Comparing Medical Utilization and Cost Outcomes in Oral Versus Injectable Immunotherapy Users with Chronic Inflammatory Joint and Skin Diseases.

BACKGROUND: Rheumatoid arthritis (RA), psoriatic arthritis (PsA), and psoriasis (PSO) are immune-mediated systemic, chronic inflammatory conditions. Moderate to severe disease is treated with conventional disease-modifying antirheumatic drugs (DMARDs) such as methotrexate, sulfasalazine, or leflunomide. If a patient does not respond to these firstline treatments, then tumor necrosis factor inhibitor (TNFi) or non-TNFi immunotherapy agents are administered via infusion, injection, or taken orally. Although the effectiveness of established infusion, injection, and newer oral therapies are known, the relative effectiveness among the routes of administration is not well understood. OBJECTIVE: To compare drug use, health care resource utilization, and costs among patients who are treatment-naive to oral immunotherapy and injectable biologic immunotherapy. METHODS: This retrospective observational study used claims data from a large U.S. health plan to identify new users of oral and injectable immunotherapy, diagnosed with a joint (RA or PsA), skin (PSO), or joint and skin condition from July 1, 2014, to June 30, 2017. The index date was the first claim for an oral or injectable medication. Medicaid, Medicare Advantage, and commercial plan patients aged 19-89 years with continuous enrollment 6 months before and 12 months after the index date were included in the study. Outcomes were adjusted using propensity score by inverse probability of treatment weighting. Treatment discontinuation, switching, health care resource utilization, and costs were measured during the post-index period. RESULTS: Oral versus injectable users with joint (n = 458 vs. 3,875), skin (n = 265 vs. 951), or joint and skin (n = 171 vs. 805) conditions were identified. For drug utilization outcomes, no differences in discontinuation rates were observed between oral and injectable groups for any of the cohorts. However, those in skin and joint and skin cohorts had higher rates of switching to other immunotherapies in patients initiated on orals compared with injectables. Health care resource utilization outcomes were mixed. While mean outpatient and physician office visits were significantly higher in oral compared with injectable groups across all 3 cohorts, no differences were observed for inpatient stays. Total costs (medical plus pharmacy) were lower for oral groups across all 3 cohorts. Pharmacy costs were lower for oral groups, but medical costs were higher for oral groups across all 3 cohorts. CONCLUSIONS: This is the first population-level study at a route-of-administration level, which compared switching, health care resource utilization, and costs across several conditions. Switching drugs was more likely in the oral group, which may indicate lower effectiveness or tolerability of oral immunotherapies relative to injectables. Health care resource utilization was higher in the oral group, but total costs were lower, which was likely driven by the lower costs of oral drugs. DISCLOSURES: This study was a Humana internal study, and all authors were at the time employees of Humana and used Humana resources. The authors have no conflicts of interest or financial interests to disclose that relate to the research described in this study. This study was presented as a podium and poster presentation at the AMCP Managed Care & Specialty Pharmacy Annual Meeting; April 23-26, 2018; Boston, MA.

Efficacy, immunogenicity and cost analysis of a systematic switch from originator infliximab to biosimilar CT-P13 of all patients with inflammatory arthritis from a single center.

Biosimilar drugs are intended to be as effective as the originator product but with a lower cost to healthcare systems. In our center we promoted a switch from originator infliximab (IFXor) to biosimilar infliximab (CT-P13). We analyzed efficacy, safety, immunogenicity and cost savings of switching. Eligible patients were adults with the diagnosis of rheumatoid arthritis (RA), spondyloarthritis (SpA) and psoriatic arthritis (PsA) on therapy with IFXor for at least 6 months and with stable disease activity. Efficacy was measured considering change from baseline in Disease Activity Score in 28 joints (DAS28) for RA and PsA and in Ankylosing Spondylitis Disease Activity Score (ASDAS) for SpA. Disease worsening was considered when an increase of 1.2 from baseline in DAS28 or an increase of 1.1 in ASDAS occurred. Serum IFX levels (sIFX) were dichotomized as therapeutic (between 3-6 µg/mL), low (< 3 µg/mL), and high (> 6 µg/mL). Anti-drug antibody (ADA) levels were dichotomized into detectable (> 10 ng/ml) or non-detectable (< 10 ng/ml). A cost analysis was done based on the purchasing prices of the 2 drugs at our center. During a period of 1 year switch to CT-P13 was performed in 60 patients for non-medical reasons. We had a total of 36 patients with SpA, 16 with RA and 8 with PsA. Disease activity was stable over the observation period and similar to the values observed with IFXor. Median follow-up time was 15 months during which 5 patients stopped CT-P13. Forty two switchers had blood samples collected before and after switch. A total of 27 patients had unaltered sIFX levels and ADA status during follow up. Three patients had detectable ADA at baseline, with low sIFX levels. After switch, ADAs became negative in 2 of those patients, and the other patient kept detectable ADA levels. ADAs became positive in 5 patients after switch. The switch to CT-P13 represented a 26.4 % reduction of costs in the use of IFX therapy in these patients. The switch in routine care of a group of RA, SpA and PsA patients from IFXor to CT-P13 did not affect efficacy, safety, immunogenicity and reduced costs in 26.4%. The observed changes in blood samples were not associated with higher disease activity and did not lead to stopping IFX therapy.

Cost-Effectiveness of Tight Control of Inflammation in Early Psoriatic Arthritis: Economic Analysis of a Multicenter Randomized Controlled Trial.

OBJECTIVE: Treat-to-target approaches have proved to be effective in rheumatoid arthritis, but have not been studied in psoriatic arthritis (PsA). This study was undertaken to examine the cost-effectiveness of tight control (TC) of inflammation in early PsA compared to standard care. METHODS: Cost-effectiveness analyses were undertaken alongside a UK-based, open-label, multicenter, randomized controlled trial. Taking the perspective of the health care sector, effectiveness was measured using the 3-level EuroQol 5-domain, which allows for the calculation of quality-adjusted life-years (QALYs). Incremental cost-effectiveness ratios (ICERs) are presented, which represent the additional cost per QALY gained over a 48-week time horizon. Sensitivity analyses are presented assessing the impact of variations in the analytical approach and assumptions on the cost-effectiveness estimates. RESULTS: The mean cost and QALYs were higher in the TC group: £4,198 versus £2,000 and 0.602 versus 0.561. These values yielded an ICER of £53,948 per QALY. Bootstrapped uncertainty analysis suggests that the TC has a 0.07 probability of being cost-effective at a £20,000 threshold. Stratified analysis suggests that with certain costs being controlled, an ICER of £24,639 can be calculated for patients with a higher degree of disease severity. CONCLUSION: A tight control strategy to treat PsA is an effective intervention in the treatment pathway; however, this study does not find tight control to be cost-effective in most analyses. Lower drug prices, targeting polyarthritis patients, or reducing the frequency of rheumatology visits may improve value for money metrics in future studies.

A two-phase model for chronic disease processes under intermittent inspection.

A model is developed for chronic diseases with an indolent phase that is followed by a phase with more active disease resulting in progression and damage. The time scales for the intensity functions for the active phase are more naturally based on the time since the start of the active phase, corresponding to a semi-Markov formulation. This two-phase model enables one to fit a separate regression model for the duration of the indolent phase and intensity-based models for the more active second phase. In cohort studies for which the disease status is only known at a series of clinical assessment times, transition times are interval-censored, which means the time origin for phase II is interval-censored. Weakly parametric models with piecewise constant baseline hazard and rate functions are specified, and an expectation-maximization algorithm is described for model fitting. Simulation studies examining the performance of the proposed model show good performance under maximum likelihood and two-stage estimation. An application to data from the motivating study of disease progression in psoriatic arthritis illustrates the procedure and identifies new human leukocyte antigens associated with the duration of the indolent phase. Copyright © 2017 John Wiley & Sons, Ltd.

Singapore Chapter of Rheumatologists consensus statement on the eligibility for government subsidy of biologic disease modifying anti-rheumatic agents for the treatment of psoriatic arthritis.

AIM: In Singapore, patients with psoriatic arthritis (PsA) constitute a significant disease burden. There is good evidence for the efficacy of anti-tumor necrosis factor (anti-TNF) in PsA; however cost remains a limiting factor. Non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) hence remain the first-line treatment option in PsA in spite of limited evidence. The Singapore Chapter of Rheumatologists aims to develop national guidelines for clinical eligibility for government-assisted funding of biologic disease modifying anti- rheumatic drugs (bDMARDs) for PsA patients in Singapore. METHODS: Evidence synthesis was performed by reviewing seven published guidelines on use of biologics for PsA. Using the modified Research and Development/University of California at Los Angeles Appropriateness Method (RAM), rheumatologists rated indications for therapies for different clinical scenarios. Points reflecting the output from the formal group consensus were used to formulate the practice recommendations. RESULTS: Ten recommendations were formulated relating to initiation, continuation and options of bDMARD therapy. The panellists agreed that a bDMARD is indicated if a patient has active PsA with at least five swollen and tender joints, digits or entheses and has failed two nbDMARD strategies at optimal doses for at least 3 months each. Any anti-TNF may be used and therapy may be continued if an adequate PsARC response is achieved by 3 months after commencement. CONCLUSION: The recommendations developed by a formal group consensus method may be useful for clinical practice and guiding funding decisions by relevant authorities in making bDMARD usage accessible and equitable to eligible patients in Singapore.

Of patents and patent disputes: The TNFα patent files. Part 1: Humira.

This article discusses the patent strategy underlying the world's best selling drug, AbbVie's Humira®. Despite a non-optimal starting position, AbbVie has established an extensive portfolio to fend off biosimilar competition. This article is the first part of a trilogy that discusses IP issues related to anti-Tumor Necrosis factor α (TNFα) biologics.

A Retrospective Cohort Study Comparing Utilization and Costs of Biologic Therapies and JAK Inhibitor Therapy Across Four Common Inflammatory Indications in Adult US Managed Care Patients.

INTRODUCTION: Biologic therapies are used to treat several inflammatory diseases, including rheumatoid arthritis (RA), psoriasis (PsO), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). Data from a commercial claims database were used to evaluate utilization and cost of biologic treatment for these conditions. METHODS: Data were obtained from the Optum Research Database. Patients were aged 18-63 years with diagnosis of moderate to severe RA, PsO, PsA, and/or AS and first (index) claim for biologics abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab, or ustekinumab or non-biologic tofacitinib between March 1, 2011 and February 28, 2013. One-year treatment costs were based on observed paid amounts and used to impute dosing. Treatment patterns (persistence, switching, discontinuing, restarting) were evaluated. RESULTS: Data from 20,159 patients were analyzed for index medications abatacept (n = 583), adalimumab (n = 6521), certolizumab pegol (n = 415), etanercept (n = 9116), golimumab (n = 231), infliximab (n = 1906), rituximab (n = 295), tocilizumab (n = 165), ustekinumab (n = 922), and tofacitinib (n = 5). For patients with RA only, costs were lowest for tofacitinib ($18,769), rituximab ($19,569), or abatacept ($21,877), and ranged from $23,682 to $30,269 for all other medications. For patients with PsO only, costs were lowest for adalimumab ($29,186), etanercept ($31,212), and infliximab ($32,409) compared with ustekinumab ($53,746). For patients with PsA only, costs were lowest for etanercept ($26,916), followed by golimumab ($27,987), adalimumab ($28,749), and infliximab ($31,974). Costs were lowest with etanercept for RA plus PsA ($25,477) and for PsO plus PsA ($29,376), and with golimumab for AS only ($24,225). Across indications, annual costs were $29,521, $27,488, and $28,672 for adalimumab, etanercept, and infliximab, respectively; persistence was greatest with infliximab (range 66-79%) compared with 11-59% for all other biologics. CONCLUSION: One-year treatment costs varied considerably between medications and indications. Some newly approved agents had lower costs but further research is needed to confirm these estimates as more patients are treated. FUNDING: Immunex (a wholly owned subsidiary of Amgen Inc.) and Wyeth (acquired by Pfizer).

Cost-efficacy of biologic therapies for psoriatic arthritis from the perspective of the Taiwanese healthcare system.

BACKGROUND: Biologic therapies are more effective but more costly than conventional therapies in treating psoriatic arthritis. OBJECTIVES: To evaluate the cost-efficacy of etanercept, adalimumab and golimumab therapies in treating active psoriatic arthritis in a Taiwanese setting. METHODS: We conducted a meta-analysis of randomized placebo-controlled trials to calculate the incremental efficacy of etanercept, adalimumab and golimumab, respectively, in achieving Psoriatic Arthritis Response Criteria (PsARC) and a 20% improvement in the American College of Rheumatology score (ACR20). The base, best, and worst case incremental cost-effectiveness ratios (ICERs) for one subject to achieve PsARC and ACR20 were calculated. RESULTS: The annual ICER per PsARC responder were US$27 047 (best scenario US$16 619; worst scenario US$31 350), US$39 339 (best scenario US$31 846; worst scenario US$53 501) and US$27 085 (best scenario US$22 716; worst scenario US$33 534) for etanercept, adalimumab and golimumab, respectively. The annual ICER per ACR20 responder were US$27 588 (best scenario US$20 900; worst scenario US$41 800), US$39 339 (best scenario US$25 236; worst scenario US$83 595) and US$33 534 (best scenario US$27 616; worst scenario US$44 013) for etanercept, adalimumab and golimumab, respectively. CONCLUSIONS: In a Taiwanese setting, etanercept had the lowest annual costs per PsARC and ACR20 responder, while adalimumab had the highest annual costs per PsARC and ACR responder.

Long-term costs and outcomes in psoriatic arthritis patients not responding to conventional therapy treated with tumour necrosis factor inhibitors: the extension of the Psoriatic Arthritis Cost Evaluation (PACE) study.

OBJECTIVES: Poor information on long-term outcomes and costs on tumour necrosis factor (TNF) inhibitors in psoriatic arthritis (PsA) are available. Our aim was to evaluate long-term costs and benefits of TNF- inhibitors in PsA patients with inadequate response to conventional treatment with traditional disease-modifying anti-rheumatic drugs (tDMARDs). METHODS: Fifty-five out of 107 enrolled patients included in the study at one year, completed the 5-year follow-up period. These patients were enrolled in 8 of 9 centres included in the study at one year. Patients aged older than 18 years, with different forms of PsA and failure or intolerance to tDMARDs therapy were treated with anti-TNF agents. Information on resource use, health-related quality of life (HRQoL), disease activity, function and laboratory values were collected at baseline and through the 5 years of therapy. Costs (expressed in Euro 2011) and utility (measured by EQ-5D instrument) before TNF inhibitor therapy and after 1 and 5 years were compared. RESULTS: The majority of patients (46 out of 55; 83.6%) had a predominant or exclusive peripheral arthritis and 16.4% had predominant or exclusive axial involvement. There was a statistically significant improvement of the most important clinical variables after 1 year of follow-up. These improvements were maintained also after 5 years. The direct costs increased by approximately €800 per patient-month after 1 year, the indirect costs decreased by €100 and the overall costs increased by more than €700 per patient-month due to the cost of TNF inhibitor therapy. Costs at 5 year were similar to the costs at 1 year. The HRQoL parameters showed the same trends of the clinical variables. EQ-5D VAS, EQ-5D utility and SF-36 PCS score showed a significant improvement after 1 year, maintained at 5 years. SF-36 MCS showed an improvement only at 5 years. CONCLUSIONS: The results of our study suggest that TNF blockers have long-term efficacy. The higher cost of TNF inhibitor therapy was balanced by a significant improvement of HRQoL, stable at 5 years of follow-up. Our results need to be confirmed in larger samples of patients.

Psoriatic Arthritis Registries.

The introduction of new biological drugs for the treatment of rheumatoid arthritis and spondyloarthritis has led to the creation of a number of registries in Europe and the United States. Most of them are sponsored by national rheumatology societies, and provide information that is useful in clinical practice concerning the clinical characteristics, efficacy, and safety of all licensed biological drugs. Their findings also help to improve our understanding of the quality of life and working ability of patients receiving biological drugs, and suggest methods for allocating resources. However, there are only a few registries for psoriatic arthritis, and efforts should be made to increase their number to obtain further reliable and useful data.

Assessment of disease activity in psoriatic arthritis.

Psoriatic arthritis (PsA) historically has been assessed according to disease activity measures borrowed from rheumatoid arthritis. However, more disease activity measures specific to PsA have been developed. This development is appropriate, as the disease is not confined to the joints but has multiple manifestations, in addition to skin and joints. Assessments of disease activity are unique to each domain. Including different domains in composite measures increases the level of complexity. This review briefly discusses the available outcome measures, both within domains and as composite measures, and discusses likely future directions.

Disease activity and response assessment in psoriatic arthritis using the Disease Activity index for PSoriatic Arthritis (DAPSA). A brief review.

In this review we provide reasons to use joint specific composite measures of disease activity for psoriatic arthritis (PsA) rather than composite scores that combine several manifestations of psoriatic disease, including skin involvement. Based on a principal component analysis, which, indeed, excluded skin involvement as a major factor in PsA, the Disease Activity index for PSoriatic Arthritis (DAPSA) was validated using clinical trial and observational data. Further, disease activity states and response criteria were recently defined. The DAPSA is simply calculated by summing swollen + tender joint counts + patient pain + patient global assessments + CRP, using 66/68 joint counts. DAPSA has meanwhile been validated in other studies and has shown to have a very high level of validity, also when compared with joint sonography. Thus, DAPSA is useful in clinical practice, clinical trials and observational studies.

Adherence to biologic therapies and associated factors in rheumatoid arthritis, spondyloarthritis and psoriatic arthritis: a systematic literature review.

OBJECTIVES: To analyse the evidence on adherence to biologic therapies in rheumatoid arthris (RA), spondyloarthritis (SpA), and psoriatic arthritis (PsA). METHODS: Systematic review of studies retrieved by a sensitive search strategy in MEDLINE database (1961 through March 2012). To be selected, studies had to include patients with RA, SpA, or PsA, treatment with intravenous or subcutaneous biologic therapies, and had to report on measures of adherence. By design, only randomised controlled trials (RCT) or high quality cohort studies with a control group were selected. RESULTS: A total of 24 studies were included, of which 12 reported results from national or local biologic registers, 9 were retrospective studies, 2 prospective studies, and only one was an RCT. Patients included were mostly women with diagnosis of RA or SpA and, less frequently, PsA. There was a great variability in the definition of adherence, measurement methods, and associated factors analysed. In general, adherence to etanercept was superior to that of other biologics, by the measures utilised. The main predictive factors - age, sex, comorbidity, baseline clinical condition, previous or concomitant use of DMARDs, anti-TNF in monotherapy or in combination with MTX - produced diverse, even divergent results across studies. CONCLUSIONS: There is a wide variability related to the adherence concept and its measurement, reflecting the complexity of the phenomenon. In order to draw more consistent conclusions about the relative value of predictive factors on adherence and persistence of biological therapy, larger controlled studies with better selection of variables and analysis of interactions are needed.

Cost of biologics per treated patient across immune-mediated inflammatory disease indications in a pharmacy benefit management setting: a retrospective cohort study.

PURPOSE: Pharmacy benefits management companies have emerged as the national standard for the management of prescription drugs in the United States. The objective of this study was to estimate the annual costs per treated patient of 8 biologics indicated for select immune-mediated inflammatory diseases: moderate to severe rheumatoid arthritis, moderate to severe plaque psoriasis, active psoriatic arthritis, and/or active ankylosing spondylitis. METHODS: Using the Medco pharmacy benefits-management database, data from patients aged 18 to 63 years with ≥1 claim for abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab, rituximab, or ustekinumab, dated between January 1, 2008 and August 31, 2011, were collected. Eligible patients were continuously enrolled for ≥180 days before and 360 days after the date of the first biologic claim (index date), and had ≥1 claim associated with a diagnosis of rheumatoid arthritis, moderate to severe plaque psoriasis, active psoriatic arthritis, and/or active ankylosing spondylitis in the 180 days before or 30 days after the index date. The annual total costs per treated patient were calculated as the total dose of the index biologic and all other biologics for which there was a claim in the postindex period, multiplied by the wholesale acquisition cost as of October 1, 2013, plus the costs associated with administrations (calculated as number of infusions multiplied by the 2013 Medicare Physician Fee Schedule costs). FINDINGS: Within the study population (N = 8306; 5356 (64.5%) women, 2950 men (35.5%), average age: 42.3 years (SD: 10.0)), the most commonly used biologics were etanercept (43.1%), adalimumab (31.0%), and infliximab (17.0%), which accounted for 91.1% of all biologic prescriptions. Total costs per treated patient across indications were as follows: adalimumab, $23,427 to $26,304; infliximab, $22,824 to $28,907; and etanercept, $21,468 to $27,748, whereas abatacept, certolizumab, golimumab, rituximab, and ustekinumab were associated with a larger range: $17,017 to $41,888. IMPLICATIONS: The present study provides insight into the prescribing patterns and cost differences among 8 biologic agents used for the treatment of immune-mediated inflammatory diseases. This information may prove useful when designing a pharmacy benefits-management formulary.

Systematic review, network meta-analysis and economic evaluation of biological therapy for the management of active psoriatic arthritis.

BACKGROUND: An updated economic evaluation was conducted to compare the cost-effectiveness of the four tumour necrosis factor (TNF)-α inhibitors adalimumab, etanercept, golimumab and infliximab in active, progressive psoriatic arthritis (PsA) where response to standard treatment has been inadequate. METHODS: A systematic review was conducted to identify relevant, recently published studies and the new trial data were synthesised, via a Bayesian network meta-analysis (NMA), to estimate the relative efficacy of the TNF-α inhibitors in terms of Psoriatic Arthritis Response Criteria (PsARC) response, Health Assessment Questionnaire (HAQ) scores and Psoriasis Area and Severity Index (PASI). A previously developed economic model was updated with the new meta-analysis results and current cost data. The model was adapted to delineate patients by PASI 50%, 75% and 90% response rates to differentiate between psoriasis outcomes. RESULTS: All four licensed TNF-α inhibitors were significantly more effective than placebo in achieving PsARC response in patients with active PsA. Adalimumab, etanercept and infliximab were significantly more effective than placebo in improving HAQ scores in patients who had achieved a PsARC response and in improving HAQ scores in PsARC non-responders. In an analysis using 1,000 model simulations, on average etanercept was the most cost-effective treatment and, at the National Institute for Health and Care Excellence willingness-to-pay threshold of between £20,000 to £30,000, etanercept is the preferred option. CONCLUSIONS: The economic analysis agrees with the conclusions from the previous models, in that biologics are shown to be cost-effective for treating patients with active PsA compared with the conventional management strategy. In particular, etanercept is cost-effective compared with the other biologic treatments.

Can biologic therapies be withdrawn or tapered in psoriatic arthritis?

There is a paucity of data on tapering and withdrawing therapy in psoriatic arthritis but advances in treatment and outcome measures suggest it is now time to be looking more closely at this. Several highly effective therapies are available providing the opportunity to achieve low disease activity. However, these therapies are associated with a marked increase in direct costs and patients are exposed to potentially life threatening adverse events. In addition to effective therapies the science of outcome assessment means that there are now suitable validated criteria for low disease activity which will allow both treat-to-target and a suitable measure of continuing low disease. Given these conditions, suitably designed randomized controlled trials of treatment withdrawal are now needed. Such studies will allow us to determine disease characteristics predictive of flare upon treatment withdrawal. In this way identifying which patients can successfully stop therapy will allow a more personalized approach to treatment decisions in PsA and will minimise risks and costs associated with ongoing therapy.

Magnetic resonance imaging assessment of axial psoriatic arthritis: extent of disease relates to HLA-B27.

OBJECTIVE: To determine the prevalence, on magnetic resonance imaging (MRI), of bone marrow edema lesions in symptomatic axial psoriatic arthritis (PsA), and to compare this prevalence with that in nonradiographic axial spondyloarthritis (SpA) and ankylosing spondylitis (AS) and its relationship to HLA-B27 status. METHODS: We performed a cross-sectional audit of MRI scans of lumbar spine (L-spine) and sacroiliac (SI) joints. Using the semiquantitative Leeds Scoring System in which bone marrow edema is graded from 0 to 3 according to severity of the lesions, MRI scans were scored independently by 2 expert readers who were blinded to the clinical characteristics of the patients. Concordant data from the 2 readers were used to report on definite lesions. RESULTS: MRIs from 76 patients with comparable age ranges were categorized into 3 groups: those from PsA patients, those from patients with nonradiographic axial SpA, and those from AS patients. HLA-B27 positivity was similar in PsA patients (10 of 33) and patients with nonradiographic axial SpA (10 of 24) and higher in AS patients (18 of 19). Total MRI scores (L-spine plus SI joints) were higher in AS patients than in PsA patients (P = 0.025) or in patients with nonradiographic axial SpA (P = 0.007). A relationship was seen between the severity and extent of disease and HLA-B27 positivity in PsA patients, which was comparable to that in AS patients. HLA-B27-negative PsA patients had lower MRI scores than HLA-B27-positive PsA patients (P = 0.03) and AS patients (P = 0.006), whereas scores were similar in HLA-B27-positive PsA patients and AS patients. Similarly, MRI scores of HLA-B27-negative patients with nonradiographic axial SpA were lower than those of AS patients (P = 0.01). CONCLUSION: HLA-B27 positivity defines a group of patients with more severe axial bone marrow edema that is likely related to the classic AS phenotype. Clinically, HLA-B27-negative PsA is more likely to be reported as a "negative" MRI examination result.

Etanercept in psoriatic arthritis.

In this update on etanercept (ETN) in psoriatic arthritis (PsA) we analyze this drug's mechanism of action, clinical efficacy/effectiveness, optimal dosage, disease-modifying antirheumatic drugs (DMARD) association, radiological progression, safety, switching aspects, and pharmacoeconomy. The efficacy/effectiveness of ETN in PsA has been demonstrated in randomized placebo-controlled trials as well as in observational studies representing routine clinical practice. At 1 and 2 years, ETN inhibited radiographic disease progression, assessed by the modified total Sharp score. ETN (generally at a dosage of 50 mg/weekly) can be used either in monotherapy or in combination with DMARD such as methotrexate. A systematic search of randomized, placebo-controlled trials of ETN to treat adults with plaque psoriasis or PsA suggests that the short-term risk/benefit ratio is favorable. Longterm studies, such as observational studies, confirmed this safety profile of ETN. A variable percentage of patients withdrew anti-tumor necrosis factor-α (TNF-α) inhibitor treatment owing to inefficacy or poor tolerability. Observational studies showed that in the case of treatment failure with 1 agent, switching to the other agent may also be useful in patients with PsA because of the different molecular structures and targets of available TNF-α blockers. The clinical effect of ETN is associated with favorable pharmacoeconomic considerations.