Moderate EULAR Response Research Articles

A Retrospective Study on Clinical Experience with Tofacitinib in the Treatment of Rheumatoid Arthritis at a Tertiary Care Center

Abstract Introduction: Tofacitinib is the first oral Janus kinase (JAK) inhibitor approved for the treatment of rheumatoid arthritis (RA). Since the expiry of its patent, the drug has become affordable to patients in India. The present study describes our experience with tofacitinib in patients with RA. Objective: To retrospectively study the 6-month outcome of patients with RA treated with tofacitinib. Methods: We retrieved the records of all consecutive patients with RA who were commenced on tofacitinib in the rheumatology clinic of our tertiary care hospital from December 2020 to December 2021. The drug was prescribed as per recommended indications at a dose of 5 mg twice daily. Age, sex, duration of disease, and prior treatment received were noted. Baseline and 6-month data on the tender joint count, swollen joint count, patient global assessment, and physician global assessment were obtained from the records. Similarly, baseline and 6-month laboratory parameters (CBC, Erythrocyte sedimentation rate, C-reactive protein, LFT, and KFT) were also retrieved. Disease activity was assessed using SDAI at baseline and after 6 months. Adverse effects documented in the records were carefully noted. Results: Seventy-five patients had been commenced on tofacitinib between December 2020 and December 2021. Five patients were lost to follow-up. Twelve patients had stopped the drug after 2–3 months because of inefficacy while 7 had stopped the drug because of adverse effects. Thus, 51 patients (out of 75) had taken tofacitinib for 6 months or more. Of these, 39 achieved EULAR good response (low-disease activity-23, remission-16) and 12 achieved EULAR moderate response. Adverse effects occurred in 27 (36%) patients and included weight gain (8%), cytopenia (6.6%), folliculitis (4%), and alopecia (4%). Others included anxiety, dyspepsia, constipation, chest pain, dyslipidemia, herpes zoster, hypertension, oral thrush, sensory neuropathy, somnolence, and urinary tract infection. Conclusion: Tofacitinib treatment resulted in remission in 16/75 (21%) and LDA in 23/75 (31%) in RA patients who were inadequate responders to conventional synthetic disease-modifying antirheumatic drugs/biological drugs. Adverse effects occurred in 36%.

Comparison of Rheumatoid Arthritis Patients' 2-Year Infliximab, Abatacept, and Tocilizumab Persistence Rates.

Background: Drug persistence reflects an agent’s efficacy and safety in routine practice. This study was undertaken to compare the 2-year persistence rates of three biologic disease-modifying antirheumatic drugs (bDMARDs) used to treat rheumatoid arthritis (RA) and to describe their efficacy and safety profiles. Methods: This retrospective, observational, single-center study included RA patients who had received at least one intravenous dose of infliximab, abatacept, and/or tocilizumab. Two-year drug persistence was estimated using the Kaplan–Meier method. Efficacy profiles were assessed as changes of Disease-Activity Score-28 (DAS28)-based EULAR-criteria responses. Results: The infliximab, abatacept, and tocilizumab groups included 40, 72, and 93 patients, respectively. Their respective 2-year persistence rates were similar: 55.0%, 45.8%, and 62.4%. Tocilizumab recipients benefited from greater improvement than those given infliximab (p = 0.0005) or abatacept (p < 0.0001). For all groups combined, 93.1% of patients obtained good or moderate EULAR responses. Conclusions: Even if this retrospective work includes different biases (lack of data, recruitment bias, etc.), it highlights that the 2-year persistence rates for infliximab, abatacept, and tocilizumab in daily practice did not differ significantly, thereby confirming the long-term efficacies of these three bDMARDs. However, tocilizumab was associated with more significant DAS28 improvement at 2 years than infliximab and abatacept.

Combination of human umbilical cord mesenchymal stem (stromal) cell transplantation with IFN-γ treatment synergistically improves the clinical outcomes of patients with rheumatoid arthritis

ObjectivesTo clarify the key role of circulating interferon-γ (IFN-γ) and to improve the clinical efficacy of mesenchymal stem cell (MSC) transplantation (MSCT) in patients with rheumatoid arthritis (RA).MethodsStudy of wild-type...

ICHIBAN, a non-interventional study evaluating tocilizumab long-term effectiveness and safety in patients with active rheumatoid arthritis

We aimed to measure long-term effectiveness and safety of tocilizumab in patients with rheumatoid arthritis in daily German practice. ICHIBAN was a prospective, multi-centre, non-interventional study (ML22928) that enrolled adult patients with active moderate to severe rheumatoid arthritis. Patients were to be treated according to tocilizumab label and observed for up to two years. Effectiveness outcomes included DAS28-ESR remission, EULAR response, CDAI and HAQ. Overall, 3164 patients received at least one dose of tocilizumab. Patient mean age was 55.5±13.1 years (74.8% female). At baseline, 72.1% of patients had at least one comorbidity. Approximately 50.9% of patients received concomitant csDMARDs, mostly methotrexate, and 80.7% received concomitant glucocorticoids (GCs). In patients receiving GCs at baseline, the mean dose decreased from 9.32±16.36 mg/d to 4.60±4.48 mg/d at week 104. In the effectiveness population with no prior TCZ (n=2902), 61.4% of patients achieved the primary outcome, DAS28-ESR remission. Improvements were seen as early as week 4. At week 104, 77.9% of patients had DAS28-ESR low disease activity, 89.6% achieved good or moderate EULAR response, and 29.5% achieved a CDAI-based remission. Effectiveness outcomes were similar in all previous therapy subgroups. The incidence of serious infections was similar to the rates in former studies involving tocilizumab. Patients receiving GC at baseline experienced slightly higher rates of treatment-related serious adverse events, mainly infections. No new safety signals were observed. Long-term effectiveness and safety in ICHIBAN were in line with previously reported tocilizumab efficacy and safety studies.

Predictors of good response to conventional synthetic DMARDs in early seronegative rheumatoid arthritis: data from the ESPOIR cohort

Background and objectiveEarly seronegative rheumatoid arthritis (RA) is considered a specific entity, especially regarding diagnostic issues and prognosis. Little is known about its potentially different initial clinical presentation and outcome. We aimed to determine predictors of good response to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) in seronegative RA patients with early inflammatory arthritis.Patients and methodsPatients from the ESPOIR cohort with early inflammatory arthritis fulfilling the 2010 ACR/EULAR classification criteria for RA despite negativity for both rheumatoid factor and anti-CCP antibodies. The primary endpoint was a good or moderate EULAR response assessed after 1 year of follow-up, given at least 3 months of treatment with a csDMARD. Secondary objectives were to compare the early therapeutic response to methotrexate (MTX) and leflunomide (LEF) versus other csDMARDs (hydroxychloroquine, sulfasalazine) and to identify factors associated with functional disability (Health Assessment Questionnaire-Disability Index [HAQ-DI] > 0.5 at 1 year) and structural progression (van der Heijde-modified total Sharp score > 1 and > 5 points at 1 year). Logistic regression analysis was used to determine independent predictors of outcomes.ResultsOne hundred seventy-two patients were analyzed. Overall, 98/172 (57%) patients received MTX during the first year of follow-up. A good or moderate EULAR response at 1 year was associated with early use of csDMARDs (i.e., within 3 months after the first joint swelling) on univariate and multivariable analysis (odds ratio = 2.41 [95% confidence interval 1.07–5.42], p = 0.03). Response rates were not affected by other classical prognostic factors (i.e., baseline DAS28). Presence of erosions at baseline was associated with Sharp score progression > 1 point and > 5 points (both p = 0.03) at 1 year. HAQ-DI ≥ 1 at inclusion and active smoking were significantly associated with HAQ-DI > 0.5 at 1 year.ConclusionOur results suggest that delay in initiation of csDMARD more than baseline clinical, biological, or imaging features predominantly affects the outcome in early seronegative RA. These findings confirm that the usual therapeutic concepts in RA (early treatment, tight control, and treat-to-target) should be applied similarly to both seropositive and seronegative disease forms.Trial registrationClinicalTrials.gov: NCT03666091. Registered September 11, 2018.

Validity of adopting a Health Assessment Questionnaire Disability Index less than 0.5 as a target in elderly rheumatoid arthritis patients

The effect of age on the Health Assessment Questionnaire Disability Index (HAQ-DI) scores of rheumatoid arthritis (RA) patients and the validity of adopting HAQ-DI < 0.5 as the target for functional remission and comprehensive disease control (CDC) under a treat-to-target (T2T) treatment strategy were investigated. A total of 441 RA patients with > 3-year treatment under T2T were evaluated. The relationships between the HAQ-DI score at follow-up (HAQ) and 28-joint Disease Activity Score with C-reactive protein, Sharp/van der Heijde Score, age at follow-up, and HAQ-DI at baseline were statistically evaluated with best subset regression analysis in groups separated according to age and the EULAR response. CDC status was evaluated with a chi-square test. The HAQ score significantly correlated with all indices in the group ≥ 65years old (G-O) and in the group with good or moderate EULAR responses (p < 0.01). No significant correlation was observed in the group < 65years old (G-Y) or in the group with no EULAR response. The CDC ratio was not significantly different between the age groups, whereas the HAQ failure ratio was significantly greater in G-O than in G-Y (p < 0.01). No significant difference was found between the EULAR response groups. The HAQ score is influenced by age in patients > 65years. T2T is appropriate for attaining good disease activity control but does not always lead to functional remission in these patients. The HAQ score < 0.5 is not an appropriate target for functional remission according to the CDC criteria for elderly patients.Key Points• ADL in elderly RA patient aged ≥ 65years declines corresponding to his/her aging.• Functional remission for elderly RA patients is not the same as that for young RA patients.• The HAQ score < 0.5 in elderly RA patient is not an appropriate target for CDC.

Switch from reference etanercept to SDZ ETN, an etanercept biosimilar, does not impact efficacy, safety, and immunogenicity of etanercept in patients with moderate-to-severe rheumatoid arthritis: 48-week results from the phase III, randomized, double-blind EQUIRA study

BackgroundSandoz etanercept (SDZ ETN; GP2015) is an etanercept biosimilar with equivalent efficacy and comparable safety and immunogenicity to reference etanercept (ETN) in patients with moderate-to-severe chronic plaque-type psoriasis.MethodsEQUIRA was a phase III, double-blind study conducted in patients with moderate-to-severe rheumatoid arthritis and inadequate response to disease-modifying anti-rheumatic drugs. Eligible patients were randomized 1:1 to receive subcutaneous 50 mg SDZ ETN or ETN, once-weekly, for 24 weeks. At week 24, patients with at least moderate EULAR response in the SDZ ETN group continued SDZ ETN treatment, and those in the ETN group were switched to receive 50 mg SDZ ETN, for up to 48 weeks. Patients received concomitant methotrexate at a stable dose (10–25 mg/week) and folic acid (≥ 5 mg/week). Equivalence between SDZ ETN and ETN for change from baseline in disease activity score including 28 joint count C-reactive protein (DAS28-CRP) at week 24 (primary endpoint) and comparable safety and immunogenicity profile of SDZ ETN and ETN have previously been demonstrated at week 24. Herein, we present the 48-week results of the study after a single switch from ETN to its biosimilar at week 24.ResultsThe least squares mean (standard error) change in DAS28-CRP from baseline up to week 48 was comparable between “continued SDZ ETN” (− 2.90 [0.12], n = 148) and “switched to SDZ ETN” (− 2.78 [0.13], n = 131) groups. The proportion of patients achieving EULAR good/moderate responses based on DAS28-erythrocyte sedimentation rate and ACR20/50/70 response rates were comparable between the two groups. The proportion of patients with at least one treatment-emergent adverse event was 42.9% in the “continued SDZ ETN” and 38.0% in the “switched to SDZ ETN” groups. Serious adverse events occurred in 4 patients in each of the two groups. After week 24, none of the patients in the switched group developed anti-drug antibodies (ADAs), while 4 patients in the continued SDZ ETN group had single-event, very low titer, non-neutralizing ADAs detected.ConclusionsThe 48-week results from the EQUIRA study demonstrate that switch from ETN to SDZ ETN in patients with moderate-to-severe rheumatoid arthritis does not impact the efficacy, safety, or immunogenicity of etanercept.Trial registrationEudraCT number 2012-002009-23, Registered 19 April 2012—prospectively registered.

Diacerein for the treatment of rheumatoid arthritis in patients with inadequate response to methotrexate: a pilot randomized, double-blind, placebo-controlled add-on trial.

To evaluate the efficacy and safety of diacerein in patients with rheumatoid arthritis (RA) who are methotrexate inadequate responders (MTX-IR). In this pilot, multicenter, double-blind, placebo-controlled trial, MTX-IR RA patients were randomized to either diacerein or matching placebo as add-on treatment to MTX for 24weeks. Efficacy and safety were evaluated every 4weeks until week 28. Primary and secondary efficacy endpoints were the percentage of patients achieving the ACR20 criteria and a moderate EULAR response at week 24, respectively. Forty patients were equally randomized to both study treatments; 16 and 19 participants completed the study in the diacerein and the placebo arms, respectively. Baseline characteristics were similar in both groups, except that tender joint count, DAS28-ESR score, and non-steroidal anti-inflammatory drug consumption were higher in the placebo arm. The ACR20 response at week 24 was similar in the diacerein and placebo groups (65% vs 45%, P = .20). However, treatment response according to the EULAR criteria was better in patients taking diacerein (75% vs 25% of moderate response, P = .002). In the 35 patients with assessments through week 28, diacerein was superior to placebo in ACR20 at weeks 24 and 28 (both 81% vs 47%, P = .04). Incidence of adverse events was comparable in both arms, with only chromaturia being more common with diacerein than placebo (40% vs 10%, P = .03). These preliminary results show the potential benefits of diacerein on pain, joint function, and disease activity in MTX-IR RA patients. ClinicalTrials.gov Identifier: NCT01264211 Key Points • Diacerein has shown positive effects on rheumatoid arthritis symptoms. • A good safety profile of diacerein has been observed when it was administered as add-on therapy to methotrexate in patients with rheumatoid arthritis.

Long-term safety and effectiveness of tocilizumab in patients with rheumatoid arthritis and inadequate responses to csDMARDs and/or TNF inhibitors: an open-label study close to clinical practice

ObjectiveTo assess the long-term safety, tolerability, and effectiveness of tocilizumab (TCZ) as monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in clinical practice in patients with moderate to severe rheumatoid arthritis (RA).MethodsPatients in the 24-week, open-label ACT-SURE study who had at least a moderate EULAR response by week 24 and were from a participating country were eligible for this long-term extension (LTE); the patients continued to receive TCZ 8 mg/kg intravenously every 4 weeks as monotherapy or in combination with ≥ 1 csDMARD for up to an additional 108 weeks. The primary endpoint was the incidence of adverse events (AEs) and serious AEs (SAEs). Effectiveness endpoints included Disease Activity Score in 28 joints (DAS28) responses, American College of Rheumatology (ACR) responses, and patient-reported outcomes (PROs).ResultsOf the 1102 patients who completed the core 24-week study, 934 participated in the LTE; the median exposure to TCZ was 64.3 weeks. From baseline to the end of the LTE, AEs and SAEs occurred in 90% and 9% of patients, respectively. The overall event rates (95% CI) of AEs and SAEs were 406.5 per 100 patient-years (PY) (395.5, 417.8) and 8.8 per 100 PY (7.3, 10.6), respectively. Mean (SD) improvement in DAS28 was 4.12 (1.18), P < 0.0001. The DAS28 remission rates, ACR response rates, and PRO scores were maintained during the LTE study.ConclusionIn clinical practice, TCZ as monotherapy or in combination with csDMARDs was safe, well tolerated, and efficacious in patients with moderate to severe RA.

Expression levels of selected genes can predict individual rheumatoid arthritis patient response to tumor necrosis factor alpha blocker treatment

Objectives: Rheumatoid arthritis (RA) patients have many therapeutic options; however, tools to predict individual patient response are limited. The Genefron personal diagnostic kit, developed by analyzing large datasets, utilizes selected interferon stimulated gene expressions to predict treatment response. This study evaluates the kit’s prediction accuracy of individual RA patients’ response to tumor necrosis alpha (TNFα) blockers.Methods: A retrospective analysis was performed on RA patients reported in published datasets. A prospective analysis assessed RA patients, before and 3 months after starting a TNFα blocker. Clinical response was evaluated according to EULAR response criteria. Blood samples were obtained before starting treatment and were analyzed utilizing the kit which measures expression levels of selected genes by quantitative real time polymerase chain reaction (PCR). ROC analysis was applied to the published datasets and the prospective data.Results: The Genefron kit analysis of retrospective data predicted the response to a TNFα blocker in 53 of 61 RA patients (86.8% accuracy). In the prospective analysis, the kit predicted the response in 16 of 18 patients (89% accuracy) achieving a EULAR moderate response, and in 15 of 18 patients achieving a EULAR good response (83.3% accuracy). ROC analysis applied to the two published datasets yielded an AUC of 0.89. ROC analysis applied to the prospective data yielded an AUC of 0.83 (sensitivity – 100%, specificity – 75%) The statistical power obtained in the prospective study was .9.Conclusion: The diagnostic kit predicted the response to TNFα blockers in a high percentage of patients assessed retrospectively or prospectively. This personal kit may guide selection of a suitable biological drug for the individual RA patient.

THE EFFECT OF ABATACEPT ON BLOOD BIOMARKERS IN PATIENTS WITH RHEUMATOID ARTHRITIS

Objective:to estimate changes in the cytokine profile in patients receiving abatacept (ABC).Subjects and methods.The investigation enrolled 44 patients with rheumatoid arthritis (RA) who had been unsuccessfully treated with disease-modifying antirheumatic drugs and biological agents. A control group included 16 healthy donors. The majority of patients were women who were positive for rheumatoid factor (RF) (80%) and antibodies to cyclic citrullinated peptide (ACCP) (79.5%); the mean age was 49.6±13.9 years; the median disease duration was 2 [1.4; 3] years with high RA activity (mean DAS28, 5.2±0.8). The serum concentrations of interleukin (IL) 1β, IL-6, IL-17AF, tumor necrosis factor-α (TNF-α), VEGF-A, IP-10, and YKL-40 were measured by enzyme immunoassay before and 6 months after ABC therapy. Disease activity was assessed using DAS28 every 3 months. ABC was infused intravenously according to the standard regimen.Results and discussion. The patients with RA as compared with the control group had significantly elevated levels of IL-6 (2.4 [1.1; 6.4] and 0.7 [0.62; 1.0] pg/ml; p=0.0002), YKL-40 (97 [68.4; 97.9] and 64 [52.4; 107.5] pg/ml; p=0.03), IP-10 (21 [12.9; 49.8] and 14 [9.2; 15.2] pg/ml, respectively; p=0.005). ABC caused a significant decrease in RA activity after 3 months of therapy (p&lt;0.05). Following 6 months, 86% of the patients achieved good and moderate EULAR responses; low RA activity according to DAS28 was recorded in 52%. ABC induced significant decreases in the concentrations of IL-6 to 1.29 [0.9; 2.2] pg/ml (p=0.0006) and IP-10 to 14 [7.5; 28] pg/ml (p=0.007) after 6 months of therapy. A similar trend was observed when assessing changes in the concentration of matrix metalloproteinase 3 (MMP-3), which reduced from 30.1 [13; 82] to 10 [7.4; 55] pg/ml (p=0.0003), and in that of RF, which declined from 218 [9.6; 187] to 159 [9.7; 155] pg/ml (p=0.02). The lower levels of IL-6 (r=0.5) and IP-10 (r=0.32) significantly correlated with a decrease in DAS28 (p&lt;0.05). There was a trend towards a more pronounced reduction in disease activity in patients positive for ACCP and antibodies to modified citrullinated vimentine (AMCV). The percentage of non-responders to therapy in the ACCP- and AMCV-negative groups was nearly twice as high as in those who were positive for these antibodies (27.2 and 16%; 26.7 and 14.8%, respectively), but these differences failed to reach significance. However, after 6-month of follow-up, the percentage of non-respondents in the AMCV-negative group was significantly higher than in the AMCV-positive group (20% and 0%, respectively; p=0.03). The patients who did not respond to ABC therapy had higher baseline levels of IL-6 (p=0.03) and YKL-40 (p=0.02). Conclusion.ABC therapy results in a substantial reduction in the concentration of the proinflammatory cytokines IL-6 and IP-10, as well as MMP-3 and RF. The lower levels of IL-6 and IP-10 significantly correlated with a decrease in RA activity. There was a tendency towards a more pronounced reduction of disease activity in ACCP- and AMCV-positive patients. The high baseline levels of IL-6 and YKL-40 and the absence of AMCV may suggest that ABC therapy can be ineffective.

Combination leflunomide and methotrexate in refractory rheumatoid arthritis: a biologic sparing approach.

In resource-constrained settings where biologic agents are not widely available, there are limited therapeutic options for patients with rheumatoid arthritis (RA) refractory to other synthetic disease modifying antirheumatic (DMARD) therapies. The aim of this study is to evaluate the effectiveness and safety of leflunomide (LEF) with methotrexate (MTX) in refractory RA. A retrospective record review of adult RA patients treated with LEF/MTX. Demographic details, adverse reactions, and the 3-variable 28 joint disease activity score (DAS28-3) were recorded at initiation of LEF/MTX therapy, and after 4 and 12 months of treatment. Of 194 patients, most were middle-aged seropositive Black African females, with established disease [mean (standard deviation, SD) disease duration 9.4 (8.2) years] and time on previous DMARDs of 7.0 (5.5) years. Before adding LEF, the mean (SD) dose of MTX was 21.7 (3.5) mg/week, and 87.6% of patients used low dose oral corticosteroids. A good or moderate EULAR response was achieved by 44% and 42% of patients, and the retention rate was 71%. Major infections were seen in 6 patients: comprising 2 deaths, 3 cases of leucopaenia and septicaemia and 1 case of tuberculosis. Hepatotoxicity (n = 3), intolerable gastrointestinal symptoms (n = 3), and hypertension (n = 17) were the most common problems. Predictors of remission or low disease activity at 12 months was a baseline DAS28-3 ⩽ 5.5 [odds ratio (OR) = 2.7; 95% confidence interval (CI) 1.1-5.6; p = 0.01]. LEF/MTX was effective in the majority of patients in this cohort of mainly Black African women who failed other combination synthetic DMARDs, particularly in those with moderate disease activity at the time of addition of LEF. Infections and hypertension were important complications. In a setting where biologic DMARDs are not readily accessible, the combination of LEF/MTX is a cost-effective approach.

EFFICACY AND SAFETY OF GOLIMUMAB AS ADD-ON THERAPY TO DISEASE-MODIFYING ANTIRHEUMATIC DRUGS IN RHEUMATOID ARTHRITIS: RESULTS OF THE GO-MORE STUDY IN ROMANIA

Objectives. GO-MORE was an open-label, multinational, prospective observational study in patients with active rheumatoid arthritis (RA) in typical clinical practice settings in 40 countries. The trial involved patients with active rheumatoid arthritis despite treatment with disease modifying antirheumatic drugs (DMARDs) and naïve to biological agents. Considering the different countries demographic or disease characteristics, we analysed the efficacy and safety data of the Romanian subpopulation in this paper. Method. The patients received subcutaneous GOL 50 mg once a month for a period of 6 months. The primary endpoint was the percentage of patients with a good and moderate EULAR DAS28-ESR response after 6 months of treatment. Results. A total of 51 patients with active RA with an average disease duration of 3.53 years and an average DAS28 of 6.15 at baseline were included. All patients were taking DMARDs (66% patients were taking methotrexate (MTX) and 23.5% leflunomide (LEF) in monotherapy; the others were taking other background therapies or combinations of them). All these 51 patients received GOL 50 mg once a month. After 6 months 78.4% of patients showed a good or moderate EULAR response, most of them (68.6%) after the first administration; 27.5% showed low DAS28-ESR and 7.8% were in remission. GOL was well tolerated and the safety profile was consistent with the findings of previous studies. The number of serious side effects (12%) or which lead to discontinuation of therapy (8%) was generally low. Conclusions. The addition of subcutaneous GOL 50 mg once a month to different DMARDs in patients with active RA yielded a moderate or good EULAR DAS28-ESR response after 6 month in a proportion of 78.4% of patients in Romania. The response was observed after the first administration of GOL. The safety profile is consistent with other clinical trials with antiTNFi in RA with no new safety signals detected.

Concomitant methotrexate and tacrolimus augment the clinical response to abatacept in patients with rheumatoid arthritis with a prior history of biological DMARD use.

This observational retrospective study examined whether abatacept efficacy could be augmented with concomitant methotrexate (MTX) or tacrolimus (TAC) in patients with rheumatoid arthritis (RA) who experienced failure with prior biological disease-modifying antirheumatic drugs (DMARDs) and in whom favorable therapeutic efficacy is difficult to achieve. All patients with a prior biological DMARD history who were treated with abatacept for 52weeks and registered in a Japanese multicentre registry were included. Clinical efficacy and safety of abatacept according to the concomitant drug used, i.e., none (ABT-mono), MTX (ABT-MTX), and TAC (ABT-TAC), were compared. A greater mean percent change of DAS28-ESR was observed in the ABT-TAC group compared with the ABT-mono group at weeks 12 (-20.5 vs. -5.4%, p=0.035) and 24 (-25.0 vs. -11.0%, p=0.036). ABT-MTX and ABT-TAC groups had a significantly higher proportion of patients who achieved low disease activity (LDA) within 52weeks compared with the respective baselines, while no significant change was observed in the ABT-mono group. A higher proportion of patients in the ABT-TAC group achieved EULAR moderate response compared with the ABT-mono group at week 52 (66.7 vs. 35.0%, p=0.025). Multivariate logistic regression analysis revealed that concomitant TAC use was independently associated with the achievement of LDA and EULAR response at 52weeks, while concomitant MTX use was not. Concomitant TAC use may offer a suitable option for RA patients treated with abatacept after prior biological DMARD failure, likely because both abatacept and TAC affect T cell activation.

Efficacy and Safety of Golimumab as Add-on Therapy to Disease-modifying Antirheumatic Drugs in Rheumatoid Arthritis: Results of the GO-MORE Study in Spain

ObjectivesTo assess the efficacy and safety of golimumab in the 140 patients included in Spain as the first part of the GO-MORE trial, a multinational study involving patients with active rheumatoid arthritis (RA) despite treatment with different disease-modifying antirheumatic drugs (DMARDs). Patients and methodsThe patients received subcutaneous golimumab 50mg once a month during 6 months. The primary endpoint was the percentage of individuals with a good or moderate EULAR DAS28-ESR response after 6 months of treatment. ResultsA total of 140 patients were included. Of these, 76.4% had very active disease (DAS28-ESR >5.1). 76.4% were taking methotrexate, 40.0% other DMARDs in monotherapy or combined, and 65.0% received corticosteroids. After 6 months, 82.9% of the patients showed a good or moderate EULAR response, 41.4% had low disease activity, and 30.7% were in remission. The percentage of responders one month after the first dose was 69.3%. The efficacy was similar in patients treated with methotrexate or other DMARDs, with different methotrexate doses, with or without corticosteroids, or in subjects who had failed one or more DMARDs. The response to golimumab was observed from the first dose. Golimumab was well tolerated and its safety profile was consistent with the findings of previous studies. Serious adverse events were reported in 11 patients (7.9%). ConclusionThe addition of subcutaneous golimumab 50mg once a month to different DMARDs in patients with active RA yielded a moderate or good response after 6 months in 82.9% of the cases. The response was observed early, from the start of the second month, after a single dose of golimumab.

Eficacia y seguridad de golimumab añadido a fármacos antirreumáticos modificadores de la enfermedad en artritis reumatoide. Resultados del estudio GO-MORE en España

ObjectivesTo assess the efficacy and safety of golimumab in the 140 patients included in Spain as the first part of the GO-MORE trial, a multinational study involving patients with active rheumatoid arthritis (RA) despite treatment with different disease-modifying antirheumatic drugs (DMARDs). Patients and methodsThe patients received subcutaneous golimumab 50mg once a month during 6 months. The primary endpoint was the percentage of individuals with a good or moderate EULAR DAS28-ESR response after 6 months of treatment. ResultsA total of 140 patients were included. Of these, 76.4% had very active disease (DAS28-ESR>5.1). 76.4% were taking methotrexate, 40.0% other DMARDs in monotherapy or combined, and 65.0% received corticosteroids. After 6 months, 82.9% of the patients showed a good or moderate EULAR response, 41.4% had low disease activity, and 30.7% were in remission. The percentage of responders one month after the first dose was 69.3%. The efficacy was similar in patients treated with methotrexate or other DMARDs, with different methotrexate doses, with or without corticosteroids, or in subjects who had failed one or more DMARDs. The response to golimumab was observed from the first dose. Golimumab was well tolerated and its safety profile was consistent with the findings of previous studies. Serious adverse events were reported in 11 patients (7.9%). ConclusionThe addition of subcutaneous golimumab 50mg once a month to different DMARDs in patients with active RA yielded a moderate or good response after 6 months in 82.9% of the cases. The response was observed early, from the start of the second month, after a single dose of golimumab.

FRI0318 Two-Year Retention and Effectiveness of IV Abatacept in Real-Life Setting: Results from the Action Study

BackgroundInitial results from the real-world ACTION study suggest that abatacept (ABA) is clinically effective and well tolerated in pts with RA, with good pt retention over 12 mths.1ObjectivesTo assess retention...

SAT0227 Two-Year Retention and Effectiveness of IV Abatacept Monotherapy and Combination in PTS with RA Previously Treated with at Least One Biologic Agent in A Real-Life Setting: Subgroup Analysis from the Action Study

BackgroundAlthough biologic agents should be preferentially used in combination with MTX or other conventional synthetic (cs)DMARDs,1 monotherapy with a biologic may be considered, especially if there is an intolerance to...

AB0422 Serum Drug Level and Anti-Citrullinated Peptide Antibodies as Biomarkers That Predict Eular Response in Rheumatoid Arthritis - A New Step to Personalized Medicine

BackgroundRituximab (RTX) therapy for rheumatoid arthritis (RA) exhibit enhanced effectiveness in patients with positive rheumatoid factor and/or anti-citrullinated peptide antibodies (ACPA). These two findings seem to predict clinical response (1)....

THU0172 Symptomatic Subcutaneous Anti-Tumor Necrosis Factor-Treated Rheumatoid Arthritis Patients Respond to Golimumab following an Active Switch

ObjectivesGO-SAVE is a Ph3b, multi-center, switch assessment of SC and IV golimumab (GLM) in RA pts who have inadequate disease control despite treatment with etanercept (ETN) or adalimumab (ADA). Primary...