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19243211 Modulation of T-cell co-stimulation in rheumatoid arthritis: clinical experience with abat 2009 Rheumatoid arthritis (RA), characterized by progressive joint destruction, deformity, disability and impaired quality of life (QOL), is a prevalent autoimmune disease affecting 1% of adults in the US. The goal of therapy in patients with RA is to arrest the disease and to achieve remission by preventing or controlling joint damage, preventing loss of function and providing pain relief, thereby improving QOL. Non-biological disease-modifying antirheumatic drugs (DMARDs) have been the mainstay of early intervention in RA, of which methotrexate has been used most frequently. However, in the long term, patients treated with non-biological DMARDs (including methotrexate) may experience joint deterioration and subclinical inflammation even after clinical remission, emphasizing the need for alternative therapies. Several biological therapies, such as anti-tumour necrosis factor (TNF)-alpha agents, have been developed in the last decade and may be used either as monotherapy or in combination with non-biological DMARDs. Although anti-TNFalpha therapy is generally associated with an improvement in symptoms of RA, some patients may experience inadequate response to or may not tolerate these agents. The new biological agent abatacept, a recombinant protein consisting of the extracellular region of the human cytotoxic T-lymphocyte-associated antigen (CTLA)-4 receptor fused to the constant fragment (Fc) region of IgG1, binds to the CD80/CD86 molecules on antigen-presenting cells and modulates T-cell activation. Clinical trials have shown that abatacept is effective in reducing disease activity, structural joint damage and improving QOL in patients with RA who had inadequate response to prior methotrexate or anti-TNFalpha therapy. Pooled analysis of these trials showed that abatacept was also generally well tolerated in these patients. Thus, abatacept therapy may be an option for the treatment of RA in patients who have had an inadequate response to prior DMARD therapy.
20681888 Adherence to biologic DMARD therapies in rheumatoid arthritis. 2010 Sep IMPORTANCE OF THE FIELD: The efficacy of the biologic disease-modifying antirheumatic drugs (DMARDs) shown in clinical trials may be jeopardized due to prevalent poor patient adherence. AREAS COVERED IN THIS REVIEW: Patient adherence including compliance and persistence with biologic DMARDs in rheumatoid arthritis. WHAT THE READER WILL GAIN: This is a comprehensive review of the literature. The various definitions and methodologies of measurement used in adherence research are reviewed and data are presented by separating compliance and persistence. Differences in compliance rates were mainly based on numerical trends. There was evidence for and against greater persistence with infliximab versus adalimumab and etanercept. There was a trend in favour of greater compliance and lower persistence with TNF-alpha inhibitor monotherapy versus in combination therapy with methotrexate. TAKE HOME MESSAGE: The evidence suggests that adherence to biologic DMARDs is suboptimal. When further research is applied in the field, agreed definitions and methodology need to be used to allow for cross-study comparisons. In addition, adherence should be assessed in conjunction with clinical outcomes and not on its own so that it can be better understood what levels of adherence provide the required clinical outcomes.
20421343 Efficacy of initial methotrexate monotherapy versus combination therapy with a biological 2010 Jul OBJECTIVE: The target outcome in early rheumatoid arthritis (ERA) is now remission. This meta-analysis compared the efficacy of initial methotrexate monotherapy versus combination therapy (methotrexate plus biological agent) for clinical remission and radiographic non-progression among ERA patients with minimal or no previous methotrexate exposure. METHODS: A systematic search was performed for randomised controlled trials of ERA using predefined criteria. A random effects model was used to pool the risk ratio (RR) for clinical and radiographic remission at 52-56 weeks of follow-up. RESULTS: Seven trials of combination therapy with infliximab, adalimumab, etanercept or abatacept were included. The majority of studies defined clinical remission as a 28-joint disease activity score (DAS28) of 2.6 or less. Radiographic non-progression was primarily defined as a modified total Sharp score change of less than 0.5 units. All trials demonstrated risk estimates in favour of combination therapy: the pooled RR for achieving clinical remission was 1.74 (95% CI 1.54 to 1.98) and for radiographic non-progression was 1.30 (95% CI 1.01 to 1.68). Significant heterogeneity among studies for the latter outcome was detected (p<0.001). CONCLUSIONS: The efficacy of combination therapy with a biological agent is superior to methotrexate monotherapy for remission. Combination therapy has a greater initial effect on clinical remission than radiographic non-progression. Uniform definitions of remission are needed and the proportion of subjects who achieve the combined endpoint of clinical and radiographic remission should be considered as a meaningful outcome in future studies of ERA.
20197777 Methotrexate--how does it really work? 2010 Mar Methotrexate remains a cornerstone in the treatment of rheumatoid arthritis and other rheumatic diseases. Folate antagonism is known to contribute to the antiproliferative effects that are important in the action of methotrexate against malignant diseases, but concomitant administration of folic or folinic acid does not diminish the anti-inflammatory potential of this agent, which suggests that other mechanisms of action might be operative. Although no single mechanism is sufficient to account for all the anti-inflammatory activities of methotrexate, the release of adenosine from cells has been demonstrated both in vitro and in vivo. Methotrexate might also confer anti-inflammatory properties through the inhibition of polyamines. The biological effects on inflammation associated with adenosine release have provided insight into how methotrexate exerts its effects against inflammatory diseases and at the same time causes some of its well-known adverse effects. These activities contribute to the complex and multifaceted mechanisms that make methotrexate efficacious in the treatment of inflammatory disorders.
20490517 [How closely does rheumatology treatment follow the guidelines?: ambition and reality]. 2010 Jun In 2005, the first evidence-based German guideline on the management of early rheumatoid arthritis (RA) was published. With data from the national database of the German Collaborative Arthritis Centres and other health care studies we evaluated to what extent current health care is in accordance with the guideline's recommendations.A total of 66% of all newly referred RA patients seen at the national database centers in 2008 achieved the goal of seeing a rheumatologist within 3 months of symptom onset, while 75% were seen within 6 months. Before referral, 25% of the patients had DMARD therapy and 19% glucocorticoids. Of the patients in rheumatological care, 90% received DMARDs. The availability of early arthritis clinics determines the promptness of access to a rheumatologist.After 6 years of rheumatological care, around 80% of patients continuously seen were still under treatment with a conventional or biological DMARD. The highest continuation rates were seen for methotrexate monotherapy. Biologic agents were given in 2008 to 20% of patients. Of those with "severe" or "very severe" disease, 42% received biologics and 21% DMARD combination therapy. Low-dose glucocorticoids are the standard of care; of patients in rheumatological care, 88% received dosages up to 7.5 mg/d and 74% of up to 5 mg/d.
20495924 [Recommendations of the German rheumatology society on the use of tocilizumab in rheumatoi 2010 Jun The humanized anti-IL-6 receptor monoclonal antibody tocilizumab (TCZ) represents a new therapy approach for moderately severe to severe cases of rheumatoid arthritis (RA). The IL-6 concentration in the synovial fluid and peripheral circulation of patients with RA is elevated. TCZ recognises the IL-6 binding site of human IL-6R and blocks the IL-6 signaling pathway. TCZ is capable of correcting a multitude of pathological processes in RA, as has been shown in a number of studies. TCZ treatment should be combined with methotrexate. If the latter cannot be administered, TCZ can also be used as a monotherapy. The recommended dose is 8 mg/kg once every 4 weeks; the minimum dose per infusion is 480 mg. Close monitoring, in particular for infectious complications, is necessary. Clinical effects of TCZ are usually seen several weeks following initiation of therapy. If no significant clinical response is seen within 6 months, TCZ therapy should be ceased.
19587388 Improved pain, physical functioning and health status in patients with rheumatoid arthriti 2010 Feb OBJECTIVES: To determine the efficacy of CP-690,550 in improving pain, function and health status in patients with moderate to severe active rheumatoid arthritis (RA) and an inadequate response to methotrexate or a tumour necrosis factor alpha inhibitor. METHODS: Patients were randomised equally to placebo, CP-690,550 5, 15 or 30 mg twice daily for 6 weeks, with 6 weeks' follow-up. The patient's assessment of arthritis pain (pain), patient's assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) and Short Form-36 (SF-36) were recorded. RESULTS: At week 6, significantly more patients in the CP-690,550 5, 15 and 30 mg twice-daily groups experienced a 50% improvement in pain compared with placebo (44%, 66%, 78% and 14%, respectively), clinically meaningful reductions in HAQ-DI (> or =0.3 units) (57%, 75%, 76% and 36%, respectively) and clinically meaningful improvements in SF-36 domains and physical and mental components. CONCLUSIONS: CP-690,550 was efficacious in improving the pain, function and health status of patients with RA, from week 1 to week 6.
18802706 Efficacy of tacrolimus in infliximab-refractory progressive rheumatoid arthritis. 2009 Feb We report a Japanese male patient with intractable rheumatoid arthritis (RA), in whom tacrolimus was effective ultimately. Five years before the admission he was diagnosed as RA, which was resistant to various disease-modifying anti-rheumatic drugs (DMARDs). Two years before, administration of infliximab was initiated although the medicine failed to control RA. In spite of the multiple joint replacement, the RA disease activity worsened. Tacrolimus (1.5 mg/day) was administered. Twenty-four weeks of tacrolimus treatment reduced the disease activity score for 28 joints-erythrocyte sedimentation rate from 7.44 to 3.65. Herein, we present a patient with RA, who was successfully treated by tacrolimus, and in whom infliximab was not effective. Tacrolimus may be one of the drugs for RA patients refractory to the conventional treatments including methotrexate or tumor necrosis factor inhibitors.
19717399 Estimation of a numerical value for joint damage-related physical disability in rheumatoid 2010 Jun BACKGROUND: Joint damage is an important outcome in trials of rheumatoid arthritis (RA), usually assessed by Total Sharp Score (TSS). It is currently unknown how it translates numerically into disability by the Health Assessment Questionnaire (HAQ). OBJECTIVE: To determine the units of HAQ score corresponding to one TSS unit. METHODS: A short-term observational trial of glucocorticoids in RA (the 'BEst LIfe with Rheumatoid Arthritis' (BELIRA) trial) was evaluated, using randomised controlled clinical trial (RCT) data for confirmation. For each trial arm HAQ, TSS and the Simplified Disease Activity Index (SDAI) were assessed. Based on the hypothesis that short-term HAQ changes will mostly be due to changes of disease activity, activity HAQ (ACT-HAQ) at end point (EP) was determined and remaining disability defined as damage related (DAM-HAQ). Using TSS at EP, the HAQ units corresponding to a TSS unit were estimated. RESULTS: In BELIRA, one TSS unit corresponded to a mean of 0.017 HAQ units; to account for other causes of irreversible disability, the 25th percentile was used: 0.011 HAQ units/TSS unit. In RCT trial arms, the HAQ/TSS were similar (0.013 and 0.015 in established and early RA, respectively; 25th percentile: 0.010). The correlation between DAM-HAQ(EP) and TSS was r=0.829. Over 5 years, damage would amount to an increase of irreversible HAQ of 0.33 on placebo, 0.13 on disease-modifying antirheumatic drugs (DMARDs) and 0.03 on TNF inhibitors+methotrexate (MTX). CONCLUSION: An approach to estimate the numerical relationship between HAQ and damage as 0.01 HAQ points/TSS unit is presented, although the linear relationship may not be generally valid. This allows the assessment of functional correlates of radiographic changes in trials.
18787830 Effects of leflunomide and methotrexate in rheumatoid arthritis detected by digital X-ray 2009 Jan The aim of the present study was to evaluate the effect of long-term leflunomide and methotrexate (MTX) therapy during the course of rheumatoid arthritis (RA) estimated by digital X-ray radiogrammetry (DXR) and computer-aided joint space analysis (CAJSA) as diagnostic tools for the quantification of disease-related periarticular osteoporosis and joint space narrowing. Fourty matchable patients with verified RA were treated with leflunomide or MTX during an observation period of 2.5 years. All patients underwent complete computerized calculations of bone mineral density (BMD) and metacarpal index (MCI) by DXR as well as semi-automated measurements of joint space widths (JSW) at the metacarpophalangeal articulations (MCP, thumb to small finger) and proximal interphalangeal joints (PIP, index finger to small finger) using digitized hand radiographs. DXR-BMD revealed an increase of 0.4% (leflunomide-group) versus a reduction of -9.1% (MTX-group). Regarding DXR-MCI, a reduction of -1.1% (leflunomide-group) and -5.3% (MTX-group) was observed. The CAJSA parameters showed a decline of -2.7% (JSW-MCP) versus -2.1% (JSW-PIP) in patients treated with leflunomide. An accentuated joint space narrowing was revealed (JSW-MCP: -5.7%; JSW-PIP: -6.2%) in the MTX group. Digital X-ray radiogrammetry and CAJSA could discriminate the influence of different therapeutic regimes on periarticular osteoporosis and joint space narrowing showing a less accentuated radiographic progression in patients treated with leflunomide.
19607680 Methotrexate therapy associates with reduced prevalence of the metabolic syndrome in rheum 2009 INTRODUCTION: The metabolic syndrome (MetS) may contribute to the excess cardiovascular burden observed in rheumatoid arthritis (RA). The prevalence and associations of the MetS in RA remain uncertain: systemic inflammation and anti-rheumatic therapy may contribute. Methotrexate (MTX) use has recently been linked to a reduced presence of MetS, via an assumed generic anti-inflammatory mechanism. We aimed to: assess the prevalence of the MetS in RA; identify factors that associate with its presence; and assess their interaction with the potential influence of MTX. METHODS: MetS prevalence was assessed cross-sectionally in 400 RA patients, using five MetS definitions (National Cholesterol Education Programme 2004 and 2001, International Diabetes Federation, World Health Organisation and European Group for Study of Insulin Resistance). Logistic regression was used to identify independent predictors of the MetS. Further analysis established the nature of the association between MTX and the MetS. RESULTS: MetS prevalence rates varied from 12.1% to 45.3% in RA according to the definition used. Older age and higher HAQ scores associated with the presence of the MetS. MTX use, but not other disease modifying anti-rheumatic drugs (DMARDs) or glucocorticoids, associated with significantly reduced chance of having the MetS in RA (OR = 0.517, CI 0.33-0.81, P = 0.004). CONCLUSIONS: The prevalence of the MetS in RA varies according to the definition used. MTX therapy, unlike other DMARDs or glucocorticoids, independently associates with a reduced propensity to MetS, suggesting a drug-specific mechanism, and makes MTX a good first-line DMARD in RA patients at high risk of developing the MetS, particularly those aged over 60 years.
20373036 Health-related quality of life and disability in patients with rheumatoid, early rheumatoi 2010 Aug PURPOSE: To assess health-related quality of life (HR-QoL) in patients with Rheumatoid arthritis (RA), early RA and early psoriatic arthritis (PsA), and to evaluate the efficacy of etanercept in reducing disability. METHODS: Twenty healthy volunteers, 40 RA, 20 early RA and 20 early PsA patients were recruited. All patients received etanercept plus methotrexate. Assessments at baseline and after 2 years' therapy included Disease Activity Scores on 44 joints [DAS(44)], Health Assessment Questionnaire (HAQ) scores and Short Form-36 (SF-36) scores. RESULTS: HAQ and SF-36 scores were significantly worse in patients with RA, early RA or early PsA than in healthy volunteers. The HAQ score at baseline was significantly higher in RA patients than in patients with early RA or early PsA, whereas the scores were similar in patients with early RA and early PsA. Patients with early RA had greater impairment than patients with early PsA in several areas of disability. After 2 years' treatment, HAQ scores and SF-36 summary and subscale scores improved significantly in the three patient groups. CONCLUSIONS: This study suggests that early PsA is a less disabling disease than RA or early RA. It confirms the efficacy of etanercept in reducing disease severity and improving HR-QoL and suggests that early therapeutic intervention may lead to greater improvement in the mental and emotional components of these diseases.
20483049 Anti-tumor necrosis factor alpha therapy normalizes fibrinolysis impairment in patients wi 2010 Mar OBJECTIVES: Rheumatoid arthritis (RA) is associated with increased cardiovascular risk and involvement of inflammation, coagulation and fibrinolysis. Treatment with infliximab, a tumour necrosis factor-alpha (TNF-alpha) blocking chimeric monoclonal antibody, induces a long-term reduction of inflammation and coagulation, but its effect on fibrinolysis is still unknown. We carried out an observational study investigating plasma biomarkers of inflammation and fibrinolysis in RA patients before and after 14 weeks of infliximab treatment given according to the therapeutic guidelines for RA. METHODS: We studied 20 selected patients with active RA and without any other atherosclerosis risk factor as well as 40 healthy controls. Patients, treated with a stable dose of methotrexate, received infliximab (3 mg/kg) at week 0, 2, 6 and 14. At week 0 and 14, we assessed clinical, inflammatory and fibrinolyitic parameters. RESULTS: At baseline, plasminogen activator inhibitor (PAI-1) antigen, PAI-1 activity and tissue-type plasminogen activator (t-PA) antigen were significantly higher in RA patients than in controls (p=0.01, p=0.001 and p=0.0001 respectively). After 14 weeks of infliximab treatment, the levels of PAI-1 antigen, PAI-1 activity and t-PA antigen significantly decreased till normalization (p=0.0001). Plasma levels of C reactive protein (CRP) and interleukin-6 (IL-6) were directly correlated with levels of PAI-1 antigen (p=0.011 and p=0.0001), PAI-1 activity (p=0.013 and p=0.027) and t-PA antigen (p=0.017 and p=0.040). CONCLUSIONS: This study provides evidence that TNF-alpha blockade by infliximab not only decreases inflammation, but also reduces the inhibition of fibrinolysis. Such a combined effect may be pivotal in reducing the whole thrombotic risk in these patients.
19745701 Reversible methotrexate-associated lymphoproliferative disorder resembling advanced gastri 2009 Oct A 73-year-old woman with rheumatoid arthritis had been treated with weekly low-dose methotrexate (MTX) for 5 years. She suffered from epigastric discomfort. Endoscopic examination revealed a tumor resembling advanced gastric cancer. Biopsy specimens showed atypical lymphoid cell infiltration. Immunohistological studies showed that these cells were positive for CD30 and CD79a, but not for CD15 or CD20. In situ hybridization identified Epstein-Barr virus latency-associated RNA expression in these cells. Clonally rearranged immunoglobulin heavy chain JH gene was not detected by Southern blot analysis. She was diagnosed with Epstein-Barr virus-associated polymorphic lymphoproliferative disorder (LPD) due to immunodeficiency caused by MTX administration. Cessation of MTX therapy led to complete regression of the tumor. To our knowledge, this is the first case of spontaneous remission of MTX-associated gastric LPD after discontinuation of MTX therapy. Increased awareness is needed on the possible occurrence of LPD resembling gastric cancer in rheumatoid arthritis patients treated with MTX.
20337633 Effects of long-term disease-modifying antirheumatic drugs on endothelial function in pati 2010 Oct Rheumatoid arthritis (RA) is associated with enhanced atherosclerosis and impaired endothelial function early after the onset of the disease and cardiovascular (CV) disease represents one of the leading causes of morbidity and mortality. It is well known that disease modifying antirheumatic drugs (DMARDs) are able to improve the course of the disease and the quality of life of these patients, but little is known about the effects of DMARDs on CV risk and endothelial dysfunction. Our goal was to examine the effects of long-term therapy with DMARDs on endothelial function and disease activity in early RA (ERA). Twenty-five ERA patients (mean age 52 ± 14.6 years, disease duration 6.24 ± 4.10 months) without evidence of CV involvement were evaluated for disease activity score (DAS-28), 2D-echo derived coronary flow reserve (CFR), common carotid intima-media thickness (IMT) and plasma asymmetric dimethylarginine (ADMA) levels at baseline and after 18 months of treatment with DMARDs (10 patients with methotrexate and 10 with adalimumab). DMARDs significantly reduced DAS-28 (6.0 ± 0.8 vs. 2.0 ± 0.7; P < 0.0001) and improved CFR (2.4 ± 0.2 vs. 2.7 ± 0.5; P < 0.01). Common carotid IMT and plasma ADMA levels did not show significant changes. The present study shows that DMARDs, beyond the well known antiphlogistic effects, are able to improve coronary microcirculation without a direct effect on IMT and ADMA, clinical markers of atherosclerosis. Treatment strategies in ERA patients with high inflammatory activity must be monitored to identify beneficial effects on preclinical markers of vascular function.
18408246 Bone mineral density in rheumatoid arthritis patients 1 year after adalimumab therapy: arr 2009 Mar OBJECTIVE: To explore the effects of anti-tumour necrosis factor (TNF)alpha antibody therapy on bone mineral density (BMD) of the lumbar spine and femur neck in patients with rheumatoid arthritis (RA). METHODS: A total of 50 patients with active RA (DAS28> or =3.2) who started adalimumab (40 mg subcutaneously/2 weeks) were included in an open label prospective study. All patients used stable methotrexate and were allowed to use prednisone (< or =10 mg/day). The BMD of the lumbar spine and femur neck was measured before and 1 year after start of treatment. RESULTS: Disease activity at baseline (28-joint Disease Activity Score (DAS28)) and disease duration were inversely correlated with femoral neck BMD and lumbar spine BMD (p<0.05). Mean BMD of lumbar spine and femur neck remained unchanged after 1 year of adalimumab therapy (+0.3% and +0.3%, respectively). Of interest, a beneficial effect of prednisone on change in femur neck BMD was observed with a relative increase with prednisone use (+2.5%) compared to no concomitant prednisone use (-0.7%), (p = 0.015). CONCLUSION: In contrast to the progressive bone loss observed after conventional disease-modifying antirheumatic drug therapy, TNF blockade may result in an arrest of general bone loss. Consistent with previous observations, the data also suggest that the net effect of low-dose corticosteroids on BMD in RA may be beneficial, possibly resulting from their anti-inflammatory effects.
20511978 Adalimumab-induced acute pneumonitis in a patient with rheumatoid arthritis. 2010 Jun Interstitial lung disease is one of the most common and severe extra-articular manifestations associated with rheumatoid arthritis. Previous to the biologic treatment era, methotrexate was the medication known to cause acute lung disease mostly in patients with preexisting rheumatoid lung disease. However, recent case reports of patients treated with biologic therapies show an increased incidence of acute lung disease caused by tumor necrosis factor alpha inhibitors. This case will illustrate acute lung disease caused by adalimumab, a recombinant IgG1 monoclonal antibody. The rheumatology community must be aware of this adverse effect described so far with all 3 major tumor necrosis factor alpha inhibitors, before starting but also during maintenance therapy.
20210795 Clinicopathologic correlations of diffuse large B-cell lymphoma in rheumatoid arthritis pa 2010 May Among methotrexate (MTX)-related lymphoproliferative disorders (MTX-LPD), diffuse large B-cell lymphoma (DLBCL) accounts for about half. We studied the clinicopathological characteristics and prognosis of patients with DLBCL in MTX-LPD. This study included 29 patients who developed DLBCL after receiving MTX for rheumatoid arthritis. MTX was discontinued in all patients. Their median age was 62 years. Elevated lactate dehydrogenase (LDH) level was observed in 97% of the patients, bone marrow involvement in 17%, and involvement of extranodal sites in 41%. As for the cellular immunophenotype, CD20 was positive in 93%, CD5 in 3%, CD10 in 31%, BCL2 in 21%, BCL6 in 69%, and Epstein-Barr virus (EBV)-encoded small non-polyadenylated RNA (EBER) in 24%. Chemotherapy was started within 2 months after MTX withdrawal in 23 patients, of whom 12 patients received combination with rituximab. Spontaneous remission occurred in the remaining six patients. The EEBV-positive rate was 67% (4/6), and the four EBV-positive patients achieved complete response. Among the 23 DLBCL patients treated with chemotherapy, 20 patients achieved complete response. The 5-year overall survival was 74% and the 5-year progression-free survival was 65%. After the development of DLBCL, withdrawal of MTX was the first choice of treatment. Germinal center B-cell type and EBER-positive patients tended to show spontaneous remission. The utility of rituximab should be examined in future studies.
21044429 Measuring methotrexate polyglutamates. 2010 Sep Methotrexate is the most commonly used drug in the treatment of rheumatoid arthritis, although 30-40% of patients fail to adequately respond. An accurate method for measuring methotrexate polyglutamates, the stable active metabolite of methotrexate, has recently been described. The objective of this review article is to determine if clinical use of this measurement would improve methotrexate efficacy, or decrease adverse reactions. Additionally the pharmacologic rationale for this test is discussed. Although methotrexate response improves at higher methotrexate polyglutamate levels, there is no absolute correlation of level with effect. Moreover, overlapping methotrexate polyglutamate levels between clinical responders and nonresponders limits the clinical utility of this measurement.
20828279 RAPID and FAST4WARD trials: certolizumab pegol for rheumatoid arthritis. 2010 Sep In the last decade, biological therapies have dramatically changed the treatment for rheumatoid arthritis (RA) in such a way that remission is currently an achievable goal. The armamentarium of therapeutic options for RA has recently been enriched with another approved anti-TNF-alpha agent, certolizumab pegol (CZP). This article reviews the trials conducted with CZP in RA, the Rheumatoid Arthritis PreventIon of structural Damage (RAPID 1 and 2) and the EFficAcy and Safety of cerTolizumab pegol - 4 Weekly dosAge in RheumatoiD arthritis (FAST4WARD). These trials have demonstrated that this new biological agent significantly improves the clinical signs and symptoms of RA, inhibits progression of structural damage, and improves physical function and quality of life in patients with active RA who have failed treatment with methotrexate. The safety profile of CZP is acceptable and similar to that of other anti-TNF-alpha agents.