extra-burden of infliximab infusions in this patient population.

Individualised therapy is more cost-effective than dose intensification in patients with Crohn’s disease who lose response to anti-TNF treatment: a randomised, controlled trial

ObjectiveAlthough the reasons for secondary loss of response to infliximab (IFX) maintenance therapy in Crohn’s disease vary, dose intensification is usually recommended. This study investigated the cost-effectiveness of interventions defined...

Ten Years of Infliximab for Crohn’s Disease

Aim was to assess the long-term clinical efficacy of infliximab therapy in patients with Crohn's disease treated in a cohort of 2 tertiary referral centers in the Netherlands. All consecutive patients with Crohn's disease treated with infliximab were assessed. Endpoints were primary clinical efficacy, sustained benefit, efficacy of retreatment, surgical intervention rates, and safety. Sustained benefit was determined by Kaplan-Meier analysis. The estimated 5-year benefit was calculated. A total of 469 patients were included. Median follow-up length was 4.5 years (interquartile range, 2.7-6.8). Seventy patients (15%) had unsuccessful remission induction, and 316 patients received maintenance therapy. Scheduled maintenance regimen was successful in 169 of 276 (61%). Episodic maintenance therapy was successful in 19 of 40 patients (48%). Estimated 5-year sustained benefit was 55.7% (95% confidence interval, 48.8-62.6). Concomitant thiopurines were associated with improved sustained benefit. A second course of infliximab after previous discontinuation was prescribed in 131 patients with similar efficacy rates. Abdominal surgical intervention rate per 100 patient-years was significantly reduced after infliximab initiation in patients with a scheduled maintenance regime (reduction, 2.70; 95% confidence interval, -4.82 to -0.35; P = 0.018). Mortality and malignancy rates were 1.9% (0.39/100 patient-years) and 3.4% (0.70/100 patient-years), respectively. The present study shows an estimated 5-year sustained benefit of 55.7% in patients with Crohn's disease treated with infliximab maintenance therapy. Remission induction and maintenance were equally successful in patients starting infliximab and patients who temporarily stopped and were retreated. Long-term use of infliximab was safe and reduced the need for surgery in patients on scheduled maintenance therapy.

Prevention of postoperative recurrence with azathioprine or infliximab in patients with Crohn's disease: An open-label pilot study

Background and aimsPatients with Crohn’s disease (CD) often require surgery over their clinical course. However, endoscopic and clinical recurrence of disease appear respectively in up to 80% and 30% of patients after one year. Thus, a prophylactic treatment is needed to reduce the possibility of recurrence. Both azathioprine and infliximab have been demonstrated to be effective, but head to head studies have not been performed so far. Aim of this open-label prospective study was to analyse endoscopic, histological and clinical recurrence after one year of treatment with azathioprine or infliximab as postoperative therapies in CD patients with “high risk” of recurrence. MethodsConsecutive CD patients who underwent curative ileocolonic resection were randomized (1:1) to receive infliximab (standard induction and maintenance schedule) or azathioprine (2.5mg/kg/day) for 1 year. Co-primary endpoints were endoscopic, histological and clinical recurrence after 12 months of therapy. ResultsTwenty-two consecutive CD patients (15 male; median age 32years, IQR 22-38) were enrolled after curative ileocolonic resection. Eleven patients were treated with infliximab and 11 received azathioprine. Among patients treated with azathioprine, 4/10 (40%) had endoscopic recurrence compared to 1/11 (9%) in the infliximab group (p=0.14). Eight out of 10 (80%) among those who received azathioprine had severe histological activity, whereas 2/11 (18%) in the infliximab group presented histological recurrence (p=0.008). No significant clinical differences were found between the two groups. ConclusionsInfliximab was more effective than azathioprine in reducing histological, but not endoscopic and clinical recurrence after curative ileocolonic resection in “high risk” CD patients.

PWE-074 How Often do we Discontinue Maintenance Infliximab Due to Clinical Remission In Crohn’S Disease?

IntroductionBiologics are increasingly used in the management of Crohn’s disease (CD). NICE guidelines advise reassessing CD patients after 12 months of treatment with infliximab and discontinuing therapy for patients in...

PTH-112 Infliximab Promotes Steroid free Remission in Patients with Chronic Active Ulcerative Colitis– a UK Single Centre Experience

IntroductionThe role of infliximab (IFX) in the salvage treatment of acute severe ulcerative colitis (UC) is well established and both licenced and approved in the UK. Studies have demonstrated that...

Efficacy and safety of infliximab as continuous or intermittent therapy in patients with moderate-to-severe plaque psoriasis: results of a randomized, long-term extension trial (RESTORE2)

Continuous maintenance therapy with infliximab 5mg kg(-1) every 8weeks is effective for moderate-to-severe plaque-type psoriasis. To evaluate the efficacy and safety of continuous vs. intermittent infliximab maintenance therapy. RESTORE2 was a long-term extension of RESTORE1. At baseline of RESTORE2, eligible patients who had received infliximab for 26weeks and achieved Psoriasis Area and Severity Index (PASI) 75 in RESTORE1 were rerandomized 1:1 to continuous therapy (infliximab 5mg kg(-1) every 8weeks) or intermittent therapy (no infliximab until >50% loss of PASI improvement). Safety and efficacy assessments occurred throughout the study. In total, 222 patients were randomized to receive continuous therapy, and 219 to intermittent therapy. More serious infusion-related reactions occurred with intermittent therapy (8/219 patients, 4%) than with continuous therapy (1/222 patients, <1%), leading the sponsor to terminate the study. The mean duration of exposure to infliximab was 40·12weeks (SD 27·55) with a mean of 5·8 infusions (range 0-16) for continuous therapy and 22·78weeks (SD 22·98) with a mean of 3·4 infusions (range 0-16) for intermittent therapy. Although no formal efficacy analyses were conducted, continuous therapy led to greater PASI 75 at week 52 in the continuous group (81/101, 80%) than in the intermittent group (39/83, 47%); several other efficacy measures demonstrated similar patterns. For patients with moderate-to-severe plaque-type psoriasis, continuous therapy with infliximab may be more effective than intermittent therapy. The incidence of serious infusion-related reactions in the intermittent group suggests that clinicians should avoid intermittent therapy in this population.

Pre‐existing IgG antibodies cross‐reacting with the Fab region of infliximab predict efficacy and safety of infliximab therapy in inflammatory bowel disease

Infliximab (IFX) is a chimeric murine/human anti-TNF antibody (Ab) used for the treatment of Crohn's disease (CD) and ulcerative colitis (UC). Loss of response is common and associated with development of anti-IFX Abs during ongoing therapy. However, human anti-murine immunoglobulin Abs are common and may cross-react with the murine part of IFX. To investigate if Abs binding to IFX's Fab region (IFX-Fab) are present in IBD patients before exposure to IFX, and whether they predict efficacy and safety of IFX therapy. Observational, retrospective cohort study of patients with CD (n=29) and UC (n=22). Pre-treatment levels of IFX-Fab reactive IgG Abs were significantly lower in CD patients in remission after 1year of maintenance IFX (median 91mU/L, n=8) than in the rest of the patients (639mU/L, n=21; P<0.01), and lower than in patients with secondary loss of response in particular (692mU/L, n=7; P<0.01). A cut-off concentration of <439mU IFX-Fab reactive IgG Ab per litre comprised all patients who later obtained long-term sustained remission on IFX (sensitivity 100%, specificity 67%). Similar trends were observed in UC. The pre-treatment levels of IFX-Fab reactive IgG Abs were markedly higher in patients developing infusion reactions to IFX (1037mU/L, n=7) than in the remaining patients (349mU/L, n=44; P=0.036). IFX-Fab reactive IgG antibodies present in serum from IBD patients before infliximab therapy associate with lack of long-term efficacy and safety. Assessments of such antibodies may help clinicians to choose between treatment with infliximab and more humanised agents.

Tu1349 Mucosal Healing in Patients With Crohn's Disease During Scheduled Infliximab Maintenance Therapy Initiated Following Surgical Resection of Active Lesions

Tu1349 Mucosal Healing in Patients With Crohn's Disease During Scheduled Infliximab Maintenance Therapy Initiated Following Surgical Resection of Active Lesions

Mo1331 The Cost-Effectiveness of Infliximab Is Different in Ulcerative Colitis and Crohn's Disease: Markov Model in a Population-Based Incident Patient Cohort

BACKGROUND: Biologic drugs were shown to improve patient outcomes in inflammatory bowel diseases. Despite their known ability to reduce hospital admissions and surgery, these savings may not be sufficient to offset their high acquisition price, as was shown in several mathematical models. We sought to investigate the impact of infliximab (IFX) on healthcare costs and quality-adjusted life-expectancy in a real-world patient cohort. AIM: To determine direct healthcare costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs) of IFX given in UC and CD as episodic (on demand) therapy or as 1 year or 10 year maintenance treatment. METHODS: The patients comprised a pre-IFX-era, population-based, multi-national incident cohort of ulcerative colitis (UC) and Crohn's disease (CD). The patients had received standard (non-biologic) treatment for 10 years and their economic data and transition states were reported (Gastroenterology 131: 719, Aliment Pharmacol Ther 31: 735) The cohort was modeled in a Markov analysis with a 10 year horizon to allow patients to receive IFX whenever entering corticosteroid-immunomodulator-resistant or need-for-surgery transition states, by current clinical criteria. Costs, QALYs and ICERs were computed. Each patient was run in all 4 arms of the study: standard therapy, episodic IFX, 1 y maintenance IFX and 10 y maintenance IFX; the data were compared. In a scenario analysis IFX base-price of 100% was reduced to 80% and 50%; decay rate of IFX use was varied as 20%, 50% and 80%. RESULTS: There were 339 UC (mean age at onset 40.5 ± 14.8 years, 50.4% male) and 212 CD (34.4 ± 14.5 y, 49.9% male) patients in the study. CD patients had about double the costs, but lower QALYs, than UC (Table 1). A longer maintenance period engendered higher cost, but increased the QALYs. Episodic IFX treatment improved QALY's and had lower costs than standard therapy in UC and CD, and was thus dominant. In UC, I y maintenance IFX dominated episodic therapy (Table 2), but 10 y maintenance was not cost-effective except when the drug acquisition price was lowered to 50%. In CD, maintenance IFX (1 y and 10 y) produced ICERs in the range 486,806 to 48,120 Euros/QALY gained. The 10 y ICERs were lowest but still not costeffective. The price of IFX was the principal determinant of cost of treatment and magnitude of the ICERs even when the rate of decay was raised to 50% and 80%. CONCLUSIONS. In our model, standard therapy had higher costs and less favorable patient outcomes and was dominated by episodic IFX in both diseases. At current drug prices, maintenance IFX in CD patients did not provide good value for money when compared with episodic therapy, but was dominant over episodic therapy in UC when restricted to 1 year of treatment. Table 1. Mean 10 y costs and QALYs per patient

954 Infliximab Maintenance Beyond One Year Prevents Postoperative Crohn's Disease Recurrence: Long-Term Follow-up From the Randomized Controlled Pilot Study

954 Infliximab Maintenance Beyond One Year Prevents Postoperative Crohn's Disease Recurrence: Long-Term Follow-up From the Randomized Controlled Pilot Study

The impact of postoperative infliximab maintenance therapy on preventing the surgical recurrence of Crohn’s disease: a single-center paired case–control study

Preventing a recurrence of Crohn's disease is a problem that remains to be solved. We evaluated the impact of using infliximab as a postoperative therapy on preventing the surgical recurrence of Crohn's disease. We performed a pair-matched study comparing 100 patients who had received postoperative infliximab maintenance therapy with those who had not between 1995 and 2010. The patients were matched by gender, Vienna classification and age at the time of the operation. Crohn's disease-related reoperation was evaluated as surgical recurrence. In the postoperative infliximab maintenance therapy group, infliximab was administrated within 8 weeks after the operation. The median follow-up period was 36 months in the postoperative infliximab maintenance therapy group and 51 months in the control group. Surgical recurrences were recognized in 37 patients (three in the postoperative infliximab maintenance therapy group and 34 in the control group). A univariate analysis by the Kaplan-Meier method identified a body mass index >18 at the time of the operation (HR 0.19, p = 0.01) and postoperative infliximab maintenance therapy (HR 0.22, p = 0.0022) as factors related to the reduction of surgical recurrence. The multivariate analysis revealed that postoperative infliximab maintenance therapy was the only significant factor preventing surgical recurrence. Postoperative infliximab maintenance therapy for Crohn's disease prevents surgical recurrence, at least within 3 years after the operation.