Concomitant Methotrexate Therapy Research Articles

Adherence to biological therapies in patients with rheumatoid arthritis: a retrospective cohort study.

The advent of biologic disease-modifying antirheumatic drugs has dramatically changed the comprehensions of treatment and long-term prognosis in patients with rheumatoid arthritis. The potent therapeutic results can only be achieved if the patients adhere to prescribed medications. The objective of this study was to estimate the impact of age, gender, duration of the disease, concomitant Methotrexate therapy, prior exposure to biologic agents, disease activity, functional capacity, and health-related quality of life on adherence to biologic treatment among Bulgarian population with rheumatoid arthritis. This was a retrospective observational cohort study that included 179 patients. At the baseline visit and subsequent follow-up assessments at 6, 12, 24 and 36months, patients were interviewed by a physician and underwent physical examinations. We monitored the changes in disease activity, functional capacity and health-related quality of life on each time point. Univariate and multivariate binary logistic regression was used to determine the prognostic value of possible predictors of treatment adherence. Our findings showed that only DAS28 score [odd ratio (OR) = 1.174; 95% CI 1.74-2.362] and HAQ score (OR 2.803; 95% CI 1.428-5.503) remained significant for the treatment adherence throughout the study period. The adherence to the biologic disease-modifying anti-rheumatic drugs among Bulgarian patients with rheumatoid arthritis is suboptimal. A multifaceted and comprehensive knowledge of the influencing factors can be useful for the development of different strategies that can improve treatment adherence.

ОЦЕНКА ЭФФЕКТИВНОСТИ И БЕЗОПАСНОСТИ ПРИМЕНЕНИЯ ЭТАНЕРЦЕПТА У ПАЦИЕНТОВ С НЕСИСТЕМНЫМИ ВАРИАНТАМИ ЮВЕНИЛЬНОГО АРТРИТА: 10-ЛЕТНИЙ ОПЫТ ПРИМЕНЕНИЯ В УСЛОВИЯХ ФЕДЕРАЛЬНОГО ЦЕНТРА

TNF-α inhibitors are used in the treatment of non-systemic variants of juvenile idiopathic arthritis (JIA) in case of ineffectiveness or intolerance to methotrexate. Despite 20 years of experience of using of etanercept in pediatric rheumatology, a long-term study of the efficacy and safety of the drug in real clinical practice remains necessary. Objective of the study: to study the efficacy and safety of etanercept for treatment of various non-systemic JIA subtypes in real clinical practice. Materials and methods of research: data from the case histories of 375 patients (242 girls and 133 boys) with articular forms of JIA for 2010–2020 were included in a retrospective, open, uncontrolled, nonrandomized, continuous multicenter cohort study. The age of debut was 6.3 (2.9; 10.7) years. Demographic characteristics, subtypes of arthritis, indicators of laboratory activity of inflammation, and outcomes were estimated: achievement of remission, exacerbation, and switching from etanercept to another genetically engineered biological drug (GEBD) were assessed. Results: remission was recorded in 78.9% on average after 6 months. The factors that determine the likelihood of achieving remission were the absence of previous therapy with GEBD (p=0.001) and compliance with therapy – OR=2.5 (95% CI: 1.3; 4.7), p=0.006. Exacerbations were recorded in 29.5% and were associated with the presence of the HLA B27 antigen – OR=2.6 (95% CI: 1.1; 6.0), p=0.028, antinuclear factor seropositivity (p=0.060). Change of etanercept to another GEBD was made in 17.4% of children and was associated with a failure to achieve remission – OR=7.7 (95% CI: 4.0–14.3), p=0.000001, with previous exacerbations – OR=14,8 (5.3; 41.2), p=0.0000001 and the development of de novo uveitis – OR=2.4 (95% CI: 1.1–5.3), p=0.038. The arthritis subtype and the presence of concomitant methotrexate therapy did not significantly affect treatment outcomes. Conclusion: achievement of remission, compliance with therapy, history of previous therapy with GEBD, exacerbation of JIA and development of de novo uveitis determined the main outcomes of etanercept therapy. The JIA subtype, as well as concomitant therapy with methotrexate, did not significantly affect the outcomes of the disease, which makes it possible to consider etanercept therapy a very effective and safe method of treating JIA as a genetically engineered first-line therapy of any variants of articular forms of JIA, even in monotherapy with ineffectiveness or intolerance to methotrexate.

Factors associated with long-term retention of treatment with golimumab in rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis: an analysis of the Spanish BIOBADASER registry.

Retention of biological treatment provides a marker of drug effectiveness and patient satisfaction. Retention of golimumab was high in clinical trial extensions and real-world studies up to 5 years in patients with immune-mediated rheumatic diseases. To assess the probability of real-world long-term retention of treatment with golimumab up to 7 years after treatment initiation. This retrospective noninterventional study involved analysis of the Spanish biological drugs registry, BIOBADASER. Adults who had ever received golimumab for rheumatoid arthritis (RA), axial spondyloarthritis (SpA), or psoriatic arthritis (PsA), and had initiated it > 6 months before the analysis date, were included. Among 685 patients (28.5% RA, 42.9% SpA, 28.6% PsA), the overall probability of retention of golimumab treatment since initiation was 71.7% (95% confidence interval 68.1-74.9) at year 1, 60.5% (56.5-64.2%) at year 2, 55.6% (51.5-59.5%) at year 3, 50.6% (46.2-54.8%) at year 4, 45.1% (40.1-50.0%) at year 5, 44.2% (39.0-49.3) at year 6, and 39.5% (32.8-46.2) at year 7. Retention was greater in patients with axial SpA or PsA versus RA (p < 0.001) and when golimumab was used as first-line treatment versus third or later lines (p < 0.001). Factors associated with greater golimumab retention in Cox regression included use as first-line biological therapy, having axial SpA or PsA rather than RA, and concomitant methotrexate therapy. Steroids were associated with lower retention. In this real-world study of RA, axial SpA, and PsA patients, the retention rate of golimumab was 39.5% at year 7. Key Points • Retention of biological treatment provides a marker of drug effectiveness and patient satisfaction. • This real-world study of 685 patients with rheumatoid arthritis (RA), axial spondyloarthritis (SpA), or psoriatic arthritis (PsA) showed that golimumab treatment had a retention rate up to 39.5% at year 7. • Greater golimumab retention was associated with use as first-line biological therapy, having axial SpA or PsA rather than RA, and concomitant methotrexate therapy.

Comparative evaluation of efficacy, pharmacodynamics, and safety of Hetero\u2019s adalimumab (Mabura\xae, Hetero Biopharma Ltd.) and reference adalimumab (Humira\xae, Abbvie Inc.) in patients with active rheumatoid arthritis on concomitant methotrexate therapy

BackgroundOur study aimed to compare efficacy and safety of Hetero’s adalimumab (Mabura®, Hetero Biopharma Limited) versus reference adalimumab (Humira®, Abbvie Inc.) in Indian patients with active rheumatoid arthritis (RA) concomitant on methotrexate (MTX) therapy.MethodsPatients (n = 168) were randomized (2:1) to receive either test or reference product for 24 weeks with concomitant MTX. Proportion of patients achieving American College of Rheumatology 20 (ACR20) criteria at week 12 was the primary endpoint. Changes in Disease Activity Score of 28 joints–C-reactive protein (DAS28-CRP), Health Assessment Questionnaire–Disability Index (HAQ-DI), and patients achieving ACR20 at week 24, ACR50/70 at weeks 12 and 24 were secondary endpoints.ResultsPatients achieving ACR20 responses with test (96.43%) were similar to reference (96.43%) in intention-to-treat (ITT) analysis at week 12. Proportional difference (PD) between groups (PD [95% CI] 0.0 [− 6.0, 6.0], p = 1.000) for ACR20 at week 12 for ITT analysis showed lower limit of the two-sided 95% CI was above the pre-specified noninferiority margin of − 15%. Similar trend in PP analysis (PD [95% CI] 0.0 [− 0.03, 0.07], p = 1.000), confirmed therapeutic equivalence. No significant difference was noted between arms for patients attaining ACR20 at week 24 and ACR50/70 at weeks 12 and 24 (all p > 0.05). DAS28-CRP and HAQ-DI were similar between groups. Total of 54 patients reported 88 AEs during the study. Out of these, 60 AEs were reported in 34 patients with Hetero-Adalimumab and 28 AEs were reported in 20 patients with Reference-Adalimumab. Total two patients, one in each group reported two serious adverse events (Sinusitis and Viral infection) during the study and resolved completely. No deaths and no life threatening AEs were reported.ConclusionResults demonstrated Hetero’s adalimumab is as effective and well tolerated as reference adalimumab in patients with active RA concomitantly on MTX therapy.Trial registrationCTRI/2016/04/006884, Registered on 28/04/2016.

Diet and psoriasis

Background: Patients with psoriasis have a growing interest in managing their disease through diet.Objective: This review paper aims to analyze dietary interventions for psoriasis and their outcome.Methods: Terms "psoriasis AND diet" were used to search PubMed database and 63 articles describing dietary changes influencing psoriasis were selected.Results: Low calorie diet (LCD) improves Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) in conjunction with topical or systemic therapy, although LCD was unsuccessful in maintaining disease remission when patients discontinued concomitant cyclosporine or methotrexate therapy. A fish oil diet improved baseline PASI of 7.7 to 5.3 at three months and 2.6 at 6 months compared to control (PASI: 8.9, 7.8, and 7.8, respectively). A randomized, double-blind, placebo-controlled study investigating selenium supplementation in psoriasis provided no PASI improvement. Zinc supplementation with concomitant betamethasone valerate 0.0025% ointment in a randomized, double-blind, placebo-controlled study provided a mean PASI of 11.2 in the intervention group and 8.0 in the control group with no significant difference between both arms. Gluten free diet and vitamin D supplementation were also efficacious dietary changes although results were mixed.Conclusions: Dietary changes alone do not cause a large effect in psoriasis but may become an important adjunct to current first line treatments.

Regulatory T cells as a biomarker for response to adalimumab in rheumatoid arthritis

Regulatory T cells as a biomarker for response to adalimumab in rheumatoid arthritis

Role of Methotrexate in the Management of Psoriatic Arthritis.

Methotrexate is known to be safe and efficacious in the management of rheumatoid arthritis and psoriasis and thus has been used for the management of psoriatic arthritis despite a lack of evidence to support efficacy in psoriatic arthritis from randomized controlled trials. Although the largest randomized trial to date did not support its use as a disease-modifying therapy, observational studies have supported its role, and current treatment recommendations approve of its use as a first-line agent for the management of psoriatic arthritis with predominant peripheral arthritis. The first treat-to-target study in psoriatic arthritis, comparing tight control with standard care, has shown the efficacy of methotrexate as monotherapy in the first 12weeks. This trial demonstrated the effectiveness of methotrexate with improvement in peripheral arthritis, skin and nail disease, enthesitis, and dactylitis over the course of 12weeks. There is conflicting evidence about the role of combination (concomitant methotrexate and anti-tumor necrosis factor) therapy. However, drug survival and immunogenicity of certain anti-tumor necrosis factors seem to be better when used in combination with methotrexate. This report reviews the available evidence on the efficacy and effectiveness of methotrexate in psoriatic arthritis and its role in treating psoriatic arthritis to target, as well as in combination with biologic agents. Ideally, randomized placebo-controlled clinical trials evaluating methotrexate (using subcutaneous route of delivery) would provide much-needed clarity on the role of methotrexate in the management of psoriatic arthritis; however, issues around using a placebo in patients with active psoriatic arthritis may render such a trial unfeasible.

Real-World Treatment Patterns for Golimumab and Concomitant Medications in Japanese Rheumatoid Arthritis Patients.

The aim of this study was to investigate real-world treatment patterns for use of golimumab and concomitant medications in Japanese patients with rheumatoid arthritis. This study was a post hoc retrospective analysis from post-marketing surveillance data on 2350 Japanese patients with moderate/severe rheumatoid arthritis who received golimumab for 24weeks. The study population was divided based on initiation treatment or dose adjustment patterns with golimumab, methotrexate, or oral glucocorticoids. Logistic regression analysis revealed that the baseline factors associated with administration of golimumab (100mg) were higher body weight, failure of prior biological therapy (bio-failure), no previous methotrexate use, and respiratory disease, while previous methotrexate use and absence of renal impairment or respiratory disease were associated with concomitant methotrexate therapy, and previous glucocorticoid use was associated with concomitant glucocorticoid therapy. The following associations were identified with regard to dose adjustment during treatment: bio-failure, no previous methotrexate use, previous csDMARDs use, presence of respiratory disease, allergy history, and higher CRP for golimumab dose escalation; shorter disease duration, previous GC, and no previous methotrexate use for methotrexate dose escalation; no prior biological therapy and renal impairment for methotrexate dose reduction; no previous GC use for glucocorticoid dose escalation; and absence of Steinbrocker's stage II/III/IV, absence of Steinbrocker's class II, no bio-failure, and no previous csDMARDs use for glucocorticoid dose reduction. This study revealed that various baseline factors were associated with initiation of treatment and dose adjustment of golimumab, methotrexate, or oral glucocorticoids, reflecting both the treatment strategies of physicians for improving RA symptoms and/or reducing adverse events. Janssen Pharmaceutical K.K. and MitsubishiTanabe Pharma Corporation.

Predictors of hypogammaglobulinemia during rituximab maintenance therapy in rheumatoid arthritis: A 12-year longitudinal multi-center study.

Rituximab (RTX) is an anti-CD20 monoclonal antibody that selectively depletes B-cell population. Thus, it presents a potential risk for the development of hypogammaglobulinemia and related infectious events. Our aim was to identify predictors of hypogammaglobulinemia in RA patients long-term treated with RTX. Multicenter observational usual care study of patients with RA on RTX maintenance therapy (minimal exposition of 30 months). Serum protein electrophoresis was performed before each RTX infusion. Hypogammaglobulinemia and severe hypogammaglobulinemia were defined as total gammaglobulin <6g/L and <4g/L, respectively. The primary outcome was the occurrence within the follow-up period of hypogammaglobulinemia. 134 patients met inclusion criteria and were followed-up for 79.5 ± 24.6 months. Hypogammaglobulinemia occurred during the follow-up period in 23 patients (2.7 events per 100 pt-yrs). The mean time to development of hypogammaglobulinemia was 64 ± 23 months. Patients who developed hypogammaglobulinemia were more likely to experience severe infections (26.1% vs. 6.3%, P = 0.033). Multivariate Cox analysis identified gammaglobulin levels <8g/L at baseline as an independent predictor of hypogammaglobulinemia (HR 7.34 [95% CI: 2.00-26.90], P = 0.003). Concomitant methotrexate (MTX) intake was also predictive of a reduced risk of hypogammaglobulinemia occurrence (HR 0.26 [95% CI: 0.08-0.87], P = 0.03). Our results show that gammaglobulin levels of less than 8g/L at baseline is a strong independent risk factor for developing subsequent hypogammaglobulinemia, whereas concomitant MTX therapy seems to be a protective factor in RA patients treated long-term with RTX.

The management of first-line biologic therapy failures in rheumatoid arthritis: Current practice and future perspectives

The introduction of biologic disease-modifying anti-rheumatic drugs (bDMARDs) has dramatically changed the management of rheumatoid arthritis (RA). However, in a real-life setting about 30-40% of bDMARD treated patients experience drug discontinuation because of either inefficacy or adverse events. According to international recommendations, to date the best strategy for managing first-line bDMARD failures has not been defined yet and available data (especially on TNF inhibitors [TNFis]) seem to drive toward a personalized approach for the individual patient. Some TNFi partial responders may benefit from optimization of concomitant methotrexate therapy or from switching to a different concomitant sDMARD such as leflunomide. Conversely, apart from infliximab, TNFi dose escalation seems to be poor efficacious and poor cost-effective compared with alternative strategies. Albeit counterintuitive, the use of a second TNFi after the failure of the first-one (cycling strategy) is supported by clear evidences and has become widespread in the 2000s as the result of the limited alternative options till the introduction of bDMARDs with a mechanism of action other than TNF blockade. Nowadays, the use of abatacept, rituximab, tocilizumab, or JAK inhibitors as second-line agent (swapping strategy) is strongly supported by RCTs and real-life experiences. In the absence of head-to-head trials directly comparing these two strategies, meta-analyses of separated RCTs failed to find significant differences in favor of one or another choice. However, results from most observational studies, including well designed prospective pragmatic randomised analyses, demonstrated the superiority of swapping over cycling approach, whereas only few studies reported a comparable effectiveness. In this review, we aimed to critically analyze all the potential therapeutic options for the treatment of first-line bDMARD failures in order to provide a comprehensive overview of available strategies to be applied in clinical practice.

The role of methotrexate as combination therapy with etanercept in rheumatoid arthritis: Retrospective analysis of a local registry

ObjectiveIn a real-life setting, to analyse retrospectively the effects of different methotrexate regimens on etanercept efficacy during the first year of treatment for rheumatoid arthritis (RA).MethodsDemographic characteristics, clinical parameters and treatment data from patients with RA receiving the first-line biological disease-modifying antirheumatic drug, etanercept, as monotherapy or in combination with methotrexate were analysed at baseline and after 6 and 12 months. The study population was stratified into three groups according to the level of concomitant methotrexate therapy: no methotrexate, low-dose methotrexate (≤ 10 mg/week) or high-dose methotrexate (>10 mg/week).ResultsClinical response at 6 and 12 months and clinical outcome at 12 months were significantly better in patients concomitantly treated with high-dose methotrexate. Furthermore, this regimen was associated with the lowest discontinuation rate, suggesting a favourable safety profile.ConclusionThese data confirm, in a real-life setting, the importance of methotrexate as a combination therapy with etanercept and suggest that the minimal effective dose of methotrexate is >10 mg/week.

Trend of patient characteristics and its impact on the response to adalimumab in patients with rheumatoid arthritis: post hoc time-course analysis of an all-case PMS in Japan

Objectives. To investigate the relationship between changes in patient characteristics over time and the effectiveness and safety of adalimumab in the treatment of rheumatoid arthritis (RA) in clinical practice.Methods. Patients enrolled in the post-marketing registry study in Japan were divided into 5 subgroups based on the time adalimumab treatment was initiated. Demographic and baseline characteristics and responses to adalimumab were compared among the 5 subgroups to detect any time-course trend. Multiple logistic regression analysis was performed to identify characteristics that were significantly associated with the effectiveness or safety of adalimumab and to estimate response rates and the incidence of adverse drug reactions in individual subgroups.Results. During the study period, patient characteristics changed significantly over time, in particular with regard to prior biologic use and concomitant methotrexate therapy. There was a significant trend toward higher response rates and lower incidence of infections and injection-site reactions in patients initiating adalimumab later in the study. Patient characteristics, such as concomitant methotrexate therapy and early stage RA, were significant predictors of the effectiveness and safety of adalimumab.Conclusions. Patient characteristics have changed since adalimumab became available for the treatment of RA; several of these characteristics were significant predictors of adalimumab effectiveness and safety.

Effects of Concomitant Conventional and Previous Biological Disease Modifying Anti-Rheumatic Drugs Treatment on the Efficacy of Tocilizumab to Induce Remission in Patients with Rheumatoid Arthritis – An Observational Real-Life Study

Objectives: To investigate remission rates in rheumatoid arthritis patients exposed to tocilizumab treatment in real life clinical practice and to test whether concomitant conventional and previous biological disease modifying anti-rheumatic drugs treatment affects the efficacy of tocilizumab to reach remission. Methods: Between January 2009 and December 2012 disease activity was analyzed in 272 rheumatoid arthritis patients exposed to tocilizumab at the onset of treatment and sequentially thereafter, i.e. every four weeks at the time of infusion. Aside from demographic and disease-specific variables, previous and concomitant conventional and biologic disease modifying anti-rheumatic drugs therapy was documented in all patients. Multivariate logistic regression analyses were conducted to identify factors influencing Disease Activity Score 28 remission and attrition to tocilizumab treatment. Results: 219 (80.5%) of all patients were female. Mean Age was 55.48 ± 13.23 years and our patients had mean disease duration of 12.48 ± 9.30 years. Disease Activity Score 28 significantly decreased from 5.00 ± 1.52 at baseline to 3.09 ± 1.49 at the latest infusion. Mean treatment period was 58.28 ± 43.95 weeks. A total of 101 patients (42.8%) achieved Disease Activity Score 28 remission, which was significantly associated to the length of tocilizumab exposure. Achievement of Disease Activity Score 28 remission was independent from the concomitant use of conventional disease modifying anti-rheumatic drugs. Previous exposure to tumour necrosis factor inhibitors but not rituximab significantly reduced the likelihood to achieve Disease Activity Score 28 remission. Two logistic regression analyses revealed baseline disease activity and duration of tocilizumab therapy as independent factors for Disease Activity Score 28 remission, whereas age and concomitant methotrexate therapy were linked to attrition to tocilizumab treatment. Conclusion: Remission rates found in this observational study are comparable to those of randomized controlled trials and those of big post-marketing surveillance studies. Remission rates of rheumatoid arthritis patients treated with tocilizumab in clinical practice are not influenced by concomitant disease modifying anti-rheumatic drugs use. Previous exposure to tumour necrosis factor inhibitors but not to rituximab decreases the chance to reach remission with tocilizumab.

Ustekinumab for the Treatment of Crohn’s Disease

Introduction: Ustekinumab is a humanized immunoglobulin G monoclonal antibody that targets the shared p40 subunit of interleukin IL-12 and IL-23. It demonstrated promises in phase 2 trials for induction and maintenance therapy of anti-TNF resistant Crohn’s Disease (CD). In this study we sought to present our experience with subcutaneous ustekinumab in anti TNF resistant CD patients in a tertiary referral center. Methods: We performed a retrospective chart review of patients who were prescribed ustekinumab for treatment of CD between January 2010 and May 2014. Demographic, clinical, and treatment data were obtained. Primary end points were clinical response and remission which were defined as 3 points decline in Harvey-Bradshaw score from baseline and HBI less than 5 at week 8 respectively. Secondary outcomes were clinical response and maintenance of remission at 6 months. We also reviewed ancillary outcome such as modified short inflammatory bowel disease questionnaire (SIBDQ), mucosal healing, and serious adverse events. Results: The demographic characteristics of the patients were as follows: 14 (74%) female; 17 (90%) white; 2 (10%) Hispanic; mean age 36±16.7; and BMI 24±6.2. The disease characteristics based on Montreal classification were as follows: location 100% ileocolonic; disease phenotype: penetrating (B3)-90%; stricturing (B2)-10%. Twelve patients (63%) had perianal involvement, 4 (21%) had ileostomy, and 18 (94%) were steroid refractory. Previous treatment included one anti TNF failure in 5 patients (26%) and >1 anti TNF failure in 14 (74%). Three (15%), 9 (47%) and 5 (26.3%) failed concomitant methotrexate, 6 MP and imuran therapy respectively. Three patients were excluded as they just started therapy. All patients received ustekinumab 90 mg subcutaneous at week 0, 2, 8 as induction therapy. The maintenance dose was 90 mg subcutaneous every 8 weeks. Follow-up data was available for 16 and 11 patients at week 8 and 6 months respectively. Conclusion: Clinical response and remission were achieved in 13 out of 16 (81%) and 9 out of 16 (56%) patients at 8 weeks. In 6 months 7 out of 11 (63%) patients maintained their clinical response and 5 (45%) remained in clinical remission. Eleven out of 16 (69%) patients had SIBDQ improvement at week 8. Of 11 patients who had data available at 6 months, 8 (72%) had SIBDQ>35. Two out of 5 patients achieved mucosal healing at either 8 week or 6 months. Of 10 patients who had repeat imaging either at 8 weeks or 6 months, 4 showed improvement and 6 remained unchanged. None of our patients developed serious adverse events. In this cohort of patients with anti-TNF resistant CD, ustekinumab use resulted in clinical response in 81% and remission in 56% of patients with majority maintaining clinical response and remission up to 6 months of follow-up. Disclosure - Dr. Sarah Glover - Advisory Committee: Abbvie, Grant/Research Support: Biogen, Bristol Myers Squibb, Celgene, Elan, Janssen, Pfizer and UCB.

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...

SAT0243 Impact of Concomitant Methotrexate on the Enhanced Clinical Efficacy of Abatacept after 24 Weeks in Rheumatoid Arthritis Patients

BackgroundAbatacept (ABT), a selective co-stimulation modulator, is the first in a new class of biologic agents for the treatment of rheumatoid arthritis (RA) that inhibits T cell activation by binding...

Clinical efficacy of abatacept in Japanese rheumatoid arthritis patients

Objectives The purpose of this study was to examine the treatment retention and efficacy of abatacept, the first member of a new class of biologic agents, in Japanese rheumatoid arthritis (RA) patients during clinical practice.Methods A retrospective multicenter study was conducted with patients who underwent abatacept therapy for 24 weeks (n = 143).Results Patients at baseline had a mean age of 63.5 years, a mean disease duration of 11.3 years, and a mean disease activity score in 28 joints (DAS28) of 4.5. Overall retention of abatacept treatment was 83.2 % at 24 weeks, when 46.2 % of patients achieved DAS28-defined low disease activity (LDA; DAS28 <3.2) and 26.6 % achieved DAS28-defined remission (DAS28 <2.6). LDA was achieved in a significantly higher proportion of patients without prior biologics therapy compared to those with prior biologics (60.9 vs. 34.2 %, p = 0.001). There was no significant difference between patients with or without concomitant methotrexate (MTX) therapy (45.2 vs. 47.5 %).Conclusions Abatacept therapy appears to be highly effective and well tolerated during clinical treatment of RA. Abatacept was particularly effective in patients with no history of biologics use, and did not appear to be dependent on concomitant MTX therapy.

SAT0144 Can rheumatoid arthritis (RA) incomplete secondary responders to TNF-alpha attain an efficacious and safe response by switching to certolizumab pegol?

BackgroundCertolizumab pegol (CZP), an inhibitor of TNF-alpha, has demonstrated rapid and sustained efficacy in RA patients in multiple clinical trials and is approved for the treatment of RA in many...

Clinical efficacy of abatacept in Japanese rheumatoid arthritis patients

The purpose of this study was to examine the treatment retention and efficacy of abatacept, the first member of a new class of biologic agents, in Japanese rheumatoid arthritis (RA) patients during clinical practice. A retrospective multicenter study was conducted with patients who underwent abatacept therapy for 24weeks (n=143). Patients at baseline had a mean age of 63.5years, a mean disease duration of 11.3years, and a mean disease activity score in 28 joints (DAS28) of 4.5. Overall retention of abatacept treatment was 83.2% at 24weeks, when 46.2% of patients achieved DAS28-defined low disease activity (LDA; DAS28 <3.2) and 26.6% achieved DAS28-defined remission (DAS28 <2.6). LDA was achieved in a significantly higher proportion of patients without prior biologics therapy compared to those with prior biologics (60.9 vs. 34.2%, p=0.001). There was no significant difference between patients with or without concomitant methotrexate (MTX) therapy (45.2 vs. 47.5%). Abatacept therapy appears to be highly effective and well tolerated during clinical treatment of RA. Abatacept was particularly effective in patients with no history of biologics use, and did not appear to be dependent on concomitant MTX therapy.

Open-Label, Pilot Study of the Safety and Clinical Effects of Rituximab in Patients with Rheumatoid Arthritis-Associated Interstitial Pneumonia

Objective: To investigate the clinical effect of rituximab (RTX) in the management of progressive rheumatoid arthritis related interstitial lung disease (RA-ILD). Methods: A total of 10 patients with progressive RA-ILD were enrolled into this 48-week, open-label treatment study. Treatment was with RTX at 1000 mg at day 1, day 15, and again at weeks 24 and 26, with concomitant methotrexate therapy. Results: The study included 4 men and 6 women. Of 7 evaluable patients at week 48, the diffusing capacity to carbon monoxide had worsened by at least 15% in 1 patient, was stable in 4 patients, and increased by >15% of baseline value in 2 patients. The forced vital capacity declined by at least 10% in 1 patient, was stable in 4 patients, and increased by at least 10% in 2 patients. High resolution computed tomo-graphy of the chest showed improvement in 1 patient, and was unchanged in 5. Three patients were withdrawn, one who had an infusion reaction at week 0, one at week 5 who was hospitalized for congestive heart failure at week 5 and who later died at week 32 of complications following a traumatic hip fracture, and one died at week 6 of possible pneumonia. Conclusions: In this pilot study of 10 patients with RA-ILD treated with RTX, measures of lung disease remained stable in the majority of study completers. Further research is needed to clarify whether this treatment has a role in management of RA-ILD.