Biologics In Rheumatoid Arthritis Research Articles

Long-term efficacy and safety of biologics in rheumatoid arthritis

Biologic agents have been used for more that twelve years in treating rheumatoid arthritis (RA) and other rheumatic diseases. Long-term analysis for both efficacy/effectiveness and safety is now feasible for the first anti-TNF agents available, namely infliximab, etanercept and adalimumab. Open-label extension studies have shown that clinical improvement is maintained up to10 years. However, these studies include only the patients who have sustained efficacy without the development of significant adverse events that would cause the patient to exit the study prior to closure. Therefore, as with any completer analysis of efficacy, the results reported are generally positive. Furthermore, clinical trial patients may not be representative of the entire patient population since in the clinic setting the indications for treatment with biologic agents are not identical to the inclusion criteria for trials. Only a minority of the patients in the clinical setting would have been eligible for the major trials; ineligible patients have lower baseline disease activity, more comorbidity, lower functional status and lower response rates. Despite these data, long term evaluation of effectiveness and safety in observational studies and registers has shown that TNF inhibitors are still a good choice in treatment of RA and may be also associated with a reduced risk of cardiovascular events in patients with RA.

Identification of a set of eight proteins able to predict the response to methotrexate/etanercept in rheumatoid arthritis patients

BackgroundThe number of biologic agents in rheumatoid arthritis (RA) is continuously increasing. However, clinicians observe that around 30–40% of treated patients fail to respond to tumour necrosis factor α blocking...

Biologic Agents in Rheumatic Diseases

During the past three decades the treatment in rheumatology was revolutionized by the introduction of disease-modifying anti-rheumatic drugs. Advances in our understanding of the pathogenesis of rheumatic diseases have led to the discovery of critical pathogenetic mechanisms of inflammation and autoimmunity and the invention of new target-specific biologic agents. The development of biologic agents led to a new era in treatment of various rheumatic diseases. Treatments of rheumatic diseases such as rheumatoid arthritis (RA) had been very difficult in former days until conventional DMARDs was developed. Although synthetic DMARDs made it a lot easier to control rheumatic diseases, still, there were some difficulties on controlling diseases. The biologic agents inhibit specific pro-inflammatory cytokines as a targeted therapy to prevent inflammation and destruction of affected joint and/or tissues. Three TNF blocking agents, etanercept, infliximab and adalimumab, are the most well recognized and widely used biologic agents in RA, ankylosing spondylitis (AS), and some other inflammatory autoimmune diseases. Furthermore, an inhibitor of IL-1 (anakinra), a B-cell depleting drug (rituximab) and an inhibitor of T-cell costimulation (abatacept) are developed in turn asnovel biologic agents which are believed to be effective in number of rheumatic diseases. Recently, an inhibitor of IL-6 (tocilizumab) and 2 other TNF inhibitors (golimumab and certolizumab) are developed. Here, the brief descriptions of recently used biologic agents and their efficacies and safeties are discussed. (Korean J Med 2012;82:549-561)

A Dose–Response Meta-Analysis for Quantifying Relative Efficacy of Biologics in Rheumatoid Arthritis

We present a dose-response meta-analysis to quantify relative efficacy of biologic disease-modifying antirheumatic drugs (DMARDs) in patients with rheumatoid arthritis (RA). There is a strong rationale for this analysis because, although multiple biologics are available, information on head-to-head comparisons is limited. Data on the percentage of patients attaining American College of Rheumatology (ACR) 20, 50, and 70 responses were extracted from 50 randomized controlled trials representing 21,500 patients, five mechanisms of action, and nine biologics. The analysis showed that all tumor necrosis factor inhibitors (anti-TNFs) share the same dose-response relationship for ACR 20, 50, and 70, differing only in potency. Yet there are significant differences in efficacy among the anti-TNFs due to differences in the clinical dose ranges available. At the suggested starting dose, golimumab was the least efficacious, followed by infliximab, adalimumab, etanercept, and certolizumab. Significant differences in the dose-response relationship were found between anti-TNFs and other biologics, resulting in differences in efficacy and differential impact of dose titration.

Managed Care Strategies for Improving Patient Outcomes in Rheumatoid Arthritis

BACKGROUND: Rheumatoid arthritis (RA) is a chronic, systemic autoimmune inflammatory disease that affects approximately 1% of the population. Initial symptoms include joint swelling, stiffness, and tenderness, which are all causes of disability. The diagnosis of RA is based on patient history of joint pain and stiffness, the documentation of symmetric polyarticular joint synovitis, and laboratory measures including radiographs, inflammatory markers, and autoantibodies. As the disease progresses, synovial inflammation leads to cartilage damage, bone erosions, and joint destruction, the major causes of long-term disability. RA is associated with many comorbidities and complications, including cardiovascular disease, which is responsible for higher rates of mortality among patients compared with the general population. Over the past 2 decades, advances in the development of synthetic disease-modifying antirheumatic drugs (DMARDs) and biologic agents for RA have markedly changed treatment goals and management strategies. OBJECTIVES: To review recent updates in the diagnosis and treatment of RA, as well as the importance of early and aggressive treatment and management strategies. SUMMARY: Borrowing from other medical fields, a paradigm of “tight control” of RA has been supported by evidence and is gaining wide acceptance in rheumatology. In 2010, the American College of Rheumatology and the European League Against Rheumatism (EULAR) published revised classification criteria for RA, which will assist in the diagnosis of early RA and facilitate appropriate treatment intervention. Over the last decade, many patients on biologic agents have demonstrated that early and aggressive treatment of RA is beneficial in treating synovial inflammation, delaying joint damage, and improving patient outcomes. Contemporary management strategies based on early diagnosis, aggressive treatment, and regular monitoring have helped a significant number of patients with RA achieve current treatment goals of low levels of disease activity and, in some cases, clinical remission. J Manag Care Pharm. 2011;17(9-b):S3-S8 Copyright © 2011, Academy of Managed Care Pharmacy. All rights reserved. Rheumatoid arthritis (RA) is a chronic, systemic autoimmune inflammatory arthritis that affects approximately 1% of the population.1 The disease affects people of all ages but is most common from the ages of 40-70 years.1 Initially polyarticular synovial inflammation, leading to joint swelling, stiffness, and tenderness, is the major cause of disability. Over time synovial inflammation leads to cartilage damage, bone erosions, and joint destruction, the major causes of long-term disability. In addition, patients with RA have increased mortality compared with the general population, largely attributed to an increased risk of cardiovascular disease.2 The burden of illness of RA not only impacts patients and families but also society through sick leave, loss of work productivity, and utilization of health care, stressing the importance of effective management of RA.3 Over the past 2 decades, optimal use of synthetic diseasemodifying antirheumatic drugs (DMARDs) and/or biologic agents has proven highly effective in treating inflammation, delaying joint damage, and improving patient outcomes. The goals of treatment have expanded from the treatment of inflammation and achievement of a low disease activity state, to the realistic goal of achieving and maintaining clinical remission in a significant number of patients. In addition to treating inflammation, the inhibition of progressive joint destruction is also an important goal. Finally, by using DMARDs and biologic agents, physicians and their patients are striving to decrease pain and stiffness associated with inflammation, retard progressive structural joint damage, reduce RA comorbidities, restore function and quality of life, and help patients to maintain their societal roles. It is commonly accepted that early intervention leads to improved patient outcomes. This paradigm is supported by a number of clinical trials. Therefore, it is critical that patients with symptoms of RA are identified early and referred to specialists with experience in treating RA, which will facilitate initiation of disease-modifying therapy that can be systematically modified in the pursuit of the treatment goals. In this article, we will review recent updates in the diagnosis and treatment of RA as well as the importance of early and aggressive treatment. Diagnosing Rheumatoid Arthritis The diagnosis of RA is a clinical diagnosis that combines the patient history of joint pain and stiffness, the physical examination documentation of symmetric polyarticular joint swelling (synovitis), and the laboratory tests including radiographs, inflammatory markers (erythrocyte sedimentation rate [ESR] and C-reactive protein [CRP]), and autoantibodies (rheumatoid factor [RF] and anti-cyclic citrullinated peptide antibodies

Biologic agents in rheumatoid arthritis: an update for managed care professionals.

Rheumatoid arthritis (RA) is a chronic, systemic autoimmune inflammatory arthritis that clinically manifests as joint pain, stiffness, and swelling. If left untreated, persistent synovial inflammation can progress to cartilage and bone destruction and ultimately to major long-term disability and mortality. Synthetic disease-modifying antirheumatic drugs (DMARDs), such as methotrexate, leflunomide, and sulfasalazine, have markedly improved clinical symptoms and slowed joint damage in RA patients. However, despite the effectiveness of synthetic DMARDs, many patients who use them continue to have clinical symptoms of inflammation and progressive joint destruction. Recent advances in our understanding of the pathogenesis of RA have led to the identification of novel cellular and molecular therapeutic targets. Biologic agents aimed at these targets have provided some evidence of effectiveness that is transforming the management of RA. To inform health care providers about some of the recent advances in RA pathogenesis and innovative biologic therapies that have shown effectiveness in improving clinical outcomes and inhibiting radiographic progression. Although the specific trigger of the autoimmune response in RA is not known, pathogenesis is generally believed to be associated with the generation of autoantibodies through interactions of antigen-presenting cells with the adaptive immune system (CD4 + T cells and B cells). The main inflammatory mediators of joint inflammation and destruction in RA are tumor necrosis factor (TNF)-alpha, interleukin-1 (IL-1), IL-6, chemokines, and proteases. Advances in our understanding of the key cells and inflammatory cytokines have led to the development of targeted biologic agents. As of 2011, 5 TNF-alpha inhibitors are approved for use by the FDA: infliximab, etanercept, adalimumab, golimumab, and certolizumab pegol. In randomized clinical trials, all of these agents have been shown to be effective in reducing clinical signs of inflammation in RA patients who have failed synthetic DMARDs. Multiple studies have demonstrated significant benefits of early treatment with TNF-alpha inhibitors combined with methotrexate. Other FDA-approved biologic agents for treating moderate-to-severe RA include abatacept, rituximab, and tocilizumab. All biologic agents carry an increased risk of infections. Additional potential side effects include infusion and injection site reactions for intravenous and subcutaneously administered agents, respectively. All patients being considered for biologic agents should be screened annually for tuberculosis and should receive pneumococcal, influenza, and hepatitis B vaccinations.

Biologic agents for rheumatoid arthritis--negotiating the NICE technology appraisals.

In England and Wales, the National Institute for Health and Clinical Excellence (NICE) has provided guidance [technology appraisals (TAs) 130, 186, 195, 198 and 225] on the use of biologic drugs for the treatment of RA. This is based on an analysis of efficacy, safety and cost-effectiveness, and has resulted in a complex management pathway that restricts freedom to prescribe biologics according to their licensed indications. Specifically, TNF antagonists are the only class of biologics that can be used first line in DMARD-inadequate responders, and only in patients with a persistent 28-joint DAS score of ≥5.1. Alternative biologic agents are denied to those with contraindications to anti-TNF drugs and are also not supported following intolerance to TNF antagonists. Rituximab is the only class of biologic permitted after TNF antagonist inefficacy, in the absence of a contraindication to its use, whereas abatacept and tocilizumab are licensed and may be a more efficacious choice at this stage in some patient groups. Furthermore, for patients who demonstrate sequential inadequate responses, treatment is restricted to one TNF antagonist, rituximab and tocilizumab, whereas abatacept is only a permitted choice when rituximab is contraindicated or has been withdrawn because of an adverse event. In this review, we discuss the treatment algorithm published by NICE, and suggest alternatives where perceived deficiencies exist.

Study on the possible role of the -174G>C IL-6 promoter polymorphism in predicting response to rituximab in rheumatoid arthritis

Identification of genetic biomarkers of response to biologics in rheumatoid arthritis (RA) is a relevant issue. The -174G>C interleukin-6 (IL-6) promoter polymorphism was investigated in RA patients treated with rituximab (RTX), being IL-6 a key cytokine for B cell survival and proliferation, thus possibly implicated in rituximab efficacy. The study was conducted in a real-life retrospective cohort of 142 unselected RA patients (120F/22M) treated with RTX and referred to 7 rheumatologic centres in the north of Italy. One hundred and thirteen (79.6%) patients were rheumatoid factor (RF)-positive and 112 (78.9%) were anti-CCP antibodies positive. The response to therapy was evaluated at the end of the sixth month after the first RTX infusion, by using both the EULAR criteria (DAS28) and the ACR criteria. The IL-6 -174G>C promoter polymorphism was analyzed by RFLP following previously reported methods. Lack of response to RTX at month +6 by EULAR criteria was more prevalent in RA patients with the IL-6 -174 CC genotypes (9/21, 42.8%), than in the GC/GG patients (23/121, 19.0%) (OR 3.196, 95% CI=1.204-8.485; p=0.0234). Similar results were found when evaluating the response by ACR criteria. No differences were found in RA duration, baseline DAS28, baseline HAQ, RF status, anti-CCP status according to the different IL-6 -174 genotypes. IL-6 promoter genotyping may be useful to better plan treatment with RTX in RA. Larger replication studies are in course to confirm these preliminary results.

Rheumatoid factor positivity rather than anti-CCP positivity, a lower disability and a lower number of anti-TNFα agents failed are associated with response to rituximab in rheumatoid arthritis

Predictors of response to biologics in rheumatoid arthritis (RA) is an important issue in the current era. Rituximab (RTX) has been demonstrated effective and safe in active RA, resistant to traditional or biologic DMARDs. Fifty-seven patients with active longstanding RA were treated with RTX after traditional DMARD or anti-TNF alpha therapy failure. Number of anti-TNF treatment previously failed (p=0.005), HAQ (p=0.013), rheumatoid factor (RF) (p=0.0002) and anti-CCP (p=0.006) were associated with an ACR response > or =50 at the end of 6th month by univariate analysis. Multivariate analysis confirmed that the number of anti-TNF previously failed, baseline HAQ and RF, but not anti-CCP were associated with an ACR response > or =50. EULAR moderate/good response was associated with ESR value (p=0.036), HAQ (p=0.032), and RF (p=0.01) by univariate analysis, while only RF positivity was associated with EULAR moderate/good response by multivariate analysis. RF positivity rather than anti-CCP positivity is a predictor of response to RTX, suggesting that RF-positive patients with low disability may obtain a clinical response when treated to RTX after the first anti-TNF agent failure or after traditional DMARD therapies. Larger studies are required to confirm these results.

Analysis of drug and administrative costs allowed by U.S. Private and public third-party payers for 3 intravenous biologic agents for rheumatoid arthritis.

Rheumatoid arthritis (RA) is a common chronic condition with substantial morbidity that can now be treated with disease-modifying biologic agents that target tumor necrosis factor (TNF) or related mechanisms. The anti-TNF biologic agents are available in either intravenous (IV) or subcutaneous dose forms. The biologic agents with an indication for rheumatoid arthritis and administered only by IV infusion in medical offices include abatacept, infliximab, and rituximab. Although the literature on RA treatments, their outcomes, and aspects of their costs is substantial, the costs of administration by the IV route have not been directly studied. To assess the detailed costs of administering IV biologic agents for the treatment of RA in relation to the total cost of the medication itself in the United States. The sample included all patients with at least 1 medical claim with an ICD-9-CM diagnosis code for RA (codes 714.XX) in any claim field and at least 1 claim for infliximab, abatacept, or rituximab (HCPCS codes J1745, J0129, and J9310, respectively) at any time from January 1, 2006, through December 31, 2008, in a database associated with billing and claims administration for 72 U.S. medical clinics. Costs were determined using the payer allowed payment, which is the total contractual amount that the provider should receive, including the patient cost share. Costs were measured as the average cost per IV administration visit and in relation to the dose of medication billed. The authors verified that an RA diagnosis was present on 100% of infusion claims for the study drugs. Over the study period for claims with dates of service from January 1, 2006, through December 31, 2008, 72 medical clinics had claims for a total of 4,248 unique patients with RA and a total of 33,354 clinic visits in which these patients received at least 1 infusion of 1 of 3 biologic agents (26,586 for infliximab, 4,807 for abatacept, and 1,961 for rituximab). Mean (SD) total payment for all drugs and other cost components was $2,874 ($1,515) per visit, of which IV administration costs were $226 (7.9%); the mean cost of the biologic agent itself was $2,616 (91.0%), and other visit-related services were $33 (1.1%). For individual agents, the total costs of visits were $2,828, $1,827, and $6,076; and the costs of IV administration were $224, $171, and $390, respectively, for infliximab, abatacept, and rituximab. For patients who received an IV biologic agent to treat RA, IV administration costs accounted for 7.9% of the total cost of the visit.

Current Utilization and Cost-effectiveness of Biologics in Rheumatoid Arthritis: A Systematic Review of Existing Literature

Current Utilization and Cost-effectiveness of Biologics in Rheumatoid Arthritis: A Systematic Review of Existing Literature

Introduction to economic modeling for clinical rheumatologists: application to biologic agents in rheumatoid arthritis

Rheumatoid arthritis (RA) is a chronic, debilitating inflammatory, progressive musculoskeletal disease that affects 0.5-1.0% of the adult population in Western countries. The joint destruction and progressive functional disability associated with uncontrolled RA result in tremendous impacts on health-related quality of life, ability to work, and mortality. In addition, the treatment of the disease and associated complications exact a substantial economic burden to the patients, their families, and society. In the last decade, several biological agents (biologics) have been approved for use in RA, revolutionizing treatment. These biologics, which target cytokines such as tumor necrosis factor or lymphocytes such as B or T cells, reduce functional disability and substantially slow the progression of joint damage. However, because these agents typically cost ten to 100 times more than existing available older drug therapies, there has been worldwide concern regarding their impact on healthcare budgets. As such, there has been increased attention towards economic evaluation as a means to determine whether, and in which subgroup of patients, these newer, more expensive agents confer appropriate value for their additional cost. Indeed, evaluations have guided coverage decisions for both private and public health insurance agencies such as the National Institute for Health and Clinical Excellence in the UK. The use of economic evaluations to determine value for money for these agents has attracted both debate and controversy. Some of the controversy is related to the appropriateness of the structure of, and assumptions underlying, the decision models employed to estimate the long-term costs and benefits of these agents over existing therapies. To fully appreciate the debate, one must first understand the basic principles of economic evaluation and the necessity for using decision models to evaluate cost effectiveness. To understand the basic principles of economic evaluation, we refer the reader to an introductory article aimed at clinical rheumatologists. This paper attempts to explain the rationale for the use of economic modeling approaches to assess the value of biologics for RA using specific examples from the literature.

Kombinationsbehandlung von Methotrexat mit DMARDs oder Biologika – Aktueller Stand

Methotrexate (MTX) is the most frequently used drug in combination treatment with disease-modifying antirheumatic drugs (DMARDs) and biologics in rheumatoid arthritis. DMARD combinations are usually the second step after unsuccessful MTX monotherapy. Evidence-based combinations of MTX+leflunomide, MTX+cyclosporine and triple combination MTX+sulphasalazine+hydroxychloroquine (complemented by glucocorticoids) showed the best results.In the case of insufficient response to the DMARD combination, MTX should be used in combination with a biologic. To date, the most frequent biologic treatment is with TNF inhibitors, but studies have shown that all biologics (with the exception of Anakinra) have comparable success rates. The combination of MTX plus abatacept, MTX plus rituximab and MTX plus tocilizumab are very promising, both clinically and in terms of blocking radiological progression. The efficacy of biological therapy is generally better using MTX combination than monotherapy.The safety of MTX combination treatment with DMARDs is not significantly lower than that of the individual substances; therefore, the required safety controls are also the same.

Paricalcitol, a synthetic vitamin D analog: A candidate for combination therapy with biological agents in rheumatoid arthritis

Biologic agents, especially TNFα inhibitors, appear to be very effective in treatment of rheumatoid arthritis (RA). Although the use of biologic agents has greatly improved the therapeutic efficacy in management of RA, biologic therapies for RA treatment have several limitations. These agents fail to achieve complete remission in substantial portion of RA patients. Also certain adverse events have been observed, including serious bacterial infections and reactivation of latent tuberculosis. Previous reports demonstrated that TNFα inhibitors are more efficacious in combination with other drugs such as methotrexate. In this report, we suggest that paricalcitol, a synthetic vitamin D analog is another candidate molecule for combination therapy with TNFα inhibitors in RA.

Swiss Consensus Statement: Recommendations for optimising re-treatment with MabThera® (rituximab) in rheumatoid arthritis

Rituximab is an effective treatment of rheumatoid arthritis (RA), which has been approved for the treatment of moderate to severe disease in patients with an inadequate response to anti-TNF therapies. Rituximab differs from other available biological agents for RA by way of its unique mode of action and unrivalled long dosing interval. The efficacy of rituximab subsides progressively over time and re-therapy is generally required to maintain long term disease control. The timing of re-treatment is currently not well established and varies widely in clinical practice. The present document is a concise recommendation regarding re-treatment with rituximab, based on validated outcomes such as the DAS28 and the EULAR response criteria. The recommendation was established through consensus between practitioners familiar with rituximab therapy in RA. Optimisation of the rituximab re-treatment schedule may improve patient outcomes and balance risks and benefits for the individual patient.

Freedom from disease activity in multiple sclerosis

Multiple sclerosis (MS) shares many pathologic features with other immune-mediated inflammatory diseases, such as rheumatoid arthritis, Crohn disease, and psoriasis. The development of effective biologic agents for rheumatoid arthritis has resulted in a treatment paradigm shift such that disease remission is now an explicit goal. The traditional immunomodulatory disease-modifying therapies for MS (interferon beta and glatiramer acetate) delay disease progression and reduce activity on brain MRI to varying degrees; however, they have not been demonstrated to induce disease remission. Therefore, the concept of disease remission or freedom from disease activity in MS has received little attention from the neurology community. We discuss some potential definitions of disease remission in MS and whether freedom from disease activity can become an increasingly useful measure of therapeutic response. Future research should be directed at determining the long-term significance of freedom from disease activity during a short-term clinical trial in relapsing-remitting MS.

Safety of using genetic engineering biological agents in rheumatoid arthritis

The paper reviews the current trials of the safety of using genetic engineering biological agents (GEBA) in patients with rheumatoid arthritis. It is stated that before its start, GEBA therapy calls for thorough screening of patients to rule out communicable diseases (including tuberculosis) or a high risk for infections (chronic shin ulcers, severe diabetes mellitus, persistent lung infection, and the presence of a urinary catheter), cancer, and severe visceral diseases. The baseline liver status, a cardiovascular risk, neutropenia in response to basic anti-inflammatory drugs (BAID) should be also borne in mind. It is noted that when patients are correctly selected and possible adverse reactions are monitored, GEBA therapy is not worse tolerated than is BAID therapy.

Cost-Effectiveness of Biologics in Early Rheumatoid Arthritis

Letters2 March 2010Cost-Effectiveness of Biologics in Early Rheumatoid ArthritisMaarten Boers, MSc, MD, PhDMaarten Boers, MSc, MD, PhDFrom VU University Medical Center, 1007 MB, Amsterdam, the Netherlands.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-152-5-201003020-00019 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE:I think the authors and I agree on most of the issues, but we differ in the wording of our conclusions. It is wise to avoid firm conclusions in the face of shaky evidence. A model can never fully replace reality, and we probably need another 10 years of additional experience with biologics to be fully certain of their cost-effectiveness. Nevertheless, when we trust the model, and it points unmistakably in 1 direction, we shouldn't be afraid to clearly communicate what it shows. This is especially important in the area of biologics in rheumatoid arthritis, where intense marketing ...

Impact of the medicare modernization act of 2003 on utilization and spending for medicare part B–covered biologics in rheumatoid arthritis

To examine changes in utilization and expenditures for infliximab in rheumatoid arthritis (RA) patients associated with the 2 changes implemented by the Medicare Prescription Drug Improvement and Modernization Act (MMA) of 2003, specifically 1) reductions in physician reimbursement for Part B drugs between 2003 and 2005 and 2) availability of alternative RA biologics in 2006. Using 2002-2006 5% Medicare files, nationally representative estimates of infliximab use and expenditures were estimated in annual cross-sectional samples of RA beneficiaries. Infliximab initiation and continuation rates were estimated in 2-year longitudinal cohorts (2005-2006 versus 2002-2003, 2003-2004, and 2004-2005). Total payments (in 2006 dollars) for infliximab increased from $357 million in 2002 to $492 million in 2006. The largest annual increase in infliximab payments occurred in the pre-MMA period from 2002 to 2003, wherein payments per RA patient increased by 31%. From 2003 to 2004, despite the reduction in payments brought by the MMA, there was a 4% increase in total expenditures for infliximab per RA patient driven by an increase in utilization factors. Total payments for infliximab per RA patient actually decreased from 2004 to 2005, when reimbursement was further reduced. Continuation and initiation rates for infliximab use remained unchanged in 2006, as compared with previous years. Infliximab expenditures increased from 2002 to 2006, yet the passage of the MMA was associated with a remarkable slowdown in the rate of increase in expenditures. There was no evidence of significant substitution of infliximab with other biologics made available in 2006.

Retropharyngeal Abscess in the Setting of Immune Modulation for Rheumatoid Arthritis

At the conclusion of this presentation, the participants should be familiar with the management of serious head and neck infections occurring inpatients on biologic agents for rheumatoid arthritis. Present a case of retropharyngeal abscess managed in a patient on abatacept, a T cell immune modulator, for rheumatoid arthritis. Review the literature on the relationship between biologic agents for rheumatoid arthritis and head and neck infections. Case report. Retrospective case review including a review of the relevant literature. The case of a 62-year-old woman with retropharyngeal abscess is presented. Her medical history was significant for rheumatoid arthritis treated with abatacept, a T-cell immune modulator. She presented with progressive odynophagia and neck pain, and a computed tomography scan revealed large retropharyngeal abscess extending to the superior mediastinum with bilateral pleural effusions. Transcervical incision and drainage was performed and infectious disease consultation was obtained. Full recovery was achieved after a month long course of intravenous antibiotics. Biologic agents that achieve selective immune modulation have revolutionized the treatment of rheumatoid arthritis. However, there is a small but significant risk of serious infection that accompanies these drugs. Otolaryngologists should be vigilant for signs and symptoms of serious head and neck infection in patients who are on biologic agents for rheumatoid arthritis. Management of these patients must account for their diminished immune response to infection.