Discontinuation Of Infliximab In Patients Research Articles

Discontinuation of infliximab in patients with Crohn's disease on combination therapy.

Discontinuation of infliximab in patients with Crohn's disease on combination therapy.

Erratum for Two-year Outcomes of Infliximab Discontinuation in Patients with Rheumatoid Arthritis: A Retrospective Analysis from a Single Center.

Erratum for Two-year Outcomes of Infliximab Discontinuation in Patients with Rheumatoid Arthritis: A Retrospective Analysis from a Single Center.

Infliximab discontinuation in patients with ulcerative colitis

Biologics have a central role in the treatment of moderate-to-severe ulcerative colitis. However, the question of the optimal clinical scenario and timing for therapy discontinuation has become very relevant. Therapy withdrawal would minimise potential infectious and neoplastic adverse events, and save costs and patients' time. 1 Lichtenstein GR Feagan BG Cohen RD et al. Serious infection and mortality in patients with Crohn's disease: more than 5 years of follow-up in the TREAT registry. Am J Gastroenterol. 2012; 107: 1409-1422 Crossref PubMed Scopus (545) Google Scholar , 2 Lemaitre M Kirchgesner J Rudnichi A et al. Association between use of thiopurines or tumor necrosis factor antagonists alone or in combination and risk of lymphoma in patients with inflammatory bowel disease. JAMA. 2017; 318: 1679-1686 Crossref PubMed Scopus (285) Google Scholar Nevertheless, previous research has shown that episodic, intermittent therapy with anti-tumour necrosis factor (anti-TNF) agents increases the risk of immunogenicity and therapy failure. 3 Rutgeerts P Diamond RH Bala M et al. Scheduled maintenance treatment with infliximab is superior to episodic treatment for the healing of mucosal ulceration associated with Crohn's disease. Gastrointest Endosc. 2006; 63: 433-442 Summary Full Text Full Text PDF PubMed Scopus (512) Google Scholar Discontinuation of infliximab in patients with ulcerative colitis in remission (HAYABUSA): a multicentre, open-label, randomised controlled trialMaintenance of remission was significantly more common in patients who continued infliximab than in those who discontinued. Discontinuing infliximab should therefore be discussed with caution, taking both risk of relapse and efficacy of re-treatment into account. Full-Text PDF

Discontinuation of infliximab in patients with ulcerative colitis in remission (HAYABUSA): a multicentre, open-label, randomised controlled trial

Anti-tumour necrosis factor (TNF) agents are the mainstay of long-term treatment for refractory ulcerative colitis. However, long-term use of anti-TNF therapy might lead to an increased risk of malignancy or infection. To date, no randomised controlled trial has evaluated whether anti-TNF agents can be safely discontinued in patients with ulcerative colitis in remission. We therefore aimed to compare outcomes in these patients who continued infliximab with those who discontinued infliximab. We did a multicentre, open-label randomised controlled trial at 24 specialist centres in Japan. We enrolled patients with ulcerative colitis who were in remission, had been treated with intravenous infliximab (5 mg/kg) every 8 weeks, and had started infliximab at least 14 weeks before study enrolment. No restrictions regarding age and comorbidities were used to exclude participation. Patients who were confirmed to be in remission for more than 6 months, to be corticosteroid-free, and to have a Mayo Endoscopic Subscore (MES) of 0 or 1 were centrally randomised. An independent organisation randomly assigned patients (1:1) into either the infliximab-continued group or infliximab-discontinued group, using a computer-generated stratified randomisation procedure. The stratified factors were the use of immunomodulators (yes or no) and MES (0 or 1). Neither patients nor health-care providers were masked to the randomisation. The primary endpoint was the remission rate at week 48 in the full analysis set, which was based on the intention-to-treat principle and excluded participants with no efficacy data after randomisation. This study was registered with the University Hospital Medical Information Network Center Trials registry, UMIN000012092. Between June 16, 2014, and July 28, 2017, 122 patients were eligible for screening and a total of 95 patients were randomly assigned to the infliximab-continued group (n=48) or the infliximab-discontinued group (n=47). 92 patients (n=46 for both groups) were included in the full analysis set. 37 (80·4% [95% CI 66·1-90·6]) of 46 patients in the infliximab-continued group and 25 (54·3% [39·0-69·1]) of 46 patients in the infliximab-discontinued group were in remission at week 48. The between-group difference was 26·1% (95% CI 7·7-44·5; p=0·0076) before adjustment and 27·3% (95% CI 8·0-44·1; p=0·0059) after adjustment for stratification factors. Eight (17%) of 48 patients in the infliximab-continued group and six (13%) of 47 in the infliximab-discontinued group developed adverse events (between-group difference 3·9% [95% CI -10·3 to 18·1]; p=0·59). In the infliximab-continued group, one patient had an infusion reaction and two patients had psoriatic skin lesions. Eight (66·7%, 95% CI 34·9-90·1) of the 12 patients in the infliximab-discontinuation group who were re-treated with infliximab after relapsing were in remission within 8 weeks of re-treatment; none had infusion reactions. Maintenance of remission was significantly more common in patients who continued infliximab than in those who discontinued. Discontinuing infliximab should therefore be discussed with caution, taking both risk of relapse and efficacy of re-treatment into account. Mitsubishi Tanabe Pharma Corporation and the Intractable Disease Project of the Ministry of Health, Labour and Welfare of Japan. For the Japanese translation of the abstract see Supplementary Materials section.

Two-year Outcomes of Infliximab Discontinuation in Patients with Rheumatoid Arthritis: A Retrospective Analysis from a Single Center.

Objective To investigate the clinical outcomes of rheumatoid arthritis (RA) patients who discontinued infliximab (IFX) treatment at our hospital. Methods Among 249 patients receiving IFX from 2007 to 2015, we retrospectively investigated the clinical courses of 18 who discontinued IFX after achieving the 28-joint disease activity score based on the erythrocyte sedimentation (DAS28-ESR) clinical remission (CR) and whose clinical courses were available continuously for 96 weeks after discontinuation. Results At IFX introduction, the median age was 56.9 (range 36.1-72.4) years, and the disease duration was 5.2 (0.4-25.6) years. The median duration of maintaining either CR or a low disease activity (LDA) with IFX was 37.2 (4.0-91.4) months, and the total duration of IFX therapy was 45.8 (17.1-96.9) months. After discontinuation, 8 patients (44.4%) maintained CR/LDA for 96 weeks (no-flare group), and 10 (55.6%) experienced flares (DAS28-ESR≥3.2) within 96 weeks (flare group). In the no-flare group, six patients receiving intensified conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy to prevent flare ups simultaneously either with or immediately after discontinuing IFX. In the flare group, four patients received intensified csDMARD therapy. Six patients restarted biological DMARDs (bDMARDs), and all achieved CR again. Ultimately, 12 patients (66.7%) maintained a Bio-free disease control for 96 weeks. A comparison of the clinical backgrounds between the flare and no-flare groups showed no marked difference in their disease duration, IFX dosage, duration of maintaining CR with IFX, or concomitant csDMARDs use. Conclusion Irrespective of the RA disease duration, more than half of all patients maintained a Bio-free condition for 96 weeks. Continuing LDA with IFX for a sufficiently long period of time before discontinuation and preventive intensification of csDMARD therapy may help maintain a Bio-free condition.

Long-term clinical outcome after infliximab discontinuation in patients with inflammatory bowel disease

Objectives: We investigated the long-term clinical outcome and risk factors for clinical relapse in inflammatory bowel disease (IBD) patients after stopping infliximab (IFX).Materials and methods: We retrospectively reviewed the medical records of IBD patients who were treated with IFX in four university hospitals in South Korea. Among them, patients who discontinued scheduled IFX therapy with a favorable disease course were enrolled. Clinical relapse was defined as an increase in disease activity, addition of new drugs, or abdominal surgery.Results: In total, 28 ulcerative colitis (UC) patients and 17 Crohn’s disease (CD) patients were enrolled. The median duration of follow-up after discontinuation was 41 months (range: 8–109 months) in UC patients and 141 months (range: 66–262 months) in CD patients. The cumulative probability of relapse at 12 months was 32.1% in UC patients and 30.7% in CD patients. Fewer IFX infusions and a shorter duration of mesalamine treatment after IFX discontinuation were risk factors for relapse after IFX discontinuation in UC patients (p = .04 and .01, respectively). In CD patients, a higher erythrocyte sedimentation rate and CRP at IFX discontinuation and a shorter duration of azathioprine treatment after IFX discontinuation were risk factors for relapse (p = .03, .03 and .01, respectively).Conclusions: Approximately 30% of IBD patients who responded to IFX therapy experienced relapse within 1 year after discontinuation. We identified several risk factors for relapse. Further studies should identify factors predictive of the disease course after discontinuing IFX maintenance therapy.

Outcomes 7 Years After Infliximab Withdrawal for Patients With Crohn’s Disease in Sustained Remission

Little is known about long-term outcomes of patients with Crohn's disease (CD) after infliximab withdrawal. We aimed to describe the long-term outcomes of patients with CD in clinical remission after infliximab treatment was withdrawn. We performed a retrospective analysis of data from the 115 patients included in the infliximab discontinuation in patients with CD in stable remission on combined therapy with antimetabolites (STORI) study, performed at 20 centers in France and Belgium from March 2006 through December 2009. The STORI cohort was a prospective analysis of risk and factors associated with relapse following withdrawal of maintenance therapy with infliximab, maintained on antimetabolites, while in clinical remission. We collected data from the end of the study until the last available follow-up examination on patient surgeries, new complex perianal lesions (indicating major complications), and need for and outcomes of restarting therapy with infliximab or another biologic agent. The de-escalation strategy was considered to have failed when a major complication or infliximab restart failure occurred. Of the 115 patients initially included, data from 102 patients (from 19 of the 20 study centers) were included in the final analysis. The median follow-up time was 7 years. Twenty-one percent of the patients did not restart treatment with infliximab or another biologic agent and did not have a major complication 7 years after infliximab withdrawal (95% CI, 13.1-30.3). Among patients who restarted infliximab, treatment failed for 30.1% 6 years after restarting (95% CI, 18.5-42.5). Overall, at 7 years after stopping infliximab therapy, major complications occurred in 18.5% of patients (95% CI, 10.2-26.8) whereas 70.2% of patients had no failure of the de-escalation strategy (95% CI, 60.2-80.1). Factors independently associated with major complications were upper-gastrointestinal location of disease, white blood cell count ≥ 5.0× 109/L, and hemoglobin level ≤12.5 g/dL at the time of infliximab withdrawal. Patients with at least 2 of these factors had a more than 40% risk of major complication in the 7 years following infliximab withdrawal. In a long-term follow-up of the STORI cohort (7 years) one fifth of the patients did not restart infliximab or another biologic agent and did not develop major complications. Seventy percent of patients had no failure of the de-escalation strategy (no major complication and no failure of infliximab restart).

Remission induction by Raising the dose of Remicade in RA (RRRR) study: Rationale and study protocol for a randomized controlled trial comparing for sustained clinical remission after discontinuation of infliximab in patients with rheumatoid arthritis.

Infliximab, an inhibitor of TNF-α, is one of the most widely used biological disease-modifying antirheumatic drugs. Recent studies indicated that baseline serum TNF-α could be considered as a key indicator for optimal dosing of infliximab for RA treatment to achieve the clinical response and its sustained remission. The Remission induction by Raising the dose of Remicade in RA (RRRR) study is an open-label, parallel group, multicenter randomized controlled trial to compare the proportions of clinical remission based on the simplified disease activity index (SDAI) after 1 year of treatment and its sustained remission rate after another 1 year between the investigational treatment strategy (for which the dose of infliximab was chosen based on the baseline serum TNF) and the standard strategy of 3 mg/kg per 8 weeks of infliximab administration in infliximab-naïve patients with RA showing an inadequate response to MTX. The primary endpoint is the proportion of patients who kept discontinuation of infliximab 1 year after discontinued infliximab at the time of 54 weeks after the first administration of infliximab. The secondary endpoints are the proportion of clinical remission based on SDAI and changes in SDAI from baseline at each time point, other clinical parameters, quality of life measures and adverse events. Target sample size of randomized patients is 400 patients in total. The main results of the RRRR study are expected to be published at the end of 2017.

Clinical outcome after discontinuation of infliximab in patients with ulcerative colitis in deep remission

Abstract Introduction Infliximab (IFX) is effective in treating ulcerative colitis (UC) and in achieving mucosal healing (MH). Little is known about the role of mucosal healing (MH) in the subsequent evolution of the disease and the consequences of discontinuing treatment. Aims To evaluate the characteristics and evolution of patients with UC treated with IFX who discontinued treatment after disease remission. Methods Observational, prospective study of patients with moderate to severe UC, corticosteroid-resistant/corticosteroid-dependent, naive to anti-TNF. IFX administration regimen: 5 mg/kg at 0-2-6 weeks and every 8 weeks thereafter until week 54. In patients achieving MH, IFX was discontinued and the patients were followed-up for at least 20 months. Clinical remission (CR): Mayo score Results Of the 21 patients enrolled, 19 completed the study (colectomy, n = 1; non-responder, n = 1). Mean age: 47.8 years. UC: severe (n = 13) and moderate (n = 6); most patients (n = 11) were steroid-resistant; 57.8% received combined treatment with immunosuppressants, and 31.5% intensified treatment. Week 54: 16 patients (84.2%) showed clinical response, 13 (68.4%) showed CR, and 12 (63.2%) deep remission. Of these, 6 (25%) presented a new episode of UC, and in 3 (25%) IFX was restarted within 12 weeks of discontinuation, with all patients responding. Of the total sample, 91.7% remained IFX-free at week 8, and 75% at week 12, with no remission during follow-up. None of the patients required hospitalisation or surgery. Conclusions Half of patients with deep remission of UC with IFX therapy presented a new episode after treatment discontinuation, and in 25% IFX therapy was restarted.

Discontinuation of Infliximab in Patients With Ulcerative Colitis Is Associated With Increased Risk of Relapse: A Multinational Retrospective Cohort Study.

Infliximab is a safe and effective therapy for ulcerative colitis (UC). We conducted a multicenter retrospective cohort study that included 7 European countries and Israel to examine whether infliximab discontinuation can be considered for patients who achieve sustained remission. We performed a retrospective cohort study, collecting medical records from 13 tertiary care referral inflammatory bowel disease centers of all patients with UC treated with infliximab (n= 193). We compared the disease course of patients with at least 12 months of clinical remission who discontinued infliximab (n= 111) with that of patients who continued scheduled treatment (controls, n= 82). We examined the incidence rates of relapse, hospitalization and colectomy, the comparative effectiveness of different therapeutic strategies after discontinuation, and assessed the rates of response, remission, and adverse effects after infliximab re-initiation. Statistical analyses used time-to-event methods. In the entire cohort, 67 patients (34.7%) relapsed during the follow-up period. The incidence rate of relapse was significantly higher after discontinuation (23.3 per 100 person-years) compared with the control group (7.2 per 100 person-years) in univariable analysis (log-rank P < .001; hazard ratio, 3.41; 95% confidence interval, 1.88-6.20) and multivariable analysis (hazard ratio, 3.70; 95% confidence interval, 2.02-6.77). Rates of hospitalization and colectomy did not differ between groups. Thiopurines appeared to be the best treatment option after infliximab discontinuation (incidence of relapse: 15.0 per 100 person-years for thiopurines, 27.4 per 100 person-years for thiopurines plus aminosalicylates, and 31.2 per 100 person-years for aminosalicylates alone; log-rank P= .032). Response was regained in 77.1% of patients and remission in 51.4% of patients who re-initiated infliximab. However, 17.1% had infusion reactions and 17.1% reported other adverse events. In a multinational retrospective cohort study of patients with UC in sustained clinical remission, we associated discontinuation of infliximab with an increased risk of relapse. Treatment re-initiation is effective and safe.

PTU-072 Discontinuation of Infliximab in Patients with Ulcerative Colitis is Associated with Increased Risk of Relapse: A Multinational Retrospective Cohort Study

Introduction Efficacy and safety of infliximab in ulcerative colitis (UC) is well-established. We conducted a multicenter retrospective cohort study across 7 European countries, and Israel, to examine whether infliximab discontinuation can be considered for patients who achieve sustained remission. Methods The disease course of patients who discontinued infliximab was compared against that of patients who continued scheduled treatment (control group). We examined the incidence rates of relapse, hospitalisation and colectomy, the comparative effectiveness of different therapeutic strategies after discontinuation, and assessed the rates of response, remission and adverse effects after infliximab re-initiation. Statistical analyses employed time-to-event methods Results In total, 193 patients were included, 111 discontinued infliximab. The incidence rate of relapse was significantly higher after discontinuation (23.3 per 100 person-years) as compared to the control group (7.2 per 100 person-years) both in univariable (log-rank p Conclusion Infliximab discontinuation in UC patients with sustained clinical remission is associated with increased risk of relapse. Treatment re-initiation is effective and safe. Disclosure of Interest G. Fiorino Consultant for: MSD, AbbVie, Takeda, Janssen, Mundipharma, Sandoz, Pfizer, P. Cortes: None Declared, P. Ellul Grant/research support from: MSD, AbbVie, C. Felice Consultant for: MSD, AbbVie, P. Karatzas: None Declared, M. Silva: None Declared, P. Lakatos Grant/research support from: MSD, AbbVie, Hospira, Consultant for: MSD, AbbVie,Celltrion, EGIS, Falk Pharma GmbH, Ferring, Genentech, Hospira, F. Bossa Consultant for: MSD, Abbvie, Mundipharma, and Takeda, S. Sebastian Grant/research support from: MSD, AbbVie, Speaker bureau with: MSD, B. Ungar: None Declared, F. Furfaro: None Declared, K. Karmiris Consultant for: MSD, AbbVie, Takeda, K. Katsanos: None Declared, M. Muscat: None Declared, D. Christodoulou: None Declared, G. Maconi: None Declared, U. Kopylov Consultant for: Janssen, Abbvie, Takeda and CTS, F. Magro: None Declared, G. Mantzaris: None Declared, A. Armuzzi Grant/research support from: MSD, Consultant for: Abbvie, Celltrion, Ferring, Hospira, Janssen, Lilly, MSD, Mundipharma, Pfizer, Sofar, Takeda, M. M. Bosca-Watts: None Declared, S. Ben-Horin Grant/research support from: AbbVie and Celltrion, Consultant for: AbbVie, Celltrion, Janssen, Takeda and Schering-Plough, S. Bonovas: None Declared, S. Danese Consultant for: Schering-Plough, Abbott Laboratories, Merck, UCB-pharma, Ferring, Cellerix, Millenium Takeda, Nycomed, Pharmacosmos, Actelion, Danone, Alpha Wasserman, Genentech, Grunenthal, Pfizer, Astra Zeneca, Novo Nordisk, Cosmo Pharmaceuticals, Vifor, and Johnson & Johnson, Speaker bureau with: Schering-Plough, Abbott Laboratories, Merck, UCB-pharma, Ferring, Cellerix, Millenium Takeda, Nycomed, Pharmacosmos, Actelion, Danone, Alpha Wasserman, Genentech, Grunenthal, Pfizer, Astra Zeneca, Novo Nordisk, Cosmo Pharmaceuticals, Vifor, and Johnson & Johnson

Tu1344 Serology Panel for Prediction of Relapse After Discontinuation of Infliximab in Patients With Crohn's Disease Achieving Clinical Remission

Tu1344 Serology Panel for Prediction of Relapse After Discontinuation of Infliximab in Patients With Crohn's Disease Achieving Clinical Remission

P431. Serology panel for prediction relapse after discontinuation of infliximab in patients with Crohn's disease achieving clinical remission

P431. Serology panel for prediction relapse after discontinuation of infliximab in patients with Crohn's disease achieving clinical remission

Assessment of the Influence of Inflammation and FCGR3A Genotype on Infliximab Pharmacokinetics and Time to Relapse in Patients with Crohn's Disease.

Infliximab is a monoclonal anti-tumor necrosis factor-α (anti-TNFα) antibody that profoundly modified the treatment of Crohn's disease (CD). The polymorphism of Fc fragment of IgG, low affinity IIIa, receptor (CD16a) [FCGR3A] influences the biological response to infliximab in patients with CD. Our aim was to study its influence on infliximab pharmacokinetics and risk of relapse after infliximab discontinuation. In 111 CD patients in remission, infliximab was discontinued and its concentrations were measured for 30months or until relapse. Infliximab pharmacokinetics were described using monocompartmental population modeling. The elimination rate of infliximab increased with C-reactive protein (CRP) [p=0.00018] and was 16% higher in FCGR3A-158V/V patients than in F carriers (p=0.0028). Risk of relapse was higher in patients with baseline CRP≥5mg/L than in those with a lower value (p=0.0000029). In addition, there was a first-order interaction between CRP and the FCGR3A genotype; in patients with high CRP, risk of relapse was higher for V/V patients than for F carriers (hazard ratio 4.80 and 2.84 for V/V and F carriers, respectively; p=0.013). Both increased inflammation and FCGR3A-158V/V genotype are associated with increased infliximab elimination and risk of relapse after infliximab discontinuation in patients with CD.

Su1394 Prediction of Sustained Remission After Discontinuation of Infliximab in Patients With Crohn's Disease

Background & Aim: Patients with Crohn's disease (CD) or ulcerative colitis (UC) who fail to respond to induction therapy with infliximab (IFX) are considered as primary non responders (PNR). We aimed at investigating the prevalence, prediction and management of PNR to IFX in patients with CD or UC. Patients & Methods: Retrospective analysis of prospectively acquired data at a single-center which included PNRs to induction therapy with 5 mg/kg IFX at weeks 0, 2 and 6. PNR was defined as no improvement or worsening of clinical symptoms through week 14 after starting IFX as judged by the CDAI and physician global assessment. Using RFLP or allele-specific PCR, single nucleotide polymorphisms in the promoter region of the TNF gene (-238 G/A, -308 G/A, and -857 C/T) and the -158 V/F polymorphism of the FcγRΙΙΙa gene were determined in 79 patients. In 48 patients, the HLA class II DRB1 and DQB1 alleles were also determined using the complement-dependent lymphocytotoxicity (CDC) and where available the sequence-specificoligonucleotide (SSO) and primer (SSP) HLA typing methods. Antinuclear antibodies and perinuclear anti-neutrophil cytoplasmic antibodies at baseline were also evaluated in 104 and 87 patients, respectively. Results: Between 1/7/2007 and 31/8/2012, of 160 IFX-treated patients [107 CD, 53 with UC, 94 males, median age at diagnosis 23 years (IQR 17-32)], 26 (16.3%) were PNRs [8/107 (7.5%) NC vs 18/53 (34%) UC, p<0.001]. Differences between CD and UC in PNR rates may be due to inclusion of patients with severe UC treated with IFX rescue therapy. CD/PNRs to IFX received adalimumab (ADA, n=4), azathioprine (AZA, n=1), methotrexate (MTX, n=1) or surgical treatment (n=2); 2 of these 4 ADA-treated CD patients developed also PNR to ADA but the other two achieved sustained clinical response (n=1) or remission (n=1) after escalation of ADA dose to 40mg weekly. UC/PNRs to IFX were mainly treated surgically (n=12); one of whom received ADA after surgery for refractory pouchitis, and 6 patients received AZA. Univariate and multivariate analysis (including variables with p<0.2) did not reveal any clinical, serological, demographical or genetic factors as predictors of PNR to IFX. PNR to IFX was the only predictor of PNR to ADA [ΟR=8.889 (95% CI: 2.30234.316), p=0,032] as at the end of the study, only one more patient [with secondary loss of response (SLR) to IFX] of the total 43 who were switched to ADA (of the initial pool of the 160 patients), due to PNR (n=5), SLR (n=21), intolerance (n=9), or adverse events (n= 8) to IFX, developed also PNR to ADA. Conclusion: This study which mirrors real life experience indicates that PNR to IFX in UC is more frequent than in CD; PNR to IFX predisposes to PNR to ADA. Larger prospective studies are needed to identify any predictive factors for PNR to anti-TNF therapy and the ideal management of this phenomenon.

Addition of another disease-modifying anti-rheumatic drug to methotrexate reduces the flare rate within 2 years after infliximab discontinuation in patients with rheumatoid arthritis: An open, randomized, controlled trial

Objectives. We examined whether the addition of another conventional disease-modifying anti-rheumatic drugs (DMARDs) to methotrexate (MTX) upon infliximab (IFX) discontinuation in well-controlled rheumatoid arthritis (RA) patients could suppress subsequent disease flare.Methods. RA patients maintaining DAS28-CRP (Disease Activity Score of 28 joints with C-reactive protein) scores < 2.6 for ≥ 6 months with IFX were randomized either to receive addition of bucillamine (BUC) to MTX (BUC + MTX group; n = 24) or not (MTX group; n = 31) upon discontinuing IFX. The primary endpoint was the flare rate within 2 years of IFX discontinuation.Results. Six patients discontinuing MTX during the study were excluded from analyses. Seventeen patients (63.0%) experienced flares in the MTX group, which was significantly reduced in the BUC + MTX group (31.8%; p = 0.045). Further, the flare rates differed significantly between remission and non-remission by a Boolean definition upon IFX discontinuation in the MTX group (40.0% vs. 91.7%, respectively; p = 0.014), but they were comparable in the BUC + MTX group. BUC treatment was interrupted in seven patients due to rash, proteinuria and incompliance.Conclusions. DMARDs combination therapy may be a better treatment strategy than MTX monotherapy for maintaining RA control after successful discontinuation of biological agents.

Predictors of relapse in patients with ulcerative colitis in remission after one-year of infliximab therapy

Background.Some of the most important questions relating to the use of biological therapy in inflammatory bowel diseases concern the duration of maintenance therapy. The RASH study revealed that previous use of biological therapy and dose intensification are associated with restarting of biological therapy in Crohn's disease. The aim of the study was to assess the disease course and frequency of relapse of ulcerative colitis (UC) following discontinuation of infliximab in patients with remission and to determine predictive factors for relapse. Patients and methods.Fifty-one UC patients who had achieved clinical remission following 1 year of infliximab therapy and for whom infliximab was then discontinued participated in this prospective observational study. 15.7% of the patients received infliximab before the 1-year period of biological therapy analyzed in the study. Biological therapy was restarted in case of recurrent clinical activity. Data were collected from four Hungarian IBD centers. Results.Thirty-five percent of the patients needed to be retreated with infliximab within 1 year after treatment cessation. Logistic regression analysis revealed that previous biological therapy (p = 0.021) was associated with the need of restarting infliximab. None of the data relating to patients' demographic and clinical characteristics, concomitant therapy and CRP level showed association with the need for restarting biological therapy. Conclusions.Biological therapy was restarted at a median of 4 months after discontinuation in more than every third UC patients who had been in clinical remission following 1 year of infliximab therapy. Response to retreatment with infliximab was favorable in the majority of the patients who relapsed.

Mo1323 Meta-Analysis- Maintenance of Remission Following Discontinuation of Infliximab in Patients With Crohn's Disease

Infliximab is highly efficacious in induction as well as maintenance of remission in patients with Crohn's disease (CD). However, the cost and potential serious side-effects is concerning for continuing the medication on a long-term. Primary aim of this meta-analysis was to determine the outcome in patients with CD in whom infliximab was discontinued while in remission. Secondary aim was to assess the results of re-treatment with anti-TNF agents following a relapse and identify the factors associated with a relapse. MethodsWe searched Medline, Scopus, conference proceedings and Google scholar for Infliximab related trials in Crohn's disease. Studies where the information on status of remission prior to discontinuation of infliximab was unclear or the clinical outcome following the discontinuation of infliximab was unavailable were excluded. For studies which provided complete data over at least 3 years, the median remission rate was calculated using Kaplan-Meier method. For studies which provided median remission rate, an average of the remission rates was calculated. ResultsA total of 398 patients in six different studies were included in the final analysis. The average relapse rates over 1st, 2nd, 3rd, 4th and 6th year following the cessation of infliximab were 35%, 48%, 62%, 69% and 76% respectively. The results of Kaplan-Meier analysis for the 4 studies (219 patients) with detailed data over at least 3 years data are given in Table-1. Following relapse, retreatment with infliximab results in remission in 91100% (89 patients). Medication reaction following retreatment with infliximab occurred in only one patient. ConclusionMajority of patients who discontinue infliximab while in remission will relapse and most relapses will occur in first 3 years following cessation of infliximab. Retreatment with infliximab is however favorable and risk of re-treatment reaction is not increased. Kaplan Meier Statistics

Letter: persistence of anti‐infliximab antibodies after discontinuation of infliximab in patients with IBD

Letter: persistence of anti‐infliximab antibodies after discontinuation of infliximab in patients with <scp>IBD</scp>

Letter: persistence of anti‐infliximab antibodies after discontinuation of infliximab in patients with IBD – authors’ reply

Letter: persistence of anti‐infliximab antibodies after discontinuation of infliximab in patients with <scp>IBD</scp> – authors’ reply