Concomitant Methotrexate Research Articles

SAT0358 Impact of Methotrexate on Anti-TNF Treatment in Psoriatic Arthritis? an In-Depth Analysis of A Large Prospective Observational Study with Adalimumab

BackgroundIn active psoriatic arthritis (PsA) the efficacy of TNF-inhibitors (TNFi) has been proven in randomized clinical trials (RCT). Methotrexate (MTX) co-medication can improve the therapeutic benefit of TNFi in rheumatoid...

THU0153 Pregnancy Outcomes in Women Exposed to the Tumor Necrosis Factor Inhibitor, Golimumab

BackgroundRheumatologic conditions and inflammatory bowel disease can affect women of childbearing potential. Golimumab (GLM) is approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and...

AB0435 Effects of Prior Use of BIOLOGICS on the Safety and Effectiveness of Abatacept Administered with or without Methotrexate in Japanese Patients with Rheumatoid Arthritis: Sub-Analysis of the Abatacept All-Cases Post-Marketing Surveillance

BackgroundThe result of post-marketing surveillance (PMS) of 3985 patients reported previously1 indicated that prior use of biologics, with or without concomitant methotrexate (MTX), was associated with the safety and effectiveness...

FRI0333 Effects of Tofacitinib Treatment on Leptin and other Components of the Multi-Biomarker Disease Activity Score in Patients with Rheumatoid Arthritis

BackgroundThe muti-biomarker disease activity (MBDA) score has been validated as an objective tool to assess disease activity in patients with rheumatoid arthritis (RA) (1). We have previously reported that MBDA...

AB0413 Hepatitis B Serologic Profile and Reactivation in Rheumatic Patients Treated with Biological Therapies – Single Centre Experience

BackgroundBiologic therapy for rheumatic diseases has been associated with increased risk of latent infections reactivation such as tuberculosis or hepatitis B (HB), due to severe immunosuppression. However, the actual risk...

Ustekinumab: a review of its use in psoriatic arthritis.

Ustekinumab (Stelara(®)) is a human monoclonal antibody that binds to the shared p40 subunit of interleukin (IL)-12 and IL-23, blocking signalling of their cognate receptors. It is established in the treatment of moderate-to-severe plaque psoriasis, but recently received approval in adults with active psoriatic arthritis. Tumour necrosis factor (TNF) inhibitors remain first-line biological agents for the treatment of psoriatic arthritis, but alternative agents are needed. This article summarises the pharmacology of ustekinumab and reviews its use in phase 3 trials in psoriatic arthritis. In these trials, subcutaneous ustekinumab 45 or 90 mg was significantly more effective than placebo, as determined by American College of Rheumatology response criteria at week 24. The drug was also associated with significantly greater efficacy than placebo with regard to secondary endpoints, including the Psoriasis Area and Severity Index ≥ 75 % response, enthesitis and dactylitis scores, radiographic progression and Health Assessment Questionnaire-Disability Index scores. Response to ustekinumab was maintained during long-term therapy (up to week 100), and was achieved with and without concomitant methotrexate. Ustekinumab was generally well tolerated, and the tolerability profile in psoriatic arthritis was similar to that reported in plaque psoriasis. Throughout long-term ustekinumab treatment, serious infection or major cardiovascular adverse events occurred rarely. More data are needed to clearly define the place of ustekinumab in psoriatic arthritis treatment algorithms. Meanwhile the drug is a valuable additional option for patients with psoriatic arthritis in whom the response to previous non-biological disease-modifying antirheumatic drugs has been inadequate, or for those who have failed anti-TNF therapy.

THU0508 Sparing Methotrexate Results in a Less Stringent Control of Plasma Cell and Immunoglobulin Free Light Chain Production in Seropositive Patients with Rheumatoid Arthritis

BackgroundClinical trials revealed that tumor necrosis factor alpha (TNF-α) blockade is more effective if administered with concomitant methotrexate (MTX).ObjectivesBased on an observation made when studying B cell subsets in patients...

FRI0314 Safety of the Newer Biological Dmards, TOCILIZUMAB and Abatacept, in Rheumatoid Arthritis (RA) Patients with A History of HBV Infection: A REAL Life Experience

BackgroundHBV infection represents a major issue in RA patients undergoing biological disease-modifying anti-rheumatic drugs (bDMARDs) treatment (1). While several studies deal with the risk of hepatitis reactivation under anti-TNF agents,...

THU0275 IL-6 Receptor (IL-6R) Blockade with Sarilumab Reduced Circulating Markers Related to Synovial Inflammation and Structural Damage in Patients with Rheumatoid Arthritis (RA) in A Phase 2 Study

BackgroundSarilumab is the first fully-human monoclonal antibody directed against the IL-6R and is being investigated for the treatment of RA. Patients with RA have elevated tissue turnover at sites of...

AB0424 Rheumatoid Arthritis Patients Receiving Biological Therapy in Colombia. Survey of Compliance and Causes of Methotrexate Suspension

BackgroundDisease modifying drugs (DMARD) in Rheumatoid Arthritis (RA) reduce the activity of the disease, decrease radiographic progression and improve long term functional outcome as long as patients are adherent to...

THU0156 Impact of Golimumab on Physical Function and Employability of Patients with Rheumatoid Arthritis: 5-Year Data from 3 Phase III Clinical Trials

ObjectivesTo assess the impact of golimumab (GLM) on physical function and employability in patients with rheumatoid arthritis (RA) with various prior treatment histories, after 5 years of therapy.MethodsThe efficacy and...

FRI0278 The First Early Rheumatoid Arthritis, Certolizumab Pegol, Multicenter, Double-Blind, Randomized, Parallel-Group Study: C-Opera, in Patients Fulfilling the 2010 Acr/Eular Classification Criteria, Demonstrates Inhibition of Joint Damage Progression

BackgroundAssessment of structural damage progression, clinical efficacy and safety in patients with early-stage rheumatoid arthritis (RA) naïve to methotrexate (MTX) and with poor prognostic factors with certolizumab pegol (CZP) has...

AB0150 Tocilizumab Does not Induce Apoptosis in Neutrophils in Vitro

BackgroundTocilizumab is an inhibitor of the IL-6 receptor and is highly efficient in the treatment of rheumatoid arthritis. Leucopenia has been observed in 10% of the patients, which has been...

SAT0063 Importance of Concomitant Methotrexate with TOCILIZUMAB and Assessment of Structual Damage for Achieving Better Clinical Outcomes for Rheumatoid Arthritis Patients with High Disease Activity: an Observational Cohort Study

BackgroundNow, predictive factors at baseline for the good outcome of treatment with biologics are very important not to waste time to treatment goal “remission”.ObjectivesThe aims of this study are to...

PMS11 - Therapy With Certolizumab Pegol And Other Tnf-A Inhibitors In Elderly Patients With Rheumatoid Arthritis: Results From The Corrona Registry

To describe baseline characteristics of elderly patients with Rheumatoid Arthritis (RA) initiating therapy with Certolizumab Pegol ( CZP) and other TNF-a inhibitors (TNFi). Cross-sectional analysis of RA patients older than 65 years of age, initiating CZP or another TNFi following enrollment in the CORRONA registry. Baseline demographic and clinical characteristics of included patients were assessed. Each characteristic was compared between CZP and other TNFi initiators using either Student’s two-sample t-test or the chi-square test. 1062 initiations of TNFi in RA patients older than 65 years were analyzed; 136 (12.8%) patients initiated CZP and 926 (87.2%) another TNFi. Baseline characteristics for CZP initiators (versus other TNFi): age (mean±Standard deviation (SD)) 72.2±6.4 (vs. 72.1±6.3, p>0.05), female 72.8% (vs. 74.6%, p>0.05), disease duration 12.1±9.9 (vs. 13.5±11.3, p>0.05), baseline CDAI 23.8±14.4 (vs. 18.0±12.9, p: <0.001), baseline mHAQ 0.50±0.51 (vs. 0.46±0.50, p>0.05). At the time of CZP initiation 45.9% of patients had high disease activity and 39.8% had moderate disease activity by CDAI (vs 32.8% and 33.7 respectively for other TNFi initiators, p: <0.0001). Concomitant methotrexate use was present in 49.3% of CZP initiators (vs 63.3 for other TNFi, p 0.002). In 40.4% of CZP initiators, CZP was used after failure of two or more prior biologics (vs 30.2% in other TNFi initiators, p: 0.026). The present descriptive analyses suggest that elderly CZP initiators have similar demographic characteristics with initiators of other TNFi. However, CZP is used more frequently after prior failure to 2 or more TNFi, is more commonly given as monotherapy, and initiated in patients with a higher mean disease activity compared to other TNFi.

Tu1203 Nutrient-Induced Reduction of IL-8 Release in Paediatric Human Ascending Colon

p<0.001). In addition, IFX levels were compared based on the phase of therapy (induction vs. maintenance) and antibody status (detectable vs. non-detectable) (Table 1). Conclusions: This study is to our knowledge the first analysis of IFX levels and ATI in pediatric patients with IBD utilizing the newly-available commercial electrochemilumescense assay. As expected, IFX levels were higher during induction compared to maintenance. In addition, we found a strong inverse relationship between IFX and ATI levels which suggests the important clinical potential of this tool in the treatment of IBD. Patients with elevated ATI are being studied longitudinally to determine whether ATI levels can be reduced by increasing IFX levels. In our population only 51% were on concomitant thiopurine or methotrexate, reflecting the concern of pediatric gastroenterologists for increased malignant potential. The authors report no conflict of interests. This study was internally funded and received no commercial support. Table 1. Infliximab levels based on phase of therapy and antibody status

Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of a randomised, placebo-controlled trial (the GO-REVEAL study)

ObjectivesAssess golimumab's long-term efficacy/safety in psoriatic arthritis (PsA).MethodsAdults with active PsA (≥3 swollen and tender joints, active psoriasis) were randomly assigned to subcutaneous placebo, golimumab 50 mg, or golimumab 100...

Tocilizumab is clinically, functionally, and radiographically effective and safe either with or without low-dose methotrexate in active rheumatoid arthritis patients with inadequate responses to DMARDs and/or TNF inhibitors: A single-center retrospective cohort study (KEIO-TCZ study) at week 52

Objectives. To explore the effectiveness and safety of tocilizumab (TCZ) with or without methotrexate (MTX) in active rheumatoid arthritis (RA) patients showing inadequate responses to DMARDs and/or TNF inhibitors in clinical practice.Methods. We observed consecutive 115 RA patients initiating TCZ treatment in Keio University Hospital, dividing them into two groups with (TCZ + MTX group) or without MTX (TCZ group), and evaluated clinical, functional and structural outcomes besides safety at week 52.Results. Overall mean age, RA duration, and DAS28-ESR were 55.4, 8.4 years, and 5.0, respectively. Proportions of the prior use of TNF inhibitors and concomitant MTX were 45.5% and 57.4%, respectively. Mean dose of concomitant MTX was 8.4 mg/week. Baseline characteristics were comparable between the groups. TCZ improved disease activity measured by DAS28-ESR to 2.1 at week 52 overall, without significant difference between the groups. Clinical (DAS28-ESR < 2.6), functional (HAQ-DI ≤ 0.5), and structural (ΔTSS ≤ 0.5) remission rates in the TCZ group and the TCZ + MTX group were 79.1%/63.8% (P = 0.10), 62.8%/54.4% (P = 0.40), and 70.0%/53.8% (P = 0.61), respectively. Retention rates were 81.0% in the TCZ + MTX group and 88.5% in the TCZ group (P = 0.47). The rate of serious adverse events was comparable between the groups.Conclusions. TCZ was clinically, functionally, and radiographically effective and safe either with or without low-dose MTX.

A 10-year, single tertiary care center experience on the durability of infliximab in pediatric inflammatory bowel disease.

Despite increasing use of infliximab (IFX) in children with Crohn's disease (CD) and ulcerative colitis (UC), long-term durability and safety of IFX beyond 1 year is limited in pediatric inflammatory bowel disease. We performed a 10-year single-center retrospective cohort study of 188 patients initiating IFX at <21 years of age with 1-year minimum follow-up. Data were retrieved from medical records. IFX outcomes were defined as sustained remission in the absence of dose modification (sustained durable remission), recaptured response, and treatment failure. Adverse events, anti-infliximab antibodies (ATI), and role of concomitant low-dose oral methotrexate (<10 mg/wk) on IFX durability were analyzed. Univariate associations and survival analysis were performed. As of the last follow-up, 39% of patients with CD and 29% of patients with UC achieved sustained durable remission and another 60% recaptured and maintained response. For CD, 88% remained on IFX at 1 year, 80% at 2 years, and 82% at 5 years. In UC, 70% avoided colectomy at 1 year. Of IFX failures, 25% with CD and 11% with UC developed ATI. The most common adverse event causing cessation of therapy was infusion reactions. Treatment limiting recurrent infections occurred in <1%, and 1 patient developed lymphoproliferative disease. Low-dose methotrexate did not influence any IFX outcomes. IFX is safe and effective for long-term maintenance therapy in pediatric patients with inflammatory bowel disease. IFX dose intensification can optimize durability and overcome loss of response. Loss of response is likely affected by development of ATI. Higher doses of oral methotrexate may be needed to optimize IFX.

Vaccine Responses in Patients with Rheumatoid Arthritis Treated with Certolizumab Pegol: Results from a Single-blind Randomized Phase IV Trial

To evaluate the humoral immune response to pneumococcal and influenza vaccination in adults with rheumatoid arthritis (RA) receiving certolizumab pegol (CZP). In this 6-week, single-blind, placebo-controlled trial with optional 6-month open-label extension (NCT00993668), patients were stratified by concomitant methotrexate (MTX) use and randomized to receive CZP 400 mg (loading dose; according to CZP label) or placebo at weeks 0, 2, and 4. Pneumococcal (polysaccharide 23) and influenza vaccines were administered at Week 2. Satisfactory humoral immune response, defined as ≥2-fold titer increase in ≥3 of 6 pneumococcal antigens and ≥4-fold titer increase in ≥2 of 3 influenza antigens, were assessed independently 4 weeks after vaccination. Following pneumococcal vaccination, 62.5% of placebo patients and 54.5% of CZP patients without effective titers at baseline achieved a humoral response (difference in proportions was -8.0 percentage points; 95% CI -22.5 to 6.6%). Following influenza vaccination, 61.4% of placebo and 53.5% of CZP patients without effective titers at baseline achieved a humoral response (difference in proportions: -8.0 percentage points; 95% CI -22.9 to 7.0%). In all patients, including those with effective titers at baseline, 58.2% of placebo and 53.3% of CZP patients developed satisfactory pneumococcal titers, and 54.1% of placebo and 50.5% of CZP patients developed satisfactory influenza antibody titers. Vaccine responses to pneumococcal and influenza antigens were reduced similarly in both treatment groups with concomitant MTX use. Humoral immune responses to pneumococcal and influenza vaccination are not impaired when given during the loading phase of CZP treatment in patients with RA. (ClinicalTrials.gov NCT00993668).