Therapeutic strategies utilization and resource consumption in patients treated for psoriatic arthritis: findings from a real-world analysis in an Italian setting.

PURPOSE: The purpose of this study was to analyze the therapeutic strategies and estimate the health care resource consumption in patients with psoriatic arthritis (PsA). PATIENTS AND METHODS: An observational retrospective cohort analysis of administrative databases of six Italian Local Health Units was performed. Patients ≥18 years with a hospitalization discharge diagnosis of PsA (International Classification of Diseases, Ninth Revision code: 696.0) or exemption code (045.696.0) for PsA from January 1, 2010 to December 31, 2015 (inclusion period), with at least one prescription of any therapy used for PsA were included. The index date (ID) was the first date matching with at least one of the inclusion criteria during the inclusion period. All patients were followed up after the ID until the end of data availability. Baseline C-reactive protein (CRP) levels (±6 months in relation to the ID) were also analyzed. RESULTS: A total of 2,408 (prevalence 0.83 per 1,000) patients with PsA (male 52%; median age 54 years) were included in the study; patients were already treated for PsA in 42.4% of cases. At 1 year of follow-up, 73% of the patients received one systemic drug, while 22% of patients received two systemic drugs; in addition, our results show an increase in the number of add-on or switches in a longer follow-up period. The utilization of biologic agents was higher among patients with previous PsA treatment, showing a progression of the pathology. Overall, a medium/high level of CRP at baseline was observed among more than half of the overall sample, with slight changes across subgroups in analysis. The average health care costs were €1,966.4 and €13,914 per year for patients treated with conventional systemic therapy and biological agents, respectively. CONCLUSION: A better knowledge of prescription therapeutic scheme and economic burden of PsA could stimulate the rational development of health programs aimed at potentiating services for its management.

Classification and clinical assessment.

There are at least nine classification criteria for psoriatic arthritis (PsA) that have been proposed and used in clinical studies. With the exception of the ESSG and Bennett rules, all of the other criteria sets have a good performance in identifying PsA patients. As the CASPAR criteria are based on a robust study methodology, they are considered the current reference standard. However, if there seems to be no doubt that they are very good to classify PsA patients (very high specificity), they might be not sensitive enough to diagnose patients with unknown early PsA. The vast clinical heterogeneity of PsA makes its assessment very challenging. Peripheral joint involvement is measured by 78/76 joint counts, spine involvement by the instruments used for ankylosing spondylitis (AS), dactylitis by involved digit count or by the Leeds dactylitis index, enthesitis by the number of affected entheses (several indices available) and psoriasis by the Psoriasis Area and Severity Index (PASI). Peripheral joint damage can be assessed by a modified van der Heijde-Sharp scoring system and axial damage by the methods used for AS or by the Psoriatic Arthritis Spondylitis Radiology Index (PASRI). As in other arthritides, global evaluation of disease activity and severity by patient and physician and assessment of disability and quality of life are widely used. Finally, composite indices that capture several clinical manifestations of PsA have been proposed and a new instrument, the Psoriatic ARthritis Disease Activity Score (PASDAS), is currently being developed.

The psoriatic arthritis cost evaluation study: a cost-of-illness study on tumour necrosis factor inhibitors in psoriatic arthritis patients with inadequate response to conventional therapy.

OBJECTIVE: To evaluate costs, benefits and cost-effectiveness of anti-TNF agents in PsA patients with inadequate response to conventional treatment. METHODS: A total of 107 patients, from nine Italian rheumatology centres, with different forms of PsA were given anti-TNF treatment, mainly etanercept (87%). Information on resource use, health-related quality of life, disease activity, function and laboratory values were collected at baseline and through out the 12 months of therapy. Cost (expressed in euro 2007) and utility (measured by EuroQol) before and after anti-TNF therapy initiation were compared in order to estimate the incremental cost per quality-adjusted life year (QALY) gained, and cost-effectiveness acceptability curve was calculated. RESULTS: At the end of 12 months, there was a significant increase in direct cost due to an increase of drug cost caused by TNF inhibitors that was only partially offset by the decrease in indirect cost. In the last 6 months of therapy, the direct cost increased by euro5052, the cost for the National Health System (NHS) by euro5044 and the social cost by euro4638. However, a gain of 0.12 QALY resulted in a cost per QALY gained of euro40 876 for the NHS and of euro37 591 for the society. The acceptability curve showed that there would be a 97% likelihood that anti-TNF therapy would be considered cost-effective at willingness-to-pay threshold of euro60 000 per QALY gained. CONCLUSION: Cost-effectiveness ratios are within the commonly accepted willingness-to-pay threshold. These results need to be confirmed in larger samples of patients.

Retrocalcaneal bursitis in spondyloarthropathy: assessment by ultrasonography and magnetic resonance imaging.

OBJECTIVE: To establish by magnetic resonance imaging (MRI) and ultrasonography (US) the frequency of retrocalcaneal bursa involvement in Achilles enthesitis of spondyloarthropathy (SpA) and to compare the results of the 2 examinations. METHODS: Nineteen Achilles tendons with severe enthesitis and 9 normal tendons of 14 patients meeting the Amor criteria for SpA were examined by MRI and US. RESULTS: Both MRI and US showed a significant increase in the mean Achilles tendon thickness in the pathologic legs compared to the normal legs both at the superior calcaneal surface and 3 cm above. MRI showed retrocalcaneal bursitis in 14 (73.7%) of 19 pathologic legs and superficial bursitis in 2 (10.5%). US showed fluid collection only in 7 of 14 retrocalcaneal bursae positive on MRI, and failed to show fluid in the 2 superficial bursae involved. Using MRI as the gold standard, US showed 50% sensitivity and 100% specificity for retrocalcaneal bursa involvement and lacked sensitivity for superficial bursitis. CONCLUSION: Achilles tendon involvement in SpA is not only a disease of the enthesis but also of the adjacent bursae.

Diagnostic and classification criteria, clinical and functional assessment, and therapeutic advances for spondyloarthropathies.

Two sets of criteria have been proposed and widely accepted in the last few years for the classification of the whole spectrum of spondyloarthropathy, including the undifferentiated forms. These classification criteria--the Amor criteria and the European Spondyloarthropathy Study Group criteria--are not, however, particularly helpful for diagnosis because they do not include the milder and monosymptomatic forms. Outcomes research in spondyloarthritis is growing, and new instruments have been suggested. An international study group of experts is working to propose a core set of measures to be included in future clinical trials on ankylosing spondylitis. Intrasynovial corticosteroid injections in the sacroiliac joints may represent a valid alternative for patients with inflammatory low back pain that is unresponsive to nonsteroidal anti-inflammatory drugs. Sulfasalazine is an effective therapy for the psoriatic arthritis and peripheral arthritis of ankylosing spondylitis. A recent study has suggested its efficacy in reactive arthritis as well. In reactive arthritis, the use of long-term antibiotic therapy has been proposed and is under study.