Months Of Infliximab Research Articles

Infliximab for parenchymal neuro-Behçet's syndrome: case series and meta-analysis.

This study aims to evaluate the efficacy and safety of infliximab (IFX) in patients with parenchymal neuro-Behçet's syndrome (p-NBS). We retrospectively analysed eleven p-NBS patients treated with IFX at our institution and combined them with studies from database searches for a meta-analysis. Pooled estimates of clinical response (complete and partial remission) and MRI improvement at months 3, 6, and 12 were calculated. One patient achieved CR and the other ten patients achieved PR at our institution. 8 studies (77 patients) were included in the meta-analysis. At 3, 6, and 12 months, 97% (95%CI 61.9-100%), 89.6% (95%CI 45.9-100%), 100% (95%CI 96.0-100%) of patients showed clinical response and 100% (95%CI 89.7-100%), 89.1% (95% CI 26.3-100%), 99.5% (95% CI 96.0-100%) of patients showed radiological improvement, respectively. Severe adverse events were observed in 7 patients. IFX was effective and relatively safe for p-NBS. Patients should be re-evaluated after 3 months of IFX to determine further therapy.

Survival of biological therapeutics in psoriasis: retrospective analysis of 3-years data in a Turkish registry, PSORTAKSIS.

TPSORTAKSIS is a psoriasis registry, which is used for follow-up of patients in Kayseri City Education and Research Hospital, Dermatology Clinic since 2016 in Turkey. PSORTAKSIS includes demographic data, follow-up clinical findings, laboratory output, and treatment information of patients. Here, drug survivals of biologic therapeutics (BT) according to three-year data of PSORTAKSIS will be presented. Drug survival of BT in PSORTAKSIS was analyzed from 2016 to March 2019. 158 patients (111 of them BT-naive) with psoriasis under BT were enrolled in the current study. Drug survival analysis of patients with ongoing BT (158 treatment periods) revealed mean survival time as 15.49 months for ustekinumab, 15.37 months for adalimumab, 14.00 months for etanercept, 5 months for infliximab, and 4.59 months for secukinumab. The differences between drug survivals of BT were statistically significant (log-rank test, χ2 = 79.915, p < 0.0001).

Dose Augmentation of Tumor Necrosis Factor Inhibitors is Frequently Performed in Persons With Inflammatory Bowel Disease in the Absence of Objective Evidence of Active Inflammation.

Antitumor necrosis factor (anti-TNF) dose augmentation is frequently utilized in the management of inflammatory bowel disease (IBD), yet the extent to which clinicians assess for objective markers of inflammation before using the strategy is unknown. To determine the incidence of anti-TNF dose augmentation and the frequency with which it is preceded by the objective assessment of IBD activity. All 23 prescribers of anti-TNF for IBD in Manitoba facilitated chart review of their adult anti-TNF users from 2005 to 2016. Time from anti-TNF initiation to dose augmentation was recorded for all previously biologic-naïve patients. The practices of 11 of 23 prescribers were audited in greater detail and the biochemical, imaging, and endoscopic investigations conducted in the 90-day preceding dose augmentation extracted. A total of 838 patients met inclusion criteria; 70.4% had Crohn's disease, whereas 29.6% had ulcerative colitis or IBD unclassified. The median duration of follow-up was 22.6 [interquartile range (IQR), 10.3-43.2] months for adalimumab and 28.4 (IQR, 10.2-59.9) months for infliximab (P=0.01). The cumulative incidence of dose augmentation at 12 months was 32.9%. Dose augmentation occurred more often in ulcerative colitis than in Crohn's disease (hazard ratio, 1.83; IQR, 1.36-2.47). Overall, 70.7% of patients underwent some form of testing to assess the inflammatory burden before dose augmentation. Objective evidence of inflammation supporting dose augmentation was documented in only 24.7% of cases. One third of previously biologic-naïve patients had anti-TNF doses increased within the first 12 months of treatment. Dose augmentation frequently occurred in the absence of objective evidence of inflammatory disease activity.

Real-World Outcomes of Biologic Therapy for Juvenile Idiopathic Arthritis Associated Uveitis

Purpose: We aim to report the outcomes and complications of patients with uveitis from Juvenile Idiopathic Arthritis (JIA) treated with biologic therapy. Materials and Methods: All patients who underwent treatment with biologic therapy for uveitis in the context of JIA between 2016 and 2017, followed in the Uveitis Department in Hospital de Santa Maria, were retrospectively included in the study. Patient medical records were analyzed retrospectively and clinical outcome and complications were registered. Results: Nine patients (7 females, 2 males, 18 eyes) were included in the study. The mean age of JIA diagnosis was 6.6 years (±4,5) and the mean age of uveitis diagnosis was 7.9 years (±3,0). Six patients were being treated with adalimumab (ADA), 2 with Infliximab (IFX) and 1 with Tocilizumab (TCZ), and of them 8 (88,9%) were treated successfully for uveitis. The resolution of anterior chamber inflammation was obtained with a mean interval of 2 months for ADA and 3 months for IFX. Before starting biologic therapy 33,3% (n=3) patients were on oral steroids, 55,6% (n=5) were doing methotrexate and 11,1% (n=1) was doing cyclosporine. After biological treatment, no patient was on oral steroids. Regarding adverse effects, there are records of one reaction to infusion during the treatment with IFX and liver enzymes derangement with ADA, that resulted in the switch of therapy respectively to ADA and IFX. Conclusion: In this small cohort, ADA, IFX and TCZ showed to be effective and relatively safe for treatment of JIA-associated uveitis.

Treatment of Active Cardiac Sarcoidosis with TNF Alpha Inhibitors

Background Cardiac sarcoidosis (CS) is associated with significant morbidity and mortality including progressive heart failure and sudden cardiac death. High-dose steroid immunosuppression remains standard of care for CS but there is a lack of randomized clinical trial data. As a result, there remains significant treatment variability among specialized centers. TNF alpha inhibitors are widely used for other inflammatory diseases and are generally well tolerated. However, little data, if any, exists regarding their utility in CS. TNF alpha inhibitors are particularly attractive given the potential adverse effects of chronic glucocorticoid based immunosuppression. The purpose of this study was to explore the effectiveness of TNF alpha inhibitors in active CS. Methods We performed a retrospective analysis of patients with metabolically active CS (defined by increased FDG avidity by cardiac PET imaging) who were treated with TNF alpha inhibitors. All patients underwent follow up PET imaging. Disease activity was quantified by the number of left ventricular (LV) myocardial segments with FDG avidity (based on a 17 segment model of the LV). Adverse events related to therapy was also recorded. Results Nine patients treated with TNF alpha inhibitors were included in this analysis. Eight Patients received the TNF alpha inhibitor, infliximab, one patient received adalimumab. Eight of the nine patients had previously received prednisone for CS; four transitioned from prednisone to infliximab due to adverse effects of steroid use; three transitioned because of continued active CS despite steroid therapy; one patient exhibited recurrent cardiac FDG avidity after prednisone discontinuation and another declined steroid treatment. The number of LV myocardial segments with active CS decreased from 8.6 +/- 3.6 to 1.9 +/- 3.5 (p=0.001) after a mean treatment duration of 7 months of infliximab that represents a decline of FDG avid LV segments by 72%. There was no significant change in LV ejection fraction (45 +/- 15% to 50 +/- 11% after therapy, p=NS). Six of the nine patients had complete resolution of active CS, and two had partial improvement. One patient experienced pancytopenia felt possibly related to infliximab; no other obvious adverse events were observed. Conclusions In this retrospective cohort, TNF alpha inhibition lead to significant improvement in disease activity based on FDG PET imaging. Most patients demonstrated complete resolution of active CS with minimal adverse effects. Further investigation into the use of TNF alpha inhibitors for treating active CS is warranted.

Concentrations of Adalimumab and Infliximab in Mothers and Newborns, and Effects on Infection

Little is known about in utero exposure to and postnatal clearance of anti-tumor necrosis factor (anti-TNF) agents in neonates. We investigated the concentrations of adalimumab and infliximab in umbilical cord blood of newborns and rates of clearance after birth, and how these correlated with drug concentrations in mothers at birth and risk of infection during the first year of life. We performed a prospective study of 80 pregnant women with inflammatory bowel diseases at tertiary hospitals in Denmark, Australia, and New Zealand from March 2012 through November 2014: 36 received adalimumab and 44 received infliximab; 39 received concomitant thiopurines during pregnancy. Data were collected from medical records on disease activity and treatment before, during, and after pregnancy. Concentrations of anti-TNF agents were measured in blood samples from women at delivery and in umbilical cords, and in infants for every 3 months until the drug was no longer detected. The time from last exposure to anti-TNF agent during pregnancy correlated inversely with the concentration of the drugs in the umbilical cord (adalimumab: r= -0.64, P= .0003; infliximab: r= -0.77, P < .0001) and in mothers at time of birth (adalimumab, r= -0.80; infliximab, r= -0.80; P < .0001 for both). The median ratio of infant:mother drug concentration at birth was 1.21 for adalimumab (95% confidence interval [CI], 0.94-1.49) and 1.97 for infliximab (95% CI, 1.50-2.43). The mean time to drug clearance in infants was 4.0 months for adalimumab (95% CI, 2.9-5.0) and 7.3 months for infliximab (95% CI, 6.2-8.3; P < .0001). Drugs were not detected in infants after 12 months of age. Bacterial infections developed in 4 infants (5%) and viral infections developed in 16 (20%), all with benign courses. The relative risk for infection was 2.7 in infants whose mothers received the combination of an anti-TNF agent and thiopurine, compared with anti-TNF monotherapy (95% CI, 1.09-6.78; P= .02). In a prospective study of infants born to mothers who received anti-TNF agents during pregnancy, we detected the drugs until 12 months of age. There was an inverse correlation between the time from last exposure during pregnancy and drug concentration in the umbilical cord. Infliximab was cleared more slowly than adalimumab from the infants. The combination of an anti-TNF agent and thiopurine therapy during pregnancy increased the relative risk for infant infections almost 3-fold compared with anti-TNF monotherapy. Live vaccines therefore should be avoided for up to 1 year unless drug clearance is documented, and pregnant women should be educated on the risks of anti-TNF use.

EFFICIENCY OF ANTI-INFLAMMATORY THERAPY IN PATIENTS WITH ANKYLOSING SPONDYLITIS ACCORDING TO THE RESULTS OF A PROSPECTIVE FOLLOW-UP STUDY

In accordance with the Ankylosing Spondylitis Assessments (ASAS) International Working Group guidelines, tumor necrosis factor-α inhibitors are recommended in patients with ankylosing spondylitis (AS) refractory to at least two nonsteroidal anti-inflammatory drugs (NSAIDs) and in those with the peripheral form of the disease. Previous investigations suggest that when long used, infliximab (INF) shows a steady-state efficacy in the vast majority of patients with active AS. Works evaluating the efficiency of combined therapy using NSAIDs and INF are scarce. Objective: to evaluate the efficiency of therapy with NSAIDs and INF in patients with AS from the results of a prospective study. Subjects and methods. A total of 72 men with a valid diagnosis of AS were followed up. All the patients were allocated to two groups according to the option of basic therapy: 1) 29 patients received combined therapy with INF and NSAIDs; 2) 43 had NSAID monotherapy. Clinical, laboratory, and instrumental examinations were performed every 12 months. Results and discussion. At 12 months of INF therapy, there were significant reductions in the values of BASDAI, BASFI, back pain, fatigue, and patient-rated global activity assessment. High BASDAI values remained in only 10 patients. At 24-month follow-up, the above measures did not significantly change as compared to the results obtained at 12 months and remained stable at 36 months. At 12 months of NSAID therapy, there were significant reductions in the values of BASDAI, back pain, fatigue, and patient-rated global activity assessment (p < 0.05). The reduction in BASFI values was insignificant. At 24 months of treatment all the measures versus those obtained after 12 months did not significantly change, except pain in the examined region of the spine, which became significantly severer than that at the 12-month follow-up. These results were also preserved at 36 months. There were more patients achieving 20% and 40% improvements and remission according to the ASAS criteria, and those with a 50% BASDAI improvement after 36 months of INF + NSAID therapy versus NSAID monotherapy (p < 0.05). Conclusion. The highest clinical effect of INF + NSAID therapy was observed within the first year and the measures in question remained stable at the 36-month follow-up after both treatments.

AB0437 Clinical Utility of Measuring Drug and Anti-Drug Antibody Concentration of Biologic Agents in Rheumatoid Arthritis Patients with Moderate and High Disease Activity

BackgroundBiologicals possess a large variation in pharmacokinetics (1). Subtherapeutic drug levels and formation of anti-drug antibodies (ADAb) decrease their efficacy in rheumatoid arthritis (RA) patients (2). Measuring these can become...

Human Polyomavirus JC monitoring and noncoding control region analysis in dynamic cohorts of individuals affected by immune-mediated diseases under treatment with biologics: an observational study.

BackgroundProgressive multifocal leukoencephalopathy (PML) onset, caused by Polyomavirus JC (JCPyV) in patients affected by immune-mediated diseases during biological treatment, raised concerns about the safety profile of these agents. Therefore, the aims of this study were the JCPyV reactivation monitoring and the noncoding control region (NCCR) and viral protein 1 (VP1) analysis in patients affected by different immune-mediated diseases and treated with biologics.MethodsWe performed JCPyV-specific quantitative PCR of biological samples collected at moment of recruitment (t0) and every 4 months (t1, t2, t3, t4). Subsequently, rearrangements’ analysis of NCCR and VP1 was carried out. Data were analyzed using χ2 test.ResultsResults showed that at t0 patients with chronic inflammatory rheumatic diseases presented a JCPyV load in the urine significantly higher (p≤0.05) than in patients with multiple sclerosis (MS) and Crohn’s disease (CD). It can also be observed a significant association between JC viruria and JCPyV antibodies after 1 year of natalizumab (p=0.04) in MS patients. Finally, NCCR analysis showed the presence of an archetype-like sequence in all urine samples, whereas a rearranged NCCR Type IR was found in colon-rectal biopsies collected from 2 CD patients after 16 months of infliximab. Furthermore, sequences isolated from peripheral blood mononuclear cells (PBMCs) of 2 MS patients with JCPyV antibody at t0 and t3, showed a NCCR Type IIR with a duplication of a 98 bp unit and a 66 bp insert, resulting in a boxB deletion and 37 T to G transversion into the Spi-B binding site. In all patients, a prevalence of genotypes 1A and 1B, the predominant JCPyV genotypes in Europe, was observed.ConclusionsIt has been important to understand whether the specific inflammatory scenario in different immune-mediated diseases could affect JCPyV reactivation from latency, in particular from kidneys. Moreover, for a more accurate PML risk stratification, testing JC viruria seems to be useful to identify patients who harbor JCPyV but with an undetectable JCPyV-specific humoral immune response. In these patients, it may also be important to study the JCPyV NCCR rearrangement: in particular, Spi-B expression in PBMCs could play a crucial role in JCPyV replication and NCCR rearrangement.

Dual Therapy With Infliximab and Immunomodulator Reduces One-Year Rates of Hospitalization and Surgery Among Veterans With Inflammatory Bowel Disease

Effectiveness of early treatment with biologics and immunomodulator therapy on healthcare utilization remains poorly defined. We assessed rates of hospitalization and surgery within 1year after initiation of infliximab and/or immunomodulator therapy in a United States cohort of patients with inflammatory bowel disease. We conducted a retrospective, observational cohort study of veterans with Crohn's disease orulcerative colitis by using administrative data from 176 Department of Veteran Affairs facilities (October 1, 2001 through September 30, 2009). Inpatient, outpatient, and death records were linked longitudinally with prescription fill data. Each person-day of follow-up was assessed for treatment with infliximab, immunomodulators, both (dual therapy), or neither. We calculated drug exposure time and used Poisson and logistic regression analyses to assess outcomes. The cohort of 20,474 patients included 8042 patients with Crohn's disease and 12,432 with ulcerative colitis (93.9% male; 72.5% white; mean age, 60.9 ± 14.5 years) prescribed infliximab (0.17%), immunomodulator (1.3%), or dual therapy (1.5%). Adjusted models revealed 50% relative reductions in hospitalization among patients who received 9.2 months of immunomodulator monotherapy, 8 months of infliximab, or 7.7 months of dual therapy. A 50% relative reduction in surgery was observed among patients receiving 7 months of infliximab or 5 months of dual therapy. Analysis of dose-response data revealed 73.1% and 92% reductions in risk of hospitalization and surgery, respectively, after 9 months of dual therapy. On the basis of a retrospective cohort study, dual therapy with infliximab and an immunomodulator for <8 months is associated with significant reductions in hospitalization and surgery within 1 year of the start of therapy. These findings indicate that patients with IBD are more likely to benefit if dual therapy is initiated earlier in their first year of therapy.

SAT0150 Soluble FAS/FASL levels in rheumatoid arthritis patients treated with infliximab and adalimumab

BackgroundRheumatoid Arthritis (RA) is an autoimmune disease characterised by chronic inflammation and synovial hyperplasia caused by influx of inflammatory cells and by a reduced rate of programmed cell death. In...

Cost Analysis of Screening According to ECCO Guidelines for Prevention of Opportunistic Infections in Infliximab-Treated IBD Patients

Introduction We previously reported that our practice of screening for and prevention of opportunistic infections (OI9s) in at risk IBD patients was not in line with ECCO recommendations.12 In this study, we aimed first to seek evidence of OI9s in our historical cohort of infliximab (IFX)-treated patients who had not been screened according to recommendations and second, to analyse the cost-effectiveness of screening of, and prophylaxis as required for tuberculosis (TB) and hepatitis B (hep B) in IFX-treated patients. Methods An audit of consecutive patients treated with IFX (2005–2009) was conducted and occurrence of OIs and duration of IFX were recorded. A cost-minimisation analysis was performed using clinical decision analytic modelling to assess cost outcome of screening and prevention versus not screening and prevention. Model branch probabilities were obtained from a Medline search. The cost perspective was the health sector. Hospital admissions were based on Healthcare Resource Group (HRG4) codes. Results There were no OI9s identified in 92 IBD patients treated with a median of 21 months of IFX. For 1000 hypothetical Crohn9s patients in a western European population, the model predicted 15 screened patients required isoniazid prophylaxis, with 0.5 unscreened patients admitted to hospital with TB. There was an incremental cost for screening of £39.50/patient for CXR alone, or £125.60 for CXR combined with an interferon release assay. Conversely, there was a cost saving for screening in Southern Europe (£12/patient). For Hepatitis B in the Western European population, the model predicted 35.7 screened patients required lamivudine prophylaxis, whereas in the unscreened group, 2 patients reactivated with hepatitis, 3 patients with liver failure, and one required a transplant. There was a cost saving of £32/patient for screening. Conclusion There were no significant OI9s identified in this audit of IFX-treated IBD patients despite failure to screen according to ECCO guidelines. The cost analysis model demonstrates cost saving for hepatitis B screening because of the significant cost of hepatitis B reactivation. In the southern European population there is a cost benefit for TB screening due to a high rate of latent TB whereas in the western European population, there is an incremental cost for screening because of a lower risk of TB reactivation there. This cost should be balanced against the risk of death due to TB reactivation (reported in Southern but not Western Europe).3

Cost analysis of screening according to ECCO guidelines for prevention of opportunistic infections in infliximab-treated ibd patients

IntroductionWe previously reported that our practice of screening for and prevention of opportunistic infections (OI's) in at risk IBD patients was not in line with ECCO recommendations.1 2 In this...

Tumour necrosis factor inhibitor-related lupus: safety of switching agents

An increase in reports of systemic lupus erythematosus (SLE) related to tumour necrosis factor inhibitor (TNFi) therapy has recently been highlighted. We report new-onset SLE in a 22-year-old woman after 13 months of infliximab for ankylosing spondylitis (AS). Lupus symptoms promptly resolved and serologic abnormalities improved after infliximab was ceased. A flare of AS symptoms after 2 months prompted cautious introduction of an alternative TNFi, etanercept. At 14 months follow-up, neither clinical nor serologic flare of lupus had occurred. To our knowledge, this is the third reported case of infliximab-related lupus that did not recur on switching to an alternative TNFi.

The cost effectiveness and budget impact of natalizumab for formulary inclusion

Background: Crohn's disease (CD) and multiple sclerosis (MS) are debilitating autoimmune diseases, which represent a substantial cost burden in the context of managed care. As a corollary, there is an unmet pharmacotherapeutic need in patient populations with relapsing forms of MS, in addition to populations with moderately to severely active CD with evidence of inflammation who have experienced an inadequate response to other mainstream therapies. The purpose of this study was to analyze the clinical and economic data associated with natalizumab (Tysabri) and to determine the potential impact of its formulary inclusion in a hypothetical health plan.Findings: Regarding MS, the implemented cost-effectiveness and budget-impact models demonstrated an anticipated reduction in relapse rate of 67% over 2 years, and a total therapy cost of $72,120 over 2 years, equating to a cost per relapse avoided of $56,594. With respect to the model assumptions, the market share of natalizumab would experience an increase to 8.5%, resulting in a total per-member, per-month healthcare cost increase of $0.003 ($0.002 for pharmacy costs and $0.001 for medical costs).Regarding CD, over a 2-year period outlined by the model, natalizumab produced the highest average time in remission, steroid-free remission, and remission or response in comparison to the other agents. The mean total costs associated with the initiation of natalizumab, infliximab, and adalimumab were $68,372, $62,090, and $61,796, respectively. Although natalizumab's costs were higher, the mean time spent in remission while on this medication was 4.5 months, as opposed to 2.4 months for infliximab and 2.9 months with adalimumab. This shift in market share was used to estimate the change in total costs (medical + pharmacy), and the per-member per-month change for the model's base case was calculated to be $0.035.Limitations: The aforementioned cost-effectiveness results for natalizumab in the treatment for CD and MS were limited by the model's predetermined assumptions. These assumptions include anticipated reduction in relapse rate after 2 years of therapy and acquisition costs in the MS model, as well as assuming a certain percentage of patients were primary and secondary failures of TNFα inhibitor therapy in the CD model.Conclusion: The evidence presented here demonstrates that natalizumab provides clinical practitioners with another tool in their fight against both MS and CD, albeit by way of a different mechanism of action. After a thorough review of the evidence, the authors find that natalizumab has been shown to be relatively cost effective in the treatment of both conditions from a payer perspective; the therapy adds a new option for those patients for whom conventional treatment was unsuccessful.

TNF antagonists in the treatment of inflammatory bowel disease: Results of a survey of gastroenterologists in the French region of Lorraine

We conducted a survey of nonacademic gastroenterologists to evaluate the use of tumor necrosis factor (TNF) antagonists in inflammatory bowel disease (IBD). A total of 100 questionnaires were sent by mail to a representative sample of gastroenterologists practicing in the French region of Lorraine. Forty-six practitioners responded to the survey, of whom 95.5% prescribed scheduled infliximab treatment. After 6 months of infliximab in combination with azathioprine, 55% then prescribed infliximab as monotherapy. A complete pretherapeutic assessment was performed by only one fourth of the gastroenterologists. When the PPD skin test measured 7 mm, nearly half of the physicians introduced anti-TNF therapy without chemoprophylaxis (versus only 2.4% when the diameter was 11 mm). In the event of quiescent Crohn's disease (CD) after 1 year of anti-TNF treatment, 35.7% stopped the drug. In refractory CD, 72.7% prescribed infliximab as the first-line therapy (versus 27.3% who used adalimumab). In patients with urinary tract infection, 44.2% initiated antibiotics and delayed anti-TNF treatment, while 46.5% initiated anti-TNF therapy along with antibiotic therapy. This study is the first survey upon the use of TNF antagonists by nonacademic gastroenterologists, and the findings suggest that physicians using these drugs may require more information about the pretherapeutic assessment and management of the infectious risk.

An exploration of patients' experiences of anti‐TNF therapy

To explore the experience of rheumatoid arthritis patients receiving anti-tumour necrosis factor (anti-TNF) therapy on physical, psychological and social well-being. Seven patients with rheumatoid arthritis (RA) who received six months of infliximab were interviewed in depth by one researcher to identify their experiences of this treatment. The interviews were tape-recorded and analysed using Colaizzi's procedural steps. Four main categories were identified from the interview relating to the patient's experience of anti-TNF therapy. These included: The impact of living with RA on physical, psychological and social function. The influence of anti-TNF therapy on physical, psychological and social function. The experience of attending for treatment. The impact of discontinuing anti-TNF treatment. All seven patients experienced benefits from receiving anti-TNF therapy. These benefits were not maintained once the treatment period was completed.

Etanercept en pacientes con artritis reumatoide y escasa respuesta terapéutica a infliximab

Knowing the efficacy of tumor necrosis factor alpha (TNF-alpha) antagonists infliximab or etanercept in patients with rheumatoid arthritis (RA), when one of these agents has failed, has important clinical implications. The aim of this study was to evaluate the efficacy and safety of etanercept in patients with RA, who had previously failed to infliximab. All patients with RA of our center, who were previously treated with infliximab and then switched to etanercept for at least 6 months were included. Several clinical and biological parameters of inflammatory activity along with the disease activity index DAS-28 were assessed at baseline, after 6 weeks, at the last infusion of infliximab and after 0, 3 and 6 months on etanercept. EULAR criteria of response to therapy were used. Fourteen RA patients (13 females) who fulfilled the inclusion criteria were selected. These patients had been treated with infliximab for a mean (SD) of 14.6 (8.3) months when this drug was stopped. Drug withdrawal owed to inefficacy in 12 patients and to adverse events in 2 patients. Most patients achieved a satisfactory clinical response within the first months of infliximab, with a subsequent loss of the therapeutic effects in spite of an increase in the infliximab dose or a reduction of the interval between infusions. In the group of 12 patients switched to etanercept because of infliximab inefficacy, a therapeutic response was achieved in 10 (83%) of them after 6 months of etanercept therapy. The DAS-28 score (SD) improved from 5.6 (1) to 4.3 (0.8) (p = 0.019). An even better therapeutic response to etanercept was observed in those patients with an initial poor response to infliximab. No serious adverse effects were recorded during etanercept treatment. Etanercept is an efficient and safe therapy in RA patients when infliximab treatment has failed.